1 DEPARTMENT OF
HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
PUBLIC MEETING ON IMPLEMENTING
THE PEARSON COURT DECISION AND OTHER
HEALTH CLAIM ISSUES
Tuesday, April 4, 2000 9:04 a.m.
Department of Education Auditorium 400 Maryland Avenue, S.W.
FDA PANEL MEMBERS:
Joseph A. Levitt, Director, Center for Food Safety and
Christine Lewis, Director, Office of Nutritional
Products, Labeling, & Dietary Supplements
Michael M. Landa, Deputy Chief Counsel
Margaret Dotzel, Acting Associate Commissioner for
Rachel E. Behrman, Deputy Director, Office of Medical
Policy, Center for Drug Evaluation and Research
A G E N D A
Opening Remarks and Key Issues
Joseph A. Levitt, Director, Center
for Food Safety and Applied Nutrition 5
Panel I - Should health claims be allowed on
dietary supplements on a basis other than significant
scientific agreement? If so, what should that basis be and
what are appropriate criteria for making decisions about
allowing such claims?
Jonathan W. Emord, Emord & Associates 19
Bruce Silverglade, Center for Science
in the Public Interest 26
Bruce Chassy, University of Illinois 34
John Hathcock, Council for Responsible
Alice Lichtenstein, Tufts University 47
FDA Panel Discussion 56
Panel II - If such health claims on dietary
supplements are to be appropriately qualified so that
consumers are not misled, what should be the
characteristics of such qualifying language? Should FDA
require any other information to assist consumers in
health claims and prevent them from being misled?
Mario Teisl, University of Maine 90
Michelle Rusk, Federal Trade Commission 98
Scott Bass, National Nutritional Foods
James S. Turner, Citizens for Health 111
Brett Kay, National Consumers League 118
FDA Panel Discussion 124
Panel III - Should health claims go beyond claims
about reducing the risk of a disease to
include claims about mitigation or treatment of an existing
disease, or are such claims drug claims? Where is the boundary,
if any, between these claims?
Introduction - Christine Lewis 147
Claudia A. Lewis-Eng, Emord & Associates 151
H. Logan Holtgrewe, American Urological
William Soller, Consumer Healthcare
Products Association 163
Marsha Cohen, Hastings College of
the Law University of California 169
Regina Hildewine, National Food
Processors Association 177
FDA Panel Discussion 185
Norman Singleton, Legislative Aid to
Congressman Ron Paul 209
Stacey A. Zawel, Grocery Manufacturers
of America 212
John C. Hammell, International Advocates
for Health Freedom 215
Richard Hanneman, Salt Institute 220
Ben Lieberman, Competitive Enterprise
Mark S. Ullman, Ullman, Shapiro & Ullman 229
Candace Campbell, American Preventive
Medical Association 233
Stephen McCurry, Dietary Ingredient
Andrew Baer, The Life Extension Foundation 239
Joy A. Peletier, Pure Encapsulations,
Julian Whitaker, Physician 248
Alyce Ortuzar, Well-Mind Association
of Greater Washington 252
Charles B. Simone, Simone Protective
Cancer Institute 255
1 P R O C E E D I N G S
2 OPENING REMARKS AND KEY ISSUES
3 MR. LEVITT: Good morning. I might get people's
4 attention. Since we'll all want to end on time, I think
5 it's important we try to start on time, as well.
6 Let me begin by welcoming you. My name is Joe
7 Levitt. I'm director of FDA's Center for Food Safety and
8 Applied Nutrition and I will be the host for today's
10 What we would like to do is begin with a short
11 overview and background context to put today's discussions
12 in context, and then I'll go through what logistics of the
13 meeting would be.
14 As I think everybody knows, the subject of today's
15 meeting is to talk about the FDA's implementation of a court
16 decision, the name of it being called Pearson v. Shalala.
17 We also want, at the same time, to deal with claims about
18 mitigation or treatment of disease. Both of these deal with
19 the issue of health claims involving dietary supplements.
20 While the court case and preceding rule-makings
21 have a long history over the last decade, the recent
22 chronology may simply be summarized as follows. In January
23 of 1998, the District Court ruled in favor of the
24 government's position. The plaintiffs then appealed to the
25 Court of Appeals. About a year later, the Court of Appeals
1 reversed the District Court's decision and ruled in favor of
2 Pearson. The government asked for a rehearing in the Court
3 of Appeals. The rehearing was granted but the result was to
4 again deny the government's petition. And that takes us to
5 where we are.
6 There was some ensuing time for consideration of
7 review by the Supreme Court. That was not exercised and so
8 we have this decision to implement.
9 The decision has five basic elements that we need
10 to understand. Number one, the FDA is instructed by the
11 court to reconsider whether to authorize the four health
12 claims at issue. Second, in the absence of significant
13 scientific agreement, the FDA must determine if the
14 scientific evidence in support of the four claims--and these
15 will be done individually--if the scientific evidence in
16 support of the claim outweighs the scientific evidence
17 against the claim. So there's a threshold scientific
19 If so, number three, the FDA must consider whether
20 the disclaimer or other qualifying language could make the
21 health claim nonmisleading to consumers. And finally, the
22 FDA was also instructed to clarify the significant
23 scientific agreement standard for authorizing health claims.
24 FDA has set about to implement this decision in an
25 orderly fashion as follows. Number one, we have within our
1 center our annual program priorities document, which
2 essentially is the center's work plan. We updated that plan
3 in July of last year and among the few updates that we added
4 was the importance of the implementing of the Pearson v.
5 Shalala decision. So that was what we call our A list item,
6 one of our A list items, something we need to devote our
7 highest level of energies to.
8 Number two, in August with respect to the four
9 particular claims at issue, we issued a contract for a
10 literature review. The claims had last been reviewed in the
11 early part of the 1990s following the passage of NLEA and we
12 wanted to be sure that we had an up-to-date version of what
13 the scientific literature was with respect to each of the
14 four claims.
15 In September we published a Federal Register
16 notice soliciting scientific data on the four claims for
17 members of the public, to complement what the contractor was
18 doing for us. We also wanted any interested parties again
19 to send us what the updated information is.
20 In December we published our Federal Register
21 notice on what we said was our strategy for implementing the
22 court's decision, which had been our goal for the previous
23 summer, to arrive at an overall strategy or a blueprint for
24 how we're going to proceed.
25 That strategy, in and of itself, had five points.
1 The first was that we would update the significant
2 scientific evidence on the four claims, and you've already
3 seen me speak to that in terms of the contract review and
4 the solicitation of public comments for that. Two, we would
5 issue a guidance clarifying the significant scientific
6 agreement standard. That was a portion from the court
7 decision dealing with clarifying what FDA meant by that.
8 Third, that we would hold a public meeting to
9 solicit input on changes to the general health claim
10 regulation. So looking beyond the four claims in general,
11 to what extent should FDA be reconsidering the general
12 health claims regulation we have with respect to dietary
13 supplements, in light of the Pearson decision. That's the
14 meeting that we're all at today.
15 Four, that FDA would be conducting a rule-making
16 to reconsider the general health claim regulations for
17 dietary supplements in light of the Pearson decision. So
18 that will be one of our important next steps following this
20 And finally, we know that we need to go
21 individually for each of the four claims involved in the
22 Pearson decision and conduct rulemaking specifically for
23 each of those, as instructed by the court.
24 So that's what we set out in December as far as
25 our blueprint and how we're going to proceed ahead in an
1 orderly fashion. We then picked up right from there and
2 later that month we did issue guidance on the significant
3 scientific agreement standard for the review of health
4 claims. That came out just before Christmas and is
5 available on our web page.
6 In January, at the request of the plaintiffs in
7 the litigation, we extended the comment period on the
8 Federal Register notice soliciting information until April
9 3, which was yesterday. The reason for that was they wanted
10 to be sure that they could make a submission on the four
11 claims in light of what that significant scientific
12 agreement standard document said. That made perfect sense
13 to us and so we agreed and extended the comment period. As
14 I said, it was just closed yesterday, timely in nature of
15 today's meeting.
16 We followed through in January and in our various
17 planning documents, both our long-term strategy plan, as
18 well as our 2000 priorities, continued to include
19 implementation of the Pearson decision as a high priority
21 And today, in April, we have convened a public
22 meeting to solicit public comments on changes to the general
23 health claim regulations for dietary supplements in light of
24 the Pearson decision.
25 So that is how we have gone about trying to
1 approach this court decision in the area that an many ways
2 is novel and challenging for all of us.
3 In the Federal Register notice announcing this
4 meeting, we listed a long series of questions. In order to
5 then take that and try to reframe that in a way that could
6 help us deal more specifically with a large discussion in
7 front of today's group, we have divided the day into three
8 general question areas and we'll have one panel addressing
9 each of those three areas separately.
10 The first question is, and these questions are on
11 your agenda in your packet today, the yellow piece of paper
12 that I see some of you have in front of you--the first
13 question says: Should health claims be allowed on dietary
14 supplements on a basis other than significant scientific
15 agreement? If so, what should that basis be and what are
16 the appropriate criteria for making decisions about allowing
17 such claims?
18 That essentially is the standard of evidence
19 question. What does it mean when the court says there is
20 more evidence for than against the claim?
21 Second is: If such health claims on dietary
22 supplements are to be appropriately qualified so the
23 consumers are not misled, what should be the characteristics
24 of such qualifying language? Should FDA require any other
25 information to assist consumers in evaluating health claims
1 and prevent them from being misled? So this becomes more of
2 a how-to. If we've met the scientific threshold that the
3 evidence in support of it is more than against, what is the
4 nature of the disclaimer or qualifying language that should
5 be used? And we'll have a separate panel devoted to that
7 And third, while it is not an outgrowth of the
8 Pearson decision itself, it involves many of the same
9 parties and it also involves the issue of dietary
10 supplements and health claims, and that is a question of:
11 Should health claims go beyond claims about reducing the
12 risk of the disease to also include claims about mitigation
13 or treatment of an existing disease? Or are such claims
14 drug claims? Where is the boundary, if any, between these
16 That will be the third panel. That's the result
17 of a health claim petition we got with respect to Saw
18 Palmetto and the treatment of BPH and we'll have a separate
19 intro for that when we get to that panel this afternoon. So
20 for now I will just put that aside and focus back on the
21 first two Pearson questions that I've already gone through.
22 Now in terms of logistically how we're going to
23 proceed through the day, number one is we will, on each of
24 those three questions, have a panel presentation. These are
25 people that have been invited to the FDA who are known to
1 have an interest and who are known to represent a spectrum
2 of different views. We want to be sure that all different
3 views are appropriately heard today.
4 Each of those speakers will be given 10 minutes to
5 make their presentations. When you get here, you'll find
6 logistically if you can possibly do it sitting at the table,
7 it will make it easier than people jumping up and down, and
8 I would encourage the speakers to start thinking now in
9 terms of that. We're kind of crowded up here. It's okay
10 when there's one of me.
11 Third is that following the three panels--sorry.
12 What will happen with each panel is there will be the five
13 presentations, four or five, depending on how many people
14 there are, and then the FDA panel, which I'll introduce in a
15 moment, will ask questions.
16 FDA is very much in a listening mode. Our
17 questions will be designed to elicit information from the
18 speakers, elicit potential differences between the different
19 speakers. We'll allow the speakers to respond to each other
20 during that phase. We have done this several other times, I
21 think, pretty successfully in terms of fostering a
22 discussion among the people out here.
23 I kind of consider this kind of meeting, if you
24 will, to be a discussion between a small group in front of a
25 larger group. But it tends to work if we can get a
1 discussion among the people and between the FDA folks.
2 There only are a few instances where the FDA gets
3 to hold a meeting and not have to answer questions itself.
4 This is one of those few times. So we will refrain from
5 responding but we'll try, as I said, to be very much in a
6 listening mode and in a probing mode to try to bring out all
7 the important information.
8 Following the three speakers, there will be an
9 opportunity for individuals who asked to present and you all
10 will be given, if you've not already in your package, you
11 will have a number, so we'll simply go in order from your
12 numbers and everybody at that point will have five minutes.
13 So to the extent people are already in the audience, I would
14 really urge you to keep your presentations to five minutes.
15 We've done this again on other occasions and it is very
16 capable of happening. And out of respect for your other
17 colleagues who also have to present, we do need to be out of
18 the room on time.
19 Finally, I believe we're having a transcript made.
20 I want to verify that with somebody in the audience who's
21 going to nod their head. Is there a transcript being made
22 of this proceeding?
23 Yes, there is a transcript being made of this
24 proceeding. Good, it's up there. So there will be a full
25 record of everything that is said here. In light of that, I
1 would ask for there not to be any other recording devices in
2 the room. We are making the transcript and that will be
3 available and we'll make that through our web page, and so
5 Finally, there are some words on logistics I need
6 to get to. Some of these I have probably covered, so just
7 give me a moment.
8 Outside at the table, for those that did not see
9 it, there are a couple of notebooks that have some of the
10 background materials if anybody wants to refer to them in
11 terms of the guidance on significant scientific agreement, a
12 copy of the court decision in Pearson, our Pearson
13 implementation notice, the structure/function final rule,
14 information on how to access comments to the docket, and
15 statements or testimonies of other speakers and presenters.
16 We don't have copies for everybody but we do have some table
17 copies if people want to refer to that during one of the
19 Ah, important information. Bathrooms. The
20 women's bathroom is on the C Street side of the auditorium,
21 which I believe means it's over there, the way you came in,
22 down towards the end by the public doors. The men's room is
23 on the Maryland Avenue side, which means you just have to
24 kind of go and turn left there and it's right by the
25 entrance to the cafeteria, as the plumbing goes, on the
1 other side of the plumbing. So if you find the ladies room,
2 you'll be able to follow around and find the men's room on
3 the other side.
4 Security--this is a government facility. People
5 are aware of the security when you come in. Each time you
6 go in and out of the building you will need to go through
7 that again, as all of us do. If you have a visitor's pass,
8 please hold onto that because you'll need that to get back
9 in or you'll have to go through that process again. So
10 please hold onto your visitor's badge and your ticket,
11 especially if you're leaving the building.
12 Finally, just before lunch I'll try to remind
13 everybody about the facilities that do exist for eating
14 lunch. There is a cafeteria in this building. There are a
15 number of places you can easily walk to outside of the
16 building and we will try and remind you of that just before
18 Finally, as a courtesy to everyone if you would
19 please, everyone, if you have cellphones, if you have pages,
20 if you could kindly turn them off. You will be relieved
21 from hearing from everybody and we will be relieved, also.
22 As you know, it is a distraction to hear those things going
23 off through the day.
24 If you have brought a copy of your comments or
25 speech, please leave a copy at the registration desk so we
1 have a copy of that.
2 And finally, I have one correction, which is we
3 issued a Federal Register notice that told everybody there
4 would be provision for written comments. I jumped over
5 that. When we were up there you saw the four things; it
6 said written comments. We do welcome written comments
7 following this meeting. The Federal Register notice states
8 that the time period for that is essentially two weeks,
9 which would close on April 19.
10 Now I highlight that for two reasons. One is that
11 we sent out an advance letter notifying people of this
12 meeting and in that letter we mistakenly said that the
13 written comment period would be open for a full month. We
14 decided to shorten it for 15 days in light of the fact that
15 this matter is a subject of ongoing litigation and we want
16 to get on with proceeding. However, I also tell people if
17 you just can't get your comments in within that 15 days,
18 FDA has a general policy of accepting comments up until
19 we've actually made decisions. But really we urge people,
20 if at all possible, to try and make it within that two-week
22 Finally, I just want to reiterate that I think
23 everybody here--and look around the room; there's a lot of
24 people that came to this meeting--there's a lot of interest
25 in this meeting. Today you will hear a lot of different
1 views. You will not hear too many views that agree with
2 each other. You'll hear a lot of views that disagree with
3 other people's views. That is the nature of the subject.
4 That is perfectly permissible.
5 The one thing I ask is that the deal I always make
6 at these meetings, I say we at the FDA will listen to
7 everybody if, in turn, you'll listen to each other. That, I
8 think, is a fair deal and that everybody be respectful of
9 everybody else's comments and maintain an appropriate
10 decorum in the room through the meeting.
11 With that, I look forward to what we are about to
12 undertake today. This is, I think, an important area for
13 many interested groups. And with that, I will, I think,
14 begin by welcoming the FDA panel to the stage. In doing
15 that, the others will see, I guess, to get up here you've
16 got to walk up and around the edge. But as we're welcoming
17 the FDA panel up, I'll let them take their seats and I'll
18 introduce them and then I'll move over there, also.
19 Speakers note the delicacy with which one enters
20 the chairs, since it looks like they touch each other. So a
21 deep breath is also appropriate.
22 As people are taking their seats, I'll be sitting
23 on the end, so I've already introduced myself. To my
24 immediate right is Christine Lewis, who is the new director
25 of our Office of Nutritional Products, Labeling and Dietary
1 Supplements in the Center for Food Safety and Applied
3 Sitting to her right is Michael Landa, who is now
4 the deputy chief counsel in the Office of Chief Counsel.
5 Mike has recently returned to FDA after a long career first
6 in FDA and then out in private practice. We're delighted to
7 have Mike back.
8 Next is Peggy Dotzel, who is the Acting Associate
9 Commissioner for Policy in the office of the Commissioner.
10 And finally, next to her is Dr. Rachel Behrman, who is from
11 the Center for Drug Evaluation and Research. I think many
12 of you know that in many of these areas, the two centers are
13 working collaboratively. We recently had a meeting just
14 last week dealing with structure/function claims and
15 pregnancy claim issues and at that case, the Center for Drug
16 Evaluation had the lead and we were there in the supporting
17 role, so we are trying to work together on a number of
19 With that, if you'll just give me one moment to
20 take my seat, I think they're going to do something with the
21 podium and we'll invite the first panel up there. Again
22 thank you very much for your attention and for your
23 participation in this meeting throughout the day.
24 PANEL I
25 MR. LEVITT: Okay, if we could welcome the first
1 panel up? We've tried to make life easy for you by putting
2 your name tag where you sit and by putting them in the order
3 so we'll be able to go right down the table.
4 First is Jonathan Emord from Emord & Associates.
5 Then Bruce Silverglade, Center for Science in the Public
6 Interest. Bruce Chassy, University of Illinois. John
7 Hathcock, Council for Responsible Nutrition. And Alice
8 Lichtenstein from Tufts University.
9 I won't make the mistake of asking if everybody's
10 comfortable. I will ask if everybody feels that you're at
11 least situated in a way that you can participate.
12 All right. What we will do then, if we could ask
13 the microphone to be moved down to Mr. Emord. We have, I
14 guess, two microphones for five people.
15 The only thing I'll point out to the speakers is
16 the timer is actually sitting right in the middle, in front
17 of Bruce Chassy there. It has a 10-minute timer associated
18 with it. There is maybe a yellow light that goes on with
19 three minutes left. If you see that, that's what it means.
20 If not, the red light will go on after 10 minutes and if you
21 see that, I would ask that you try to summarize, in fairness
22 to the other speakers and getting going today.
23 With that, Mr. John Emord, if you would begin.
24 JONATHAN W. EMORD, EMORD & ASSOCIATES
25 MR. EMORD: Thank you very much.
1 The questions posed to the panel are, in fact,
2 legal issues that have already been resolved in a final and
3 binding order of an authority higher than this agency, the
4 United States Court of Appeals for the D.C. Circuit, in the
5 case of Pearson versus Shalala. The questions are thus res
6 judicata. They have been judicially acted upon and decided.
7 They're settled by the judgment of the court.
8 It is thus not the time to ask these questions.
9 It is, rather, long past the time for the agency to comply
10 with the court's order.
11 In Pearson versus Shalala, the United States Court
12 of Appeals held unconstitutional under the First Amendment
13 the four FDA rules that suppressed four separate health
14 claims my clients wish to make. The court's decision
15 invalidated the agency's rules. As a matter of law, the
16 rules are of no legal force or effect. Yet FDA continues to
17 enforce them.
18 The court's mandate to implement its decision
19 issued to this agency on April 20, 1999. Upon receipt of
20 the mandate, FDA's duty was clear. It had to discontinue
21 enforcement of the invalidated rules immediately and it had
22 to allow my client's claims to be made with dispatch.
23 In flagrant defiance of the court's order, this
24 agency, over 11 months later, still enforces all four of the
25 constitutionally invalid rules. Moreover, it has adopted a
1 cumbersome, extensive and protracted series of regulatory
2 steps that it intends to take before finally addressing the
3 court's constitutional mandate. Those steps appear
4 calculated to postpone FDA compliance with the court's order
5 for years. FDA is thus engaged in a pattern of delay and
6 denial of its constitutional duties.
7 This past Friday my firm filed an application for
8 preliminary injunction with the United States Court of
9 Appeals to stop the agency from continuing to enforce the
10 four invalid rules. FDA's continued enforcement of those
11 rules is an act of contempt in the face of a final and
12 binding order. It is an act that challenges the supremacy
13 of the Constitution over contrary agency laws. It is an act
14 taken by officers of this agency, who have sworn oaths to
15 support and defend the Constitution. It violates those
17 To be sure, FDA is not above the law. It is
18 certainly not above the Constitution. The Constitution is
19 the supreme law and FDA must obey it. FDA should take heed
20 and immediately, this very day, discontinue enforcement of
21 the invalidated rules. It should authorize all four of the
22 plaintiffs' health claims with the disclaimer specified by
23 the court, at least on an interim basis. It may thereafter
24 proceed with its rulemaking to determine precisely how, if
25 at all, it should tailor those disclaimers. But it may not,
1 consistent with the First Amendment, continue to suppress my
2 clients' protected speech, their health claims, for a moment
4 The Supreme Court has held violation of a First
5 Amendment right even for a very short period of time an
6 irreparable injury. See Elrod versus Burns, and I quote:
7 "The loss of First Amendment freedoms for even minimal
8 periods of time unquestionably constitutes irreparable
10 When First Amendment rights are violated, the
11 Supreme Court expects government to eliminate the violation
12 without delay. It considers delay intolerable. See Riley
13 versus National Federation of the Blind and I quote:
14 "Speakers cannot be made to wait for years before being able
15 to speak with a measure of security."
16 So then what are the Court of Appeals' legally
17 binding answers to the questions you pose? The Pearson
18 court held that FDA may not suppress health claims on the
19 basis that they do not satisfy its significant scientific
20 agreement standard, regardless of how FDA defines that
21 standard. In letters to me of October 5, 1999 and February
22 17, 2000, Director Levitt accepts this legal requirement.
23 Thus separate from FDA's health claims review
24 standard by which FDA officially authorizes and approves
25 claims under 21 U.S.C. Section 343(r) is the First
1 Amendment, by which it must allow even claims it does not
2 authorize and approve if those claims can be rendered
3 nonmisleading through the addition of a disclaimer. FDA may
4 not substitute a new scientific validity test for the First
5 Amendment standard articulated in the court's decision.
6 The Constitution is supreme law and the agency
7 must ensure protection for all lawful commercial speech, not
8 just a subset of that universe. The FDA must do so in
9 strict accordance with the standards articulated in the
10 Pearson decision itself.
11 Consistent with rules of statutory construction,
12 FDA may not construe its statutory obligation under 21
13 U.S.C. Section 343(r) as in conflict with the First
14 Amendment. See generally De Bartolo Corporation versus
15 Florida Gulf Coast Building and Construction Trades Council.
16 Rather, as the Pearson court explained, under the
17 statute, FDA must define a procedure and standard for
18 authorization and approval of health claims, but under the
19 First Amendment, even if a claim is not authorized and
20 approved by the agency, it must nevertheless be allowed to
21 be made so long as the addition of a disclaimer can render
22 the claim nonmisleading.
23 The purpose of the disclaimer is to inform
24 consumers of the lack of conclusive evidence for a claim and
25 of such other information as is necessary on a case by case
1 basis to avoid consumer misperception.
2 In light of the infinite variety of potential
3 nutrient disease claims, case by case evaluation is
4 unavoidable. The Pearson court held that inconclusive
5 health claims may not be suppressed by FDA unless they
6 convey no scientific information or unless they otherwise
7 cannot be rendered nonmisleading through the addition of a
8 disclaimer. Rather, FDA's remedy for inconclusive claims is
9 the addition of a disclaimer, making the inconclusiveness
10 clear to consumers.
11 The Pearson court squarely placed the burden upon
12 FDA to favor disclosure over suppression in every instance
13 where a disclaimer can eliminate a misleading connotation.
14 Thus, for example, if a claim accurately conveys a nutrient
15 disease association, FDA must allow it, even if the agency
16 believes the evidence preliminary, unless FDA also
17 reasonably finds no disclaimer capable of eliminating a
18 misleading connotation.
19 The First Amendment makes FDA, like every other
20 government agency that censors speech, need a high threshold
21 burden of proof to justify claim suppression, proof that a
22 claim cannot be rendered nonmisleading through the use of a
23 disclaimer. The general rule is disclosure of information.
24 That is the constitutionally preferred means for overcoming
25 misperceptions in the market.
1 Turning to the four claims at issue in Pearson,
2 this agency should note well that the court found all of the
3 claims, at worst, only potentially misleading. The court
4 wrote specific disclaimers for each of the claims, to cure
5 that potential. The court explained that FDA could avoid
6 the erroneous public view that the agency had authorized the
7 claims by including an additional disclaimer; to wit, "FDA
8 does not approve this claim."
9 Given the Pearson court's constitutional order to
10 this agency, FDA must immediately discontinue enforcement of
11 the four invalidated rules and must, until it ultimately
12 decides the precise language it prefers for the disclaimers,
13 authorize on an interim basis all four Pearson claims with
14 the disclaimers the court has recommended.
15 Pearson tells this agency that its legacy of
16 suppression must come to an end, that it must henceforth
17 favor disclosure over suppression as the rule, not the
18 exception, that it may not use its health claims review
19 standard as a barrier to the communication of any claim that
20 can be rendered nonmisleading through the addition of a
21 disclaimer, and that the court will view as dubious any
22 agency justification for suppression that is based on the
23 alleged benefits of public ignorance.
24 Consumers can make choices they perceive in their
25 own best interest if well enough informed. It is the
1 constitutional duty of this agency to ensure that they are
2 so informed and to favor disclosure over suppression as its
3 standard practice. Thank you.
4 MR. LEVITT: Thank you very much.
5 If we could pass the microphone over to Mr. Bruce
6 Silverglade from Center for Science in the Public Interest
7 and if we could reset the timer.
8 BRUCE SILVERGLADE
9 CENTER FOR SCIENCE IN THE PUBLIC INTEREST
10 MR. SILVERGLADE: I'm going to wait till that
11 timer's reset.
12 Well, as you stated, there is going to be some
13 disagreement on the panel and perhaps not surprisingly, we
14 have a different reading of the court's decision.
15 The U.S. Court of Appeals held in Pearson versus
16 Shalala that based on the administrative record before it,
17 the Food and Drug Administration must consider whether the
18 use of a disclaimer would eliminate the potential for
19 deception before the agency decides to prohibit health
20 claims not supported by significant scientific agreement.
21 So I think we have a basic disagreement right now because we
22 believe the court's decision should be read as just
23 requiring the FDA to consider whether the use of a
24 disclaimer would eliminate the potential for deception, not
25 require it in all cases.
1 Moreover, the court created at least three major
2 exceptions to its overall holding and discussed the
3 situations in which disclaimers would not be sufficient to
4 prevent consumer deception and need not be considered by the
5 FDA as a possible course of action. These include
6 situations in which first, permitting a health claim not
7 supported by significant scientific agreement would threaten
8 consumer health; second, where scientific evidence
9 supporting a health claim is outweighed by evidence that is
10 qualitatively or quantitatively superior; and third, where
11 empirical evidence demonstrates that a disclaimer is
12 insufficient to protect consumers from deception.
13 These exceptions to the court's primary holding
14 significantly limit the number and types of health claims
15 that can be made in the absence of significant scientific
16 agreement. And today I am releasing a letter from 15
17 national public health medical and consumer organizations to
18 the FDA that urges the agency to fully implement this
19 portion of the court's decision. And since the letter is
20 addressed to Mr. Levitt, I thought I'd pass it down, pass it
21 over at this point.
22 The organizations urging the FDA to follow the
23 course it has taken in this area include the American
24 Association of Family and Consumer Services, the American
25 Association of Retired Persons, the American Cancer Society,
1 the American College of Preventive Medicine, the American
2 Dietetic Association, the American Heart Association, the
3 American Institute for Cancer Research, the American Public
4 Health Association, the American Society for Nutritional
5 Sciences, Consumer Federation of America, the National
6 Consumers League, Society for Nutrition Education, and the
7 Association of American Medical Colleges.
8 Let me, in my remaining time, more fully elaborate
9 on the exceptions to the court's opinion that I have
10 outlined. First, the FDA is not obligated to consider using
11 the disclaimer approach when a preliminary health claim
12 raises health and safety concerns. It should be emphasized
13 that the court's overall holding was premised on the basis
14 that supplements at issue in the case do not "in any fashion
15 threaten consumers' health and safety." I'm quoting the
17 However, since the court's opinion there's been a
18 steady stream of reports concerning the hazards of dietary
19 supplements. The Washington Post, for example--I'm sure
20 those in the audience who live in the Washington area saw
21 this article a couple of weeks ago--ran a front page story
22 that proclaimed "Herbal products boom take human toll."
23 So the government apparently did a poor job of
24 bringing this type of information to the court's attention
25 and the court simplistically assumed that supplements in
1 general pose no health hazard.
2 In light of this naive assumption, the relevance
3 of the court's primary holding is quite limited. As the
4 court noted, kind of as an afterthought, "The government may
5 have more leeway in choosing suppression over disclosure as
6 a response to the problem of consumer confusion where the
7 products affect health," and again the mistake of the court
8 and the mistake of the government was not to bring this
9 evidence before the judiciary and the court again naively
10 assumed that all supplements are safe. That was really a
11 very unfortunate mistake.
12 Health claims for dietary supplements that are not
13 supported by significant scientific agreement can have an
14 adverse impact on health in several ways, so let me talk
15 about this in just slightly more detail.
16 First, health claims that are preliminary and
17 relate to essential bodily organs or serious health
18 conditions may certainly affect. And under the court's
19 opinion, the FDA need not and should not consider using the
20 disclaimer approach if a proposed claim not based on
21 significant scientific agreement pertains to such
23 So, for example, claims regarding the heart, lung,
24 brain and liver and claims regarding serious health
25 conditions, such as risk factors for cancer and heart
1 disease or conditions such as asthma, birth defects, HIV and
2 so forth, these are not the place to make preliminary health
3 claims with disclaimers and the court recognized that in
4 such situations where consumer health or safety is involved,
5 claims supported by preliminary scientific evidence would be
6 inappropriate, even if accompanied by a disclaimer. You
7 simply can't disclaim the core of the problem in that area.
8 And the court's holding on this point is well
9 grounded. I would note that in the 1990s beta carotene
10 supplements were being touted by the supplement industry as
11 substances that might reduce the risk of cancer.
12 Preliminary studies did demonstrate a promising link between
13 the consumption of beta carotene-rich foods and reduced risk
14 of cancer but later clinical studies showed strong evidence
15 of actually no benefit from beta carotene supplements and
16 indicated that the use of such products by smokers might
17 actually increase their risk of lung cancer.
18 So that situation we had with beta carotene really
19 shows the health risk involved with allowing preliminary
20 health claims, and this was recognized by the court,
21 although not the focal point of its decision.
22 Second, health can be affected when a preliminary
23 health claim would cause consumers to forego a proven
24 dietary or other therapy in favor of a supplement that may
25 or may not be beneficial. As the court recognized, the FDA
1 may choose to suppress claims not supported by significant
2 scientific agreement in situations where supplements affect
3 health and preliminary claims for supplements that may not
4 be beneficial can cause injury to consumers if they lead the
5 public to choose them over proven approaches to medical or
6 nutritional problems.
7 So thus, under the court's holding the FDA is not
8 obligated to permit preliminary health claims with a
9 disclaimer if the claim would lead consumers to rely on an
10 unproven supplement instead of a proven dietary or other
12 Third, the FDA need not consider using the
13 disclaimer approach when consumers, based on their own
14 observations, cannot determine whether a claim is true.
15 Consumers who rely on preliminary health claims and take
16 dietary supplements for conditions that are difficult to
17 self-diagnose have no way of knowing whether the products
18 are really working.
19 The use of a preliminary health claim not
20 supported by significant scientific agreement is
21 particularly dangerous in such cases because it may lead
22 consumers to rely on treatments that are not effective. And
23 the court's decision in Pearson does not require the FDA to
24 approve preliminary claims with a disclaimer if the health
25 and safety of consumers are threatened, as it would be in
2 Now, the second major exception to the court's
3 holding that I outlined earlier was that FDA is not
4 obligated to consider disclaimers when a claim is outweighed
5 either quantitatively or qualitatively by superior evidence.
6 I think this speaks for itself. It calls on the agency to
7 engage in a weighing of the scientific evidence, and the FDA
8 is certainly equipped to do that and make that
10 The third major exception to the court's holding
11 that I outlined earlier was that the FDA is not obligated to
12 consider permitting preliminary health claims when empirical
13 evidence shows that the claim disclaimer is insufficient to
14 protect consumers from deception. Let me discuss this in a
15 little detail.
16 The court, in Pearson, stated that disclaimers
17 would not be required where empirical evidence that
18 disclaimers similar to the one suggested by the court would
19 bewilder consumers or fail to correct for deceptiveness.
20 The Food and Drug Administration should thus conduct
21 research so that it can obtain empirical evidence indicating
22 when and when not disclaimers prevent consumer deception.
23 The Federal Trade Commission has conducted a study
24 on health claims in advertising and that study did conclude
25 that certain types of disclaimers are insufficient to
1 protect consumers. Now it's the Food and Drug
2 Administration's turn to conduct its own research on dietary
3 supplement labeling claims.
4 The examples of the disclaimer suggested by the
5 court in Pearson, in our view, do not provide consumers with
6 any useful additional information to help them evaluate the
7 safety and health benefits of a supplement. The court
8 suggested simply informing consumers that the scientific
9 evidence is inconclusive or that the Food and Drug
10 Administration has not approved a claim. But that type of
11 statement merely constitutes a disclaimer of responsibility.
12 Such statements do not provide consumers with additional
13 useful information to remedy an otherwise misleading claim.
14 There is a vast difference between merely
15 disclaiming responsibility and disclosing useful information
16 that qualifies an otherwise deceptive statement. While the
17 court expressed confidence in the specific wording of the
18 disclaimers that it suggested the FDA utilize, it did not
19 "rule out the possibility" that its suggested approach would
20 "bewilder consumers and fail to correct for deceptiveness."
21 So the court itself admitted that its suggested
22 disclaimers in its opinion were not foolproof and it
23 conceded that it wouldn't rule out the possibility that the
24 disclaimers it suggested in its opinion wouldn't work. So
25 it's therefore incumbent upon the Food and Drug
1 Administration to conduct the necessary research and resolve
2 the court's uncertainty about its primary holding.
3 In conclusion, the Pearson decision, by its own
4 terms, significantly limits the applicability of its primary
5 holding to the FDA's health claim review process. And each
6 of the factors that I addressed and that are addressed in
7 the letter by the 15 national health and consumer
8 organizations to the FDA need to be considered by the agency
9 before any health claim, including those four at issue in
10 the Pearson case, is permitted in the absence of significant
11 scientific agreement. Thank you.
12 MR. LEVITT: Thank you very much. I'm always
13 amazed how much good information people can get in in 10
15 Next is Bruce Chassy, University of Illinois.
16 BRUCE CHASSY, UNIVERSITY OF ILLINOIS
17 MR. CHASSY: Well, I'm going to take a different
18 tack, Joe. I'm not going to have a great deal of
19 information. I'm not burdened by any knowledge of the law.
20 I can speak maybe as a scientist who's been in this field
21 for a number of years might look at some of these issues and
22 they're somewhat different than the legal issues that we've
23 heard from the first two presenters.
24 The first thing I'd like to do is talk a little
25 bit about the context in which we have dietary supplements
1 and health claims and then take a couple of moments to talk
2 about the actual health claim standard as it's applied and
3 what it means to consumers and how they get information
4 related to health and dietary supplements and then see if we
5 can't put it together with answering the two questions posed
6 to this panel.
7 We have a very heightened interest in diet and
8 health in this country. That is very clear. It's in the
9 media. It's the subject of a court case today. It's
10 something that has perplexed scientists, consumers.
11 Certainly the dietary supplement industry, a very consumer-
12 driven industry, is scrambling to stay ahead of consumer
13 demands in this area and to respond to newly emerging
14 science. So I think we all agree that there's something
15 very important and very compelling here.
16 I personally find it paradoxical in that we've
17 been trying for about 30 years to get people to eat a
18 proper, balanced diet and follow the dietary guidelines and
19 suggesting to them that that is perhaps an avenue toward
20 better health and, at the same time, we're finding that
21 there are certainly indications that specific compounds,
22 specific dietary supplements, specific foods are health
23 beneficial, health protective, and offer promise to
25 So we sort of have this balance between when do we
1 depart from a recommended dietary pattern and supplement it
2 with something that we believe will enhance or protect our
3 health. That's a tough decision for a consumer to make each
4 day when you can clearly see that it's a difficult decision
5 for scientists to make.
6 As a result of it being a difficult decision as to
7 when to allow a health claim, I can see that it is very
8 difficult for the courts to decide when to allow a health
9 claim. It seemed to me in the legal arguments we just
10 heard--as a scientist, not as a lawyer--that we're
11 protecting First Amendment rights perhaps, according to the
12 court, but not looking at the scientific facts and
13 publications in the case, which I think are also important.
14 I like the 1999 guidelines that the FDA has put
15 out on significant scientific agreement and one point in
16 particular that I think is extremely important is that the
17 kinds of recommendations that come with a health claim are
18 recommendations which are based in sound science that is not
19 likely to be reversed. It may be altered or modified--I'm
20 paraphrasing the words--but it's something that a consumer
21 can believe in. That promotes a confidence in science, it
22 promotes a confidence in the agency, and, as the speaker to
23 my right just pointed out, it protects the health of
24 consumers because we have at times found that what looked to
25 be very promising dietary supplements, foods, turned out to
1 have a down side.
2 The problem, of course, is that the process of
3 reaching significant scientific agreement is not clear to
4 scientists, let alone consumers, lawyers, regulatory
5 agencies or anyone else, because it's different in each
6 case. As the document points out, you could very quickly
7 reach a significant scientific agreement where the data was
8 clear, the mechanism was clear, the epidemiology was clear
9 and you could, in other cases, have, for example with soy
10 and cancer, have more than 125 or 150 studies with still no
11 clear significant scientific agreement about the
12 relationship between consumption of soy and cancer.
13 Well, what are we to do? Well, let's think a
14 little bit about what consumers--where they get their
15 information and what health claims mean to them and maybe
16 phrase it in what we learned from the Keystone Dialogue on
17 health claims on food products, wherein the FDA was
18 requested by the food industry as a recommendation, or at
19 least by the Keystone Dialogue, which was government,
20 academic, industry, consumer groups, to create at least a
21 faster approval process for dietary health claims, and I
22 think I'm going to, as I say, apply that to supplements, and
23 to make shorter, simpler health claims available to
25 The FDA has worked on both of these and I think
1 this is a very important feature. And the reason why is the
2 one thing that nobody has mentioned today is where these
3 health claims appear. They appear on a bottle or a package,
4 the label of a food product or a dietary supplement in this
6 It is very clear that you can't put a whole lot on
7 a label. In that regard I find the court's disclaimer
8 almost laughable. Can you imagine print small enough to
9 read those disclaimers on a dietary supplement label?
10 What data from the FDA and from marketing surveys
11 showed about health claims on food packages is that shorter
12 is actually better and a long, complicated, legal
13 description on a package is not likely to be read by a
14 consumer. In fact, consumers tend to disregard health claim
15 labels. I don't know why the industry is so interested in
16 health claims if it was just to put the health claim on a
17 label because consumers know that what you find is claims on
18 labels and you disregard them and you turn around and look
19 at the ingredients and see what's in there if you're really
21 It seems to me that a suppression of First
22 Amendment rights in this case on a label may very well be
23 justified if you can't tell the whole story, but I would
24 also suggest that First Amendment rights are in no other way
25 suppressed because most consumers get the information that
1 they need about dietary supplements or foods from somewhere
2 other than a label. Usually they go into a store with a
3 purchase in mind. They do not shop health claims along all
4 the bottles and packages on the shelves.
5 There is an education component involved here.
6 People learn from the media. They learn from the press.
7 They learn from magazine articles. They learn from friends.
8 They learn by going into stores that sell these products and
9 asking people what you can do for this or that or what'll
10 help me with whatever it is. There are a whole variety of
11 ways that people learn about health claims and learn about
12 healthy, efficacious products and there's certainly a wide
13 variety of products out there today.
14 At times, it's almost like a fad. Things go in
15 and out of style. It must drive the industry crazy trying
16 to make high quality, efficacious products and chase
17 consumers around.
18 Well, why are they chasing consumers around?
19 Because consumers are getting a lot of information and
20 expressing their desires for various kinds of products. We
21 live in a consumer-driven society.
22 My contention here is just very simply that there
23 are many avenues for First Amendment expression for
24 companies wishing to offer products. In fact, the shoe is
25 really on the other foot. The consumer is driving the
1 company to offer the product. I don't think the health
2 claim has any particular value. I don't mean to offend the
3 FDA or the law or the industry in this but I think consumers
4 know better than any of those what they want and what to
5 believe in and I do not believe a little bit of geography on
6 the front of a label is going to either educate, inform or
7 persuade a consumer to buy that product.
8 To me, that is really the important point because
9 significant scientific agreement is a very high standard, a
10 very difficult thing to define. I understand the court's
11 impatience with it. Scientists can't even do it.
12 But if you're going to put on a label that
13 something is supportive or preventive or protective of
14 health, it ought to be able to endure. And I just think by
15 definition, emerging science is science which we do not know
16 will endure, which has not met the highest standards.
17 What we could do is try to make the approval
18 process faster. There are a couple of ways to do that. One
19 is to support more research and to try to get answers
20 faster. Another is to try to constitute some sort of board
21 or body or collection of scientists who basically are
22 supported, maybe more support to the FDA so that they can
23 get a panel to do this--there are various ways you can think
24 about it--to review the literature and to review the science
25 more quickly and to reach decisions more quickly without
1 changing the standards might facilitate both industry and
2 consumer interests, and I'd be very much in favor of that.
3 But I think changing the standard of what significant
4 scientific agreement is or applying a lower standard would
5 be, from a scientist's point of view, at least, terribly
6 misleading, I think, to a consumer.
7 So rather than compromise standards, at the very
8 worst, maybe we need to create a category called emerging
9 science claims and let people make emerging science claims,
10 of which there will no doubt be hundreds or even thousands,
11 and they will in an almost anarchic way become meaningless
12 to consumers. I see that as the logical end of the court's
13 point of view.
14 MR. LEVITT: If you could try to summarize,
16 MR. CHASSY: Oh, I didn't see the lights. I think
17 that's probably a good place to stop. Emerging science is
18 just that. It's not proven science. We're interested in
19 protecting and informing consumers. An emerging science
20 that is uncertain does not inform consumers. Nor do I think
21 labels on bottles inform consumers. Thank you.
22 MR. LEVITT: Thank you very much.
23 The next speaker is John Hathcock, Council for
24 Responsible Nutrition.
25 JOHN HATHCOCK
1 COUNCIL FOR RESPONSIBLE NUTRITION
2 MR. HATHCOCK: Thank you, Mr. Levitt.
3 In planning my remarks, I note that the second
4 question to this panel refers to the basis for claims that
5 are not to be based on significant scientific agreement.
6 This seems to me to open the door for responses that may
7 also apply to the questions posed to some of the other
8 panels, and I may do so, but believe me, I'm going to be
9 brief and I think I'll be well under 10 minutes, even though
10 I may go outside the--
11 MR. LEVITT: We'll give you license.
12 MR. HATHCOCK: Consumers have a right to useful
13 information that is truthful and not misleading and thus is
14 acceptable under the general misbranding provisions of the
15 Food, Drug and Cosmetic Act. Congress imposed a higher
16 standard for health claims under NLEA, however. But the
17 Pearson decision determined that the First Amendment
18 prohibits FDA from restricting label statements that are
19 truthful and not misleading.
20 NLEA provided FDA with the opportunity to set a
21 different set of requirements for supplements than for
22 conventional foods, but the agency went through the process
23 and opted to set the same standard.
24 The Pearson decision, however, now prohibits any
25 standard for health claims for supplements other than the
1 primary one for all label information; that is that the
2 claim must be truthful and not misleading. The FDA has
3 consistently misinterpreted NLEA to mean that there must be
4 "significant scientific agreement" on the totality of the
5 evidence to support the--and I underline the
6 word--relationship between the dietary component and a
7 disease or health-related condition. This interpretation of
8 a relationship though, as the basis for the claim, directly
9 contrasts with the wording of NLEA, which states explicitly
10 that it is the claim that must be the subject of significant
11 scientific agreement.
12 The Pearson decision seems to have rendered moot
13 the significant scientific agreement standard under NLEA.
14 Whatever definition or guidelines may be worked out by the
15 agency through the rulemaking process, under Pearson, claims
16 that are truthful and not misleading must be permitted for
17 dietary supplements.
18 Nevertheless, I do not believe that claims based
19 on conflicting or weak evidence must now be permitted. The
20 power to decide whether a claim is misleading, even if it is
21 literally truthful, gives FDA the authority to prohibit
22 claims that are exaggerated beyond the substantiation and to
23 prohibit claims that are based on evidence that is so weak
24 that no amount of qualification could justify them.
25 Clearly the Pearson decision permits claims if
1 qualifiers or disclaimers are sufficient to prevent them
2 from being false or misleading. I believe that the word
3 "may" that goes into a lot of claims, however, is not a very
4 significant qualifier except when the evidence is strong
5 enough to meet the significant scientific agreement standard
6 and there, it seems to be the choice word for avoiding the
7 word "will." "May" is used so that we don't say "will."
8 The Federal Trade Commission has a set of
9 effective regulatory practices that set the quality and
10 quantity of substantiation required in proportion to the
11 strength of the claim. Similarly, a structured hierarchy of
12 claims, properly categorized and each with its corresponding
13 level of required evidence, perhaps this emerging science
14 evidence that we just heard referred to, may be a useful
15 approach to qualified claims that are to be regulated by
17 Identification of such a system, of course, would
18 require innovative, assertive and ultimately cooperative
19 rulemaking. The impact of the Pearson decision, however,
20 clearly is to place the burden on FDA if it wants any
21 substantive involvement in the regulation of claims for
22 dietary supplements.
23 I believe that the Pearson decision will allow FDA
24 to prohibit claims when the evidence is any of these three:
25 equaled or outweighed by contradictory or contrary evidence;
1 qualitatively weaker than the contradicting evidence; and
2 third, null or negative. In such cases, no amounts of
3 qualifiers would keep the claim from being misleading. If
4 it were mere speculation and there was no evidence whatever,
5 I believe it would be misleading to mention the possibility,
7 Nothing in the Pearson decision directly addresses
8 safety. The authorized health claim for calcium illustrates
9 a reasonable use of the quantitative limits and cautionary
10 language. Under all current food provisions of the Food,
11 Drug and Cosmetic Act, safety is a separate issue from
12 benefit, as this panel well knows. Although the FDA's
13 language in approval of certain food additives does make
14 some motion toward the type of risk-benefit analysis
15 required under new drug applications, I think there the
16 agency pushed a bit to try to justify approval of certain
17 food additives.
18 FDA should recognize that the educational aspects
19 of its regulations of products and labels cannot provide all
20 relevant information that the consumer needs. Resources
21 permitting, however, FDA can initiate educational programs
22 that go beyond the mere regulation of a label.
23 I believe that there are no general all-applicable
24 bright lines between reduce the risk and treat for a
25 disease. The use of dietary calcium to build bone density
1 or to reduce the loss of calcium may reduce the risk when
2 the intake is early in life and it may be more of a
3 treatment when it is used to slow the losses that occur
4 later. I think that the boundaries between treat and reduce
5 risk are artificial and you'll have a hard time doing
6 rulemaking that'll satisfy everybody on that.
7 Health claims would have been considered drug
8 claims prior to NLEA. FDA's distinction between the
9 language permitted under NLEA, such as "reduce the risk,"
10 and drug claims such as "prevent" may be a useful model for
11 claims about effects on risk factors versus symptoms of
12 disease. That's going to require a lot of thinking through
13 of the various options and implications.
14 The Council for Responsible Nutrition believes
15 that the appropriate health claims should be authorized
16 without regard to whether they seem to overlap or duplicate
17 the FDA OTC drug provisions. A justified health claim on a
18 topic addressed by an OTC monograph--that is a health claim
19 for a food on a topic addressed by an OTC monograph might
20 trigger reexamination of the basis and scope of the OTC
21 claim and it is high time that food regulations help to set
22 the scope and application of drug regulations, rather than
23 always the other way around.
24 To conclude, the Pearson decision resulted from a
25 long-standing, de facto, more rigorous standard for claims
1 on supplements compared with those on conventional foods.
2 The quick approval in the initial review of a health claim
3 for low-fat foods in relation to reduced risk of cancer
4 contrasts starkly with the initial and protracted denial of
5 the now-approved health claim on folic acid in relationship
6 with reduced risk of neural tube defects.
7 Although much more evidence for the neural tube
8 defect claim has now accumulated, nothing has changed the
9 conclusion from the original Smith et al's nonblinded
10 clinical trial, a clinical trial that was not allowed to be
11 blinded because the evidence was too strong already.
12 As an FDA employee at the time,l I recommended two
13 years before NLEA was passed that we develop a national
14 policy to get more folic acid into young women who might get
15 pregnant. It is now time for an evenhanded attitude toward
16 dietary supplements compared with those for conventional
17 foods. Thank you.
18 MR. LEVITT: Thank you.
19 Our final speaker is Alice Lichtenstein from Tufts
21 ALICE LICHTENSTEIN, TUFTS UNIVERSITY
22 MS. LICHTENSTEIN: Well, not only am I not
23 burdened by any of the legal arguments but I also feel that
24 I've just sort of come out of an ivory tower. But having
25 said that, also having been involved with the recent dietary
1 guidelines that were just submitted from the advisory
2 committee that were just submitted to Health and Human
3 Services and USDA, which was an evidence-based process and
4 now being involved in the macronutrient panel for the new
5 DRIs, which again is an evidence-based panel, so initially I
6 took the questions that were posed for the panel quite
7 literally and said, well, should health claims be allowed on
8 dietary supplements on a basis other than significant
9 scientific agreement and said well, you can't really answer
10 that until you think what would the other basis be for that?
11 That's what I'm going to address. Is there any other good
12 basis that we could use and then feel confident that the
13 information that was given to the consumers would actually
14 be accurate and would be a service to the consumer?
15 So what would the potential criterion be? Well
16 first, how do we establish the relationship between a
17 nutrient and health? And usually there are two types of
18 information that one gets. One is sort of association and
19 that's more the epidemiological data and then from that,
20 frequently there are interventional trials which then
21 actually test the hypothesis.
22 Could we not necessarily need the intervention
23 trials but stop at the point of association? There again
24 there are certain questions that need to be posed. Why,
25 prior to this, did we really feel we needed intervention
1 trials and couldn't just look at associations and assume
2 that we could make conclusion on that basis?
3 Well, the issues are that when you do have
4 associations, you look at a population and let's say you see
5 that a certain nutrient is associated with a certain disease
6 or a lack of a nutrient is associated with a disease. You
7 have to ask certain questions. Were you adequately able to
8 actually assess nutrient intake, which means was there
9 accurate reporting?
10 Well, we know that there's not accurate reporting,
11 that people tend to underreport. You can see that for
12 energy and then, by implication, all the other nutrients
13 that come along with it.
14 Is there no bias in reporting? Well, again we
15 know that if you're doing a study on fat, you're asking
16 people about fat intake and there is going to be a bias in
17 that they think that you want to hear that they're consuming
18 less fat. They're going to tell you that they're consuming
19 less fat.
20 Now with newer approaches to look at things like
21 energy intake doubly labeled water, we know that from the
22 observational stuff or observational data that actually that
23 isn't the case as far as underreporting.
24 Also, if you get information, you get data from
25 people on what, let's say, they're consuming. Then you want
1 to relate that to disease outcome. You also have to assume
2 that the database on which you are assessing the dietary
3 intake or nutrient intake is adequate and we know that the
4 databases are not that accurate and complete, especially for
5 the newer biologically active components of nutrients that
6 there's a lot of current interest in.
7 In addition to which drawing conclusions just from
8 association data are dangerous because of confounding, that
9 we know, let's say, nutrient X is associated with also the
10 intake of nutrient Y, whether it be something like beta
11 carotene with fruits and vegetables and Vitamin C, so you
12 really don't know if it's one or the other.
13 Then we also know that there are certain lifestyle
14 behaviors that are associated with certain nutrient intake,
15 so that people that eat more fruits and vegetables tend to
16 be more active and they tend to smoke less. So it becomes
17 very difficult to attribute the observation of either
18 increased or decreased risk of a certain disease to whether
19 it had to do with the nutrient that you can measure more
20 accurately than the other nutrient or you have more
21 discriminatory power, or whether it has to do with other
22 lifestyle behaviors.
23 I'd like to now give you a couple of examples
24 about why I think there needs to be significant scientific
25 agreement, and that has to do with some of the recent cases
1 that we've had where there have been some indications that
2 Vitamin E was associated with decreased risk of
3 cardiovascular disease, yet when the intervention studies
4 were done, whether it be the GISSI study that just came out
5 of Italy, whether it's the HOPE study that just came out of
6 Canada, the alpha tocopherol beta carotene study that came
7 out of Finland, really in none of those cases was there a
8 positive association between taking Vitamin E and decreased
9 risk of cardiovascular disease. There was only study, the
10 CHAOS study, and there was some concern regarding control of
11 that study. And similarly with cancer, the effect seems to
12 be null.
13 As was already brought up, there is the beta
14 carotene issue, which looked very hopeful with respect to
15 cancer and cardiovascular disease because increased fruits
16 and vegetables is associated with decreased risk and also a
17 lot of biochemical data to suggest the positive effect of
18 beta carotene on malignancy. And again we have a number of
19 studies. The first was the alpha tocopherol beta carotene
20 study, again from Finland, showing a null effect on
21 cardiovascular disease, perhaps in smokers a negative effect
22 of the beta carotene; the CARET study in the United States
23 again showing a null effect on cardiovascular disease and
25 Then we have a situation which is a little bit
1 different and again, how do you come up with an assessment
2 here? This is with folate, that folate has already been
3 mentioned with respect to decreasing the incidence of neural
4 tube defects and good intervention study. There's also a
5 lot of interest with respect to cardiovascular disease.
6 There's now mandatory fortification. The mandatory
7 fortification did have the effect of increasing folate
8 levels in the population, decreasing homocystine levels,
10 However, still we don't know what the outcome is
11 going to be with respect to cardiovascular disease. From a
12 biochemical level you would predict a decreased risk of
13 cardiovascular disease, but we don't know.
14 And then the last example is Vitamin C and what
15 I'm going to do is cite three news reports that came out,
16 that consumers are actually being exposed to. One was--and
17 these all happened this month. The first one is March 9.
18 It was an Associated Press story and it said Vitamin C
19 supplement intake and progression of carotid
20 atherosclerosis, Vitamin C supplement use associated with
21 progression of arterial thickening. You think, "Oh, no."
22 Would you make a claim there saying that people shouldn't
23 use Vitamin C on the basis of one study? No, unlikely.
24 Then March 27, doctors warn against big doses of
25 Vitamin C in cancer treatment. Vitamin C might
1 inadvertently protect tumors from radiation and
2 chemotherapy. Again this is something that the consumer is
3 being exposed to. This was actually just made on the basis
4 of cell culture work.
5 But then, the next day, Vitamin C and E protect
6 against aging brain. Vitamin E and C supplements may
7 protect against vascular dimension, may improve cognitive
8 function later in life.
9 Okay, so here the consumer is now, just in one
10 month, being exposed to a lot of different claims. It's
11 sort of a ping-pong thing back and forth with respect to
12 Vitamin C. What would you put on the label? Could you
13 adequately put all that on the label? Would you really want
14 to put all that on the label? I think most scientists would
15 say one study doesn't mean anything.
16 Would you do a tally sheet--five good studies,
17 four bad studies or five bad studies, four good studies and
18 then you would put a claim on the label on that basis? No,
19 probably not because not all studies are equal and not all
20 the evidence is compelling from the different studies, which
21 is why I think you have to go back to significant scientific
22 agreement from a group of individuals that are familiar with
23 the strengths and limitations of the totality of the body of
24 scientific data.
25 I think we're very much hampered because we are
1 limited still, even in the year 2000, we're limited with
2 respect to what we know about essential nutrients. We're
3 not sure we have identified all the essential nutrients.
4 Although we have a list, we know that there are other
5 nonessential biologically active components. We know that
6 the intake of some nutrients will impact on the intake of
7 other nutrients as far as requirements go. So I think we
8 need to be concerned that if a claim is made for a certain
9 supplement and that the intake is increased of that specific
10 nutrient, will it have an effect on the other one? We have
11 well established ones with respect to things like selenium
12 and Vitamin E but there are a lot of others with respect to
13 minerals and altered absorption.
14 There are also interactions--well, those really
15 are the interactions. There are also issues related to
16 whether an individual is taking what I'd call sort of more
17 in the physiological range of a nutrient versus a
18 pharmacological range. In both cases they can potentially
19 be valid. Physiological ranges of nutrients can also impact
20 on the biological effect of each other. Then you have
21 something like niacin, which can be used in pharmacological
22 levels as a hypocholesteremic agent. Again we certainly
23 have data about that and what the side effects are but with
24 a lot of the other nutrients, we don't really have that
1 So what it comes down to, and unfortunately I
2 can't see the light. Am I on yellow on red?
3 MR. LEVITT: You're doing okay.
4 MS. LICHTENSTEIN: Great. So I'm posing
5 essentially now some open questions because I think that
6 it's very difficult to come up with criterion other than
7 scientific agreement. And one is, and I think this was
8 touched on by one of the speakers, that there's a lot we
9 don't know about how this information would be used by
10 consumers. How do consumers use health claims on dietary
11 supplement labels, both the intended use and the actual use?
12 Do health statements on dietary supplement labels
13 effectively communicate the message? And I mean that in
14 terms both of accurately and understandably. Because if
15 it's not, then what's the use of having it? We're fooling
16 ourselves if we think just by giving the information, that's
17 our responsibility and now it's caveat emptor, buyer beware.
18 I don't think that that's an appropriate burden to put on
19 the consumer.
20 Were supplement information to be added to
21 nutrient labels, again, how would it be interpreted?
22 Another open question is would health claims on
23 dietary supplement labels alter food choices and displace
24 conventional treatment? I think it's something sometimes we
25 throw up those red flags as issues of concern. I think it's
1 something we really don't know that much about.
2 However, you can now go and get something like a
3 vegetable concentrate and maybe the vegetable concentrate
4 can make the same claim as if you eat fruits and vegetables,
5 has all the nutrients, but what other impact does it have on
6 the diet? Does that mean--is that equivalent to eating a
7 diet that's high in fruits and vegetables and perhaps not
8 eating other things or just taking a concentrate of
9 vegetables and then eating all the other types of foods that
10 may not be associated with the positive effect on that
11 disease? Will the information and the claims alter
12 consumers' choices with respect to other health treatments?
13 Again I think it's something that we don't know
14 about but we should know a little bit more about.
15 Should health claims be allowed on dietary
16 supplements on a basis other than scientific agreement? At
17 this point I would say no and I'd say we really have to look
18 at the risk-benefit ratio and we need to first keep in mind,
19 first, do no harm.
20 FDA PANEL DISCUSSION
21 MR. LEVITT: Thank you very much. Thanks to all
22 five of the speakers.
23 We'll now proceed to the more active dialogue
24 section. Again just to remind everybody, the process we'll
25 use is each of us will try to ask one question. My
1 experience is rarely does only one person want to answer, so
2 we'll give whoever in the group who wants to answer the
3 question an opportunity, beginning with me.
4 And I think I'll pick up where the last speaker
5 left off, which is I'll say notwithstanding some of the
6 difficulties that you point out, the court has instructed
7 us, as the first speaker said, to look at these claims and
8 as a threshold matter, to look at does the evidence for the
9 claim outweigh the evidence against the claim?
10 If you were the FDA, how would you do that?
11 MS. LICHTENSTEIN: The only way I could see doing
12 it is collecting all the evidence because you don't want to
13 just collect all the good evidence and it wouldn't be right
14 just to collect all the bad evidence for the example being
15 just this month in Vitamin C.
16 I can't see getting around not collecting all the
17 evidence, looking at it, looking at the quality of each
18 individual piece of evidence and then making some decision
19 as to whether the level of evidence is adequate to support
20 the claim.
21 Now, whether that is called significant scientific
22 agreement or just independent assessment from individuals
23 that are knowledgeable in the field but are not biased,
24 that's semantics.
25 MR. LEVITT: Yes?
1 MR. CHASSY: I think when scientists look at
2 conflicting evidence, it's a red flag. We're trying to
3 lower the dissonance to where all the evidence is pointing
4 in the same direction. And I think the concept that the
5 court has written there, that you look at the preponderance
6 of the evidence, may be a sound legal concept but that would
7 drive scientists crazy. We would say no conclusion is
9 MR. LEVITT: Mr. Emord?
10 MR. EMORD: The critical question, again there's a
11 distinction between the First Amendment requirement, which
12 is paramount, and any standard that you would set on the
13 validity of science, the First Amendment taking precedence
14 over anything else because of its legal predominance in the
16 So the question becomes you first look at the
17 actual claim before you, not a hypothetical nutrient-disease
18 association but the actual language of the claim before you.
19 You read it according to its literal meaning, not its
20 hypothesized meaning, not according to some esoteric
21 conception of what consumers may view because you can't make
22 that judgment in isolation.
23 So looking at the language before you, you asked
24 what its literal meaning is. Let me give you an example.
25 Let's say that the claim is nutrient X cures bladder cancer,
1 but the science before you only shows that nutrient X
2 increases killer cell activity. Let's say there's either no
3 study associating the nutrient with bladder cancer or there
4 is one or two old studies that are no longer viewed as
5 methodologically appropriate, statistically sound, what have
7 In that case, the claim by its very language is
8 inherently misleading. There's no disclaimer you could
9 reasonably use to correct the misleading connotation.
10 However, if the claim instead was nutrient X may increase
11 killer cell activity and the scientific evidence before you
12 was not conclusive on that point but there were studies
13 indicating that nutrient X may increase killer cell
14 activity, the literal meaning of the claim would invite a
15 qualification so as to avoid the misperception in the public
16 that the claim is conclusive.
17 We cannot presume that the public is too ignorant
18 to comprehend scientific information. We can also not
19 presume that the claim is the end-all and be-all of all
20 scientific wisdom in the universe and that consumers will
21 not be going through the Internet and other sources of
23 Consumer will. The question for you is do you
24 have a mass black market in claims, such as you currently
25 have now, or do you have a functional system where people
1 find the disadvantages associated with the review not
2 impossible and are willing to file a claim, to trust the
3 agency to ensure its agency.
4 Few people will file claims for which there is no
5 scientific evidence. Few people will file claims for which
6 there is conclusive evidence because virtually no
7 nutritional claims come with conclusive evidence. It's the
8 nature of the beast.
9 So the vast majority of science is in the realm of
10 inconclusiveness and the question is how does the government
11 follow the principle of disclosure over suppression? How
12 does it become a vehicle for the communication of truthful
14 Intelligent minds can create disclaimers.
15 Inconclusiveness can convey to a consumer information. The
16 study cited by Bruce, done by the FTC, did show that in the
17 case of qualitative disclaimers, they were effective and
18 dissuaded people from purchasing products if their interest
19 was to avoid cancer and the evidence was inconclusive. But
20 we get this plethora of information from the marketplace
21 about it and you don't have a chance to pass upon that. And
22 quite frequently, as Dr. Lichtenstein pointed out, you get
23 one study out there that says Vitamin C is going to thicken
24 the walls of your arteries and you have 200 that are locked
25 away in the scientific literature showing the contrary, and
1 the consumer is being fed misinformation.
2 The study that the court relied upon in a footnote
3 that we presented to them showed that the consumer relies
4 upon information at the point of sale to predicate its
5 judgment about buying. That's an FTC study done a number of
6 years ago and it shows that just like in my case, when I go
7 to look at a dietary supplement in the store, I do look at
8 the able. I don't just look at the nutrition facts panel.
9 I look at what's on there. I try to figure out what it's
10 about. What are they trying to sell this for? I think most
11 people do.
12 The reason why the industry is interested in
13 claims is because they see this vast quantity of nutrition
14 science in the literature, not necessarily conclusive but
15 indicative, and on a risk-benefit analysis, this is how
16 consumers make purchasing decisions in the dietary
17 supplement marketplace.
18 So why not trust consumers with the information?
19 And why not become a vehicle for the dissemination of
20 information rather than a barrier to its dissemination?
21 This is the court's emphasis: disclosure over suppression.
22 MR. LEVITT: Thank you.
24 MR. SILVERGLADE: Well, I just want to add a
25 couple of different points. I think the hypothetical that
1 Jonathan spelled out there would be invalid under our
2 interpretation of the court case because it would affect
3 health in an adverse fashion and the court specifically
4 acknowledged that where health is at risk, the FDA can ban
5 claims outright.
6 I'd also like to make a comment on what was
7 suggested or brought up about weighing the evidence. The
8 word preponderance of the evidence was brought up and it was
9 said that that's a legal concept that drives the scientific
10 community crazy because in scientific terms you can't just
11 say well, 51 percent of the studies say this and 49 say
12 that, so this claim is valid. Scientific validity is much
13 more complicated than mere preponderance.
14 So I would like to encourage the FDA not to
15 proceed down the route of a preponderance of the evidence
16 standard, that in a sense, that would be misleading in and
17 of itself because it doesn't represent scientific validity.
18 And in the weighing of the evidence, both quantitatively and
19 qualitatively, there has to be clear and convincing evidence
20 that the claim is valid.
21 MS. LICHTENSTEIN: I'm a little bit concerned with
22 the concept of giving consumer the information versus
23 burdening the consumer with information without the benefit
24 of input from people that are familiar with the different
25 subtleties and innuendoes of a subject.
1 From my perspective, if it has something to do
2 with, let's say, child safety, I would like the government
3 to have certain standards, hopefully with input from the--I
4 don't know if it's academic that test that or whoever--who
5 adequately has the expertise to rigorously test it, assess
6 the different responses, risks, and gives me, as a consumer,
7 the best information on whether it's something that's safe
8 or not safe.
9 In the same way with dietary supplements, it's one
10 thing to give people the information; it's something else to
11 try to ferret out whether that information is valid, whether
12 there's enough of the information to actually support the
13 claim. And I think without having scientific input and some
14 kind of consensus, in a sense, there's an abdication of
15 responsibility, and that's what I'm concerned about.
16 MR. LEVITT: One quick comment and then we'll move
17 to the next question.
18 MR. CHASSY: I'm a little concerned about the
19 reliance on that 1989 FTC study. I didn't mean to insult
20 the FTC but it's an old study and I think there's more of
21 that kind of work that needs to be done because I don't
22 think any of us can really say for certain what consumers
23 interpret when they read these labels and what would be or
24 would not be useful to them.
25 I don't think, though, that it's the FDA's job, as
1 I see it, to be validating sort of soft claims. The
2 consumer, as Jonathan just pointed out, is seeing all these
3 claims in literature and is making their own decision, so it
4 seems to me we have full disclosure. You read it, you make
5 your decision, and it's the FDA's job to allow a health
6 claim when there is a significant scientific agreement.
7 MR. LEVITT: I'm going to pass the microphone over
8 to Chris Lewis.
9 MS. LEWIS: Thank you. I'd like to pick up on a
10 few of the themes that I've heard and I'm not quite sure I
11 can phrase the question correctly, but relative to the
12 scientific standard for something less than significant
13 scientific agreement, and particularly perhaps for Dr.
14 Chassy and Mr. Hathcock, the issue was brought up of the
15 idea of claims being reversed by science. And Dr.
16 Lichtenstein talked about the ping-pong nature of daily data
17 that hit the consumer.
18 I guess I did hear some introduction of the idea
19 of a place for emerging science and I'm not quite sure I'm
20 hearing that there's a standard for that other than the
21 standard of significant scientific agreement and maybe you
22 could talk about is there one or is there not. I think I've
23 heard several different points at different times. That
24 would be helpful.
25 Dr. Chassy, in particular I think I'd like to hear
1 from you.
2 MR. CHASSY: If I were the agency, I wouldn't want
3 to be administering that. I think it's difficult.
4 I think in this particular case, for example, the
5 health claims that were not allowed by the FDA are very good
6 examples of those that would fully meet the emerging science
7 kind of requirement. I think what you would want to have is
8 basically--I don't want to use the word preponderance of
9 evidence--maybe all of the evidence pointing in a direction
10 but perhaps the definitive or corroborative studies haven't
11 been done.
12 You know, we always say that if you're going to do
13 an intervention trial, somebody else should do it somewhere
14 else and it should come out the same way if it had the same
15 design, and that makes you feel good. But what about when
16 you know the mechanism, you've seen the epidemiological
17 data, they're all pointing in one direction and somebody
18 does a clinical trial and it's very supportive of what you
19 were thinking going into it. Maybe that's emerging science
20 that people have a right to know about.
21 If the intervention, as is the case in beta
22 carotene studies, doesn't bear out the epidemiology and the
23 mechanistic hypothesis, then you wouldn't do that. You
24 wouldn't say that this is a promising piece of science.
25 So again I think you need consistency. It's maybe
1 the amount of evidence you have and the length of time that
2 it's been available. We also say that science needs to
3 stand the test of time.
4 So I would look at it as something with a shorter
5 time frame and less than a complete set of evidence but all
6 pointing in the same direction. And I do think these four
7 claims clearly fall into that.
8 MR. HATHCOCK: Dr. Lewis, as you know, science
9 never provides certainty. That's true whether we're talking
10 about clinical trials or epidemiological evidence or a
11 mixture of the two.
12 A preponderance of the evidence could actually
13 change with time. We can increase the evidence for
14 something; we can increase the evidence against something.
15 So the proportionality in the preponderance can easily
16 change. And it's not only epidemiology but also clinical
17 trial. It is not just nutrition, but we don't have
18 certainty in the drug area, as well.
19 The way that preponderance can change can
20 sometimes, I believe, change the decision that ought to be
21 enforced regarding whether or not a particular claim is
22 permitted, assuming that FDA has the authority that is
23 granted under NLEA for authorization for a claim before it
24 can be made.
25 With the Pearson decision relating to dietary
1 supplements, I'm not sure--and, as you know, I'm not an
2 attorney; I'm simply trying to look at this in a logical
3 way--I'm not sure that FDA has this kind of premarket
4 authorization authority for the claim. It's simply if it's
5 truthful and not misleading, it can be made and most
6 labeling is not authorized by FDA.
7 The primary standard under the misbranding
8 provisions of the Food, Drug and Cosmetic Act does not
9 require premarket authorization of the claim. And if FDA
10 finds that something is not truthful or it is misleading,
11 then it has the authority to take an action to declare the
12 product misbranded. But having said that, it's not an issue
13 perhaps of authorization.
14 So the preponderance would apply in either way but
15 the preponderance does need to be read in these ways that
16 rely on interpretation of the quality, as well as the
17 quantity of the evidence. Simply counting studies doesn't
19 MR. SILVERGLADE: I'd like to add a few points.
20 On preauthorization, I think the court's opinion is very
21 clear that FDA does have the authority, both under the
22 statute and the Constitution, to require premarket approval
23 of claims. That was not criticized by the court.
24 Second, we object to the term "emerging science,"
25 which has been mentioned several times this morning.
1 Emerging science is somewhat of a marketing term, I think,
2 that the industry has come up with. It sounds to me like
3 it's new and improved. It implies that that science will
4 emerge when, in fact, it may or it may not emerge. It
5 implies a presumption that the science will pan out when we,
6 in fact, don't know.
7 So what we're really talking about is not emerging
8 science but uncertain science, uncertain science.
9 The court really kind of got it mixed up when it
10 talked about disclaimers and disclosures. The classic
11 Supreme Court case on disclosures in consumer advertising is
12 where the lawyer advertised that he would take your case for
13 free, on contingency, and even if you lost, he wouldn't
14 charge you anything; there would be no cost to you. And, in
15 fact, the lawyer made the consumer pay court costs, which
16 can be quite substantial, if the case was lost.
17 So that was deceptive and the Supreme Court said
18 that the answer is to require disclosure, not to ban the
19 advertising but to require disclosure that the consumer
20 would still be liable for court costs if the case was lost.
21 And that type of disclosure does present useful information
22 because after the consumer reads it, the consumer can say,
23 "Aha, now I know the truth. This is the missing link. With
24 this disclosure, now I see what they're advertising. Now I
25 know the truth."
1 And the problem with the disclaimers suggested by
2 the court is that it doesn't give the consumer the missing
3 information to close the loop, to say "Now I know the truth"
4 because, in fact, all the consumer knows is that the FDA may
5 not have approved the claim or that the scientific community
6 is disputing it, but they don't know if it's safe; they
7 don't know if it's effective, and that's really what the
8 consumer wants to know.
9 MR. LEVITT: Mike?
10 MR. LANDA: This question is for, initially, at
11 least, Jonathan Emord and Bruce Chassy.
12 How, assuming you would take safety into account
13 in the context of a health claim or the acceptability of a
14 health claim, how would you do that?
15 MR. EMORD: I think here, as well as many other
16 instances but here particularly, I think Bruce got it wrong.
17 The issue on safety that the court addressed was whether or
18 not these particular ingredients were unsafe when consumed,
19 not the question of whether the claim would render them
20 unsafe in some hypothetical sense--long-term risk-benefit
21 sense. The court looked specifically at the question: Are
22 these things unsafe? The substances, not with regard to the
24 Then, finding the substances to be safe, and safe
25 is a relative term and here the agency has a spotted
1 history. In the Kessler administration the attempt was to
2 take virtually unlimited dose levels and say that if at some
3 dose level it's unsafe, it's unsafe.
4 But the point is we have to look at it in
5 perspective. If the dose recommended is one that would not
6 result in harm to consumers, it's safe.
7 Is there an instance where a claim could render a
8 dietary supplement unsafe? I'm sure there is such an
9 instance. For example, if the claim were "Discontinue
10 chemotherapy; rely on Vitamin C as your exclusive remedy"
11 and that was submitted to the FDA, I think you could easily
12 deny that claim. And if the claim is inherently misleading,
13 you can suppress it outright.
14 The question becomes one, I think, of recognizing
15 that with emerging science, and here again I disagree with
16 Bruce's definition. I think emerging science, if we
17 understand it correctly and we can even define it, is that
18 which is part of an evolutionary process which has not yet
19 reached a degree of conclusiveness that is generally
20 accepted in the scientific community. Virtually nothing
21 reaches that level of conclusiveness. A few things do, and
22 even that level of conclusiveness is subject to change in
23 the case of drugs and supplements. And we have to look at
24 the question of the claim's terms within the current
25 environment. We can do nothing more than that. We can't
1 hypothesize about whether science will ultimately be
2 conclusive in one direction or another. If it ultimately is
3 conclusive against the claim, you could then deny the claim.
4 I think we have to be--this is a static--this is
5 not a stationary process. It's evolutionary.
6 Safety is the same point. What we believe to be
7 safe today may, in 20 years, be regarded as wholly unsafe,
8 but we should look at the substance and determine safety,
9 not look at the claim and say that the claim--hypothesize
10 and say because we associate a reduction in the risk of
11 cancer with the consumption of anti-oxidants that there may
12 be a reduction, that that means that people will discontinue
13 chemotherapy. That is not the claim before you.
14 Otherwise, if we hypothesize endlessly and assume,
15 presume the consumers will act in one way or another, you
16 can never fulfill the First Amendment duty, which is
17 necessarily language-based. It's necessarily focussed on
18 the meaning of the terms before you.
19 MR. LEVITT: Anyone--
20 MR. CHASSY: With two Bruces, I didn't know which
21 one you meant. But since I used the term "emerging
22 science," I want to return to it.
23 I actually agree with the other Bruce here; it's
24 uncertain science. And I agree with Jonathan; it's emerging
25 science. It is both at the same time, whether it's an
1 industry term or not.
2 Jonathan used a word in talking about what he
3 considered a reasonable disclaimer that I think is found in
4 health claims and in emerging science claims, and that's the
5 word "may." The word "may" is itself a disclaimer. It
6 seems to me that consumers understand or ought to understand
7 what the word "may" means, and that's why I was somewhat put
8 off by the lengthy court disclaimer. I think you can, with
9 a very few fudge words, make a health claim considerably
10 softer because you are, in fact, not promising someone that
11 something will do something. I think it is understood that
12 even a health claim is the best available knowledge.
13 That said, I can give you an example of safety in
14 a food product and make a comment about that. There is a
15 body of evidence that says consumption of phytoestrogens may
16 have health-beneficial effects, particularly related to
17 cancer, particularly in post-menopausal women, whatever.
18 There's also a body of evidence that says that consumption
19 of phytoestrogens can promote estrogen-dependent mammary
21 So if you had a health claim saying phytoestrogen
22 consumption is going to protect you against cancer, you
23 would certainly want to quality that by saying unless you
24 happen to have an undetected estrogen-dependent mammary
1 Secondly, we're talking about an area where these
2 aren't drugs that have immediate effects or necessarily
3 acute toxicity. We're talking about dietary remedies,
4 supplements, that are going to be used over 20 or 30 or 40
5 years before their full impact is felt. And I take issue a
6 little bit with Jonathan in the sense that yes, you want to
7 look at the immediate acute toxicity and the immediate
8 safety, but you would also want to know that over 20 or 30
9 or 40 years, consumption of novel amounts of novel
10 ingredients would, in fact, have long-term safety for the
11 consumer. Hence the reluctance to approve a health claim
12 without having it stood the test of time, in addition to
13 having a body of scientific evidence that was pretty
15 MR. HATHCOCK: I beginning that the safety issue
16 can devolve into an unanswerable set of questions if we
17 aren't very careful. If the product is safe under the law
18 and is in the marketplace legally, even if nothing is said,
19 then that safety should not be an issue with regard to the
20 health claim that's made, unless the health claim recommends
21 dosages that are considered unsafe and are prohibited by
23 If a high dose that would be needed in order to
24 achieve a health benefit carries significant risk that
25 causes it to be adulterated at that dosage, then you don't
1 need to consider the safety as part of the health claim
2 issue; you should have those dosages out of the marketplace
3 by declaring them adulterated and removed from the market on
4 that basis, rather than weighing into how it would impact on
5 the claim.
6 MR. SILVERGLADE: The other Bruce.
7 The court's discussion of the use of disclaimer
8 situations where a supplement affects health was quite
9 broad. Those were the words of the court--"affects health,"
10 and that could, of course, mean acute toxicity. It could
11 also mean encouraging a consumer to use an unproven remedy
12 when there's a proven remedy available. That consumer,
13 whatever their symptoms were, they're not going to get
14 better, they're going to get worse, and that's going to
15 affect their health.
16 Even in a worst case scenario, the consumer's not
17 going to know whether or not this supplement that's promoted
18 on the basis of a preliminary claim is actually working or
19 not. They may think it's working but they may be suffering
20 from a condition that's difficult or impossible to self-
21 diagnose and again their condition could worsen quite a bit
22 and they won't even know it.
23 So there's any ways for supplements promoted on
24 the basis of preliminary health claims to affect health and
25 we certainly believe the court, who certainly cares about
1 consumer welfare, would take all of these into account.
2 MR. EMORD: One additional point to qualify
3 Bruce's point. The court expressly stated to the agency
4 that similarly they say--well, we can just abbreviate it.
5 If the court says, and I quote, "The government's interest
6 in preventing the use of labels that are true but do not
7 mention adverse effects would seem to be satisfied, at least
8 ordinarily, by inclusion of a prominent disclaimer setting
9 forth those adverse effects."
10 So again the notion is full disclosure and
11 disclosure of the adverse effects.
12 MR. SILVERGLADE: The only problem is that
13 sometimes we don't know the adverse effects. Like on beta
14 carotene, we didn't know that the studies would actually
15 show that it might increase the risk of cancer in the
16 smokers. No one knew that so it's impossible to make an
17 effective disclosure in that situation.
18 MR. EMORD: I think you can. The disclosure is
19 simple. If you smoke, you might do well by not taking a
20 supplement with beta carotene in it.
21 The point is, and the scientific evidence there is
22 subject to dispute; it's not a conclusive point. One point
23 that needs to be pointed out here, I think, is that if you
24 wish to qualify something, the evidence had better be of
25 high quality to do that because you are necessarily
1 informing consumers of something that is negative, that will
2 dissuade them from doing something. And if the evidence is
3 inconclusive and you say it's inconclusive, that's fine.
4 But if the evidence is inconclusive and you suggest strongly
5 that it ought to be followed, then that, too, is misleading.
6 So Bruce's position that if there's inconclusive
7 evidence it ought to be stated categorically in a negative
8 sense is misleading to consumers.
9 MR. LEVITT: Dr. Lichtenstein, you'll have to
10 close up this question.
11 MS. LICHTENSTEIN: Two quick points. One is I'm
12 getting a little bit concerned about hearing about putting
13 claims on the label and also about putting disclaimers on
14 the label and how big the label actually is. From a very
15 practical point of view, I don't know if any studies have
16 been done on how likely it is that consumers are going to
17 read something dependent on font size but I think it's
18 actually an issue that can't be underestimated.
19 MR. LEVITT: Our second panel will get to address
21 MS. LICHTENSTEIN: Okay. The other issue has to
22 do with safety and it has to do with dosages. If the
23 recommended dosage is assumed to be safe or if there's no
24 evidence that there's an adverse effect, I think one also
25 needs to take into consideration that if I get a bottle of
1 something and it says that it may reduce my risk of breast
2 cancer, I may decide well, you know, if one pill's may
3 reduce my risk of breast cancer, maybe two definitely will.
4 And one can't assume that people are just going to be taking
5 what is in the actual dosage.
6 MR. LEVITT: Just before I pass the microphone
7 down to Peggy, we actually have reached the end of our
8 allotted time. Because I think this panel is so central to
9 what we're doing throughout the day, we'll go a little while
10 longer but we'll try to end by 12.
11 MS. DOTZEL: My question is directed at no one in
12 particular. I'd actually like to hear from as many members
13 of the panel who would like to address it.
14 What we're talking about today is providing
15 information to consumers and providing good information to
16 consumers. And my question is that if we're talking about a
17 standard, whether it be the emerging science standard or
18 some other standard other than significant scientific
19 agreement, it seems to me, and correct me if I'm wrong, that
20 we're getting into an area where it's probably more likely
21 that at some point in time we will learn new information
22 about certain claims, so the information that we put on the
23 label would have to change.
24 And my question is to the extent that we want to
25 give consumers good information on the label, how do we
1 address the issue of changing labels? If we have to change
2 these labels every year or two years or whenever new
3 emerging science comes out, how are we going to continue to
4 supply good information and how do we address any kind of
5 confusion that might create in the marketplace?
6 MR. EMORD: The question is a good one, obviously,
7 and science, because it is evolutionary, will result in
8 changes in information. We all recall the Surgeon General's
9 report on a package of cigarettes, something I know that's
10 rather sensitive to discuss with the agency today after the
11 Supreme Court's decision.
12 But to notice that the Surgeon General's language
13 evolved over time and that the recommendations on a
14 cigarette package evolved to mention other disease effects
15 that were a consequence of it, the point is that if
16 scientific evidence does establish that there is an adverse
17 effect that previously was unknown--anaphylactic shock and
18 peanut butter--a disclaimer alerting those individuals who
19 are in that subcategory that would be affected is
20 appropriate and the agency, as part of its duties to protect
21 the public interest and health, should be active in that
23 So I don't think it's appropriate--and the same is
24 true with regard to the drug regime. You update labels on
25 drugs periodically based on new scientific information; the
1 same should be true for supplements.
2 MR. SILVERGLADE: I think that's a very good
3 question. And as Dr. Lichtenstein illustrated with her
4 prepared statement, there's really new studies every couple
5 of months or every week really on some of these products.
6 And at a minimum, it would seem like the FDA would have to
7 require the industry to reprint labels twice a year or
8 something of that sort, which would just--I know from my
9 experience with nutrition labeling, the food and supplement
10 industries consider that to be a impossible burden, so I
11 really don't see how it's workable.
12 MR. CHASSY: I'm going to pick up on what Bruce
13 just said, even though it's not the question. I think that
14 industry would consider it an impossible burden to be
15 printing all the disclaimers that we're talking about.
16 I think you would need to set up a mechanism for
17 review. I think it's unrealistic to think that you could do
18 it on a rolling basis or every six months, but there should
19 be some ongoing review, which would mean a lot more agency
20 resources devoted to this category because there are a lot
21 of products out there. But unless you do that, you're going
22 to have to rely on manufacturers to be scanning the
23 literature and voluntarily updating however they qualified
24 their statement.
25 MR. HATHCOCK: I would just address two points
1 very briefly. The first is the idea that a claim should be
2 unlikely to change with new additional scientific
3 information that will accumulate in the future.
4 Let's suppose that you have a situation in which a
5 body of scientific evidence is judged barely to make the
6 significant scientific agreement standard or barely judged
7 to miss it. It's a close call either way, that boundary
8 under current practice. Those two bodies of evidence are
9 not significantly different other than they happen to be
10 with a very fine line drawn between.
11 So I think this concern about it being unlikely to
12 change can be exaggerated and perhaps it's been done
14 With regard to the controversy and the uncertainty
15 and the evidence that comes out even in a short period, as
16 Dr. Lichtenstein mentioned, that's not only true for
17 supplements but look at hormone replacement therapy. It's
18 one of the fixed features of health news, that somebody has
19 a new study on hormone replacement therapy and they've found
20 a benefit, but then they've found a new risk or have
21 repeated the same risk that we already knew as a point of
23 So I think it's not just the supplements; it
24 applies to practically all consumer products, including
1 MS. LICHTENSTEIN: Even if there was a mechanism
2 for updating labels, even if it was technically possible to
3 do it every six months, I think it's not necessarily going
4 to be possible to reprogram the way people think about the
5 claim that they have read because it's unlikely that people
6 are going to keep rereading the labels on their supplement
7 bottles, assuming that they've made a decision six months
8 ago, a year ago.
9 And that's why I think that one needs to have a
10 very, very significant body of evidence that most
11 likely--knowing that everything may change and that all
12 science is continually being reassessed, caution, as opposed
13 to assuming that you can just keep updating every one is
14 probably a more reasonable tack.
15 MR. EMORD: This is the precise reason why the
16 court's disclaimer is so good, because the term is used,
17 inconclusive. The claim is inconclusive and as long as the
18 claim is inconclusive, and that's the vast majority of
19 scientific information, there will be this bandying about in
20 the scientific community.
21 One way of serving the public and aiding in this
22 regard is for FDA to take an affirmative role, such as we've
23 suggested in our litigation, posting on your web site and
24 requiring in the label a reference to the web site, where
25 the agency's analysis of the varying conflicting scientific
1 evidence is presented there, and you can update this
3 If the evidence--so we have a weighing of the
4 evidence. You have the disclaimer that the evidence is
5 inconclusive. That carries along a rather good period of
6 time, I would suggest, because in most instances that's the
7 given play of science and there isn't a conclusive answer.
8 If there does come a day when there's a conclusive
9 answer that the claim is false, then it's inherently
10 misleading and the agency can say it's inherently
12 If there comes a day where there's information
13 about an adverse effect not previously a part of the claim,
14 then the agency can inform a party of that. And Bruce and
15 others will petition the agency. The agency will be
17 So I think that you could have an evolutionary
18 role and serve the public by posting on a web site this
19 information, as you do in so many other instances, as when
20 there is actual adulteration in the market, you use that.
21 You don't require all companies to put on their label that
22 some product imported was adulterated; be careful to examine
23 this product in detail to determine that it does not have
24 that in it.
25 So you can be fully disclosing information without
1 always changing the label.
2 MR. LEVITT: One final point here.
3 MS. LICHTENSTEIN: I'm very concerned about
4 relying on updating people on the basis of what happens to
5 be on a web site because I think it cuts out a lot of people
6 with respect to getting that information and it's perhaps
7 some of the people that it's most important to get it.
8 There's got to be another kind of mechanism. The literacy
9 rate in the United States is extremely high. Access and
10 utilization of the web is not, at this point.
11 MR. EMORD: One other point. We also recommended
12 an 800 number where the company would sponsor the 800 number
13 and you could call and get the information in print.
14 MR. LEVITT: We have time for one last question
15 but I'm going to ask the panelists to try to be brief with
16 this answer.
17 MS. BEHRMAN: Okay, and it's somewhat targeted.
18 It's for the panel members who believe that we should adopt
19 a standard less than significant scientific agreement. And
20 if we do adopt that standard or if that's how claims were to
21 be evaluated, I'm a little confused as to what would, in
22 fact, be full disclosure because we all agree there's going
23 to be conflicting evidence. And in drugs we have a slightly
24 different view of that and how we handle that but we also
25 have a whole lot more space on our label, and we have a
1 learned intermediary, so it's really different.
2 What should we be obligated to do with the
3 conflicting evidence? How do we fully inform and do so in a
4 way that actually will achieve some sort of consumer
6 MR. EMORD: First I think it's an important point
7 to note that as a matter of law, it's a fait accompli that
8 significant scientific agreement is not legally the barrier
9 to the dissemination of information.
10 Your standard is the First Amendment. The court
11 supplies you with the definition of the standard in the
12 decision. That's the standard you must apply. If you
13 constrict the universe in any way by substituting some
14 validity test for the First Amendment test, you necessarily
15 violate the First Amendment again.
16 So on the question of conflicting information, you
17 accurately characterize it for the consumer.
18 MS. BEHRMAN: Well, can I press you on that
20 MR. EMORD: Sure.
21 MS. BEHRMAN: Let's go back to not being
22 misleading, then. We have 11 studies, six of which are
23 favorable, five of which are not. So very vague. And I
24 believe by your standard you would believe that a claim
25 could be supported by that. How does one convey that degree
1 of uncertainty to the consumer?
2 MR. EMORD: Well regrettably, you have not
3 supplied sufficient information for anyone to knowledgeably
4 write a claim because the question is the qualitative value
5 of the study, what is being conveyed, the actual language of
6 the claim. We look at this very literally and it's the only
7 way you can do it. From an English language perspective,
8 what is the plain meaning of these terms? When we look at
9 the scientific evidence, is it conclusive? Is it
10 inconclusive? Is it so preliminary that there is--and it's
11 irrelevant. Is it relevant and preliminary? Is the claim
12 merely preliminary? Is the claim--let me give you an
14 Is the claim that there's little--this is the
15 claim. There is little scientific evidence to associate X
16 nutrient with Y disease. Nevertheless, we've included that
17 nutrient in here in the hopes that you may find it useful.
18 That's the claim that the person submits to you, okay?
19 MS. BEHRMAN: That's unlikely.
20 MR. EMORD: You see, the question is accuracy.
21 The question is accuracy and you can turn this agency into a
22 vehicle for disseminating information accurately to
23 consumers or you can reject that and create an iron wall or
24 even a semi-porous wall that robs consumers of health
1 What the court's telling you to do is to favor
2 disclosure over suppression. It's not easy in every case.
3 It's going to require, just as evaluating every drug
4 application is a different experience every time, the same
5 is going to be true here. You can't create a standard that
6 is invariable. You have to use the court's definition. It
7 is at a higher level of actualization.
8 MS. LICHTENSTEIN: I think we may actually be
9 agreeing for the first time. I think your example is very
10 good, that you've got six studies that say one thing and
11 five studies that say the opposite and you're right; we
12 don't have enough information. And I think that's where it
13 comes in to having to evaluate--one needs to evaluate each
14 individual study and then come to some kind of consensus,
15 whether it be scientific consensus or whatever, on whether
16 it's sufficient to actually make a claim.
17 MR. HATHCOCK: I concur with that. It will
18 require judgment. You must weigh the quality, as well as
19 the quantity, of the evidence and come to any decision.
20 Whether you use predominance of evidence or whether you use
21 preponderance of evidence or whether you use significant
22 scientific agreement or any other term, there's still a
23 judgment about what it all adds up to, and I don't think you
24 or we can avoid that.
25 MR. SILVERGLADE: I would just add again the
1 threshold question, though, for the agency is would the
2 preliminary claim adversely affect health? And there's a
3 very broad interpretation of that that can be surmised from
4 the court's opinion. And the agency shouldn't be in the
5 business of getting into weighing preliminary evidence if it
6 turns out that the preliminary claim could adversely affect
8 MR. LEVITT: In this case, the other Bruce.
9 MR. CHASSY: Let me pick up on that to say--
10 MR. LEVITT: And we'll have this be the last word.
11 MR. CHASSY: Include in "adversely affect health"
12 things that people might not now be consuming because of a
13 change that they made in their choice of either supplements
14 or foods. I think that's important.
15 My last word ius this. I don't understand how the
16 consumer is going to be robbed of precious information if we
17 put down an assertion and a disclaimer. We already say
18 "may" on even the validated health claims. If we soften it
19 more and we make it very long on the label, I just don't see
20 how that violates First Amendment rights. I understand the
21 legal issues here but to me, people are getting their
22 information other places.
23 As FDA's own studies show, a content claim on a
24 package is just as compelling to a consumer as a health
25 claim because the consumer already knows that Vitamin C is
1 good for them or beta carotene is good for them.
2 I would not lower the standard.
3 MR. LEVITT: Thank you and let me thank all the
4 panel members. I think it's worth a round of applause.
6 MR. LEVITT: This concludes our first panel.
7 Look in your sheet. The most important thing you
8 have is a green sheet which shows you places to eat. We
9 will try to reconvene at about 1:00. It's a little less
10 than an hour but I think there's time to get in and out.
11 1:00 we'll reconvene. Thank you.
12 [Whereupon, at 12:05 p.m., the meeting recessed
13 for lunch, to reconvene at 1:00 p.m., the same day.]
1 A F T E R N O O N S E S S I O N
2 [1:03 p.m.]
3 MR. LEVITT: If I could get people's attention,
4 please, it's time to start the afternoon session. Thank you
5 very much.
6 PANEL II
7 MR. LEVITT: Let me begin by welcoming the members
8 of our second panel, who are still in the course of
9 adjusting how to fit on very small chairs in a relatively
10 small space. So from this side of the table, we understand.
11 Our panelists this afternoon for the second panel
12 are Mario Teisl from the University of Maine, Michelle Rusk
13 from the Federal Trade Commission, Scott Bass, a lawyer
14 representing the National Nutritional Foods Association,
15 James Turner representing Citizens for Health, and Brett Kay
16 representing the National Consumers League.
17 We will follow the same procedure that we did this
18 morning. Each panelist will have 10 minutes and we'll go
19 right down the order. There is a little clock. Actually we
20 learned from this morning that you have to put your name
21 down so that people can see the clock. The way it was set
22 up, I could see it fine but the speakers couldn't.
23 The yellow light goes on when you've got about
24 three minutes left and the red light goes on when your time
25 is up. If the red light does go on--not to put any pressure
1 on you but in the last panel only one red light went on--and
2 I will remind you that the time is up and if you could try
3 to summarize, please.
4 We'll then go through a question and answer
5 format, going down the panel and having a discussion back
6 and forth.
7 To remind people, this is a continuation of our
8 discussion from the Pearson case. We've kind of shifted to
9 should you and what are the criteria for qualified claims to
10 a much more practical discussion of how do you make
11 qualified claims--what kinds of disclaimers, and so forth.
12 The actual question we wrote was: If such claims on dietary
13 supplements are to be appropriately qualified so that
14 consumers are not misled, what should be the characteristics
15 of such qualifying language? Should FDA require any other
16 information to assist consumers in evaluating health claims
17 and prevent them from being misled?
18 And with that, we'll start with Mario Teisl from
19 the University of Maine.
20 MARIO TEISL, UNIVERSITY OF MAINE
21 MR. TEISL: Good afternoon. Before continuing, I
22 want to thank the Food and Drug Administration for inviting
23 me to this important forum.
24 Today I'm going to answer the main question with
25 some specific recommendations based upon results from a wide
1 variety of consumer research. Although many of these
2 studies do not focus on dietary supplements, the
3 recommendations I make are based on findings that are
4 relatively consistent across studies. However, one should
5 note that consumer reactions to labeling programs often
6 differ based upon product-specific factors, and I would
7 recommend that more research be performed to gauge consumer
8 reactions to specific examples of dietary supplement
10 Finally, I would like to add that some of my
11 recommendations are contingent on the assumption that there
12 will be multiple levels of health claim substantiation
14 Now for the first recommendation. Disclaimers
15 should be simple, direct and strongly worded. The wording
16 of disclaimer messages can greatly influence their
17 effectiveness. Disclaimers that provide background or
18 general information are often ineffective. In fact,
19 consumers often view general disclaimers as simply a tool
20 the manufacturer uses to protect themselves legally.
21 In addition, the effectiveness of the disclaimer
22 is greater if it is intensely worded. Weakly worded
23 messages, even from highly credible sources, are ineffective
24 in changing consumer perceptions.
25 Recommendation two. Disclaimers will have to be
1 claim-specific to indicate to the consumer that the
2 substantiation of different health claims will vary.
3 Previous to Pearson, FDA had one uniform standard for all
4 health claims. However, after Pearson it seems that this
5 will no longer be true. Consumers will need to be informed
6 about this for several reasons.
7 First, consumers need to understand the
8 particulars of each product's level of substantiation to
9 more correctly evaluate the credibility of the claim. A
10 second reason for clearly delineating across claims is to
11 maintain the credibility of more highly substantiated
12 claims. Meagerly supported claims that may change
13 repeatedly across time as new health-related research is
14 performed are likely to generate higher levels of skepticism
15 for all health-related claims.
16 In addition, the reputation of agencies like the
17 FDA seen as regulating the health claims is also likely to
19 Number three, disclaimers should focus on
20 providing information that is new to the consumer. Telling
21 the consumer what they already know is not particularly
23 Number four, disclaimer items should be physical
24 separated from other nondisclosure items. There are two
25 reasons to separate disclaimer from the other information.
1 First, reducing the amount of informational clutter around
2 the disclaimer increases the readability and ease of use.
3 Second, the disclaimer should be understood by consumers as
4 a regulatory mechanism, not as part of the marketing
5 information provided by firms. Consumers see regulated
6 information mechanisms as much more credible than firm-
7 provided information.
8 Number five, the actual disclaimer should be
9 placed on the back of a product container. In general,
10 consumers view the front of the container as the area that
11 the manufacturer uses to sell the product, whereas the back
12 of the container is the area where regulated information is
14 Number six, a reference to the disclaimer should
15 be located close to the claim and clearly refer to the
16 presence of a disclaimer. In general, the presence of a
17 disclaimer tends to reduce the likelihood that consumers
18 will continue their information search onto the back of the
19 container. Thus as asterisk or simple footnote-type
20 reference may not be enough because consumers may mistakenly
21 think that the footnote refers to material that supports the
23 Number seven, to enhance readability and increase
24 effectiveness, the font size for the disclaimer and for the
25 reference to the disclaimer should be comparable to the font
1 used in the health claim.
2 Number eight, definitions of all terms should be
3 consistent with common understanding and usage. Consumers
4 must be able to understand before they can use the
5 information provided. Research should ensure that
6 consumers' perceptions of any important information are the
7 same as those that the agency intends.
8 Number nine, the disclaimer label should provide
9 references to disclosures of supporting documentation
10 available at off-label locations. Informed consumers should
11 have access to detailed information about a health claim's
12 level of substantiation. The label does not have the room
13 needed to provide this detail, thus necessitating an off-
14 label disclosure.
15 Number 10, if the disclaimer is to have supporting
16 documentation, then this documentation should be placed
17 prominently at the point of purchase and be made available
18 on a secure FDA website to permit consumers to examine and
19 easily compare different products. Each product's
20 disclaimer should refer to the availability of the
21 supporting information.
22 Number 11, all disclaimer and disclosure
23 information should be presented in a standardized format to
24 decrease consumer confusion and increase credibility. Where
25 possible, this includes standardizing the size and location
1 of displays, font type and size, terms and definitions and
2 any graphical elements. If different products exhibit
3 different disclosure structures, then making comparisons
4 among products will be difficult. Consumers want product
5 information standardized so that they can make apples-to-
6 apples comparisons.
7 Number 12, research should be performed to
8 determine the feasibility of developing methods to summarize
9 or score the level of substantiation for a claim. Even with
10 the availability of more detailed supporting documentation,
11 time and cognitive constraints will probably not allow many
12 consumers the ability to assimilate the detailed
13 information. One simplifying strategy would be to create
14 some sort of ranking or rating scale that could be used as a
15 signal for the level of support made for a claim. Of
16 course, a major difficulty here is that developing such a
17 scheme will be highly difficult and probably highly
19 Thirteen, if a scoring mechanism can be developed,
20 then providing some sort of benchmark information may
21 provide clarity and increased understanding. An example
22 would be the inclusion of a minimal acceptable score or some
23 descriptive text highlighting whether the level of
24 substantiation was low or high.
25 Number 14, disclaimers and other disclosure
1 information should be product-specific. Consumers want to
2 know about the attributes of the product. For example,
3 dietary supplement users want to know about recommended
4 dosages, possible interactions between the supplement and
5 other medications, the overall safety of the product, any
6 side effects associated with the product, any special
7 considerations for specific population groups--for example,
8 children. General information will not allow consumers to
9 differentiate products in the manner they most desire.
10 Finally number 15, dietary supplement labeling
11 should be part of a more general information strategy.
12 There are two parts to this information strategy, each
13 having its own aim. One part of the information strategy
14 should focus on heightening consumer awareness of the new
15 labeling program. Successful labeling programs are often
16 linked to either a public education campaign or to a
17 heightened exposure of the problem within the media. It is
18 a combination of labeling and off-label education that seems
19 to be most effective in altering consumer perceptions and
21 The aim of the second part of the information
22 strategy is to have consumers question the prior
23 assumptions. One incorrectly held assumption is that some
24 consumers think that after they use a particular product,
25 they can independently assess whether the product was
1 effective, which in most cases the consumer cannot do.
2 Another incorrectly held assumption is that
3 consumers seem to view health claim disclaimers solely as a
4 comment about the reliability of the supporting research.
5 However, the disclaimer is often meant as a commentary on
6 both the reliability and the validity of the supporting
8 These two assumptions taken together lead many
9 consumers to believe that the only way to determine the
10 effectiveness of a product is to try it and see. This try-
11 it-and-see attitude complicates matters in the long run
12 because positive perceptions of one product experience can
13 influence how consumers view similar products.
14 Further, as consumers develop increased experience
15 with products, they're more likely to reduce the level of
16 information search prior to purchasing similar products.
17 The summation of all these effects is that the
18 impact of any disclaimer information will be greatly reduced
19 with more experienced consumers. Labeling by itself will
20 probably not affect these individuals unless an information
21 campaign successfully makes these consumers question their
23 To finish I'd like to reiterate that the actual
24 implementation of these recommendations will require
25 additional research. Given the low level of scientific and
1 statistical literacy in the U.S. and the complex nature of
2 determining health effects, an expanded health claim
3 labeling program for dietary supplements will have to be
4 carefully designed. Poorly designed labeling is likely to
5 generate confusion, which will lead to incorrect product
6 choices and to an overall reduction in societal welfare.
8 MR. LEVITT: Thank you very much.
9 Our next speaker is Michelle Rusk for the Federal
10 Trade Commission. And as people have heard already, their
11 research has been cited several times today.
12 MS. RUSK: For all kinds of propositions.
13 MR. LEVITT: So we're glad you came.
14 MICHELLE RUSK, FEDERAL TRADE COMMISSION
15 MS. RUSK: Thank you for allowing me to take part
16 in this meeting this morning and to describe the FTC's
17 experience with qualified health claims in advertising. I
18 hope it will be helpful as you develop your labeling
20 Before I begin I need to make a qualified claim
21 myself and that is that while I can describe the
22 commission's policy and our experience with qualified health
23 claims, any opinions I give today are my own and not the
24 official opinions of the commission.
25 My comments this morning will cover four aspects
1 of this issue. First, I'm going to outline the FTC's policy
2 on health claims in advertising. Second, I will talk about
3 what the FTC has learned from consumer data and cases about
4 the content of disclosures; that is, what it takes to
5 effectively qualify claims to reflect the state of the
6 science. Third, some facts about format and you'll hear a
7 lot of what you've already heard from Mario this
8 morning--how disclosures should be presented, what are the
9 elements of a clear and prominent disclosure?
10 And finally, I'd like to stress the importance of
11 gathering consumer research to confirm that the right
12 message is really getting across.
13 Under Section 5 of the FTC Act, claims are
14 permitted in advertising as long as they can be qualified to
15 prevent the misleading interpretations. The commission will
16 only prohibit or ban a claim outright if the potential for
17 deception cannot be cured by disclosure. And that's the
18 starting premise for the FTC's approach to health claims,
19 which we described in our '94 Food Enforcement Policy
20 Statement. That policy statement dealt with food health
21 claims but the same principles apply equally to supplements
22 and we reiterated those in our Dietary Supplement
23 Advertising Guide.
24 Very simply, the FTC views health claims as
25 falling into sort of three basic categories. One is the
1 unqualified health claim--"This product will do X." The
2 second is a qualified claim based on strong emerging
3 science, and the third, a claim that runs contrary to the
4 weight of the evidence.
5 For the first category, for unqualified claims,
6 the FTC has recognized that the significant scientific
7 agreement standard, as applied by FDA, is the principal
8 guide that we also use in determining whether the claim is
9 adequately substantiated. An unqualified claim, if it has
10 not been approved for labeling by FDA, is likely to be
11 considered deceptive under FTC law for advertising.
12 The second category is carefully qualified health
13 claims based on a strong area of emerging science. The FTC
14 law does provide some leeway for qualified claims and I'll
15 quote from the Food Policy Statement. "The commission
16 recognizes that there may be certain limited instances in
17 which carefully qualified claims may be permitted under
18 Section 5, although not yet authorized by the FDA if the
19 claims are expressly qualified to convey clearly and fully
20 the extent of the scientific support."
21 Finally, if a claim is contrary to the weight of
22 the evidence, it is likely to be deceptive under FTC law and
23 therefore prohibited no matter how carefully it is
25 Our experience has been that figuring out how to
1 effectively qualify that middle category of claims is a real
2 challenge. Without adequate disclosures that clearly convey
3 any significant limitations or any inconsistencies in the
4 literature, consumers can easily be misled.
5 Generally, consumer evidence on the subject of
6 qualification of claims suggests that it can be very, very
7 difficult to do effectiveness, especially where
8 qualification is necessary to communicate complex scientific
9 information. There are a number of challenges.
10 The first hurdle is the amount of information
11 consumers can and do assimilate. At least in the
12 advertising context, the data shows that disclosures need to
13 be simple, concise and direct and that consumers don't
14 really absorb more than one or two simple messages.
15 Condensing information about the weight and validity of
16 scientific evidence into a simple, comprehensible disclosure
17 is not going to be easy.
18 Another hurdle is the consumer's tendency to
19 discount negative information when it's qualifying a primary
20 and positive claim, and there is even some evidence that a
21 subsequent disclosure can have the perverse effect of
22 actually reinforcing rather than limiting the primary claim.
23 And I want to give you a quick example of that from our food
24 copy test.
25 Part of that copy test, which was commissioned and
1 released in '98, looked at a hypothetical ad touting the
2 health benefits of a high fiber soup. The question was
3 whether the health claim would create a halo effect that
4 would override any other negative information about the
5 product. We looked at the effect of various disclosures
6 that were designed to convey that the soup was also high in
7 sodium, to the point of perhaps being unhealthful.
8 What we found, at least in this one example, in
9 this copy test, was that the conflicting positive and
10 negative health messages confused many consumers. Even when
11 the disclosure was worded as a direct health warning about
12 the high sodium content, many consumers tried to interpret
13 that as being somehow a positive commentary on the food.
14 The FTC has also done some consumer research as
15 part of that same copy test specifically on the issue of
16 what it takes to qualify claims based on emerging science.
17 Consumers in this part of the test were shown one of a
18 series of mock ads with increasingly strong disclosures that
19 described limitations on the science supporting a
20 hypothetical health claim.
21 As an example, one group of ads described the
22 science linking a fictitious anti-oxidant vitamin supplement
23 with a reduction in cancer risk. The ads ranged from ones
24 that stated science had proven a cancer benefit through four
25 ads, each with increasing decrees of qualification about the
1 science. Consumers were then asked, for each ad, how sure
2 scientists were about the cancer benefit.
3 The results of the test suggest that claims based
4 on emerging science require strong, specific and direct
5 disclosures if they're going to succeed in conveying
6 anything about the limitations of the science. For an
7 example, the most effective of the ads that we tested
8 contained the language--I'm quoting from the ad--"It's too
9 early to tell for sure. Some recent studies have failed to
10 show a benefit. Longer-term research is needed." And only
11 when all of those phrases appear together in one ad do
12 consumers' rating about the scientific certainty drop below
13 their rating for the absolute proof claim.
14 Another very relevant finding, and I think it
15 directly contradicts something that one of the speakers said
16 this morning, was that simply inserting the word "may" into
17 the claim--"Studies are now finding that the product may
18 reduce the risk of cancer"--had no effect on how consumers
19 viewed the state of the science.
20 It's also important to note that the copy test
21 chose areas where we felt, at least at the time, there was a
22 reasonably strong body of emerging science and it seems
23 reasonable to assume that claims based on more preliminary
24 evidence would likely require even stronger qualification.
25 Getting the content of the disclosure right
1 doesn't guarantee that consumers are going to get the right
2 message. The other challenge is to get the format right and
3 to present it in a manner that consumers both notice and
4 understand any disclaimer.
5 The commission has developed some principles
6 defining what constitutes a clear and conspicuous disclosure
7 and the goal really is don't be subtle.
8 Placement or proximity to the claim. Obviously a
9 disclosure is most effective when it is placed near the
10 claim it qualifies. Proximity increases the likelihood that
11 consumers will see the disclosure and that they will relate
12 it back to the relevant claim. Is it adjacent to the claim?
13 Is it separated by other text or graphics? Is it on the
14 same panel or is there an asterisk to another part of the
16 Prominence. Type size also matters. The FTC has
17 often rejected disclaimers that were appearing in fine print
18 footnotes. It's important to consider the relative type
19 sizes of the disclosure compared to the claim it's limiting.
20 Contrasting color. A surrounding border to offset
21 the disclosure can help to make it more noticeable.
22 Distracting elements. Clutter on the label or in
23 the ad obviously are going to interfere with the disclosure.
24 So you really have to look at all of the elements
25 of the label to ensure that other text and graphics are not
1 going to distract consumer attention away from the
2 qualifying message.
3 And finally clarity--almost done.
4 MR. LEVITT: Your time is up but you should
5 continue because this is groundwork for the rest of the
7 MS. RUSK: I have one minute.
8 MR. LEVITT: Go ahead.
9 MS. RUSK: Clarity is closely related to content
10 issues. In the FTC's experience, a disclosure needs to be
11 presented in clear, simple language and syntax with as
12 little technical or medical jargon as possible. And I think
13 there's a real tension there in keeping the message simple
14 and communicating something as complex as varying level of
16 If there's one message I want to stress on this
17 slide, and it's nicely hidden at the bottom here, but fine
18 print footnotes just are not going to be effective.
19 The last thing I'd like to say is I really want to
20 stress the importance of looking at consumer research in
21 this area, given the inherent difficulties here. Under FTC
22 law, the adequacy of disclosure is measured by its
23 performance. How do consumers actually perceive it? Do
24 they understand it within the context of the entire ad or
1 Our experience has been that it is hard to get it
2 right, that consumer research has often shown us that a
3 disclosure that seems reasonable on its face turns out to be
4 ineffective or have unintended effects. Thank you.
5 MR. LEVITT: Thank you very much.
6 Our next speaker is Scott Bass, even though we
7 have asked him to take his name down so we can see the timer
8 in front. Scott is representing the National Nutritional
9 Foods Association.
10 SCOTT BASS
11 NATIONAL NUTRITIONAL FOODS ASSOCIATION
12 MR. BASS: Thank you for requesting the input of
13 NNFA. This is oldest and largest association representing
14 thousands of natural product retailers, distributors and
15 manufacturers. NNFA has been active in governmental
16 proceedings affecting dietary supplements and other products
17 for over 60 years.
18 I'm a partner in the Washington, D.C. office of
19 Sidley & Austin, general counsel for NNFA.
20 NNFA has been asked to deal with the question of
21 how to phrase qualifying language for health claims and
22 whether additional information is necessary to assist
23 consumers with health claims. Before answering those
24 questions, we must touch upon the issues posed to panels one
25 and three, starting most logically with the latter.
1 At bottom, NNFA believes in the integrity of the
2 product category system. That's the system established in
3 the federal Food, Drug and Cosmetic Act. It believes that
4 some products are so severe in effect and carry such high
5 risk in relation to their potential high benefit that they
6 need careful FDA review.
7 In short, NNFA believes that this country does
8 need a drug approval system. We note that this was
9 reflected in the negotiations that led to DSHEA. Sections
10 201(f)(f)(3) and 403(r)(6) explicitly separate dietary
11 supplements from drugs.
12 Pearson, taken to its logical extreme, could be
13 misread to permit any claim to be made with appropriate
14 qualifiers. NNFA strongly opposes any such reading or
15 implementation of that decision.
16 NNFA does wish to note that there may be other
17 drug categories, such as traditional herbal medicines, for
18 which it would not be appropriate to impose premarket
19 approval regimens. But once again NNFA acknowledges that
20 greater controls are necessary than in the food or dietary
21 supplement area.
22 Assuming then that there should be health claims
23 and not just one category of therapeutic health claims with
24 endless qualifiers, the question is what is the appropriate
25 standard and what type of disclaimers may be made that are
1 consistent with that standard?
2 NNFA believes that the significant scientific
3 agreement standard was too rigidly applied by FDA and is
4 still the subject of too much confusion. In the dietary
5 supplement context we note that the reason that Section
6 403(r)(5)(d) was drafted in NLEA was precisely to permit FDA
7 to incorporate rapidly advancing science into the health
8 claims approval process and to adapt this new marketplace.
9 FDA's failure to implement that newer standard in proposed
10 regulations in 1991 actually spawned the DSHEA effort.
11 DSHEA and Pearson alter the FDA claims review
12 standard. NNFA believes that the significant scientific
13 agreement standard should operate in practice more like the
14 manner in which GRAS panels operate. There is give and
15 take, there is consideration of alternatives, and there's
16 very careful consideration of the advancing state of
18 What NNFA believes should not occur is the
19 rigidity with which the old food additive standard was
20 applied as a safety measure to set dietary supplements.
21 Moving then to disclaimers, Pearson says that
22 disclaimers are preferable to suppression. NNFA agrees.
23 That case also says that FDA can ban claims where the
24 evidence against the claims outweighs the evidence in favor
25 of the claims. NNFA wants to see consumers protected.
1 A key portion of adequate substantiation is the
2 consideration of safety. The higher the risk, the stronger
3 the disclaimer needs to be. A good example of strong
4 disclaimers are the warnings that responsible companies have
5 adopted on Effedra labels.
6 NNFA believes that qualifying language should be
7 short, very short. It should be very pointed. The warning
8 should be phrased in a way--or disclaimer--that product
9 liability warnings are phrased, by experts who draft such
10 warnings. Phrases such as "Animal studies only; not tested
11 on humans," "Limited number of human trials; efficacy not
12 fully established," and/or "Not proven in humans" are
13 examples of such strong language.
14 We do disagree with FTC to the extent that they
15 believe that prefatory language has no role. We believe
16 that precatory language is understandable to consumers.
17 NNFA believes that disclaimers should be in
18 proximity to the principal claim and they should appear
19 whenever that claim appears on labels, labeling, or in
21 On the other hand, NNFA does not believe that FDA
22 should require disclaimers for every type of health claim.
23 It is only where the science falls short of a reasonable
24 significant scientific agreement standard or where safety
25 issues so mandate that a disclaimer should be required.
1 NNFA does believe that there should be additional
2 information provided by FDA through publicity and through
3 consumer booklets and website information. One area that
4 would be very helpful would be category-specific information
5 in addition to general information on what disclaimers mean.
6 NNFA does not believe that consumers will absorb general
7 rules about health claims and disclaimers but will focus
8 upon the names of the products they intend to purchase.
9 Needless to say, NNFA believes that the
10 information provided to consumers should not be negative
11 about a product or product category but rather, informative.
12 NNFA believes that the majority of the dietary
13 natural products industry is responsible and desires proper
14 guidelines. The interests of the consumers are paramount
15 and while there's some inherent risk in promoting the
16 benefits of healthful products, that risk is far lower for
17 dietary supplements than it is for prescription drugs.
18 Congress made a definitive statement when it
19 created a new dietary supplement category in DSHEA. It also
20 left the drug category intact. NNFA believes that Pearson
21 should be implemented in a fashion that gives full meaning
22 to Judge Silberman's decision while, at the same time,
23 retaining the safety underpinnings of the drug versus
24 nondrug categorization in the federal Food, Drug and
25 Cosmetic Act.
1 In assessing the viability of disclaimers on
2 health claims, that effort should not extend beyond health
3 claims as such. Assuming that the bright line dividing
4 health claims from structure/function claims is the mention
5 of disease and assuming that health claims are primarily
6 claims for prevention or risk reduction of long-term or
7 chronic disease conditions, disclaimers can be fashioned in
8 simple, strong language that inform the consumer and permit
9 an expanded array of claims. Thank you.
10 MR. LEVITT: Thank you very much.
11 Fourth speaker in this panel is James Turner,
12 Citizens for Health. Jim?
13 JAMES S. TURNER, CITIZENS FOR HEALTH
14 MR. TURNER: Thank you very much. Citizens for
15 Health also thanks you for inviting us to participate.
16 Citizens for Health was very much involved in the passage of
17 DSHEA, having generated a substantial number of comments to
18 Congress. Also it's been involved in a couple of other
19 campaigns--one getting responses to the USDA's comments or
20 proposals on organic food, and then also to FDA with regard
21 to the definition of disease.
22 And we also wanted to, as I said I would say last
23 time, thank the agency for having responded in a way that we
24 felt was responsive to our comments. I hope they had some
25 help in shaping that view.
1 In the current situation, we feel very strongly
2 that the core decision-maker about the relationship between
3 whether--the decision about whether somebody should or
4 should not consume a dietary supplement is an issue that a
5 consumer should make for themselves and we see the agency as
6 being an ally in helping the consumer make that decision, to
7 be able to create data, information, knowledge, guidance
8 that will help consumers make this ultimate decision.
9 In that framework, I believe that there's somewhat
10 of a historical shift from the FDA being a surrogate
11 decision-maker for the consumer; that is, an agency that
12 defined the things that people should take or could take or
13 be allowed to take. And I believe that that direction,
14 which is, I believe, under way in the consumer community
15 itself, is being reinforced by both Congress and the courts
16 in the kinds of decisions we've been seeing.
17 I think this offers a significant challenge to FDA
18 in expanding its role as a new kind of regulator. It's not
19 a stop-go regulator as much as it's now an accelerator-brake
21 In that setting, I think that the FTC guidelines
22 that have been articulated here provide a very interesting
23 and useful framework. With a couple of comments, the area
24 of using emerging science claims in the FTC--that whole set
25 of guidelines was established before Pearson in the area
1 that recognized the idea of emerging science claims was in
2 an area that was outside of what FDA had allowed using
3 significant scientific agreement.
4 What I'm suggesting now is that that category has
5 broadened enormously in the framework of Pearson, and I have
6 a small footnote. The first time I was aware of emerging
7 science as a concept was during the Keystone project on
8 food, nutrition and health, and one of the committees which
9 I served on generated that concept for a very specific
10 reason. That reason was that there is no limitation
11 whatsoever on what can be said by people about dietary
12 supplements and their usefulness by people who do not sell
13 dietary supplements. That is a book can be written and can
14 say anything.
15 So you have an enormous area of speech that is
16 totally protected, where the consumer is gathering
17 information with no regulatory guidelines of any kind.
18 Our idea was to create a framework where there
19 could be some help to the consumer to evaluate the kinds of
20 claims that were coming from the general society by allowing
21 claims that could go onto labels that were more robust in
22 their content than the specific, narrow stop-go kinds of
23 claims that were being referenced with significant
24 scientific agreement.
25 The idea was, in fact, to expand the regulatory
1 framework to allow FDA to have a participation in more
2 things that the consumer was using to make decisions, all
3 with the idea of helping the consumer make decisions.
4 I also want to make another point, which is
5 significant scientific agreement still isn't defined, so
6 we're not at all clear what category we're talking about.
7 But if you were to follow the FTC guidelines and create a
8 larger framework from the FDA for emerging science claims,
9 you have a much broader area, even for FTC activities to
10 regulate or to allow is what I'm saying.
11 When you broaden out the amount of information the
12 consumer is going to receive that is proactive about a
13 substance, then the need for disclaimers becomes more
14 necessary. And I think again a context is needed to think
15 about what the disclaimer-claim relationship is.
16 We got into the area of proving efficacy in the
17 1962 amendments when the concept was that efficacy could be
18 established by substantial evidence. That particular
19 standard, according to the legislative history, was a
20 standard that was designed to prevent fraud. The idea was
21 to prevent a claim for which there was no evidence.
22 That, over time, has evolved into a much more
23 rigid claim in the drug area, so that you now have to
24 establish efficacy. But the purpose when the law was passed
25 was substantial evidence was necessary to support a claim of
1 efficacy in the drug area. The purpose was to avoid a claim
2 or to make illegal a claim for which there was no evidence,
3 and substantial evidence at that time, the way it was used,
4 meant more than a scintilla of evidence. There was some
5 evidence to support that claim.
6 The Pearson case and the history of FDA claims,
7 the way that they're unfolding, is moving back in that
8 direction with regard to this category of products, which,
9 by the way, were always foods and still are foods. Dietary
10 supplements are foods. In fact, DSHEA--the complete
11 opposite of what we read in the press--DSHEA did not weaken
12 the regulation of dietary supplements; it strengthened it.
13 It strengthened it in quite dramatic ways, and that's
14 important to understand.
15 In this claim situation that we're talking about,
16 once you start moving into an area which is required by the
17 First Amendment to allow manufacturers of products or
18 sellers of products to make claims that are comparable to
19 the claims that are made by unregulated speech in books that
20 are people unrelated to a product, as soon as you start
21 moving into that area, the most important single fact is
22 that the information allowed be accurate, that it be clear
23 and accurate.
24 Interestingly enough, in the first NLEA proposed
25 regulations, this kind of information was contemplated. One
1 of the sections allowed the statement, "Preliminary data
2 suggest that X may Y." "Preliminary data suggests" is a
3 disclaimer that was actually originally thought to be part
4 of the way that NLEA was proposed, was passed, and FDA
5 proposed regulations including that.
6 When FDA promulgated the final regulations, it
7 rejected that alternative but never said it didn't have the
8 authority to require that alternative or to allow that
9 alternative. It merely said they felt that it was not
10 appropriate because it was not easy for consumers to
11 understand. It did not, however, say that it could not,
12 under NLEA, permit such a preliminary data statement.
13 It's our belief that in the context of the notion
14 that what we're attempting to do here is to move information
15 into the hands of consumers through the commerce vector, to
16 make it possible for consumers to have a better standard or
17 better quality of information than they get from totally
18 unregulated information, that in order to do that
19 effectively, using things such as "Preliminary data
20 suggests" helps the consumer make those kinds of choices.
21 Now I noted in the FTC presentation the notion
22 that there was a halo effect that was identified around the
23 soup example. There is also evidence in FTC studies that
24 disclaimers such as those that can be made about anti-
25 oxidants do affect consumer choice. They do change the way
1 that consumers buy.
2 In other words, we need to have more data on how
3 these things actually work and how they are working in the
4 marketplace against the standard of making as much clear
5 information available to the consumer as possible. That's a
6 standard that is a different standard than saying we must be
7 careful to protect the consumer from information that may be
8 harmful. They're two sides of the same coin. I believe the
9 outcome of doing the former would be the same, in the
10 positive sense, with less negative pay-off.
11 Finally, it's our view from Citizens for Health's
12 point of view that this is a sound category that is part of
13 the consumer taking on--that is, the category of dietary
14 supplements is a sound category that is evidence of the
15 consumer taking on more responsibility for their own health
16 and choices and that the FDA role is to move with that
17 desire and effort on the part of the individual consumer and
18 consumers as a class to help them make those kinds of
19 decisions, rather than to stand in the way and try to make
20 the decisions for them or to guide them into certain kinds
21 of decisions.
22 In the law, the standard is that the reasonable
23 consumer is the one to be looked at, not the at-risk
24 consumer--in labeling law, we're talking about. The
25 reasonable consumer is the standard to be used, not the at-
1 risk consumer, for this kind of decision-making.
2 Thank you very much.
3 MR. LEVITT: Thank you.
4 The final speaker in this panel is Brett Kay,
5 National Consumers League.
6 BRETT KAY, NATIONAL CONSUMERS LEAGUE
7 MR. KAY: Thank you. Again I want to thank the
8 FDA for inviting me here to present the views of the
9 National Consumers League, America's oldest nonprofit
10 consumer advocacy organization.
11 I believe I can answer the question that was
12 presented before this panel in one word, which is context.
13 Consumers need information that makes sense to them and it
14 needs to be in a context that they can understand when
15 they're taking these products.
16 What I mean by that is much of the information in
17 labeling on dietary supplements currently does not fully
18 explain what it's intended to do, how it works, what are the
19 best ways to take it, things such as warnings and
20 contraindications, and without such information, consumers
21 cannot make informed choices. I feel that the health claims
22 will only further serve to confuse consumers if there are no
24 Just as in the direct-to-consumer ads for
25 prescription drugs that are currently out there, there must
1 be a fair balance, there must be talk about risks and
2 benefits. So, too, must health claims have a fair balance
3 to explain the science and the claims being made.
4 According to a survey that NCL, the National
5 Consumers League, commissioned last year by Lou Harris and
6 Associates, consumers feel labeling and product information
7 have improved over the last decade and consumers do feel
8 that their shopping skills have improved, as well, and
9 that's the good news. With the passage of important
10 consumer labeling laws, such as the Nutrition Education
11 Labeling Act, the NLEA, consumers have much more information
12 about the food that they're eating and, more importantly,
13 they have a context with which to judge that food.
14 As Mr. Teisl alluded to earlier, not only is there
15 more information on fat, saturated fat, fiber and
16 cholesterol, for instance; they've also learned why these
17 are important because there have been public education
18 campaigns that have followed up behind that to alert people
19 of the new labeling and to get them to understand not only
20 what is on the label but why what is on the label is
21 important and how it has a significance to their health.
22 And I feel that the same needs to hold true now
23 for the health claims and for dietary supplements. The bad
24 news, I guess, is sort of that when it comes to dietary
25 supplements, we're still in pre-NLEA days. Consumers do not
1 have this type of information on the backs of the products
2 in the same way and there's not any type of consumer
3 education, public campaigns to help explain to consumers
4 what these products are for and not only what they're for
5 but why it's important that when they're taking them, how to
6 take them and how it relates directly to their health.
7 NCL feels that this information is necessary to
8 make educated choices, yet unfortunately, consumers are
9 increasingly using dietary supplements, most times without
10 such information or the supervision of doctors and
11 pharmacists or other health professionals. Without some
12 form of qualifying language, consumers just don't have all
13 the facts.
14 To give you an example which is sort of off to the
15 side but I think illustrates some of this issue of having
16 qualifying language, it's ginseng. There's three different
17 types of ginseng. There's an Asian, a Siberian and an
18 American, and each has different properties and active
19 ingredients in them but they're often lumped together as
20 just ginseng or all three of them are combined into one
21 product, with similar claims for its effects.
22 Now according to some of the traditional Chinese
23 medicine and some of the other herbal experts, traditional
24 Chinese medicine treats according to balances in the
25 body--the yin and yang, hot and cold. The Asian ginseng is
1 regarded as a heating tonic and a yang, which would be
2 inappropriate for those who are already heated up, while
3 American ginseng is a cooling tonic, a yin. So thus they
4 have opposite effects and purposes.
5 So what happens then if they are combined? Do
6 they cancel each other out? Are there synergistic effects
7 which make one superpotent? What I'm trying to say is what
8 if the consumer is looking for one but gets the other? They
9 don't have a context. There's nothing explained to them why
10 one product is used for one thing or the other and this only
11 serves to confuse consumers.
12 And I certainly don't expect American consumers to
13 learn the intricacies of traditional Chinese medicine
14 clearly, but what they do need to know, and which
15 disclaimers on labels can help is to explain why they're
16 taking it and what the products are intended to do. That's
17 sort of what I mean by context, what I feel needs to be
18 qualified by health claims so that consumers are not misled.
19 I know that's sort of a jump. I tried to use that as the
21 In the area of dietary supplements, the term is a
22 bit misleading these days. In today's market, whereas the
23 name implied that supplements were products intended to
24 supplement the diet, replace or enhance nutrients that one
25 does not get from their diet and are regulated certainly in
1 law as foods, this is not how supplements are being used or
2 marketed currently. I think that the paradigm has shifted
3 and supplements are really being treated more like
4 medicines. And I think this is the area where we need to
5 look at them in terms of the claims and the qualifying
7 Consumers are taking supplements to treat diseases
8 and health conditions, such as depression and high
9 cholesterol, prostate problems, arthritis, and the list goes
10 on, whether or not this is what they're ultimately intended
11 to do. I know the disclaimer on them currently says not to
12 treat--you know, the product is not intended to treat, cure
13 or prevent disease. However, that is what consumers are
14 using them for and that's what the implications are when
15 they go to purchase these products.
16 They see a label claim, whether it be a
17 structure/function claim, a nutrition content claim or
18 health claims, and they don't make the distinction that has
19 been established by Congress or the FDA or lawyers who have
20 written these claims. I think that the legal nuances are
21 often lost on the average consumer. They see a claim and
22 assume that the FDA has approved the product and that it's
23 safe and effective. Without some kind of qualifying
24 language, I think that the consumer might not know that
25 there is some type of science that says that this may be
1 effective or not proven in animal studies.
2 I agree with Mr. Bass in the sense that there
3 needs to be strong, clear language that qualifies these
4 health claim statements and it must be easily understood.
5 In order to ensure that consumers are not misled,
6 I think that there, as I've said, needs to be clear language
7 that's written in lay terms. It can't be in legalistic
8 jargon designed to sort of straddle a regulatory hurdle but
9 it needs to be designed to inform the consumer about the
10 product that they are taking, language similar to the
11 medicine guide requirement language, which was approved by
12 Secretary Shalala in 1996 during the Keystone process that
13 Mr. Turner talked about for prescription drug labeling--not
14 to say that they should be regulated in the same way, but
15 the information that is out there to the consumers needs to
16 be laid out in a similar format, which is medguides are
17 designed to provide context for consumers taking the
19 The name of the drug, what it's used for, how it's
20 taken are all laid out in simple, clear format in consumer
21 language. They would use white space. Important is
22 readability on some of these claims, as well. you know,
23 clear fonts in a black type with a white background. A
24 standard format is necessary if consumers are to be able to
25 look up the information and get it and glean what is the
1 important parts of it from that. I feel that the health
2 claims on the dietary supplements are going to need similar
3 labeling and similar format so that consumers are fully
4 informed and not misled.
5 There is some precedent with this currently in
6 that the new over-the-counter medicine OTC label language
7 has come out, which has helped to really clear up, I
8 think--they're not implemented yet but they have been
9 passed--to clear up a lot of the formatting and design on
10 OTCs to help consumers, make them much more readable and
11 much clearer, and I think that the qualifying language for
12 health claims needs to have a similar format so that
13 consumers really can get the important information in an
14 easy-to-read format. Thank you.
15 FDA PANEL DISCUSSION
16 MR. LEVITT: Thank you very much.
17 Just looking at the time and looking at what is on
18 the yellow sheets, we started about 15 minutes late from
19 what this sheet said, so we'll try to run this panel about
20 20 minutes, until quarter after. We'll use the same format
21 as we did before. I'll start.
22 My question relates to whether we should think of
23 what I would call generic disclaimers or whether we should
24 try to think of what I would call tailored disclaimers more
25 specific to specific cases. And for that, I would focus on
1 the category of claims where the issue is efficacy, not
2 safety. So I'll take the safety issues aside.
3 If the issue is efficacy and FDA did determine as
4 a threshold matter that there was more evidence in support
5 of the claim than against, so that was met, but it did not
6 meet significant scientific agreement, should we try and
7 point out very specifically what deficiencies are in the
8 data or should we try to come up with something generic,
9 taking into account the kinds of general points you've
10 already made?
11 Who wants to start with that one? Scott? Scott,
12 you can put your name up again. We don't need the timer
14 MR. BASS: Well, I think I addressed that
15 partially in my initial comments, Joe, but I think the
16 answer is that the repetition of generic disclaimers
17 vitiates their value. Also, I think there would be a
18 tendency to fight overly restrictive language and perhaps
19 generic disclaimers to too many health claims where it may
20 not be appropriate.
21 Inherent in your question is you've changed the
22 SSA determination methodology and I think the view of NNFA
23 anyway is that you need to be more product category-specific
24 in order to have any effect on informing consumers of the
25 differences because otherwise, you're really running into
1 your warning language. I stayed away from that in our
2 comments because that's a whole different area. But I think
3 again the more generic you get, the more you get into
4 warnings and then if you have combined structure/function
5 claims and health claims, you run into inherent
6 contradictions with the Section 6 disclaimer, which will
7 wreak not only product liability havoc but a lot of other
8 interpretational problems.
9 MR. LEVITT: Who wants to go next? Michelle?
10 MS. RUSK: I guess I have a little bit of a mixed
11 reaction to which would be better but my first instinct is
12 that generic probably would be something that would cause
13 consumers eventually to just tune out, that if they keep
14 seeing the same generic phrase over and over again, it's one
15 of those government things and you just kind of ignore it
16 and look at the claim.
17 I also think maybe they might not work when you're
18 trying to apply a generic to an industry that involves such
19 a wide variety of products that consumers are using in such
20 a wide variety of ways, that it may be very hard to come up
21 with something that really fits all of the different
23 On the other hand, if you start tailoring to each
24 specific claim, you've got an infinite variety, you're
25 obviously increasing your burden exponentially and I don't
1 know whether it becomes a workable system. I also don't
2 know if you have a different and specific disclaimer for
3 every product that's out there whether it's just going to be
4 too much.
5 MR. LEVITT: Okay, thank you. Other thoughts?
7 MR. TURNER: It seems to me that whenever a
8 situation presents itself with an either/or of that kind,
9 that probably there's a place for both.
10 So in my mind, this statement that FDA first
11 proposed in 1991, "Preliminary data suggests" and "may,"
12 that framework might be a useful framework in a broad set of
13 categories, but I also think that the kinds of specifics
14 that the FTC identified as being very useful to consumers
15 would be valuable to add to that. So you could, for
16 example, say, "However, some studies failed to show," if
17 that's a fact.
18 Again the standard that I think is the best
19 standard to apply is the most accurate presentation of the
20 data that's specifically relevant to that product.
21 Now, it may well be that a whole bunch of products
22 have a very relevant piece of information that can be put in
23 exactly the same terms--for example, "Preliminary data
24 suggests." It also may be that some of those have studies
25 that were attempted that did not show the connection that
1 was being referred to, and that should be there. It should
2 not be left out. And there are other things that I suspect
3 exist about specifics that would not be wise to be left out.
4 MR. LEVITT: Thank you. Mario?
5 MR. TEISL: I guess I also agree with Michelle,
6 that quite often we have sort of vague or general
7 disclaimers or warning messages and people just tune them
8 right out.
9 However, there is also another sort of thing to
10 think about. What is it in the disclaimer that you're
11 trying to do? If you're trying to differentiate a certain
12 class of products because you choose a different--let's say
13 you have three different levels of substantiation--low,
14 medium, and high--and you want to indicate that this class
15 of products has low and this one has high. I mean that has
16 some, I think, some benefits to consumers.
17 However, there's also, within a class of the low,
18 let's say, or the high, there can be differences across
19 products in terms of how much of the effective ingredient is
20 actually in the product and that sort of thing, whereas if
21 you just had sort of a general disclaimer, there is some
22 sort of value in differentiating among classes but not
23 necessarily products within a class. But tied in with the
24 general idea that general vague disclosures are pretty
25 ignored, I'd say try to be as specific as you can.
1 MR. LEVITT: Thank you. Chris?
2 MS. LEWIS: The question I have focusses--I guess
3 one way to word it is the general applicability of the kinds
4 of data we have. And maybe the flip side of it is there's
5 something special about dietary supplements as a category,
6 compared to perhaps foods or drugs, that would be an issue
7 in disclaimers.
8 Then also are there differences in the principles
9 we see for advertising types of disclaimers on those versus
10 labeling that would play into this whole notion of
11 disclaimers on dietary supplements? I guess I'm looking for
12 ideas or comments. Or are there data that would talk about
13 how movable these concepts are for dietary supplements?
14 MR. TEISL: I'll take a little bit of a stab at
16 With respect to the first part of your question,
17 what's so special about dietary supplements that's different
18 than food, although there are some people today that
19 specifically said that they think that consumers view
20 dietary supplements as food, I'm not convinced of that,
21 quite honestly. I think that it's more likely that--and I'm
22 not talking about vitamins and minerals, where people do
23 understand that they can get Vitamin from a food and this is
24 a way to supplement their diet, but when you're talking
25 about things like black currant or Saw Palmetto, those are
1 things that people normally do not consume as food, at least
2 in the United States, and because they're being marketed
3 mostly as affecting some sort of bodily function or helping
4 in some sort of long-range risk reduction in terms of
5 disease--I mean people are more likely to think about
6 dietary supplements more like they think about over-the-
7 counter drugs, rather than foods.
8 So I think that because consumers probably think
9 that way, it's probably not appropriate to think of the
10 labeling regulations of dietary supplements to mimic those
11 of food.
12 MR. TURNER: I would like to comment the opposite
13 way. What I said was that under the law, dietary
14 supplements are foods. We would argue that the kinds of
15 claims that are being made for dietary supplements should
16 also be allowed for food and presented in exactly the same
17 way. We would support the GMA on that issue, that the
18 distinction between food and dietary supplements is an
19 artificial one.
20 We have not taken a position on the question of
21 how dietary supplements and over-the-counter drugs might be
22 comparable, but the distinctions between those three
23 categories tend to be rather arbitrary and not necessarily
24 all that significant.
25 So in some ways, for example, if somebody has
1 three things that are good to lower cholesterol--a food, a
2 dietary supplement and an over-the-counter drug, all three
3 of those things--I'm not sure that the way that one would
4 put that claim forward and how one would disclaim that claim
5 would be different between those three categories.
6 So the issues that I've been addressing have been
7 addressed as dietary supplements because that's the title of
8 the program, but we feel strongly that the relationship
9 between claims on food and claims on dietary supplements
10 should be treated comparably. And I suspect if we look
11 closely at it, a similar claim on an over-the-counter drug
12 would be similarly treated, although that's not our
13 position; we've not articulated that.
14 MR. LEVITT: Scott?
15 MR. BASS: I guess in the first part of your
16 question, Dr. Lewis, I would say that Congress spoke to this
17 issue twice in four years. In 403(r)(5)(d) in NLEA it said
18 there's something different about supplements and referred
19 specifically to the rapidly advancing science in a floor
20 statement. And then in the preamble to DSHEA there's a good
21 deal of language about why supplements are different in
23 Notwithstanding that, I think we need to default
24 to position under Pearson what the court said, because I
25 guess the hearing today is about the court decision, and the
1 court decision doesn't distinguish the two, really, but for
2 the nature of the claims at issue.
3 I think while you have to treat foods and
4 supplements the same way under the health claims rubric
5 under 403(r), in practice, they're not the same and the
6 reason is exposure. The very same reason that you have
7 issues on functional ingredients that are treated
8 differently based on the fact that you will be eating soup
9 every day and your exposure levels may be different and the
10 disclosure, therefore, of safety concerns is different, as
11 opposed to the volitional act of taking a pill or a capsule
12 every day and limiting that based upon some recommended
14 The categories have to be treated the same, I
15 think, under law, but there is a difference nonetheless that
16 Congress has recognized in supplements and I agree with
17 Michelle that it's going to be harder but I don't see any
18 way around it.
19 It goes back to Mr. Levitt's question, which is
20 how are you going to do this generically or specifically. I
21 don't think there's any way but to do it specifically
22 related to the science.
23 As for your second question, as you know, the
24 prescription drug people at FDA have struggled with this
25 question for years and the fair balance issues in
1 prescription drug advertising have caused a lot of
2 consternation, but there is a solution, at least that's been
3 implemented. Most of the regulated industry doesn't like it
4 and it may have been administered in a rigid way but I think
5 there is a distinction between labeling and advertising that
6 allows for briefer and fewer disclaimers in advertising than
7 they would on labeling. And given perception patterns for
8 consumers, say, through radio or television spots, there
9 would be a difference in how many times you have to repeat
10 it, whether it would have to be proximate to every claim, et
11 cetera, et cetera.
12 Those theories are well backed-up by research the
13 FDA has already done in the prescription drug area.
14 MR. TURNER: Let me respond very quickly on
15 Congress's distinction between foods and dietary
16 supplements. It is a fact that Congress did distinguish
17 between--did say there was a difference, but the House said
18 they should be more strictly regulated, dietary supplements,
19 and the Senate said they should be less strictly regulated,
20 and it was sent over to the FDA to figure out how to
21 interpret that.
22 What I'm suggesting--
23 MR. LEVITT: For which we're grateful.
24 MR. TURNER: And what I'm suggesting is that the
25 claim about a food and the claim about a dietary supplement
1 is a useful place to look to see how one would articulate
2 what's positive and then put in what the disclaimer is,
3 starting with the claim. And I think you would end up with
4 sort of a generic form with specific product statements that
5 would come out on the basis of information about that
6 specific substance.
7 MR. LEVITT: Any FTC help here?
8 MS. RUSK: Yes, I want to respond to that.
9 On the first part of your question about is there
10 a difference that you need to be considering between the
11 different product categories, I guess our approach, because
12 we don't have the same regulatory framework that you have,
13 has been to treat all the categories the same and to focus,
14 rather than on what the product is, on what the claim is
15 that's being made.
16 And if you look at it that way, if you're going by
17 what the claim is, there probably isn't really a need to
18 differentiate between the categories. I do think that
19 supplements are more often marketed for therapeutic
20 purposes, directly or indirectly marketed that way, and are
21 certainly used more for therapeutic purposes. So in a
22 practical sense, maybe there is a difference.
23 On the question about differences between how
24 consumers view labels and ads, yes, I think there are a lot
25 of differences and Scott mentioned some of them. You don't
have maybe the same recall problems that you have in
2 advertising. You have physical constraints that we heard a
3 lot about this morning, about what you can put on the label.
4 I think people weren't thinking about labeling in a broader
5 sense than the box or the bottle, but still you have
6 physical constraints.
7 On the other hand, there's less variability, I
8 think, in the label than in an ad, which, depending on so
9 many other gratuitous elements, can completely change the
10 meaning that consumers are taking away. So in that sense,
11 you maybe have a little more control.
12 MR. LEVITT: Thank you. Mike?
13 MR. LANDA: Thank you.
14 This is for Mario Teisl and anyone else who cares
15 to respond.
16 With respect to the studies you referred to in
17 framing recommendations for disclaimers, do those studies,
18 those recommendations apply to information about side
19 effects? Do they have anything to tell us about how to
20 convey that information?
21 MR. TEISL: Most of the consumer research that I
22 looked at focussed on warning and disclaimer messages with
23 respect to tobacco, with respect to alcohol. There was some
24 health claim food research. In all of those cases that I
25 reviewed, because there wasn't a lot with respect to dietary
1 supplements, you know, per se, I didn't find things that
2 talked about dosages. I didn't look at OTC drug research or
3 prescription drug research, that sort of thing.
4 There were a few studies that looked at iron
5 supplements, the warning labels on that with respect to
6 children overdosing and in those cases--actually, that's FDA
7 research--the primary focus of that research was that when
8 the dosage limits, if I can remember correctly, the dosage
9 limits, because it was really new information to parents,
10 they were quite important. I can't remember if there were
11 any specific recommendations of how the dosage should be
12 presented, though.
13 MR. LEVITT: Any other reactions to that question
14 about safety information?
15 Okay, Peggy?
16 MS. DOTZEL: My question is directed to Mario and
17 Michelle but others may want to comment, as well.
18 My question is this. In looking at the type of
19 information that consumers find useful in disclaimers, is it
20 more, have you found or has anyone looked at whether it's
21 more helpful for consumers to hear information evaluating a
22 claim? A claim is made and the disclaimer would somehow
23 evaluate that, as opposed to other information--in other
24 words, balancing information.
25 I guess the example I would use is you make a
1 claim that ingredient X decreases the risk of disease Y. Is
2 it more helpful for consumers if the disclaimer were to tell
3 you the quality or somehow evaluate that claim, or would it
4 be more useful if the disclaimer were to say, but there are
5 other studies saying something else about this, something
6 else about the relationship, maybe negative information
7 about the relationship?
8 MS. RUSK: I don't know if I can point to
9 empirical evidence but I guess in terms of our policy, what
10 the commission has articulated is that you really need to do
11 both. You need to give consumers some sense of where on a
12 continuum the science is and if there's contrary evidence,
13 if there's significant contrary evidence, you need to let
14 them know about that, too.
15 I'm not sure if this is responsive to the safety
16 question that you raised but I think certainly depending on
17 the claim, the health claim that you're making, there may be
18 a need for disclosures about safety for that claim not to be
19 misleading to consumers, that if the safety concerns are
20 significant enough or if the claim somehow triggers the
21 safety issue by virtue of what it's advocating, then you may
22 need safety information, as well.
23 MS. DOTZEL: Obviously I guess I agree that
24 probably the more information that we give, the better, but
25 I'm thinking in terms of we have limited labeling space on
1 these products, and so to the extent that we have to take
2 that into account.
3 MS. RUSK: Speaking only from my own instincts
4 now, I would suspect that it would be more useful and maybe
5 easier for consumers to have an assessment, a more
6 qualitative assessment of the science than to have them be
7 told only animal studies or only in vitro studies. A lot of
8 people are not going to know what to do with that. You need
9 to kind of rate somehow where the science is.
10 MR. TEISL: I basically will ditto that. I think
11 that in essence, one of the reasons probably that FDA has
12 not provided a lot of information for a lot of stuff in the
13 past is that I think it's quite reasonable to think that
14 consumers are going to be pretty confused about six of this,
15 four of that, but this one is more valid and this one's in
16 animal and this one's clinical. I would get confused
17 reading all that information.
18 So in essence, what FDA would end up doing is
19 instead of deciding--well, in a sense, what you already do
20 is decide what level of research is allowable and then you
21 allow the health claim.
22 Here you basically would have to expand it so that
23 you would make a reasonable determination of what the level
24 is and then you would provide that information to people.
25 So you'd still be doing some filtering here. Most consumers
1 don't understand probabilities and scientific validity and
2 things like that.
3 MR. LEVITT: Thank you. Brett?
4 MR. KAY: I agree with what Mr. Teisl is saying.
5 I think that some of what we have to be careful about is
6 when you're putting--I think this is sort of what's been
7 happening with science in general in the public, when it's
8 published--consumers are getting increasingly sort of
9 confused and frustrated when something comes out and says
10 this works for X, Y and Z and then two days later or a month
11 later, something else says well, actually we've found out
12 that it doesn't work or that it's more dangerous. Then it
13 flips back the other way and it keeps flip-flopping. What
14 happens is that consumers get increasingly frustrated or may
15 start ignoring all of the claims altogether. Hopefully then
16 they sort of adhere to the everything in moderation tenet,
17 but it's not always assured what happens, that they may or
18 may not then really follow the labels at all. They'll just
19 think nobody really knows, nobody's made up their mind, and
20 really discredit all of the information that goes up there.
21 So I think you need to be careful with what the
22 disclaimer says in terms of six studies say yes but four
23 studies say no, really how to filter that. As Mr. Teisl
24 said, there's got to be a level that FDA sort of determines
25 what the filter is and then allows it to come through at
1 that level with a clear statement that's concise, that
2 doesn't constantly flip-flop or contradict itself.
3 MR. LEVITT: Jim?
4 MR. TURNER: It seems to me that the concept of a
5 disclaimer and a claim doesn't necessarily have to be
6 completely separated. So, for example, the way I read
7 "Preliminary data suggests" is both providing information
8 and containing something of a disclaimer.
9 Now if you use the principle that I feel is the
10 core principle, which is to be accurate in the statement
11 that's made, then if you do have data that says or you do
12 have studies that fail to make that connection and say
13 that--"Preliminary data suggest that there's a connection
14 but there are also studies that fail to establish that
15 connection"--that provides a lot of useful information that
16 I don't think is going to turn people off.
17 I mean the consumers that we deal with at Citizens
18 for Health really want information. They're very, very high
19 information people and I think somewhat representative of
20 the dietary supplement world.
21 So I guess that being very accurate and specific
22 can be very useful in getting information to the consumer.
23 MR. LEVITT: Mario had one more?
24 MR. TEISL: As sort of a reaction to that, the
25 consumers that you deal with are probably selective
1 consumers. The thing is that this labeling requirement has
2 to be for a lot more consumers than those very educated
4 MR. TURNER: We have to be very careful. The
5 consumers we deal with are the ones that consume dietary
7 MR. TEISL: I understand that. What I'm saying is
8 I think--
9 MR. TURNER: Well,that's the ones who'll be
10 reading the claims on the dietary supplement products, I
12 MR. TEISL: No.
13 MR. TURNER: You don't think so?
14 MR. TEISL: No, what I'm thinking is--
15 MR. TURNER: You mean people who don't consume
16 dietary supplements--
17 MR. TEISL: What I'm saying is that I think it's
18 in the interest of the industry to market beyond just the
19 current users of dietary supplements.
20 MR. TURNER: Well, it's about 70 percent of the
21 population right now.
22 MR. TEISL: If you take away all vitamins and
23 minerals, it's a lot smaller than that.
24 MR. LEVITT: I think both points are made.
25 One last question. Rachel, please?
1 MS. BEHRMAN: This is for whoever would like to
2 address it.
3 An issue that was raised this morning and that we
4 discussed a little bit at the break has to do with what to
5 do when there's no effective therapy. So if it's a
6 condition, for example, that's left untreated or poorly
7 treated, it could lead to serious morbidity and there is no
8 effective therapy, should that be addressed in the
9 disclaimer and if so, how? In other words, there are
10 competing interests.
11 MS. RUSK: I'm not sure if I understand the
13 MR. TEISL: You're talking about the substitution
15 MS. BEHRMAN: Exactly. It's competing, that the
16 product may be competing--someone may decide either to alter
17 their current therapy, avoid their current therapy, not
18 initiate current therapy. In other words, there's a
19 competing interest in the supplement and the other therapy
20 that they're already getting or should be getting.
21 MR. LEVITT: In another context somebody would ask
22 if you need to phone a friend at this moment.
24 MR. LEVITT: Again the question you just framed is
25 if this is a claim for prevention or reducing the risk of X
1 and everybody acknowledges that it's preliminary evidence
2 and there is another product for which there is a clear
3 demonstration of a reduction of risk, should that disclosure
4 be made on the first product to alert the consumer that
5 essentially the evidence here is not as good as another
6 product where evidence exists.
7 MR. BASS: Let me take a stab at that. We dealt
8 with that question during the drafting of DSHEA, in part,
9 and the first answer is that it's not a drug and therefore
10 we have to eliminate the treatment side of your question.
11 So we limit ourselves then just to the prevention or
12 reduction of risk side.
13 MR. LEVITT: Directly competing claims.
14 MR. BASS: Right. And I would say the position of
15 NNFA would be absolutely not, that you would not feel that
16 you were mandated to say that something else works better.
17 Disclosure means that it may not work well or it
18 may work well or it may not work at all. But then to go a
19 further step and make an affirmative disclosure that there
20 are two other products, one of which is an herb, one of
21 which is a prescription drug, that work better, I think
22 would be A, not a disclaimer but rather a warning, in line
23 with interaction warnings, and the subject, I think, of a
24 different discussion and B, not mandated, I think, within
25 the reasonable rubric of disclaiming an efficacy claim for
1 prevention or reduction of disease.
2 MR. LEVITT: What about something that instead of
3 identifying a product, just say "See your physician; you may
4 want to consult your physician. There are effective
5 treatments for this"--treatment is the wrong word--
6 MR. BASS: I think the NNFA would be in favor of
7 something like that in appropriate situations, just like
8 they've supported that in the EPHEDRA context when Texas has
9 talked about that.
10 However, it's only when it is appropriate, when
11 there's some demonstrated need, that there's a high risk and
12 there is a therapeutic danger for people ignoring something
13 else. But that's still, I think, a warning question, not a
14 disclaimer question.
15 MS. RUSK: I'm trying to think about how we deal
16 with that in advertising law and whether, under a deception
17 analysis, you would need to disclose that there was a more
18 effective therapy or treatment and I can't think of a
19 situation where we've done that.
20 I guess it's a concern that we have in the
21 supplement area that there is real risk of consumer injury
22 if people are taking less proven products and avoiding
23 proven therapies.
24 I think the way it comes into play at the FTC is
25 it's a reason to make sure that the claim is really well
1 substantiated and that you do describe the limitations of
2 the science.
3 MS. BEHRMAN: When you're thinking about it do you
4 calculate that? In other words, if you know that there's an
5 effective therapy, does that change how well substantiated
6 you believe the claim should be?
7 MS. RUSK: Well, part of our substantiation
8 standard, one of the factors that comes into play is what is
9 the risk of injury to consumers if the claim turns out not
10 to be true? So I guess that's how it comes into play.
11 MR. TURNER: Using the principle of accurate,
12 clear information, we would say that there should be that
13 kind of information. However, I would put it in the context
14 that Scott did, as a warning.
15 MR. KAY: We would also support some kind of at
16 least a warning to see a doctor or other health
17 professional. Maybe "This preliminary evidence suggests
18 that this may be effective. However, contact your physician
19 or health professional for further information or treatment
20 options," something along those lines. It's tough.
21 MR. LEVITT: With that, let me draw this panel to
22 a conclusion. I want to thank each of the speakers. Again
25 MR. LEVITT: We're going to let this group exit
1 before the next group comes on, just because getting on and
2 off has its own logistics here. We will be going to the
3 next panel before our afternoon break.
4 If I could ask people in the audience to please
5 take your seats, we're going to start the next panel. We
6 will have an official break after this panel but we're
7 trying to do two panels in succession before the break.
8 Again if I could ask people in the audience to sit down? If
9 you need to step out into the hall, that's fine.
10 PANEL III
11 MR. LEVITT: We're ready to begin the third of the
12 three panels, the final panel discussion. We're going to
13 shift gears here a little bit and move away from the Pearson
14 case per se and move into a different issue also related to
15 health claims in the context of a dietary supplement that
16 was raised by a petition for Saw Palmetto in the treatment
17 of BPH.
18 It's a specific question that we've listed on the
19 agenda. It says, "Should health claims go beyond claims
20 about reducing the risk of a disease to include claims about
21 mitigation or treatment of an existing disease, or are such
22 claims drug claims? Where is the boundary, if any, between
23 these claims?"
24 So here we're talking about a boundary between
25 everybody saying these are disease claims; the question is
1 whether or not they are claims that may be made under the
2 health claim provisions of NLEA or whether they are
3 inherently drug claims that have to go through the drug
5 As a way to further frame that, Chris Lewis is
6 going to do a short introduction which I referenced this
7 morning, but before I turn to Chris, let me just introduce
8 the afternoon panelists that we have.
9 First is Claudia Lewis-Eng from Emord &
10 Associates. Second is Dr. Logan Holtgrewe from the American
11 Urological Association. Third is Bill Soller, Consumer
12 Healthcare Products Association. Marsha Cohen, Hastings
13 College of Law. And Regina Hildwine from National Food
14 Processors Association.
15 We will be following the same procedures we've
16 done already so I won't repeat them. They're now familiar
17 to everybody. But we will ask Chris Lewis to further frame
18 the question and the issue for this panel.
19 INTRODUCTION BY CHRIS LEWIS
20 MS. LEWIS: Thank you.
21 As Mr. Levitt has already mentioned, the topic for
22 the third panel is still within the realm of health claims
23 but the focus is different from that of our two previous
24 panels. We're changing the subject a bit.
25 The third panel, this panel coming up, has been
1 asked to address the issue of the scope of health claims
2 under the Nutrition Labeling and Education Act here in the
3 context of dietary supplements. Basically the question is
4 whether health claims may include claims about mitigating or
5 treating a disease.
6 By their very nature, claims about the effects on
7 an existing disease are aimed at people who are already
8 suffering from the disease and to date, health claims
9 authorized have been targeted either at the general
10 population or at a subgroup who are at risk for the disease
11 but who are not sick. They don't have the disease. In
12 short, health claims have been about reducing the risk of
14 The wording of the statute is not specific in this
15 area but among other factors, the structure of the statute,
16 which makes a distinction between foods and drugs, has led
17 FDA to provide for health claims about reducing the risk of
18 disease but not about treating or mitigating a disease,
19 which have been viewed as claims belonging in the realm of
20 drug claims.
21 In establishing the regulations for health claims,
22 FDA tried to strike a balance between one, recognizing that
23 foods, including dietary supplements, can influence disease
24 outcomes without ceasing to be foods and two, honoring a
25 distinction between drugs and foods.
1 And just by way of some quick background, FDA has
2 taken the position that nutritional effects of food
3 substances are appropriate subjects for health claims but
4 that effects that are therapeutic, medicinal or
5 pharmacological would not be appropriate subjects for health
7 It's worth mentioning here that there are such
8 things as medical foods. They're defined by the Food, Drug
9 and Cosmetic Act and are formulated for the dietary
10 management of disease and are to be used under a physician's
11 supervision. More specifically, medical foods are for the
12 management of diseases or conditions for which distinctive
13 nutritional requirements are established by medical
15 So already existing in the realm of regulated
16 foods are foods formulated and intended for the purpose of
17 dietary management of diseases. Medical foods were exempted
18 from the NLEA provisions and so have not historically been
19 the subject of health claims.
20 But if we return to the issue at hand, the scope
21 of health claims under NLEA relative to mitigating or
22 treating disease has become an issue now because, as Mr.
23 Levitt mentioned, in 1999 FDA received a petition for a
24 health claim concerning dietary supplements containing Saw
25 Palmetto and symptoms associated with BPH or benign
1 prostatic hyperplasia. We did not take action on this
2 petition, indicating we needed time to consider its
3 implications against the existing background relative to
4 NLEA-driven health claims.
5 So, as part of this effort, we're today asking
6 questions about the issue of mitigation and treatment of
7 disease; that is, are health claims aimed at sick people or
8 persons with diseases appropriate as the topic of health
10 Earlier, I should remind you, as part of our
11 implementing regulations on health claims, we had indicated
12 that it would be necessary for a health claim petitioner to
13 show that the claimed effect on disease is associated with
14 the normal functioning of the body and that claims to
15 correct an abnormal physiological function caused by a
16 disease would be drug claims, rather than health claims.
17 In order to revisit these issues, we're asking
18 several questions. We're asking if the language and
19 structure of the act restrict the permissible type of
20 substance-disease relationships that can be described in
21 health claims, and how we should interpret the situation or
22 the milieu created by health claim and drug provisions of
23 the act, as well as by the provisions for medical foods.
24 We're also asking about the criteria for making
25 determinations between health claims and drug claims and
1 about the ramifications for over-the-counter drugs, should
2 health claims be expanded to include treatment and/or
4 We do recognize that this is a complicated topic
5 and we are looking forward to the next few moments. Thank
7 MR. LEVITT: Unlike the morning discussion, which
8 was not complicated.
9 Okay, let's turn--again, same rules as before--10
10 minutes. If you can see the light in the middle, if not,
11 we'll give Mr. Soller a special reannouncement of his name
12 several times if he'll put his thing down or move it away a
13 little. Thank you.
14 Claudia, why don't you go ahead?
15 CLAUDIA A. LEWIS-ENG, EMORD & ASSOCIATES
16 MS. LEWIS-ENG: Thank you.
17 Good afternoon. I welcome this opportunity to
18 comment on the question posed to the third panel. It's a
19 topic that's very important to many of the firm's clients
20 and, in fact, we represented the clients that submitted the
21 Saw Palmetto BPH health claim petition to the agency.
22 Unfortunately, on December 1, 1999, FDA summarily
23 denied the health claim petition associating the Saw
24 Palmetto, an herbal dietary supplement, with a reduction in
25 the symptoms of mild benign prostatic hyperplasia. It did
1 so without following the procedure for dietary supplement
2 health claims review specified in the Nutrition Labeling and
3 Education Act and without following the First Amendment
4 requirements of Pearson v. Shalala.
5 FDA based its refusal to follow the governing law
6 on the view that the claim goes beyond risk reduction to
7 claim an effect on an existing disease, which FDA surmises
8 may only be made if the dietary supplement is granted new
9 drug approval under the act's drug approval provisions.
10 Based on FDA's refusal to process the health claim
11 under the act's health claim provision and under the Pearson
12 standard, my firm filed a suit against FDA seeking
13 declaratory and injunctive relief.
14 The question posed to the panel arises out of
15 FDA's summary denial of the Saw Palmetto claim. The
16 question suggests that FDA wants the scope of the NLEA
17 health claims provision to be construed narrowly, reaching
18 not all nutrient-disease relationship claims but only those
19 that concern disease risk reduction.
20 But the plain language of the NLEA health claims
21 provision and its underlying history make it clear that
22 Congress meant for all dietary supplement claims that
23 associate a nutrient with a disease to be subject to the
24 NLEA health claim provision. FDA's attempt to restrict the
25 scope of the health claims definition causing dietary
1 supplement health claims to be redefined as drugs is a
2 rather obvious attempt to hinder, rather than foster, the
3 dissemination of dietary supplement nutrient-disease
5 It is also an anti-competitive move designed to
6 protect the drug approval process from competition arising
7 from full implementation of the NLEA health claims
8 provision. That attempt violates the NLEA. It violates
9 Congress's intent. It violates the First Amendment. And it
10 violates the Administrative Procedure Act.
11 In 1994 Congress reviewed FDA's implementation of
12 the health claims provision of NLEA. Congress concluded
13 that FDA has a long history of bias against dietary
14 supplements. In fact, Congress faulted FDA for hindering,
15 rather than fostering, the dissemination of truthful and
16 nonmisleading information about the nutrient-disease
17 relationship. Congress concluded that FDA has acted to
18 restrict the information that the public may receive about
19 dietary supplements.
20 The United States Court of Appeals for the D.C.
21 Circuit similarly found in Pearson v. Shalala that in
22 general, the FDA appears quite reluctant to approve health
23 claims on dietary supplements. FDA's current attempt to say
24 that health claims do not include disease treatment and
25 mitigation claims is yet another effort to block full
1 implementation of the NLEA health claims provision. If FDA
2 redefines health claims to exclude disease mitigation and
3 treatment claims, it would defeat the essential purpose of
4 the NLEA health claims provision.
5 In 1990 the President signed the NLEA into law.
6 Prior to its adoption, FDA treated as drugs all foods and
7 dietary supplements that included disease treatment claims.
8 NLEA was specifically designed to make it possible for
9 dietary supplements to carry disease claims without having
10 to become approved drugs, without having to satisfy the
11 substantial evidence, near conclusive proof premarket drug
12 approval standard specified in the act.
13 Congress expressly rejected the drug certainty
14 standard as a legal condition for dietary supplement health
15 claim approval. If FDA redefines health claims to exclude
16 disease mitigation and treatment claims, it will effectively
17 prohibit those claims altogether.
18 Under 21 U.S.C. Section 379(h)(b)(1), those who
19 wish to file a new drug application must pay the FDA the
20 hefty and anti-competitive sum of almost $260,000 per
21 application. In addition, proof of drug efficacy is
22 required; that is, proof to a near certain degree under the
23 substantial evidence drug standard.
24 In adopting the NLEA health claims provision,
25 Congress intended to avoid this heavy burden for dietary
1 supplements. Congress wanted disease claims to be possible
2 on dietary supplements without having to obtain drug
3 approval for them. FDA has no statutory authority to define
4 health claims in a manner contrary to the NLEA.
5 NLEA defines dietary supplements health claims
6 broadly to include ones which characterize a relationship of
7 any nutrient to a disease or health-related condition. It's
8 important to note that Congress has used the broadest
9 possible language--any relationship between a nutrient and a
10 disease or health-related condition. The term
11 "relationship" in its ordinary sense and meaning refers to a
12 connection of one thing to another, without restriction.
13 Disease treatment and disease mitigation are
14 plainly within the universe of nutrient-disease
15 relationships. To prove that Congress intended something
16 other than the plain meaning of the statutory language
17 requires proof and legislative history that the plain
18 language was not intended.
19 You will look in vain, however, to find any basis
20 in the legislative history to support FDA's position.
21 Congress has never stated any intention to define nutrient-
22 disease relationships to exclude statements that associate
23 nutrients with disease treatment or mitigation.
24 In the 1990 committee report from the House
25 Committee on Energy and Commerce, Congress emphasized that
1 the NLEA health claims provision applied to any disease
2 claim and never once stated that the provision was meant
3 only to apply to those claims that refer to disease risk
4 reduction, as opposed to disease treatment or mitigation.
5 In respect to NLEA, Congress stated, "Section 403(r)(3)
6 regulates disease claims. It prohibits any disease claim
7 unless the claim meets the requirements of regulations
8 promulgated by the Secretary. The requirement applies to
9 any disease claim that is made with respect to acquired
10 nutrients and other nutrients in foods."
11 Again in 1994, Congress made clear that Congress
12 intended the NLEA to permit authorization of all manner of
13 nutrient-disease relationship claims, not just disease
14 reduction claims. Moreover, it made clear that dietary
15 supplements were expressly intended to bear health claims
16 without having to be separately approved as drugs.
17 Congress stated, "One of the salutary purposes of
18 the Nutrition Labeling and Education Act was to allow claims
19 for nutrient-disease relationships to reflect current
20 science without bringing food within the drug definition of
21 the federal Food, Drug and Cosmetic Act." A clear purpose
22 of the NLEA was to assure that the public would be provided
23 with clear information about the relationship of a nutrient
24 to a disease and to ascertain that the information will be
25 accurate and not misleading.
1 Congress was thus concerned that the nutrient-
2 disease relationship be accurately characterized, not that
3 the relationship be limited to exclude disease treatment and
4 mitigation. Were it concerned that the naturally all-
5 encompassing term "relationship" be interpreted in a less
6 than all-encompassing way, we should expect to find evidence
7 of that intent in the legislative history. There is none.
8 Contrary to the position FDA tries to maintain,
9 Congress sought to ensure that the claims were accurately
10 stated. If claims were artificially limited to exclude
11 treatment and mitigation and include only risk reduction,
12 the result would necessarily be a mass suppression of
13 accurately stated nutrient-disease claims, ones that
14 accurately reflect the disease treatment or disease
15 mitigation effect of certain nutrients.
16 Following FDA's position would also produce the
17 unconstitutional result of causing the NLEA health claim
18 provision to conflict with the First Amendment by denying
19 consumers access to scientifically accurate information that
20 dietary supplements treat or mitigate disease symptoms.
21 Consistent with the rules of statutory construction, FDA
22 must not construe the NLEA to conflict with the First
23 Amendment; it must construe the two to be in harmony with
24 one another.
25 Repeatedly in the legislative history, Congress
1 has emphasized that the NLEA health claims provision was
2 designed to be flexible and was to embrace all types of
3 disease claims.
4 In closing, FDA's denial and suppression of the
5 Saw Palmetto BPH claim not only violates the NLEA health
6 claims provision but also the First Amendment. Under
7 Pearson v. Shalala, the health claim is protected commercial
8 speech that may not be suppressed outright but must be
9 authorized with such disclaimer or disclaimers as FDA
10 reasonably deems necessary to avoid a misleading
12 Consistent with its commitment to the court, FDA
13 should reverse its position and evaluate the Saw Palmetto
14 claim under the NLEA health claim provision and under the
15 First Amendment standard established in Pearson. It should
16 stop trying to end-run around the NLEA and, once and for
17 all, implement fully and faithfully, consistent with the
18 intent of Congress and with the First Amendment. Thank you.
19 MR. LEVITT: Thank you.
20 Next is Dr. Holtgrewe.
21 H. LOGAN HOLTGREWE, AMERICAN UROLOGICAL ASSOCIATION
22 DR. HOLTGREWE: Thank you very much. On behalf of
23 9,500 American urologists who are the members of our
24 association, we thank you for the opportunity to give our
25 view on this very, very important topic.
1 First of all, and I want to set the record
2 straight on this in the strongest of terms, lower urinary
3 tract symptoms in older men--that is, frequency of
4 urination, urgency of urination, getting up at night to
5 urinate, the feeling of incomplete bladder emptying--these
6 are symptoms that are not--repeat not--a phenomenon of
7 normal aging. They are always due to disease. The question
8 is what disease?
9 Arteriosclerosis is a common problem in older men
10 but no one would regard arteriosclerosis with coronary
11 artery disease as a normal phenomenon of aging; it's a
12 disease. And lower urinary tract symptoms are in the same
13 category. They're always due to a disease. As I said, the
14 question is what disease?
15 We have a concern at the AUA and amongst
16 urologists that men who have these symptoms and treat
17 themselves with an over-the-counter product may be doing
18 themselves irreparable harm and indeed enticing death
19 because there are multiple reasons for lower urinary tract
20 symptoms; some of them are benign; some of them are not
21 benign. Cancer of the prostate is the leading cause of
22 cancer death in African-American males in this country
23 today. It's the second leading cause of cancer death in
24 Caucasian males. Bladder cancer is also very common.
25 The symptoms of prostate cancer and bladder cancer
1 are the same as those of benign enlargement of the prostate
2 or simple lower urinary tract symptoms and it takes an
3 evaluation to find out.
4 Furthermore, when bladder cancer or prostate
5 cancer leaves the confines of those organs, there's no
6 effective cure. The only chance we have of curing men
7 plagued with these disease and unfortunate enough to have
8 them is to make a timely, early diagnosis and institute
9 proper therapy. It is our concern that a man with these
10 symptoms might buy a product and take it, not see a
11 physician, and end up losing that golden moment of cure.
12 Now certainly there must be package inserts, but
13 any such insert has to have clearly stated the risk of
14 taking this product without a proper diagnosis, and I think
15 that insert has to contain the words "cancer," "possible
16 death," and I think these things should be clearly
17 understood by anyone who markets these. Our fear, however,
18 is that package inserts are not always read and, when read,
19 aren't always understood and aren't always taken under
20 proper advisement. So we feel very, very concerned about
22 The other concern we have is that there's a lack
23 of adequate data in the urological literature of the world
24 today sustaining the value of dietary supplements in the
25 treatment of even benign disease. The data is meager, of
1 short duration. We have an absolute dearth of prospective
2 randomized clinical trials that are the standard, the gold
3 standard, of medical research.
4 I am not an attorney and I'm not a politician and
5 I don't understand these issues as well as some others in
6 this room. I'm a urologist, I'm a physician, and our
7 mission as physicians is to treat the patient, protect the
8 patient and provide the best possible care.
9 I think that our concern at the American
10 Urological Association is that by not having the patient
11 fully understand what he may be doing in taking these
12 products, he may be losing his only opportunity to be spared
13 a significant problem or even a cancer death.
14 We believe at the AUA that these food supplements
15 or dietary supplements are being marketed to treat symptoms,
16 which are always due to disease. Therefore, these drugs are
17 being marketed to treat disease and they should be under the
18 control of the Food and Drug Administration, just as are
19 other pharmacological products advocated and marketed to
20 treat disease. If you're treating disease, it should be a
21 level playing field.
22 We feel very strongly that the products that we're
23 discussing here today should have Food and Drug
24 Administration control. We would want to have prospective
25 randomized clinical trials of proper character put together
1 and carried out under the auspices of the FDA. And if these
2 trials show that there is safety and efficacy to these
3 products, then we would certainly want them and welcome them
4 to the armamentarium of the American physician and the
5 American urologist.
6 We also harbor some concern about the content of
7 these products, which is rather ill-defined. Sometimes
8 they're a mix of products. Are they compatible one with the
9 other? And what of taking these products in possible
10 interaction with other prescription drugs the older man
11 might be taking, such as cardiovascular medicines,
12 hypertensive medicines, antidiabetic medicines and an array
13 of other medications that he might be taking in treatment of
14 other diseases? What are the interactions? We have no data
15 on that in the current literature.
16 So in conclusion, I would like to say that in the
17 Federal Register of March 16, 2000, there is a statement
18 that I have underlined here that I think says it actually
19 very, very well. "Section 201(g)(1)(b) of the act provides,
20 in part, that articles intended for the mitigation of
21 disease are drugs." And I think that's exactly what we're
22 talking about. These food supplements and dietary
23 supplements are being marketed as drugs.
24 I think therefore they should be brought under the
25 aegis of the Food and Drug Administration and that we need
1 prospective randomized trials of these agents. We welcome
2 those and if, as I said, they prove to be efficacious and
3 safe, let's have them in our armamentarium. Thank you very
5 MR. LEVITT: Thank you.
6 Next is Bill Soller, Consumer Healthcare Products
8 WILLIAM SOLLER
9 CONSUMER HEALTHCARE PRODUCTS ASSOCIATION
10 MR. SOLLER: Thank you.
11 To set the stage for our remarks on this panel,
12 what I'd like to do is to make two brief remarks that harken
13 back to the previous panels, if I may. I think at least one
14 prior contestant here had that opportunity, as well. Mr.
15 Levitt, if that's all right--
16 MR. LEVITT: It's your 10 minutes.
17 MR. SOLLER: By law and regulation, a health claim
18 means that any claim made on the label of a food, including
19 a dietary supplement, that expressly or by implication
20 characterizes the relationship of any substance to a disease
21 or health-related condition, and that's the basic definition
22 that we're dealing with. And key words here are
23 "characterizes a relationship," "any substance," and
25 A truthful statement, even if qualified, about how
1 a substance may prevent or treat a disease is a
2 characterization of that substance's relationship to the
3 disease under consideration, so we think that truthfulness
4 of the health claim is the basic boundary.
5 Second, FDA's definition of significant scientific
6 agreement, we think, is inconsistent with the Pearson
7 decision. It focusses on the validity of the substance-
8 disease relationship as the decision point, when Pearson
9 dictates the focus to be on the claim that characterizes the
10 relationship and its truthfulness.
11 FDA's creation of the standard of scientific
12 validity as an approach in responding to the Pearson
13 decision to define significant scientific standard indicates
14 that the agency either does not understand the intent of the
15 court or is unwilling to follow its dictate. If the
16 standard for a health claim is so high as to be not reversed
17 by evolving science, as indicated by the guidance, why then
18 would the court permit the use of a qualifier? FDA's
19 definition of the standard of scientific validity to replace
20 the statutory requirement of significant scientific
21 agreement seems no better than wordsmithing of FDA's
22 original position to the court.
23 In essence, what is needed is an articulation of a
24 truth-in-labeling standard not unlike FTC's truth-in-
25 advertising standard. So we request that FDA retract the
1 guidance on significant scientific agreement and adopt one
2 that is statutorily based and expresses the intent of the
3 Pearson decision.
4 In this regard, the Federal Trade Commission has
5 already addressed the issue of the characteristics of
6 disclaimers and qualifiers to address truthfulness of a
7 dietary supplement claim in the guidance to the dietary
8 supplement industry that FTC put out a couple of years ago.
9 First, per that guidance, the substantiating
10 evidence should provide a reasonable basis for making the
11 claim. A reasonable basis, per the guide, depends greatly
12 on what the claims are being made, how they are presented in
13 the context of the entire ad, how they are qualified, yet it
14 should be flexible to ensure that consumers have access to
15 information about emerging areas of science and sufficiently
16 rigorous to ensure that consumers have confidence in the
17 accuracy of information presented. Then if the qualifier or
18 disclaimer is to be used, and FTC outlines several
19 criteria--clear, simple, prominent, able to be understood in
20 terms of the extent of the scientific support and the
21 existence of any significant contrary evidence--then based
22 on studies and other support, that is a stronger body of
23 evidence than any contrary information. And I think we
24 heard some other criteria that were elaborated that could be
25 incorporated into that.
1 So we request that FDA adopt FTC's guide as a
2 framework for creating a guidance on significant scientific
3 agreement for the purposes of health claims.
4 Now as to this particular situation, health claims
5 relating to disease treatment are an issue that potentially
6 have great public health benefits. Importantly, this issue
7 bears a clear relation to the Pearson decision, which
8 concludes that truthful promotion that is related to lawful
9 activities is entitled to the protections of the First
10 Amendment, notwithstanding the fact that Pearson did not
11 address treatment health claims per se.
12 But to reiterate our foundational position here, a
13 health claim means any claim made on the labeling of a food,
14 including a dietary supplement, that expressly or by
15 implication characterizes the relationship of any substance
16 to a disease or health-related condition. A truthful
17 statement, even if qualified, as I mentioned earlier, about
18 a substance, how a substance may treat or prevent a disease,
19 is a characterization of that substance's relationship to
20 the disease under consideration.
21 In sum, it is not, we believe, the validity of the
22 relationship but the truthfulness of the claim about the
23 relationship that is at the core of this overall issue.
24 To date, health claims authorized by FDA had been
25 for reducing the risk of disease in the general population.
1 An example of such a claim that was published in FDA
2 Consumer was as follows: "Regular exercise and a healthy
3 diet with enough calcium helps teen and young adult white
4 and Asian women maintain good bone health and may reduce
5 their high risk of osteoporosis later in life."
6 However, treatment of osteoporosis, while
7 requiring a diagnosis, includes calcium supplementation.
8 Indeed, the efficacies of currently used prescription drugs
9 are based, in the main, on use of concomitant calcium
11 Hence truthful and not misleading information on
12 the label of calcium supplements about the use of calcium in
13 the overall treatment of osteoporosis, in addition to
14 calcium's role in the prevention of osteoporosis, would be
15 an important public health outreach to a vulnerable
16 population. Indeed, such a treatment claim for calcium for
17 osteoporosis could be qualified to recommend a physician
18 visit to determine whether a potential product user was
19 suffering from the disease.
20 And note in the FTC arena, FDA permits self-care
21 products with labeling recommending physician diagnosis
22 prior to use--bronchodilators for asthma, anti-fungals for
23 vaginal candidiasis--and such labeling was undertaken at the
24 discretion of the agency, entirely within existing law and
1 Further, FDA could specify the scope and extent of
2 safety information needed for a disease treatment health
3 claim and even elements of required labeling to ensure that
4 there is not an unreasonable risk.
5 In sum, diet-disease treatment relationships can
6 be a logical health-based extension of dietary supplement
7 function. FDA's recognition of this issue carries First
8 Amendment implications. We think therefore it would be
9 sound public policy to amend the health claim regulations to
10 permit such preapproved claims. And, in so doing, we think
11 a reconsideration of nutritive value, how it's defined,
12 might be important to undertake, to recognize that the
13 processes by which a dietary constituent promotes health,
14 maintains proper bodily function, protects the body from the
15 development of chronic disease or other health-related
16 conditions and facilitates and/or restores healthy
17 functioning are, in and of themselves, characteristic of
18 nutritive value, thereby creating a more logically flexible
19 approach to health claims.
20 In conclusion, we think truthfulness should be the
21 boundary for health claims. We think it's important to
22 develop a regulation permitting qualifiers and disclaimers
23 in health claims. We think that the guidance on significant
24 scientific agreement should be retracted.
25 And the FTC guidance, as a framework, should be
1 adopted for guidance on health claims. We think that the
2 FTC guidance has criteria that are very helpful in it, how
3 to describe what a disclaimer or qualifier would be. And we
4 think that disease treatment health claims should be
5 permitted in the context of the truthfulness as the boundary
6 for the health claim. Thank you.
7 MR. LEVITT: Thank you.
8 The next speaker is Marsha Cohen from Hastings
9 College of Law.
10 MARSHA COHEN, HASTINGS COLLEGE OF THE LAW
11 UNIVERSITY OF CALIFORNIA
12 MS. COHEN: Good afternoon. I spent a lot of time
13 in the past week wondering why I agreed to come to this
14 meeting, especially since my original invitation was to be
15 on Panel II and then I found myself on Panel III, and I've
16 been wondering what I can contribute, since I basically
17 disagree with the premise of the earlier debate, namely that
18 there is a First Amendment barrier to setting minimum
19 standards for claims made on the labels of government-
20 regulated products.
21 Note that I projected the dictum of Pearson beyond
22 food supplements, as there's a whole host of government-
23 regulated products and disclosures in the marketplace to
24 which its notions could apply.
25 Consider, for instance, to get away from safety
1 issues completely, the disclosure requirements of the Truth
2 in Lending Law or RESPA, the Real Estate Settlement
3 Procedures Act. The premise of those whole laws is that
4 only standardized disclosure protects consumers from being
5 confused even by literally true, in those cases, financial
6 information. There are a whole lot of regulated issues that
7 were not even considered by the Pearson court and yet if you
8 read their language broadly, it would apply.
9 As a law professor, it's part of my job
10 description to deconstruct and criticize judicial decisions.
11 Pearson leaves me much room for both and I decided to do
12 this, even though they're off the declared subject, because
13 we need to consider the exact task that FDA has been
14 presented by the court.
15 The Pearson holding has been stated, I think,
16 rather overbroadly earlier today. It is a remand to the
17 Food and Drug Administration to respond to its First
18 Amendment--I'm reading from page 11 of the version that was
19 sent out by the agency. "We do not presume to draft precise
20 disclaimers for each of the appellants' four claims. We
21 leave that task to the agency. Nor do we rule out the
22 possibility that where evidence in support of a claim is
23 outweighed by evidence against the claim, the FDA could deem
24 it incurable by a disclaimer and ban it outright," and so
1 On significant scientific agreement, that standard
2 wasn't deemed to be incurably reversed by the court. In
3 fact, it ordered FDA to articulate what it means by that,
4 which FDA has done and has met that.
5 In fact, for two years I was part of the Keystone
6 Dialogue that earlier speakers have mentioned and I never
7 perceived that anyone with a science background was confused
8 by what significant scientific agreement meant, although it
9 might have been unclear to some of the lawyers. But I think
10 FDA has made it unclear no more, given its guidance.
11 As to the application of that now well articulated
12 standard to the four sets of claims, that is well beyond my
13 competence but I assume that FDA will be revisiting the
14 evidence and providing adequate explanations of its
16 The various First Amendment dicta are troubling
17 for a number of reasons. I'm no expert on the First
18 Amendment--that is not my field--but I'm very troubled that
19 the FDA didn't raise one of its most potent arguments at the
20 appropriate time and thus it was not heard, although that
21 may be different in the litigation after the remand.
22 It was Congress, after all, that decided there
23 ought to be some circumscribed exceptions to the drug
24 approval provisions of the Food, Drug and Cosmetic act to
25 meet, as it said, "the growing need for emphasis on the
1 dissemination of information linking nutrition and long-term
2 good health." Congress thus devised a regulatory scheme
3 that allows food supplements to bear health claims that,
4 prior to the legislation, would have caused the products to
5 be regulated as drugs. The significant scientific agreement
6 standard is Congress's creation.
7 The Pearson court considered drugs to be an
8 entirely different category than food supplements,
9 notwithstanding its recognition of the new law as creating a
10 safe harbor from drug status for supplements bearing
11 approved health claims.
12 In fact, there's considerable potential for
13 overlap. Food supplements, to the extent that they make
14 certain claims, are legally still drugs.
15 I'm also troubled by the analysis applying the
16 First Amendment to the issues in this case. The much-cited
17 Central Hudson case, in fact, provides that the government
18 may ban forms of communication more likely to deceive the
19 public than to inform it. It may well be that advertising
20 will rarely fall into this category. The significant cases
21 upon which Pearson relies all involve advertising.
22 Furthermore, some of the critical cases, like 44
23 Liquor Mart, involve bans on the advertising--again
24 advertising--of very basic factual information--that was a
25 total ban on liquor price advertising--the objective truth
1 of which can be fairly easily determined.
2 But here we're concerned with the food and drug
3 product label, a highly regulated space where there are
4 required disclosures in mandatory format, even with
5 mandatory type size requirements. Consumer expectations
6 about information conveyed in that space are, I am certain,
7 quite different than about advertising. And we're dealing
8 with information, the substance of the claims, the objective
9 truth of which cannot easily be determined by the consumer.
10 But the shortcomings of Pearson obviously are not
11 our primary focus, especially at this time of the day. The
12 boundary line between drug claims and other claims is our
14 I should state up front that I wish Congress had
15 never started down this path and I'm quite skeptical that
16 even "reducing the risk of" claims are read in the limited
17 fashion which their language literally states.
18 If these products could move beyond risk reduction
19 to mitigation of treatment claims, I think the public would
20 be seriously deserved. While some consumers purchase food
21 supplements as preventive medicine, many others are, in
22 fact, turning to supplements as alternative medicine, hoping
23 to obtain drug-like benefits without what they perceive to
24 be far greater side effects--the whole notion of if it's
25 natural, as food supplements are perceived to be, as opposed
1 to drugs, often similarly natural in their source, that they
2 are safer.
3 There may well be a lot of legitimate benefits
4 from the world of herbal and other supplement products as
5 alternative medicine, but these products should be subject
6 to a regulatory regime at least similar to that imposed on
7 more traditional drugs, to assure consumers equivalent
9 There should not only be adequate evidence of
10 their safety and efficacy but also assurance that dosages
11 are properly recommended, that there is product-to-product
12 and sample-to-sample bioequivalence, that good manufacturing
13 practices are followed, and that prescription requirements
14 have been considered.
15 Congress, in NLEA especially, made a limited
16 exception from drug status, and recall why it did that. It
17 did that because food companies wanted to put labels on
18 their cereal products about things like the benefit of
19 having fiber in your diet and its influence not just on
20 nutrition generally but to state that that might help
21 prevent certain diseases. That was the basis. That was the
22 factual format in which the NLEA came to pass.
23 They did not intend to eviscerate our drug
24 approval protections. That would have been a very different
25 debate. And there's nothing anti-competitive about
1 this--simply a level playing field between supplements and
2 all other products if they wish to be drugs.
3 Oh, and I should also note that in Pearson, in
4 footnote 6, the court said, "Oh, drugs are different." So
5 you have to be careful in drawing your conclusion.
6 The current regulatory scheme falls far short, it
7 seems to me. It's the worst of all possible worlds. In the
8 Washington Post, which I saw in its national weekly edition,
9 an official of California's Department of Health Services
10 characterized the current supplement scene as like the wild,
11 wild West and I wholeheartedly agree. FDA doesn't even know
12 about many of the products making claims, has insufficient
13 manpower to ensure that they're substantiated and some
14 skepticism that such substantiation exists is surely
16 Yet some herbal products could be good medicine.
17 I understand, for example, that St. John's Wort is the most
18 frequently prescribed anti-depressant in Germany, with a
19 lower risk profile than its traditional anti-depressant
20 competitors. This fact is hardly lost on American
21 consumers, who read the structure/function claim on St.
22 John's Wort, "May help enhance mood" and draw the obvious
23 and intended conclusion about its medical purposes.
24 I mean those of us who are sort of always high
25 certainly don't need it, yet a claim that St. John's Wort
1 mitigates or treats depression should not be allowed in the
2 United States today because that's clearly a drug claim.
3 This supplement is not being regulated as a drug. And Saw
4 Palmetto--I don't know about its efficacy--should be treated
6 I would be pleased if Congress were to go back and
7 undo the disaster that it's created and create a statutory
8 means for alternative medical products that meet drug
9 standards of safety and efficacy to obtain drug approval as
10 drugs in a somewhat different way, without each seller, for
11 instance, having to obtain an individual NDA, because that's
12 what makes it very expensive. Yet each seller would have to
13 demonstrate compliance with GMPs, dosages, labelings and
14 similar requirements under some sort of master approval,
15 like the food additive petition-type process.
16 Some supplement products so approved might need to
17 be covered by prescription requirements, although most would
18 be found probably relevant for over-the-counter sale.
19 I appreciate FDA's attempt to deal with the
20 semantics of what is a structure/function claim, what is a
21 drug claim. The agency's Federal Register publication of
22 January 6 could legitimately bear the claim "Promotes
23 soothing sleep." I doubt its careful distinctions are
24 appreciated by typical readers of the claim and I would like
25 to see some research, as people said today, about what
1 exactly is communicated by the various claims. If what is
2 communicated is in the nature of a drug claim, then the
3 public deserves the full panoply of patient protections in
4 our drug laws. Thank you.
5 MR. LEVITT: Thank you very much.
6 Final speaker on this panel from National Food
7 Processors Association, Regina Hildwine.
8 REGINA HILDWINE
9 NATIONAL FOOD PROCESSORS ASSOCIATION
10 MS. HILDWINE: Thank you very much.
11 I'm with the National Food Processors Association
12 or NFPA, which is the voice of the food processing industry
13 and my comments today are going to be framed in the context
14 of conventional food. So you're going to hear something a
15 little different than you've heard from the rest of the day.
16 I'd like to thank FDA for the opportunity to speak on this
18 NFPA has a very strong interest in the discussion
19 that's going on today, not the least because we were the
20 petitioner in 1994 in a rulemaking that's now pending on
21 health claims and nutrient content claims flexibility. Our
22 1994 petition argued the same First Amendment points that
23 were central to the Pearson case, but discussion of this
24 issue is not how I plan to spend my 10 minutes today.
25 One does not have to stray far from the text of
1 the federal Food, Drug and Cosmetic Act to find the answer
2 to the first question asked of this panel. And here it's
3 going to sound like an echo. The statute authorizes
4 substantiated food claims that characterize the relationship
5 of any nutrient to a disease or health-related condition.
6 We've come to call this category of food claims
7 health claims, but the authorizing provisions of the act,
8 which were adopted through the 1990 NLEA, were put forward
9 in an effort to counteract FDA's preexisting categorical ban
10 of all disease claims on foods under the drug definition in
11 Section 201(g)(1)(b) of the act. My lawyer had to write
12 that out for me.
13 That definition notes that the drug is an article
14 intended for use in the diagnosis, cure, mitigation,
15 treatment or prevention of disease. Notably, in elaborating
16 the NLEA provisions, and here I would differ from Marsha
17 Cohen, Congress made no effort to limit the nature of
18 disease claims that were approvable as health claims to
19 claims about prevention or risk reduction.
20 To the contrary, Congress deliberately adopted
21 broad language which embraces the full spectrum of potential
22 relationships between nutrients and disease, including all
23 those relationships that are named in the drug definition.
24 Claims characterizing the relationship between nutrients and
25 disease plainly could include not only preventive
1 relationships but mitigation, treatment, cure, and perhaps
2 even diagnosis.
3 The only question that is relevant is whether the
4 relationship that is claimed is properly substantiated. And
5 if it is, the statute says that FDA shall authorize the
7 The health claim provisions go on to include
8 conforming amendments to ensure that foods bearing
9 authorized health claims cannot be regulated as drugs under
10 Section 201(g)(1)(b).
11 So the bottom line, to us, is that FDA lacks any
12 authority to confine health claims to those expressing a
13 specific type of diet-disease relationship. FDA's authority
14 must be directed toward ensuring that claims are properly
15 substantiated and are stated in a truthful and nonmisleading
16 manner, in view of the nature of all available
17 substantiating evidence.
18 FDA, in asking these questions today, appears to
19 signal that it believes certain types of claims are
20 appropriate for foods. This thinking reflects an arbitrary
21 value judgment, in our view. It appears to be the kind of
22 paternalism that the court in Pearson versus Shalala soundly
24 The Pearson court made it clear that the
25 government, and specifically FDA, must not stand as a
1 gatekeeper restricting the flow of truthful, nonmisleading
2 information. To justify restrictions on label information,
3 the restrictions must relate directly to alleviating real
4 harms that the information itself otherwise would inflict.
5 Advancing science has shown that many lines that
6 might be drawn between prevention, treatment and mitigation
7 are, at best, fluid if they exist at all. FDA's own
8 regulations for foods for special dietary use make that
9 point and those regulations are, in fact, the orphan
10 regulations in this discussion.
11 The special dietary use regulations recognize that
12 foods can be an important part of managing disease by
13 addressing particular physiological needs that exist by
14 reason of physical, physiological, pathological or other
15 conditions. Foods and nutrients that help prevent disease
16 frequently also mitigate and even treat disease. If
17 consuming a food is potentially helpful in relationship to a
18 disease, that information could be communicated lawfully to
19 consumers through food labeling.
20 We believe we must get away from arbitrary line-
21 drawing exercises that have no scientific or legal basis and
22 are destined to failure in the end.
23 So the short answer to the question--Should health
24 claims go beyond claims about reducing the risk of disease
25 to include claims about mitigation or treatment?--is yes.
1 There is no basis for doing otherwise.
2 The question certainly provokes a great deal of
3 thinking about the role of foods and nutrients in preventing
4 and treating diseases and mitigating their symptoms. For
5 example, can a high fiber cereal be included as part of the
6 treatment plan for certain digestive diseases, such as
7 diverticular disease? Is it true that diets with controlled
8 levels of calories, carbohydrates and other nutrients could
9 be useful in managing noninsulin-dependent diabetes
10 mellitus? Can some patients manage their Type 2 diabetes
11 through diet alone? Can eating chicken soup be effective in
12 providing temporary relief from the symptoms of the common
13 cold? Who would ever do that?
14 Can dietary calcium do more than merely reduce the
15 risk of osteoporosis? I'm sure many of you know what the
16 recent NIH consensus conference had to say on that point.
17 Can dietary calcium be used to treat orthopedic conditions
18 other than reducing risk of osteoporosis?
19 For the last of these questions, I'm going to tell
20 you a personal anecdote. A few months ago I fractured two
21 bones in my arm, which was the result of a clumsy fall. It
22 was a simple, nondisplaced fracture, but I had two broken
23 bones nonetheless. I had damaged a bodily system such that
24 it no longer worked properly. I had a disease or health-
25 related condition.
1 The standard and even time-honored treatment for
2 simple fractures is reduction, immobilization, pain
3 alleviation and time, but at my first consultation with my
4 orthopedist, he also asked me if I was a milk drinker and
5 was very pleased when I said yes. He told me to be sure to
6 keep my calcium up. And, of course, this is happening in
7 about five seconds. Keep my calcium up, get 100 percent of
8 the RDA--he used the old terminology--and take a calcium
9 supplement if I have to.
10 From that moment, I considered dietary calcium to
11 be a part of the treatment plan of my fracture, along with
12 Ibuprofin and Acetametaphin. I did not need to see reams of
13 scientific studies to persuade me to follow a course that,
14 to me, made perfect sense. After all, if it is well
15 accepted that calcium helps build strong bones--it is, after
16 all, the quintessential structure/function claim for foods
17 in all the illustrations--it was logical to me that calcium
18 might provide some beneficial effect to help rebuild bone
19 injured through fracture. If such a claim could be
20 hypothesized for foods, even in concept, it could create an
21 opportunity for some serious scientific research and soon we
22 might even see milk bars on the ski slopes. And, by the
23 way, my arm's fine.
24 All are orthopedists as aware of dietary factors
25 as the one that first treated me, even about a substance as
1 elemental to their profession as calcium? I'm not sure
2 about that. The challenge then becomes how to make
3 physicians as aware of the usefulness of dietary factors for
4 treatment as they are about drugs so that they can advise
5 their patients on the potential health benefits of foods in
6 the treatment of their conditions. Fortunately, the First
7 Amendment environment for this is now more amenable to
8 meeting the challenge.
9 From fiber to chicken soup to dietary calcium,
10 people have been using foods to help treat or mitigate the
11 symptoms of diseases from the beginning of time. Everyone
12 has to eat, so why not eat something that may help with your
13 particular condition? This is an area of vigorous
14 scientific research and the body of evidence is growing that
15 could be used to substantiate such beneficial claims.
16 But it's another matter entirely for FDA to
17 authorize a health claim on food labeling along these lines,
18 since the agency typically has interpreted the health claim
19 provisions to be limited to risk reduction. Through this
20 approach, FDA has adopted an interpretation that places
21 undue impediments before claims for conventional foods that
22 should require no FDA preapproval.
23 The history behind the dental caries-sugar-alcohol
24 health claim, which appears at it very foundation to be a
25 nutrient avoidance claim coupled with a structure/function
1 claim, raises many questions. FDA's recent rulemaking on
2 structure/function claims for dietary supplements--in this
3 rule, the tension between FDA's policy on implied health
4 claims and structure/function claims has grown increasingly
5 obvious. Heart symbols or pictures of electrocardiograms on
6 food labels have been regulated as health claims in need of
7 the safe harbor of prior approval, while FDA says that
8 cardio health is a structure/function claim.
9 This internal inconsistency and arbitrary line-
10 drawing illustrates the need for a new way of thinking, a
11 paradigm shift. FDA is now, under Pearson's court order, to
12 create that shift by making room for the free flow of
13 truthful, nonmisleading claims and confining restrictions to
14 those that are needed to remedy the concrete harms presented
15 by fraudulent and deceptive claims.
16 We think the time has come for FDA to embrace the
17 First Amendment. The statutory language on health claims
18 defines the scope of the vessel, saying it's a glass. FDA,
19 in its implementing policies and regulations, has filled the
20 glass only about one-quarter full. There is much more room
21 in the glass than FDA has been prepared to fill.
22 The Pearson court tells us that the government
23 must not be so restrictive when the people thirst for truth.
24 We urge FDA to open up the flood gates and let truthful,
25 nonmisleading information flow. Thank you.
1 FDA PANEL DISCUSSION
2 MR. LEVITT: Thank you very much.
3 Let's move right into the questions. I will
5 Dr. Holtgrewe in his presentation emphasized the
6 point of people self-medicating, in this particular case
7 with Saw Palmetto for BPH but you could extrapolate more
8 broadly also in terms of self-medicating and masking a
9 serious disease, in this case cancer, which can be fatal.
10 In an area like that particularly, what would be
11 the safe circumstances under which that product could be
12 sold as a dietary supplement, for those who think that it
13 should be?
14 DR. HOLTGREWE: First of all, there is no known
15 medication of any kind that is known to prevent prostate
16 cancer or bladder cancer--none. There's one pharmacological
17 product that we now know can block the progression of benign
18 prostatic hyperplasia; it is not a food or dietary
20 The issue here is, I think, very simple. I've
21 heard a lot of talk about legal issues and about court
22 trials and I haven't heard a lot of talk about the patient,
23 the gentleman who has symptoms, who's going to be taking
24 this, who is the market for this product.
25 Ms. Hildwine said something about paternalism. I
1 think this is very important. I think that's the role of
2 government, to be paternal, to protect the American public
3 and, in this case, in the case of our patients, the older
4 male who has symptoms. We want to protect him against
5 taking a wrong turn in the road, a wrong action, and losing
6 valuable time or to be treating himself in an ineffectual
8 What we need is not more legal action, court
9 action or congressional action. What we need are properly
10 controlled prospective randomized clinical trials showing
11 the efficacy and the safety of these food supplement
12 products, which currently do not exist. That's the answer.
13 It will not be found in a court of law or in the
14 hallowed halls of our Congress. What we need to know is are
15 these effective and are they safe? And we have some data,
16 but it's limited. I don't feel that it's adequate and I
17 don't think we have adequate information.
18 So rather than court actions or governmental or
19 political actions, what we need are medical treatments.
20 This is a medical issue, not a legal issue and not, in my
21 view, a political issue. Are they effective? Yes/no. Are
22 they safe? Yes/no. Proper prospective, randomized clinical
23 trials and only that can prove the case. That's our
25 MR. LEVITT: Bill?
1 MR. SOLLER: I think what's important here is just
2 to step back for a moment because the danger of medical
3 paternalism is that it will take the issue in the extreme
4 and cloud all the other issues that might be attendant here.
5 What Regina and I were trying to convey is that
6 there is broad language as we think about the definition of
7 health claim. There are two questions that Regina
8 identified and the two questions that we, as an industry
9 group, interassociation, in grappling with this issue,
10 agreed to prior to this meeting.
11 The first is is the relationship substantiated?
12 And second, is it stated in a truthful and not misleading
14 Pearson instructs us to favor disclosure, not
15 suppression. So really the question here is not whether but
16 how. And I think on balance, you've heard a couple of
17 examples here. On the one hand, I provided an example of
18 calcium in terms of how, in the treatment of osteoporosis,
19 it's expected. You're not going to look at an Rx drug, new
20 chemical entity unless an individual's on calcium
22 As an aside for the record, when I broke two bones
23 in my ankle in January it was a supplement, Regina, not
24 milk. I worried about my cholesterol and my physician said
25 to take a supplement.
1 There is an example where on one end of the
2 spectrum, and I don't mean to bring the case examples in but
3 it really speaks to the patient, the consumer. Both of us
4 were instructed. We wanted to know information. We wanted
5 to hedge whatever we could to have the most rapid recovery
6 from our particular condition.
7 And I think in that particular situation where you
8 have something like calcium, where you know how it's being
9 treated, to be able to put that into the product label makes
10 a whole lot of sense.
11 Stepping back from that, if--I'll pick red rice
12 yeast extract not because I'm advocating this for
13 cholesterol reduction at all but take ingredient X in that
14 category. If it's determined that if an individual not only
15 is at risk for cardiovascular disease but actually has it
16 and is worried about the cholesterol and this can add
17 something else into the overall prescription therapy, it
18 makes sense to get that information on the label.
19 Now you step back and you move along the continuum
20 and you get into St. John's Wort for frank depression and
21 you may be in a whole different category.
22 MR. LEVITT: Because?
23 MR. SOLLER: Well, you may be in a whole different
24 category because you may determine, when CHPA petitions you
25 to approve it for severe depression, in making a
1 determination, that it represents an unreasonable risk to
2 the particular patient group that's involved. You've made
3 that determination. And in my comments I mention that you
4 could stipulate in guidance the kind of safety information
5 that you might expect along this continuum.
6 I think it's very helpful that you brought this
7 particular meeting together to help focus these kinds of
8 thoughts. I will tell you we haven't defined in that
9 continuum exactly what that criterion, set of criteria might
10 be that would distinguish, but certainly to take the extreme
11 and throw everything else out is not what the Pearson court
12 is about, it's not what the consumers want and it is not in
13 the best interest of patients that have the kind of broken
14 bones that we had that benefitted from our physician adding
15 something else onto the particular device that he happened
16 to put on my ankle.
17 MR. LEVITT: Claudia?
18 MS. LEWIS-ENG: I just want to make a point. I
19 want to address the safety and efficacy concerns that my
20 colleague to my left mentioned.
21 We submitted a health claims petition pursuant to
22 the health claims provision, as outlined in the NLEA, and we
23 submitted volumes of information that address both the
24 safety and efficacy of Saw Palmetto for the reduction of
25 symptoms associated with BPH.
1 So I think that in keeping with some concerns that
2 the doctor addressed, that we have addressed those when we
3 submitted the information to the agency. And in the claim
4 itself if you don't want people to forego medical treatment,
5 you could always include a disclaimer at the bottom saying
6 that you should consult your physician if your symptoms
7 worsen or your conditions are not exactly within the
8 confines described on the label.
9 MR. LEVITT: And do you think those data would
10 meet the drug standard?
11 MS. LEWIS-ENG: It's not designed to meet the drug
12 standard. It's designed to meet the significant scientific
13 agreement that Congress subscribed for dietary supplements.
14 DR. HOLTGREWE: May I respond to that?
15 I'm very conversant with the literature on benign
16 prostatic hyperplasia. In fact, I'm on a panel that's
17 drawing up guidelines that will be sequel to the guidelines
18 put out by the Agency for Healthcare Policy and Research
19 back in 1994.
20 There is nothing in the peer-reviewed literature
21 of the world that conclusively proves the efficacy or safety
22 of any of the products we're talking about. Yes, there's
23 literature, there's studies, but they are of short duration.
24 I don't think that any of them are really of the type that
25 would convince me or any scientifically thinking individual
1 that there's efficacy or safety to these products.
2 We need these studies. We welcome these studies.
3 We want these studies. And if these studies show the
4 efficacy and safety of these products, as I said before, we
5 welcome them to our armamentarium. We're always looking for
6 a way to treat a patient.
7 But we have this concern that it will mask a
8 significant cancer and we have the concern that we really
9 don't see the efficacy proven in the studies that currently
11 So there are studies--I would concur with
12 that--but I think they don't have great scientific merit.
13 MR. LEVITT: Let's quickly try to finish this
14 question because we have some others to move on to.
16 MS. COHEN: I'm just concerned. If I were
17 currently brewing up some new chemical entity for some
18 disease, which I'm not, and listening to this I would say,
19 aha; I'm going to do a little something different. I'm
20 going to save my many millions of dollars of study and I'm
21 going to, because I've got enough--I can get general stuff
22 as good as supplements have. I'm going to package it as a
23 food supplement, sell it as a food supplement for the relief
24 of the conditions of whatever, disease X which I'm working
25 on, and I'm wondering how you prevent me from doing that if
1 FDA moves this one step further.
2 In other words, wouldn't all people who are now
3 drugmakers suddenly become food supplement makers at great
4 savings to themselves?
5 MR. LEVITT: Next I'll move it on to Chris Lewis
6 for the next question.
7 MS. LEWIS: Actually, Marsha, thank you. That's a
8 little bit of a lead-in--
9 MS. COHEN: Was that your question?
10 MS. LEWIS: No, not quite. But at the risk of
11 getting too legal, I do want to return to the fact that I
12 think the questions the agency listed in the Federal
13 Register notice suggest we're wrestling a great deal with
14 the distinction between foods and drugs.
15 And I guess Regina and Claudia Lewis-Eng and
16 Marsha, you, as well, the question in my mind is how should
17 we or could we or do we distinguish between foods and drugs?
18 Are we on the right path with this concept of mitigation and
19 treatment being drug claims? Clearly I'm hearing not, at
20 least from some of you.
21 So the question is what's the difference between a
22 food and a drug? Is it simply the claim itself? Is there
23 something else going on that we need to consider if that is
24 an important goal? And maybe you need to talk about whether
25 that's an important goal. One of the questions we asked is
1 what happens to OTC drugs? How does this impact on those
3 MS. HILDWINE: I'm going to start this simply by
4 saying that we in the food industry are kind of struggling
5 with this, too. Initial thinking is that it's not the claim
6 that determines it or should determine it but perhaps we
7 need to look not so much at the definition of drugs again
8 but the definition of food. What is food? What are the
9 conditions of use of food? And as we settle on how that
10 works, perhaps this is all going to filter out.
11 We found that in the past decade or so, all of the
12 focus has been on drug-related issues and not enough on
13 food-related issues and yet this is an area where in the
14 development of such products as functional foods, we really
15 now need to understand what is a food.
16 You look at the statute and essentially the
17 statute begins by saying a food is a food, and that may not
18 be good enough. So we need to struggle with that.
19 But I think that issues that relate to the form of
20 the product, the conditions of use of the product have some
21 merit in terms of advancing the discussion.
22 DR. HOLTGREWE: I'll say again that in the March
23 16, 2000 Federal Register there's a sentence on page 3 that
24 says it all. It's quite simple, straight to the point.
25 "The act provides, in part, that articles intended for use
1 in the mitigation of disease are drugs."
2 And in the case of lower urinary tract symptoms,
3 medications and food supplements and dietary supplements,
4 they are attempting to treat symptoms that are due to a
5 disease; therefore they are treating a disease. And if
6 you're treating a disease, there's no difference between the
7 food supplement, the dietary supplement, and an ethical
8 pharmacological product, the latter of which, of course,
9 goes through a very rigorous food and drug control course
10 before it gets to the public.
11 So there is no difference between a product--I
12 don't care whether it comes from a banana tree or a walnut
13 or whether it comes out of the laboratory of a distinguished
14 pharmacological house. If that product is being marketed to
15 treat a disease, and these products are, they should be
16 controlled in a comparable manner.
17 MR. SOLLER: Just a comment in terms of food and
18 drug and the importance of considering the intended use,
19 conditions of use, but to reiterate also our comment on the
20 truthfulness of the claim, all important but perforce, that
21 will put you at times into grey areas, which we're
22 struggling with today.
23 We do have a carve-out area for disease risk
24 reduction claims. What we're saying is that in selected
25 circumstances for dietary supplements, recognizing that
1 there is a range over which these claims might be made, that
2 the agency could quite properly, appropriately and for the
3 benefit of the consumer, place information on the label
4 about the treatment of disease, calcium being one of the
6 MR. LEVITT: Next question, Mike Landa.
7 MR. LANDA: I want to pick up on Marsha's
8 question. Thank you.
9 Let's assume that you go beyond risk reduction.
10 What's the effect on the drug development process?
11 MR. SOLLER: Keep in mind that we're not dealing
12 with the structure/function claim regulatory process but
13 we're dealing with a preapproved authorization process where
14 the information is brought in to you.
15 MR. LANDA: But it's not the same as the drug
17 MR. SOLLER: Well, information is provided for
18 you. We're working on a fish oil submission to the agency
19 that is quite extensive and the information we're providing
20 in there provides what we think would be the appropriate
21 type of claim to allow the safe and beneficial use of this
22 particular product and in the context of all the information
23 and a truthful description of what that is.
24 It is not that sort of high proof standard of
25 drugs because, per Pearson, would allow disclaimer
1 information that would be applied to that particular claim.
2 But again I think it's in the overall context of how that's
3 being made and a determination that you can make as an
4 agency as to whether that's an unreasonable risk, given what
5 you have to play into there in terms of disclosure and not
6 suppression of information per Pearson.
7 But I think it's that balance. It's not an easy
8 one. It's case-specific, as will be the disclaimer.
9 Now on the drug approval process itself, remember
10 that if it's a new concoction, as I'm hearing here, there is
11 a new dietary supplement approval procedure and you can make
12 a determination there, as well, as to the kind of
13 information that you additionally would need before you
14 would allow that product to go to market.
15 And from the standpoint of new chemical entity in
16 the prescription field, I have a doubt that it's going to
17 significantly dent the PhRMA R&D machinery and the idea for
18 exclusivity and the whole reimbursement scheme and how that
19 plays out in terms of patient care.
20 MS. LEWIS-ENG: I have a comment. Your question
21 is what happens to the drug approval process? Nothing has
22 to happen. We have two distinct processes--one for drugs
23 and one for dietary supplements. So one doesn't necessarily
24 have to affect the other.
25 MR. LANDA: The question more directly is why
1 would one go to the drug approval process?
2 MS. LEWIS-ENG: Because dietary supplements are
3 regulated differently and there's one definition for dietary
4 supplements and a separate one for drugs.
5 DR. HOLTGREWE: I can't resist responding. There
6 should be no difference. You're treating disease; you're
7 treating disease. Whether it's with an apple or a banana or
8 with a pharmacological agent, you're treating a disease.
9 Why should there be a different standard?
10 MS. LEWIS-ENG: Because Congress said--
11 DR. HOLTGREWE: Well, I think Congress, in its
12 infinite wisdom, was wrong and it's just that simple.
13 MS. COHEN: I think the question is whether
14 Congress said that and it seems to me that the debate was
15 not about whether you change the drug approval process for
16 food supplements. That is probably, as I mentioned, that is
17 probably a debate that might be worthwhile--what do you do
18 with traditional medicine to enable it where you can't get
19 the exclusivity in the same way you can with the new
20 chemical entities? Is there a way to create a simpler, less
21 expensive means of the same goal, however? Someone's got to
22 prove the stuff is safe and effective if it is being used
23 for treatment.
24 MR. LEVITT: Peggy?
25 MS. DOTZEL: I guess one thing I'm not sure I
1 understand, so I would ask some people to respond to this,
2 is when we're talking about the proponents of expanding what
3 we have traditionally included in the realm of health claims
4 to treatment or mitigation claims, in proposing this, are
5 there any limits of the types of claims? I mean is there
6 any limitation on this or are you advocating opening the
7 door all the way?
8 And then if the answer to that is yes, my follow-
9 up question would be so then we have a scheme here where,
10 and this follows up a little bit on Mike's question, we have
11 a scheme here that we have drugs that are out there and the
12 claims are approved on the basis of substantial evidence and
13 we have dietary supplements and the claims are approved on
14 the basis of significant scientific agreement or something
15 less with a disclaimer.
16 How are consumers to know the difference? And
17 where is the distinction? How are they to distinguish these
18 two types of claims?
19 MR. SOLLER: The two types of dietary--repeat the
20 last part.
21 MS. DOTZEL: And how are they to distinguish the
22 two types of claims, the drug claim versus the health claim?
23 DR. HOLTGREWE: Well, in the silence, I hate to
24 monopolize things but the answer is very simple. They
25 cannot, of course. That's the problem. They cannot tell
1 the difference. The patient is not a graduate of a medical
2 school; nor is he a pharmacologist. He's a patient. He has
3 symptoms and he reads the disclaimer and it depends, of
4 course, on what the disclaimer says.
5 But, as I said in my earlier testimony, if you're
6 going to have a disclaimer on products marketed to treat
7 lower urinary tract symptoms, there should be in big, bold
8 letters, "You may have cancer and it may kill you." But
9 anything short of that I think is inadequate.
10 And I think it also should say that there is not a
11 great deal of compelling evidence that what you're taking
12 will help you.
13 There's another problem. Men with lower urinary
14 tract symptoms have an enormous placebo effect. If you go
15 to the scientific literature and look at studies on prostate
16 disease and the medical treatment of prostate disease, we
17 know for a fact in many, many well controlled prospective
18 randomized clinical trials that men on a sugar pill will get
19 something like a 30 to 40 percent improvement in their
20 symptoms just because they're taking a pill. That's a known
21 placebo effect. It's been all over the literature for
22 decades. We've known this.
23 So that's another risk. Even if they take
24 something, it's effective--it isn't effective; there's a
25 placebo effect. And what we need are these trials I keep
1 talking about.
2 I'm not against food supplements. I'm not against
3 plant extracts. It may sound like it; I'm not. I just want
4 information about them. And until we have that information,
5 I think we must think first of the patient and protect the
6 patient. That is our primary responsibility.
7 And to answer your question, there's no way the
8 patient can tell the difference. Somebody else may
10 MR. SOLLER: You asked if there are any limits in
11 the type of claims and would you open the door all the way.
12 I wasn't trying to convey that in my formal remarks or my
13 follow-up remarks earlier. What I was trying to convey was
14 that a body of evidence would be put at FDA's door and there
15 would be a claim, plus a disclaimer possibly that would be
16 tied to it in the context of health claim, asking for
17 essentially preapproval of that particular claim.
18 I think those types of claims, just given my
19 experience in the approval process with FDA and what I know
20 about dietary supplements and where the companies may be
21 thinking about it, may range across a spectrum. And there
22 may be somewhere a very simple qualifier or claim or very
23 limited information maybe attendant to that. I happen to
24 think calcium is that example. That's why I brought I up.
25 I think, and I'm not going to get into BPH but I
1 bring up that point because this is so much case-specific.
2 I know that you have to think about it in generalities
3 because ultimately you have to do something with it and the
4 generalities are characterized by the specifics.
5 The only way I'm comfortable thinking about this
6 is across a continuum of claims and therefore across a
7 continuum of qualifiers and disclaimers. And you may get to
8 a point where you say no, that's just not it. That's not
9 what's in the best interest and on a safety issue, you're
10 taking a stand. And I think that, looking at the criticism
11 for the agency in the Pearson, I think that was one of the
12 pieces which was thought to have been left out. I think in
13 terms of where you have your best way to put a barrier in
14 that regard is in the context of safety.
15 But where it makes sense and where it is adding
16 something overall and you're giving information to consumers
17 so that they can do something with it, I think you will see
18 that as a type of claim that should appropriately be put
19 onto a dietary supplement. And to try and put the kind of
20 language around that that describes what that was is our
21 version of trying to have FDA focus on the truthfulness of
22 the claim, as opposed to the validity of the relationship.
23 And I think if you make that paradigm shift over
24 to the truthfulness of the claim, you then think about this
25 in terms of the continuum of claim and where you then are in
1 the preapproval authorization seat of deciding from a safety
2 standpoint and from a benefit standpoint where you're going
3 to draw the line.
4 MR. LEVITT: Marsha?
5 MS. COHEN: You did mention benefit at the end but
6 I think we need to focus on the fact that nothing is safe if
7 it isn't efficacious. Even the slightest bit of risk is too
8 much risk if it doesn't help, if it doesn't do anything, and
9 I think that's--if we're in the medical world.
10 I mean if you take a lot of a water soluble
11 vitamin and you know, it doesn't do all those things that
12 you were sort of promised it would do and you just excrete
13 it, you've wasted money. But if the promise is that it
14 would mitigate or cure, treat a disease you have and you
15 have wasted critical time, that's critical. You can't
16 focus--and I think that's another flaw of Pearson, that it
17 was so focussed on safety as a drug thing and safety's not a
18 health claim thing. You have to focus on efficacy and not
19 just marginal--oh, it may work but here's the disclaimer
21 MR. SOLLER: I didn't mean to try and grab it from
23 MS. COHEN: But you did.
24 MR. SOLLER: We're agreeing. We were agreeing. I
1 But we're not disagreeing in the sense that I'm
2 not going to put something into FDA if I think there's no
3 benefit there. If I don't have a benefit that I can then
4 express to the consumer to sell my product and it's in a
5 preauthorization process, so benefit is part of this
7 MS. COHEN: But the question is the standard by
8 which that benefit is judged. The gold standard is what we
9 use for drug approval. That is the gold standard and we
10 occasionally have diverted.
11 In fact, over the last 15 years, and I live in San
12 Francisco at ground zero of the AIDS movement, because of
13 activism, we've moved back on sort of holding to the level
14 of the gold standard because people were dying and you move
15 back on that and even some advocates in that world realize
16 that mistakes were made because we were approving things too
17 quickly or weren't looking at such carefully controlled
18 clinical studies. But at least we were doing that because
19 people were dying and we had no other therapies.
20 But it was as mistake. If you're talking about
21 products that are getting preapproval on the basis of some
22 much lesser standard, that is not the equivalent of what's
23 required of a drug. It's just not equivalent.
24 MR. SOLLER: Well, I agree. It's not a drug.
25 MS. COHEN: Except you're allowing it to be used
1 as a drug. That's the question, is how we maintain a line.
2 MR. SOLLER: It is the question of where you are
3 drawing that particular line. It's not a question that you
4 don't have benefit information that is available and is
5 being reviewed by the agency, that is being put together by
6 the companies. It's not a question that you're taking a
7 small portion of that and you're ignoring all of it. It's
8 the weight of the evidence and the preponderance of the
10 It's consistent with where the law is and what is
11 expected in terms of the truthfulness of the claim. It's
12 entirely consistent with the FTC guidance, which is an
13 excellent document and one that I think should be built into
14 the basis of this in terms of putting truthful information
15 out to the consumer.
16 And we're not saying it's necessarily an
17 absolutely open door but, by the same token, depending upon
18 what that information would be and in the agency's
19 particular consideration of the patient or patient
20 subpopulation, the agency may determine that that is not an
21 appropriate health claim for safety concerns. It's a pretty
22 good standard.
23 MR. LEVITT: Okay, Dr. Holtgrewe, and then we'll
24 draw this point to a close.
25 DR. HOLTGREWE: In the case of food supplements
1 marketed for lower urinary tract symptom relief, you're
2 treating a disease and we do not have compelling evidence in
3 the peer-reviewed literature of the world that there is
4 safety or efficacy of these products, simply stated.
5 MR. LEVITT: We'll have one more question. Just
6 before I do, after we finish with this we'll have a break
7 and I have a feeling people will dart out of here.
8 Following the break, we have a number of people
9 who have asked to speak in their own individual capacity.
10 We'll provide for that. We have actually a section of the
11 room up here which we'd ask you to sit in following the
12 break. I believe you've been given numbers so we can get
13 the flow through quickly for that.
14 So I say that now and we'll turn to Rachel Behrman
15 for our final question for this panel.
16 MS. BEHRMAN: This is, to start with, for Dr.
17 Soller but then for whomever else wants to address it.
18 You seem to be suggesting a paradigm where there
19 are health claims that we could deny based on compelling
20 safety issues and you use St. John's Wort and depression as
21 an example. But you haven't spoken to the grayer areas.
22 You talk about calcium which again, if you will, is more on
23 the other extreme. There's a lot of information about
24 calcium and a lot of acceptance about that.
25 But let's say, for example, you have a compound, a
1 supplement that had some effect on blood pressure or
2 cholesterol, either one, but not a very great one and
3 clearly there are therapies, drugs, that have been held to a
4 higher standard and we have to accept that we're talking
5 about two different standards--safety and efficacy and
6 something else--we're not quite sure what that is.
7 So we a drug, a supplement, two different
8 standards and one is more effective. How would you
9 communicate that to the consumer? Do you believe that
10 should be communicated to the consumer?
11 MR. SOLLER: I think if you thought it was
12 important from a safety standpoint to communicate that, you
13 might put that into the qualifier. I think that's possible.
14 But it's very difficult--and I did say severe depression; I
15 was walking about the extreme end of this--it's sort of
16 difficult in the abstract to provide a generalized return on
17 your particular question because in the specifics, just to
18 hold the point, I might disagree with what I'm suggesting in
19 the general here.
20 And I don't mean to be convoluted, with a pretzel
21 argument, but what we're trying to convey is the concept
22 that you're going to have a range of these types of claims
23 and that the framework that should be developed should be
24 developed in the context of the truthfulness of the claim
25 but also keeping in mind that there should not be an
1 unreasonable risk, thinking back where you have your
2 enforcement authority under the act. It's that kind of
3 balance, I think, that is the paradigm shift in thinking
4 from the validity of the relationship that we're trying to
5 convey today.
6 MS. BEHRMAN: And if I could just follow that up
7 with one other point, in terms of again an analogy with OTC,
8 do you see areas that would not be acceptable for this
9 simply because of either patient recognition, ability to
10 self-diagnose, things like that, or do you really see the
11 whole gamut as a possibility?
12 MR. SOLLER: The whole gamut?
13 MS. BEHRMAN: Of types of diseases, for example.
14 MR. SOLLER: Well, I think you could have a safety
15 concern in the specifics of potential for a misdiagnosis.
16 That's possible. You take the kind of safety considerations
17 that you take on with any kind of product.
18 MR. LEVITT: Any other reactions to that question?
19 If not, let me thank this panel. It's been a very
20 lively panel.
22 MR. LEVITT: We will take a 15-minute break, which
23 by my watch says we're back here at 10 minutes after 4. And
24 again if the designated speakers could sit in front in your
25 designated order. Thank you all.
2 REGISTERED SPEAKERS
3 MR. LEVITT: Hello, if I could get people's
4 attention, we're ready to begin the final phase of this
5 meeting. We have a number of individuals--the number is a
6 little less than 20--who have asked to speak. We have a
7 podium that is set up right over here for your use. We have
8 seats with your names on them, which hopefully are in the
9 order in which you'll come out, to make it easier. And we
10 have folks who'll bring people over toward the podium about
11 three at a time in order to make it easier to get people up
12 but also not cause too much disruption during the speeches.
13 We have allotted five minutes for each speaker.
14 So when you get to the podium there is the timer over here,
15 which is reasonably in front of you. Take a moment to look
16 at it. Again, as before, when the yellow light goes on,
17 that means there is one minute left. When the red minute
18 goes on that means your time is out and in consideration of
19 the other speakers we would ask that you stop at that time.
20 Finally, if there is anybody who has managed to
21 sit here all day and did not sign up to speak but wishes to
22 do so, if you could now go out into the lobby and talk to
23 one of the women at the registration desk so we can get you
24 signed up. There is a little time but not a lot of time for
25 somebody who did not sign up in advance.
1 Finally, just one other matter of protocol. We do
2 have one member of Congress who has asked to speak and if he
3 is able to get here, we will ask him to move--if people
4 wouldn't mind letting him move next in line and then we'll
5 continue in the order that we have set out.
6 Finally, when you get up to the podium could you
7 please introduce who you are and what organization you're
9 With that, our first speaker is Mr. Norman
11 MR. SINGLETON: Can everybody hear all right?
12 Since I'm the first speaker, I'll do the requisite
13 microphone check. There's no charge.
14 My name is Norman Singleton. I'm a legislative
15 aide for education, work force and health care issues for
16 Congressman Ron Paul of Texas and I will be reading a
17 statement on behalf of Congressman Paul.
18 I appreciate the opportunity to express my support
19 for immediate implementation of the Pearson v. Shalala
20 decision. Every day the Food and Drug Administration delays
21 implementing Pearson is another day when consumers are
22 deprived of their First Amendment right to receive
23 information regarding the health benefits of dietary
24 supplements without interference from the federal
1 Such delays are especially hard to justify
2 considering that the court in Pearson suggested a reasonable
3 way for the FDA to implement the decision: allow the use of
4 disclaimers for statement that, while not approved by the
5 FDA, are not inherently misleading. Allowing manufacturers
6 to make nonapproved statements with a disclaimer is a major
7 step forward towards the creation of a true free market in
8 information regarding dietary supplements.
9 I also encourage the FDA to continue its work in
10 establishing clear scientific standards for reviewing health
11 claims of foods and dietary supplements since the court in
12 Pearson found that the FDA regulations relied on an
13 impermissibly vague standard of significant scientific
14 review. Of course, clear standards of conduct are the
15 minimum citizens in a free society should expect from their
17 Finally, I urge the FDA to allow claims regarding
18 the effect on existing diseases be made as health claims
19 without subjecting the product in question to regulation as
20 a drug.
21 Thanks to advances in nutritional science, there
22 is a great deal of information available regarding how
23 dietary supplements can help people with conditions such as
24 diabetes, heart problems, and glaucoma.
25 However, regulating food supplements as drugs will
1 have the effect of depriving consumers of a great deal of
2 this valuable information. This is because the
3 manufacturers of foods and dietary supplements containing
4 these benefits will simply refrain from informing consumers
5 of the positive effects of their products on diseases in
6 order to avoid having to go through the costly drug approval
7 process. This, of course, bodes well for certain
8 pharmaceutical companies who, some argue, exercise de facto
9 control over the FDA's regulatory actions.
10 Liberalizing the regulations on truthful health
11 claims is consistent with consumers' First Amendment
12 interest in access to truthful information about the
13 benefits of dietary supplements. Allowing participants to
14 make health claims regarding existing diseases is also
15 consistent with congressional intent, as most recently
16 expressed in the Dietary Supplement Health and Education
17 Act, popularly known as DSHEA.
18 In conclusion, I would like to reiterate my
19 gratitude to the FDA for providing this forum and express my
20 strong support for immediate implementation of the Pearson
21 decision, as well as allowing product health claims without
22 subjecting that product to regulation as a drug. Thank you
23 very much.
24 MR. LEVITT: Thank you.
25 The next speaker, please?
1 MS. ZAWEL: Good afternoon and thank you for this
2 opportunity to speak today. I am Stacey Zawel of the
3 Grocery Manufacturers of America. We are one of the world's
4 largest associations of food, beverage and consumer brand
5 companies and, as such, our member companies have very deep
6 interest in FDA implementation of the decision in Pearson
7 versus Shalala, as well as the provisions that authorize
8 disease claims for food products.
9 We commend the agency for providing this forum to
10 address how the Pearson decision will be implemented and
11 also to consider whether or not to permit health claims
12 about an effect on an existing disease.
13 First of all, I would like to address the Pearson
14 decision as we interpret it to apply to conventional foods.
15 Although the Pearson decision involved four disease claims
16 that arose in the context of dietary supplement, it applies
17 to all food and not just dietary supplements. There is
18 nothing in the Pearson decision that limits the impact of
19 the court's analysis solely to dietary supplements.
20 In order to ensure a fair, balanced and efficient
21 policy development process, it is incumbent upon FDA to
22 consider directly conventional foods, along with dietary
23 supplements. Indeed, the notice even acknowledges that the
24 treatment of health claims with respect to dietary
25 supplements is directly relevant to conventional foods.
1 The agency's apparent intent to consider these
2 issues solely in the context of dietary supplements is ill
3 conceived. FDA misses a very valuable opportunity to use
4 its resources efficiently by considering a single set of
5 issues once in connection with both dietary supplements and
6 conventional foods.
7 This concurrent approach also facilitates timely
8 development of policies. Ultimately these policies will be
9 applied to conventional foods and it is therefore rational
10 and prudent to directly consider conventional foods when
11 such policies are developed.
12 We object to FDA's determination that it will not
13 consider foods in connection with its implementation of
14 Pearson due to purported limits on its statutory authority
15 and because Pearson only involved dietary supplements. This
16 viewpoint is incorrect as a matter of law, according to our
17 lawyers--I'm a scientist--and represents unsound public
19 FDA's continued preference to read the First
20 Amendment protections narrowly to the facts of the Pearson
21 case is short-sighted. FDA should not postpone
22 consideration of these important issues in the context of
23 conventional foods until ordered to do so by a federal
24 court. And I think all of you probably saw a letter
25 submitted to the Federal Register under which GMA requested
1 that this meeting, in fact, be expanded to include dietary
2 supplements and foods, not just dietary supplements.
3 The second provision that I'd like to talk about
4 today at the request of FDA is the disease claim provisions
5 of the Food, Drug and Cosmetic Act that they applied to
6 treatment, as well as prevention of disease. Claims in the
7 labeling of a food that "characterizes the relationship of
8 any nutrient to a disease" are authorized in the act. There
9 is no limitation in this provision to the prevention of
11 Some nutrient-disease relationships involve
12 treatment, as well as prevention. For example, a person
13 with hypertension is often put on a low sodium diet that is
14 part of a treatment regimen. Similarly, patients with
15 osteoporosis, as we've already talked about a few times
16 today, are prescribed calcium for treatment. People with
17 cardiovascular disease are prescribed a diet low in fat and
18 dietary fiber as part of a treatment regimen, and the list
19 goes on and on.
20 There is, in short, no bright line between
21 prevention and treatment in the field of diet and disease.
22 In its Federal Register notice, FDA contends that
23 the disease prevention or treatment characteristic of a food
24 must be based upon its nutritional value. It is, moreover,
25 directly contrary to judicial precedent. The court in
1 Nutralab versus Schweiker concluded that food is consumed
2 "primarily for taste, aroma or nutritive value" but that "to
3 hold, as did the District Court, that articles used as foods
4 are articles used solely for taste, aroma or nutritive value
5 is unduly restrictive." Thus, food may be comprised of
6 nutritive and nonnutritive materials or completely from
7 nonnutritive materials and there is no statutory requirement
8 that the value of a food in preventing or treatment disease
9 must be derived from those nutritive components.
10 In conclusion or in summary, FDA should proceed
11 promptly to implement the Pearson decision for all forms of
12 food and to recognize that the disease claims provisions in
13 Section 403(r)(1)(b) of the act include the treatment, as
14 well as the prevention of disease. Thank you.
15 MR. LEVITT: Thank you.
16 Next speaker, please?
17 MR. HAMMELL: I am John Hammell. I represent the
18 International Advocates for Health Freedom, the largest
19 group of anti-regulatory vitamin consumers in the world.
20 We are sovereign over our bodies. No regulatory
21 body on earth has the right to tell us what we can or cannot
22 ingest into our bodies, much less restrict our access to
23 information about these substances.
24 The FDA has violated the Federal Advisory
25 Committees Act, which provides that government meetings be
1 open by taking my camcorder at the start of this meeting.
2 In light of your security notice, I wish to
3 publicly announce that although I consider the FDA to be in
4 contempt of court for not abiding by the Pearson decision
5 and that this entire meeting constitutes nothing more than
6 on-going FDA foot-dragging, for which you are already being
7 sued again by Pearson, I come in peace, unarmed, for the
8 mere purpose of informing you in person, eyeball to eyeball,
9 that I regard you to be the lowest pack of lawbreakers on
10 the planet, bar none, and your actions repulse not only
11 myself but vitamin consumers all over the world, many of
12 whom already know I'm saying this to you because I e-mailed
13 it out to them yesterday in advance of speaking here today.
14 The significant scientific agreement standard
15 cannot be scientifically defined. It is a tautology. It
16 means whatever you want it to mean. But in the Pearson case
17 the judge ruled the law is not in your mouth. We recommend
18 that you obey the law.
19 In the past, you dragged your feet before finally
20 allowing the health claim that folic acid prevents neural
21 tube defects. Through your violation of our First Amendment
22 right to free speech, you condemned untold numbers of
23 children to lives of ill health and many are currently
24 permanently paralyzed from spina bifida as a result, unable
25 to even walk or talk, because you have condemned them to a
1 hellish existence wherein they now require constant 24-hour
2 nursing care due to your genocidal actions.
3 Today you want to cause heart attacks, strokes,
4 cancer and other serious illnesses by dragging your feet on
5 approving health claims on unpatentable nutrients for which
6 there is equally great a body of evidence to support as that
7 for folic acid but, due to the revolving door between you
8 and the pharma cartel, you seek to do their bidding and not
9 do the bidding of the American people or the Court of
11 So you attempt to drive all the small vitamin
12 companies out of business by creating a regulatory nightmare
13 of red tape to enable the drug cartel to buy them out and my
14 guess is that your next move will probably be to try to
15 force the supplement industry to full HASAP GNPs or as far
16 in that direction as you can, even though such a move would
17 constitute gross regulatory overkill, which the American
18 people will not stand for.
19 Since consumers never trust anything you say and
20 generally ignore it anyway, I urge you to go ahead, put a
21 skull and crossbones on the supplement that you want to
22 condemn and give us the other half of the label. Let us say
23 anything we can back up in a court of law, as Pearson has,
24 and then honor the judge's decision after you lose.
25 It is my firm opinion that the founders of this
1 nation did not provide us with a Second Amendment so that we
2 could engage in target practice or go squirrel hunting. It
3 is my belief that this right was given to us as a check and
4 balance against corrupt, unelected bureaucrats, as well as
5 to balance the power of corrupt members of Congress and a
6 corrupt President.
7 As a Christian, I pray to God that things never
8 reach the point in this nation where we can't engage in
9 honest, two-way dialogue, so I hope you are really listening
10 to me today, not just going through the motions, as you have
11 many times in the past.
12 Before the Revolutionary War against England broke
13 out, many, many, many peaceful efforts, such as this, were
14 made, but the king broke all his promises to the colonists,
15 so they were forced to bear arms.
16 It saddens me deeply that you are so blatantly
17 ignoring a judge who ruled against you in the Pearson
18 decision, and for that reason another lawsuit had to be
20 I will not dignify any of your specific questions
21 with specific replies in my oral testimony, as all they
22 represent is more of the same sort of foot-dragging that you
23 have always engaged in in your zeal to violate the
24 constitutional rights, as you seek to do the bidding of your
25 pharmaceutical masters, the large companies that manipulate
1 you. But just to humor you, my written comments do address
2 all of your questions.
3 Many of your corporate manipulators are well
4 represented here today, such as Monsanto and Nabisco,
5 Unilever and others who would love to dismantle our dietary
6 supplement laws in order to ban consumer access to these
7 safe and effective healing agents.
8 As you engage in your corrupt effort to block the
9 making of truthful health claims on these natural products
10 and as you seek to violate our civil right to free speech,
11 please just know one thing. One day you must answer for
12 these crimes to your creator, who gave us the vitamins for
13 healing purposes.
14 And don't think you can get away with your effort
15 to make an end-run around our laws via the U.N.'s Codex
16 Salimantarius Commission, either. Do not think for one
17 minute that Congress will allow this. Do not think for one
18 minute that you are fooling anyone by trying to set us up
19 for Codex harmonization via the National Academy of
20 Science's so-called risk assessment paper, a risk assessment
21 model for establishing upper levels for nutrients, which is
22 on the IAHF website at IAHF.com.
23 On my website you will also find jif files with
24 signatures of five congressmen, including Congressman Dan
25 Burton, chairman of the House Government Reform and
1 Oversight Committee, Ron Paul, De Fazio, Cook and Stone.
2 MR. LEVITT: Excuse me. The five-minute timer has
3 completed. If you could just quickly summarize.
4 MR. HAMMELL: Just to summarize, basically obey
5 the law. You're not above the law.
6 MR. LEVITT: Thank you.
7 Next speaker, please?
8 MR. HANNEMAN: With respect, I'm Dick Hanneman.
9 I'm president of the Salt Institute and we appreciate this
10 opportunity to share with the agency our views on nutrition,
11 health and disease information that can be provided with a
12 dietary supplement or a food.
13 You've heard, I know, attempts to distinguish the
14 two. We think, as GMA testified, that really they ought to
15 be considered together and that the messages need to be
16 consistent because consumers need that consistency.
17 Historically, we've supported, with caution, the
18 FDA approach to resist health claims prior to NLEA but we
19 are concerned that consumers are being confused and misled
20 by information that they may receive about foods and
21 supplements and that claims need to be sufficiently flexible
22 and modified to reflect the new science that is coming
23 about--we don't think that's happening.
24 Courts have now ruled in a variety of contexts
25 with respect to different products that the FDA cannot
1 restrict information that's provided about a food if there
2 is a less burdensome way that the information can be
3 provided that's not false and misleading.
4 We're concerned about the implications on
5 allowable health claims and particularly, of course, on
6 sodium and hypertension when we have consistently stated
7 that that health claim improperly simplifies the role of
8 sodium in hypertension. By liberalizing allowable health
9 claims, the Pearson decision offers FDA an opportunity to
10 improve consumer understanding in this murky area of
12 Consumers do not properly understand the caveats
13 included in the current sodium hypertension health claim and
14 I'm sure that when FDA conducted its consumer polls before
15 implementing the sodium-hypertension health claim, you found
16 consumers may read the language crafted by your lawyers that
17 some people may benefit by following low sodium diets, but
18 actually consumers read this that most or all or probably
19 they personally will benefit by a low sodium diet. And, of
20 course, only the most zealous proponents of the sodium
21 hypothesis would make such an extreme claim and your
22 attorneys were careful not to make the language go that far.
23 There's no doubt that sodium reduction will confer
24 health benefits for a small subpopulation of people and
25 there's no doubt that sodium reduction increases health
1 risks for others. The current health claim conveys an
2 incorrect impression of universal benefit to all and risk to
3 no one. The Pearson decision points the way to rectifying
4 consumer misunderstandings.
5 So given the Pearson decision, FDA should require
6 or at least allow food companies to provide a more
7 comprehensive, balanced presentation of the health effects
8 of nutrients, including the debate that explains to
9 consumers the significant qualifications to the asserted
10 sodium-hypertension relationship, particularly if the health
11 claim has meaning for only certain subpopulations. This
12 will embrace the court's ruling that manufacturers have a
13 First Amendment right to provide such information as long as
14 it's presented accurately and in a balanced way.
15 Such an approach would also introduce flexibility
16 into the process of providing health claims information and
17 recognizing that significant advances in scientific
18 understanding will eventually occur, as they have, for the
19 sodium and hypertension health claim, since it was
20 authorized in '93. The scientific literature suggests that
21 there are significant health aspects for some small
22 percentage of people resulting from the low salt diets but
23 that most people do not benefit from sodium restriction,
24 that obesity and other nutrients play a much larger role in
25 the development of hypertension.
1 Today, for example, it would be much more accurate
2 to tell consumers that they would derive blood pressure
3 benefits by eating more fruits, more vegetables and more low
4 fat dairy products than to reduce dietary salt.
5 Science is the process of creative destruction, of
6 testing and replacing facts when new evidence proves them
7 inaccurate or incomplete. Scientific developments demand
8 more flexibility in health claims generation and evaluation.
9 The current rules, for example, make no direct
10 provision for modifying or deleting a health claim when
11 science shows it to be inaccurate or ineffective. No health
12 claims have been modified or discarded in the history of FDA
13 health claims regulation. If not today, eventually such a
14 system becomes unacceptably rigid in ignoring the advances
15 of science. However, an approach along the lines of
16 Pearson, where information is presented in a balanced,
17 accurate, and nonmisleading manner, can significantly assist
18 in enhancing consumer understanding.
19 In addition, FDA suggests that different standards
20 should apply to health claims on dietary supplements as on
21 food products. Unfortunately, consumers do not distinguish
22 between the information they read based on whether it's on a
23 supplement or a box of cereal.
24 Therefore, FDA should assess the acceptability of
25 health claims based on the same criteria--whether the
1 information is false and misleading. If not, the claim
2 ought to be allowed to stand.
3 In summary, the Salt Institute encourages FDA to
4 use the impetus of the Pearson decision to modify its rules
5 for both foods and dietary supplements to allow food
6 manufacturers the right to offer additional diet health
7 information in a balanced and accurate manner. The public
8 misunderstanding of the sodium and hypertension health
9 claim, in light of scientific advances, makes it an
10 instructive guide to fashioning these new FDA rules. Thank
12 MR. LEVITT: Thank you.
13 Our next speaker, please.
14 MR. LIEBERMAN: My name is Ben Lieberman. I'm
15 substituting for Sam Kazman. I'm a policy analyst with the
16 Competitive Enterprise Institute, a promarket public policy
17 group committed to advancing the principles of free markets
18 and limited government.
19 My organization has followed the dietary
20 supplement health claim debate, as well as other commercial
21 speech controversies, for many years. We are encouraged by
22 the growing body of recent case law, such as Pearson versus
23 Shalala, that has expanded the First Amendment protections
24 afforded information on product labels and advertisements
25 and we urge EPA--excuse me; we urge FDA; EPA can do a few
1 things, too--we urge FDA to quickly brings its labeling
2 policies into compliance with the First Amendment.
3 MR. LEVITT: We'll send them a note.
4 MR. LIEBERMAN: Okay. Today I'd like to briefly
5 add a few points to the issues addressed in the first two
6 panels, which centered around the significant scientific
7 agreement standard, as well as the nature and extent of any
8 required disclaimers. These issues really boil down to the
9 larger question of what information dietary supplement
10 producers will and will not be allowed to say and, more
11 importantly, what consumers will and will not be allowed to
12 read on product labels.
13 I believe that the Constitution and the public
14 interest is best served if FDA's role as information
15 gatekeeper is kept to a minimum, that of forbidding dietary
16 supplement health claims that lack scientific support. But
17 beyond restricting unsupported health claims, the agency has
18 no legitimate role in limiting truthful and nonmisleading
19 information on dietary supplement labels.
20 With regard to the significant scientific
21 agreement standard, the problem with this standard,
22 especially given FDA's tendency to interpret it fairly
23 strictly thus far, is that it has served to keep a good deal
24 of accurate and potentially beneficial information away from
25 consumers. Initially, FDA interpreted the NLEA and the
1 Dietary Supplement Act in such a manner as to prove only
2 those very few health claims that are an evidentiary slam-
3 dunk while completely suppressing all others that fall short
4 of its tough significant scientific agreement standard.
5 I hope that Pearson versus Shalala will put an end
6 to this interpretation but I'm somewhat concerned by FDA's
7 December 22, 1999 guidelines, which once again set the bar
8 very high.
9 In contrast to FDA's restrictive approach, I
10 believe that more truthful information is better than less.
11 If a dietary supplement probably has a health benefit, it's
12 better to inform consumers that it probably has this benefit
13 than to use any lingering uncertainty as a reason to tell
14 them nothing.
15 The preference for greater disclosure is
16 particularly acute in the absence of any real evidence that
17 dietary supplement health claims not meeting the significant
18 scientific agreement standard will cause any harm to
19 consumers. The Supreme Court has repeatedly held that the
20 party seeking to uphold a restriction on speech carries the
21 burden of justifying it. In the words of Justice Kennedy,
22 "This burden is not satisfied by mere speculation or
23 conjecture. Rather, a government body seeking to sustain a
24 restriction on commercial speech must demonstrate that the
25 harms it recites are real and that its restriction will, in
1 fact, alleviate them to a material degree."
2 FDA has yet to demonstrate that any such benefits
3 would be derived from banning dietary supplement health
4 claims that are accurate but do not meet the significant
5 scientific agreement standard.
6 Rather than setting a high standard that no more
7 than a handful of claims will ever meet and either
8 forbidding or requiring disclaimers for the rest, I would
9 suggest an alternative approach. I believe that FDA should
10 not place restrictions on any health claim so long as it is
11 worded so as to accurately reflect the state of the science.
12 Only those claims that misrepresent the degree of scientific
13 support or lack any support should be banned. Indeed, it's
14 hard to imagine any other standard that would not run into
15 future First Amendment problems.
16 With regard to disclaimers, I applaud the U.S.
17 Court of Appeals' clear preference in Pearson versus Shalala
18 for disclosure with disclaimers, if necessary, over a policy
19 of suppression, but since the court has given FDA wide
20 discretion in fashioning these disclaimer requirements, I
21 believe that a few words of caution are in order.
22 Keep in mind that the truth is a two-way street.
23 FDA can be just as wrong understating the benefits of a
24 dietary supplement as can the manufacturer by overstating
25 them. Unfortunately, thus far the agency has shown only
1 concern for the latter but not the former. However, a
2 required disclaimer that serves to make a dietary supplement
3 health claim sound less true than it actually is is also
4 misleading and must be avoided.
5 I'd add one last word of caution before FDA
6 promulgates its policy on disclaimers. The Bureau of
7 Alcohol, Tobacco and Firearms, which also regulates
8 products, including alcoholic beverage labels, is facing
9 similar constitutional questions regarding its refusal to
10 allow winemakers to say anything on their labels about the
11 evidence that moderate consumption of alcoholic beverages
12 confers cardiovascular and overall health benefits.
13 Though not officially banning such health
14 statements, ATF has responded with the tactic of imposing
15 disclaimer requirements so onerous that it would be nearly
16 impossible for producers to meet them. This is particularly
17 easy in the context of product labels, where there simply is
18 no room for more than a few sentences of text.
19 In fact, ATF has gone so far as to boast that any
20 disclaimer meeting its standards would be extremely unlikely
21 to fit on a typical label and has thus far successfully
22 stopped industry members from using health claims. My
23 organization is now challenging this policy in federal
25 Here any similar attempt by FDA to create
1 disclaimer requirements so burdensome so as to create a de
2 facto ban on any health claim would subvert the purpose of
3 the constitutional preference for more speech, rather than
5 In summary, there's a growing body of evidence
6 that a number of dietary supplements have health benefits,
7 yet very little of this information has thus far been
8 communicated to consumers on product labels, where it can
9 have the greatest impact. I hope that the FDA uses the
10 Pearson versus Shalala decision as an opportunity to
11 substantially modify its dietary supplement health claims
12 policy so as to comply with the First Amendment and comport
13 with the best interests of the American people. Thank you.
14 MR. LEVITT: Thank you.
15 The next speaker, please?
16 MR. ULLMAN: Good afternoon. My name is Mark
17 Ullman. I'm a partner in the New York City law firm of
18 Ullman, Shapiro & Ullman. I appear here today on behalf of
19 Traco Labs, Incorporated, a manufacturer and supplier of
20 dietary supplements based in Champagne, Illinois and, I
21 might also note, a defendant in one of FDA's black currant
22 oil cases that we like to think paved the way for DSHEA.
23 Over the past 10 years Traco has consistently
24 urged FDA to permit the free flow of all truthful,
25 nonmisleading information concerning the important health
1 benefits of dietary supplements. This position has been
2 grounded in the notion that only with this complete
3 information may American consumers take full control over
4 matters related to their health and make fully informed,
5 intelligent decisions on this all-important issue.
6 Once again today, Traco appears here to urge FDA
7 to allow the free flow of all truthful and nonmisleading
8 information to consumers by taking all necessary steps to
9 implement the D.C. Circuit Court's decision in Pearson v.
10 Shalala and by acknowledging that health claims which
11 discuss the effects of dietary supplements on existing
12 disease conditions are permissible under the federal Food,
13 Drug and Cosmetic Act.
14 In the Federal Register notice announcing this
15 meeting, FDA requested that comments address a series of
16 questions the agency posed pertaining to these issues. I
17 will attempt to address the most pertinent of these in the
18 brief amount of time allotted for this presentation.
19 On implementation of Pearson, what is the best
20 approach for public health? Traco firmly believes that the
21 answer to this question is one which allows for the free
22 flow of truthful and nonmisleading information. The public
23 health is best served when consumers are provided with
24 truthful information relating to the broad range of health
25 benefits that can be provided by dietary supplements.
1 Our First Amendment jurisprudence has repeatedly
2 expressed a preference for disclosure rather than
3 suppression of information. In its 1977 ruling in Bates v.
4 the State Bar of Arizona, the Supreme Court noted, "We view
5 as dubious any justification that is based on the benefits
6 of public ignorance."
7 Similarly in 44 Liquor Mart v. Rhode Island,
8 Justice Stevens recognized that, quoting, "The First
9 Amendment directs us to be skeptical, especially skeptical
10 of regulations that seek to keep people in the dark for
11 their own good."
12 Of equal import, however, Traco believes that
13 there is no place in the market for false, misleading
14 information. Such information is entitled to no First
15 Amendment protection and the full array of FDA's enforcement
16 powers are properly utilized against those individuals and
17 companies marketing products on the basis of such
19 On qualifying language and disclaimers, Traco
20 believes that the answer is an unqualified yes, such
21 disclaimers can be utilized to convey information in a
22 manner understandable to consumers. Several examples of
23 these disclaimers were cited by the D.C. Circuit in the
24 Pearson decision.
25 To the extent that FDA has expressed concern that
1 disclaimers and qualifying language may be so broad as to
2 justify even the most outrageous claims, Traco submits that
3 the Pearson decision does not require the agency to validate
4 any and all claims so long as they are accompanied by a
5 disclaimer. It is well established in our case that that
6 false promotional claims may not be protected by overarching
7 disclaimers. What Pearson does require, however, is that
8 FDA explain the basis for its decision in rejecting a claim
9 rather than simply announcing that it's failed to pass some
10 unarticulated standard.
11 To the extent that the agency has sought
12 information from the industry demonstrating that disclaimers
13 and qualifying language can be used in conjunction with
14 claims without causing consumer confusion, Traco notes that
15 the Pearson court expressly recognized that the burden is on
16 FDA to justify any restriction it may seek to place on
17 speech and that it's not the industry's burden to justify
18 that speech.
19 Specifically, the court stated that although the
20 government may have more leeway in choosing suppression over
21 disclosure as a response to the problem of consumer
22 confusion where products affect public health, it must still
23 meet its burden of justifying a restriction on speech.
24 On health claims on existing disease conditions,
25 Traco believes that the answer again here is an unqualified
1 yes, those claims should be allowed under the FDCA. I'm
2 going to rely basically on my written speech--I see my time
3 is running out--because I do want to address two questions
4 that were raised repeatedly to the last panel.
5 On the question of what standard to apply when a
6 health claim is submitted that is directed at treating or
7 mitigating diseases, we believe that the Pearson decision
8 allows FDA to adopt a sliding scale. The decision does
9 address FDA's public health concerns and the FDA can impose
10 a higher standard on that type of claim.
11 And, in conclusion, I'd like to suggest a
12 disclaimer FDA might be able to use to draw the
13 distinction--the agency has asked about how do we
14 distinguish between OTC products with claims and supplements
15 with health claims. The disclaimer we'd like to suggest is,
16 "This product has not undergone the FDA drug approval
17 process. You may want to consult your physician." Thank
19 MR. LEVITT: Thank you very much.
20 The next speaker, please?
21 MS. CAMPBELL: My name is Candace Campbell. I'm
22 the executive director of the American Preventive Medical
23 Association. We were one of the plaintiffs in the Pearson
24 case, so I think you know what I'm going to say.
25 For the past nine years APMA has asked FDA to
1 approve four dietary supplement health claims. FDA denied
2 the claims and refused to permit them even with disclaimers,
3 despite our successful arguments that the First Amendment
4 prohibited outright suppression of the claims and required
5 their authorization with disclaimers.
6 On January 15, 1999, the U.S. Court of Appeals for
7 the D.C. Circuit agreed with us and held FDA's four rules
8 suppressing the claims invalid under the First Amendment.
9 The court ruled that FDA may not suppress health claims if
10 it can render them nonmisleading through the addition of
11 disclaimers. The court ordered FDA to favor disclosure over
12 suppression and found almost frivolous FDA's arguments to
13 the contrary.
14 The court gave the agency precise disclaimer
15 language that the court found acceptable for use with each
16 of the four claims FDA suppressed. In other words, the
17 court gave FDA a precise road map to follow to assure full
18 compliance with the First Amendment.
19 Despite the court's orders, in over one year after
20 the court's decision FDA continues to enforce the four rules
21 the court held invalid. My attorney has been told by
22 Director Levitt that FDA will prosecute anyone who uses the
23 claims the court found wrongfully suppressed, even if those
24 claims are used with the court's preferred disclaimers.
25 In short, FDA is continuing to violate the First
1 Amendment and it is resisting compliance with the Pearson
2 court constitutional order. Where I come from that's called
3 contempt of court.
4 The Pearson court's decision is extraordinary in
5 many respects. First, the court not only ruled that the FDA
6 violated the First Amendment by suppressing the four health
7 claims rather than disclosing them; it also spelled out in
8 detail the kinds of disclaimers it found sufficient to
9 eliminate the potentially misleading connotations FDA
11 In other words, the court not only told FDA why
12 its actions were unconstitutional; it also told FDA
13 precisely how to comply with the Constitution--by
14 authorizing the claims in a nonmisleading way.
15 After the court's clear explanation to the agency,
16 one would have thought FDA would act immediately to
17 authorize the claims with those disclaimers, but FDA did
18 not. Instead, the agency has spent over 14 months enforcing
19 the very rules the court invalidated and struggling to find
20 some legal argument for not complying with the court's
21 order. FDA has refused to set a date certain by which it
22 will authorize the claims with disclaimers, despite five
23 letters from our attorney requesting a date.
24 FDA has refused to allow APMA members to use the
25 claims with disclaimers, threatening enforcement action
1 against them if they do so.
2 In today's meeting, FDA does not identify a date
3 by which it will authorize the claims. Rather, you ask
4 questions which reveal that it seeks yet another scientific
5 validity test to prevent authorization of the claims.
6 Moreover, FDA is now trying to redefine the term
7 "health claim" to exclude treatment claims from those
8 permitted without drug preapproval.
9 To be blunt, we would like to see this nonsense
10 come to an end. Rather than follow the law faithfully, the
11 FDA is doing everything it can to evade, circumvent and
12 disobey the law. These actions are reprehensible.
13 I realize from communications with the agency that
14 you believe you are responding with all due haste. Let me
15 assure you you are alone in this perception. FDA's duty to
16 comply with Pearson is clear and immediate. We have
17 suffered at least nine years of speech suppression and
18 should not be made to suffer an additional moment.
19 The court ordered this agency to authorize the
20 claims with disclaimers. The court told this agency what
21 disclaimers it found acceptable. We ask that you do what is
22 required of you and stop these obvious evasive tactics.
23 It's mind-boggling to me that we spent six years,
24 hundreds of thousands of dollars--not tax dollars--and won a
25 landmark lawsuit and the agency has yet to comply. If an
1 individual acted with such impunity, he would be in jail by
3 Please authorize all four of the health claims
4 with the disclaimers the court has given you and do so
6 I came here today to ask you, to urge you to stop
7 playing games with the Constitution. Stop running roughshod
8 over our free speech rights. FDA is not above the law.
9 MR. LEVITT: Thank you.
10 Our next speaker, please?
11 MR. McCURRY: My name is Steve McCurry. I'm here
12 representing the Research-based Dietary Ingredient
13 Association, commonly written as RDIA. I'd like to thank
14 you for this opportunity to make a few comments. We're
15 submitting written comments, as well. These will be as
16 brief as I can make them. It has been a very interesting
17 day with lots of interesting points made.
18 Certainly the First Amendment applies to
19 commercial speech. I don't think I heard anybody today
20 disagree with that notion. But problems do crop up in the
21 way it's implemented. Statements that do not meet the
22 standard of truthful and not misleading are of no help to
23 anyone. Claims that are not understood by the consumers are
24 inherently misleading and, at best, can do no harm; at
25 worst, they can do something much more difficult--claims
1 that are not understood.
2 Any disclaimer has to be worded to match the
3 health claim desired based on the totality of the scientific
4 information that's actually available for it. Especially
5 given that the scientist who tries to evaluate the study has
6 spent years going to school, has spent years gaining
7 experience and is still having trouble understanding what
8 the science actually concludes about it, it's sort of
9 difficult to imagine a way to communicate that information
10 to the public in a simple form so that it can be easily
11 understood, notwithstanding the fact that the public is
12 entitled to see the information.
13 What or how much information constitutes useful
14 disclaimers, given that the explanation over a certain
15 length, as we heard earlier today, isn't read, anyway? So
16 this is another rather large problem as far as implementing
17 meaningful disclaimers.
18 The last point I'd like to make is that a solid,
19 independent, third-party review system by experts, such as
20 has been suggested as an option in the SSA guidance document
21 by FDA, as well as during the first panel this morning,
22 would be one way to help implement such claims.
23 We've heard many concerns about safety and the
24 need for data substantiating the claims. Our organization
25 believes that the GRAS standard or the GRAS principles are
1 the same, should be the same for dietary supplements and
2 functional foods--a reasonable certainty of no harm. In
3 other words, the public is entitled to safe products.
4 We believe the claims, no matter what regulatory
5 category, have to be adequately substantiated with
6 appropriate, adequate and rigorous scientific data, and I
7 think that's all we have to say now. And the written
8 comments I hope will be a little more clear, rather than
9 some that were assembled sort of the spur of the moment in
10 response to a lot of talks today. Thank you.
11 MR. LEVITT: Thank you.
12 Our next speaker, please?
13 DR. BAER: Good afternoon. My name's Dr. Andrew
14 Baer. I'm an internist and I practice integrative medicine
15 and I'm also here representing the Life Extension
17 What are the real core issues here? I think what
18 we're really talking about is safety and efficacy as it
19 applies to dietary supplements, and that's what everybody
20 was talking about this morning ad infinitum.
21 The will of Congress was really that we not treat
22 dietary supplements in the same way we treat drugs. They
23 shouldn't be run through the same sort of process that we
24 use to approve drugs.
25 Pearson has really opened up this Pandora's box
1 yet again. I know Pearson and although he's used the First
2 Amendment, I think the First Amendment really is a cop-out
3 and that's not really what's at issue. What we're really
4 talking about is whether or not we really want dietary
5 supplements to be handled in the same fashion that we handle
7 The drug approval process is unnecessarily
8 expensive--we all know that. The companies that manufacture
9 and sell and distribute dietary supplements can't really
10 afford to do this kind of research. And really safety and
11 efficacy has been demonstrated in most of these things in
12 other countries and many of them have been used for a long
13 time without any kind of untoward effects.
14 Some years ago I remember when--just a couple of
15 years ago, really, when acupuncture needs were finally taken
16 out of the investigational class and approved by the FDA. I
17 remember thinking to myself that this was really unmitigated
18 hubris. I mean acupuncture has been practiced in China for
19 thousands of years; so has eight-principle medicine, which
20 is sort of their internal medicine, and eight-principle
21 medicine is how physicians there prescribe the herbal
22 preparations that they mix together to treat disease.
23 Certainly they've been doing this for a long
24 time--thousands of years, again--without any kind of a
25 regulatory oversight. And God knows there are still
1 billions of Chinese on the planet. They're not dropping
2 like flies from ingesting herbs.
3 Medicine is actually a dynamic process. We know
4 that things change. Everybody knows the thalidomide story
5 and what we went through about that and yet thalidomide is
6 back in the news again. We now find that there are some
7 uses for thalidomide.
8 We also know about H2 blockers and the fact that
9 we now know the etiology of peptic ulcer disease is from a
10 biological agent and not from aberrant excursions of stomach
11 acid. And yet we still have H2 blockers on the market,
12 despite the fact that having the pH of the stomach altered
13 in such a way that it's raised probably interferes with
14 digestion, leaving digestive remnants in patients that have
15 a leaky bowel. This can result in T-cell-mediated
17 I'm bringing this up because really it's very
18 difficult to regulate everything. We can't control the
19 whole world.
20 When we were talking this morning I was listening
21 to what was going on and I started thinking to myself, do we
22 really want a bottle of supplement, whatever it happens to
23 be, to look like a page from the PDR? When you think about
24 it, why is it that a prescription bottle doesn't look like a
25 page from the PDR? The reason is because we give informed
1 consent dispositions and that's what we're really talking
2 about here when we're trying to get into this whole issue of
3 the dissemination of information and disclaimers. I mean
4 there's pros, there's cons. How much of this can you put on
5 a label of anything?
6 And I think really the same sort of thing obtains
7 here that obtains with drugs. You know we've gotten so
8 crazy with informed consent that it's difficult to do this
9 without scaring off patients. I mean if we were to give
10 true informed consent about surgery, we'd tell the patients,
11 you know, you have a 1 in 10,000 risk of just dying from the
12 anesthesia alone. Do we really want to tell people
14 Well, yeah, that's fine. Yeah, that's fine. That
15 may be, but you have to make some sort of decisions about
16 how much you can tell them. Do you want to be read the
17 whole PDR page? You can go read it yourself. That's great
18 if you want me to read it to you but that's something I
19 think the American public can read themselves. They don't
20 need me to read them from the PDR just to give them the
21 details of every little possible thing that can happen,
22 especially because that's absurd. You include every
23 untoward drug reaction, whether it happens 1 in a billion.
24 That's not informed consent. That's diarrhea facts.
25 MR. LEVITT: Excuse me. The time is up. If you
1 could find a way to summarize briefly, please, and conclude.
2 DR. BAER: Anyway, the public isn't stupid. They
3 can make these decisions themselves. They don't need the
4 FDA to do that for them.
5 And the important thing is that many of the
6 supplements are now within the provision of the standard of
7 care in the community of physicians and if you prevent us
8 from being able to prescribe or disseminate information,
9 we're going to be liable to be sued and so are you. I mean
10 I can think of a lot of cardiologists that prescribe anti-
11 oxidants, so it's now within the province of the standard of
12 care. Thanks.
13 MR. LEVITT: Thank you. I do apologize for the
14 interruption from the cell phone. Does anybody else that
15 does have a cell phone or a pager here--again, I asked
16 earlier if you could please turn them off. It is
17 distracting to the speakers who, like others, have waited
18 all day for their turn. Thank you.
19 Next speaker, please?
20 MS. PELETIER: Thank you. My name is Joy
21 Peletier. I'm a biochemist and nutrition scientist for Pure
22 Encapsulations, Incorporated of Sudbury, Massachusetts. I
23 advise the company on product formulations, on the
24 scientific evidence of product ingredients and on
25 permissible claims. I spend a great deal of my time
1 reviewing peer-reviewed scientific journals in biochemistry
2 and nutrition science.
3 Nutrient disease information need not be proven
4 conclusively true to be accurately represented to the
5 public. The Pearson court understood that First Amendment
6 lesson; this agency still does not.
7 In the course of my work, I frequently encounter
8 nutrition science which although not conclusive, strongly
9 associates a nutrient with reduction in the risk of a
10 particular disease or reduction in disease symptoms. That
11 accurate information is not of the kind FDA approves under
12 its health claims review standard. In other words, although
13 a nutrient-disease association can be accurately stated, the
14 FDA prohibits it until it can be proven conclusively.
15 To follow the law, companies such as the one I
16 represent deprive consumers of truthful answers to nutrient-
17 disease questions every day. We know that truthful answers
18 on the nutrient-disease association will violate FDA's
19 health claim ban, which judges speech on conclusiveness, not
20 on truth.
21 FDA's health claim rule has blocked from consumers
22 a wealth of accurate scientific information contained in the
23 peer-reviewed literature that indicates certain nutrients
24 may affect certain diseases. The nation's leading
25 scientists and even the Surgeon General may rely on that
1 information and accurately inform patients of the
2 possibility that Vitamin E may reduce the risk of heart
3 disease, that Saw Palmetto may relieve the symptoms of
4 benign prostatic hyperplasia, that Vitamin B6, B12 and folic
5 acid may reduce the risk of vascular disease, that ginger
6 may eliminate nausea or that prune juice may relieve the
7 symptoms of chronic constipation, but that same information
8 cannot appear on the label or the labeling of a dietary
10 The ones hurt most by FDA's health claims rule are
11 consumers. Consumers buy dietary supplements for health
12 reasons. They perform a basic risk-benefit analysis before
13 making a purchase. If the product is safe and it may help
14 reduce a disease risk or disease symptoms, even if the jury
15 is still out, they may still want to give it a try.
16 Consumers are far more independent and sophisticated than
17 the FDA believes. They appreciate that very little in
18 science is proven conclusively true, yet much in science not
19 proven conclusively is still of great potential use.
20 Thus, most oncologists in the U.S. use anti-
21 oxidant vitamins. They know well that the scientific
22 evidence that anti-oxidants reduce the risk of cancer is
23 very strong but may not yet be conclusive. Most
24 cardiololgists in the U.S. consume Vitamin E. They know
25 well that the scientific evidence that Vitamin E reduces the
1 risk of heart disease is very strong but may not yet be
3 Yet the risks of consuming these products is zero
4 while the potential benefits are great. In short, it is a
5 safe bet.
6 Consumers are entitled to make these safe bets,
7 too, but they can only do so if they are accurately
8 informed. They can only be accurately informed if the FDA
9 embraces the Pearson decision and discloses this information
10 rather than suppresses it.
11 The Pearson court has ordered FDA to get out of
12 the business of suppression and into the business of
13 disclosure. This agency has to do a 180-degree turnaround
14 and start fostering the distribution of accurate health
15 claims, rather than blocking all health claims it deems
17 Consider the consequences of FDA's prohibition on
18 the dissemination of inconclusive yet accurately stated
19 science. First, the absence of accurate science at the
20 point of sale deprives consumers of information they need to
21 make informed choices. When deprived of accurate nutrient-
22 disease information at the point of sale, consumers are
23 bound to be misled by erroneous assumptions derived from
24 secondary sources, such as television, radio, magazines or
1 Second, the absence of accurate science at the
2 point of sale increases the chance that consumers will harm
3 themselves by taking too much of a product or by avoiding a
4 needed medical treatment.
5 Third, the absence of accurate science at the
6 point of sale increases the chance that consumers will be
7 defrauded. Without accurate information, consumers are less
8 likely to be skeptical about false claims.
9 Fourth, by prohibiting all but those claims that
10 are proven to a near conclusive degree, FDA has created a
11 huge black market in unapproved claims. By implementing the
12 Pearson decision and allowing inconclusive claims with
13 disclaimers, FDA will lower the bar and cause many who now
14 avoid health claim submissions to file claims. That way
15 more accurate information will reach consumers than ever
17 In sum, FDA's effective ban on all but conclusive
18 nutrient-disease information at the point of sale not only
19 violates the First Amendment right for people like me but
20 also endangers public health. It leaves fraud and
21 misinformation in the market unchecked by accurate
22 information. Remember, nutrient-disease information need
23 not be proven conclusively true to be accurately presented
24 to the public. The Pearson court understood that First
25 Amendment lesson. This agency still does not. Thank you.
1 MR. LEVITT: Thank you.
2 We have several more speakers left. The next
3 speaker, please?
4 DR. WHITAKER: Good afternoon. I'm Julian
5 Whitaker. I'm a medical doctor. I'm in private practice in
6 Newport Beach, California. I've written eight books on
7 health and unconventional methods of treatment. I write a
8 monthly newsletter, "Health and Healing," which is received
9 by 500,000 people. I consult with a nutritional supplement
10 company on matters of use and formulation.
11 I am the founder and past president of the
12 American Preventive Medical Association and was the
13 president when the American Preventive Medical Association
14 joined Pearson and Shaw as plaintiffs in the successful suit
15 brought against the Food and Drug Administration. The
16 ramifications of that suit are the reason for this hearing.
17 I am one of the petitioners to the FDA to approve
18 a claim for the use of Saw Palmetto that alleviates the
19 symptoms of benign prostatic hypertrophy.
20 Ladies and gentlemen, truthful, nonmisleading
21 information has not been on nutrition supplements for the
22 past 25 years. For instance, the labels on bottles of
23 Vitamin C should tell you that this vitamin may help in the
24 prevention of cancer and heart disease. On bottles of
25 Vitamin E it should clearly state that the supplement of
1 Vitamin E may be helpful, along with diet and exercise, in
2 preventing cardiovascular disease.
3 On bottles of B complex vitamins, it should state
4 that these nutrients may be helpful in preventing heart
5 disease, several types of cancer, neural tube birth defects.
6 These are truthful. These are nonmisleading
7 claims that are substantiated by a wealth of scientific data
8 and could be used to the treat benefit of the citizens of
9 this country.
10 You haven't seen such information as this on
11 supplement labels because the FDA has not allowed it.
12 However, the court has ruled that the FDA's censorship of
13 this kind of information on nutritional supplement bottles
14 is not only illegal but is unconstitutional. That ruling by
15 the D.C. Court of Appeals, three to zero, was handed down
16 January 1999. The court ruled that the FDA's requirement
17 that a health claim must meet FDA's standard of significant
18 scientific agreement was not only a bad idea but it was
19 illegal. That standard was undefined and thus that standard
20 was arbitrary and capricious. That is illegal for it
21 violated the Administrative Procedure Act.
22 The court also held that its prior restraint of
23 speech forbidding manufacturers and retailers from saying
24 anything good about a nutrition supplement until the FDA
25 approves such was a violation of their First Amendment
1 rights guaranteed by the Constitution.
2 The FDA appealed these rulings to the Fourth
3 Circuit D.C. court. They lost again, 13 to zero.
4 The FDA did not appeal this decision to the
5 Supreme Court for more obvious reasons. Thus, the court
6 mandate of the D.C. Circuit in Pearson and Shaw versus
7 Shalala became the law of the land in January of 1999.
8 So what has the FDA done to create its illegal and
9 unconstitutional ruling to abide by the court order?
10 Absolutely nothing. They have procrastinated, rolled out
11 excuses and dragged their feet.
12 In fact, this hearing is a fraudulent sham. We
13 are gathered here as if on a fact-finding mission to answer
14 compelling FDA questions. The first question is should
15 health claims be allowed on dietary supplements other than
16 those that meet the FDA standard, whatever it may be, of
17 significant scientific agreement?
18 Ladies and gentlemen, pardon my mirth. We need
19 not answer that question for it has already been a court
20 order and a resounding unequivocal answer of yes. The
21 answer to that question is a court-ordered yes.
22 The court ruling did not provide for the FDA to
23 have a hearing just for input as to how they should abide by
24 a court ruling.
25 Ladies and gentlemen, if a government regulatory
1 agency, such as the FDA, were engaged in a regime of
2 censorship and deprived an ethnic minority--let us say
3 African-Americans--of their constitutionally guaranteed
4 rights of speech and if the court found that the regulatory
5 agency had violated statutory law by using an arbitrary and
6 capricious ruling and that the court had ordered the agency
7 to immediately remedy their actions, do you think that over
8 a year following that decision they would be calling for a
9 hearing seeking input to see if free speech should be given
10 to the minority group? I think not.
11 Ladies and gentlemen, the FDA's illegal and
12 unconstitutional censorship of truthful and nonmisleading
13 labels on nutritional supplements has been dealt a fatal
14 blow and I am proud to be a part of those who orchestrated
15 such. Like a female lion on a hunt who has struck, we have
16 this illegal repression of speech by the throat.
17 If it has not been swept from our political
18 landscape within the next year, then we all had best worry
19 because that will mean that our system of checks and
20 balances, put in place to protect us, the citizens, from
21 overriding governmental action, not to protect us from
22 ourselves but to protect us from government, the system of
23 checks and balances to guarantee the freedom that we have in
24 this country has failed. Thank you.
25 MR. LEVITT: Thank you. Next?
1 MS. ORTUZAR: My name is Alyce Ortuzar. I'm a
2 medical, legal and social science researcher and I run the
3 Well-Mind Association of Greater Washington, a holistic
4 medicine information clearinghouse.
5 In 1949 Dr. Frederick Klenner published that he
6 had cured polio with intravenous Vitamin C. He published
7 for 40 more years and documented his success with
8 intravenous Vitamin C, often in very high dosages of over
9 200 grams in a 24-hour period with measles, chicken pox,
10 third-degree burns and pneumonia, which he said he never
11 lost a case of, no matter how close to death the patient
12 was. I personally used it to reverse my Lyme's Disease.
13 He recommended it as the treatment of choice in
14 the emergency room, called it the safest, most effective
15 antibiotic and was critical of the AMA and the FDA for
16 either recommending to lower the dose or for discrediting
17 the treatment outright.
18 In the 1950s Drs. Osmond and Hoffer documented
19 their ability to reverse certain schizophrenias with high
20 doses of Vitamin C, B3 and B6. Also in the 1950s the Chute
21 brothers documented their ability to treat and reverse heart
22 disease with Vitamin E. Intravenous magnesium was also
23 documented as a life-saving treatment in the case of heart
25 In 1962 Bill W., cofounder of Alcoholics
1 Anonymous, documented his success with a high protein, low
2 carbohydrate diet and niacin.
3 In 1966 in the National Medical Journal the title
4 of an article was "Hypoglycemia as a cause of
5 neuropsychiatric disorders," implying that with most mental
6 illnesses there was really an underlying physical cause and
7 focussing on the brain or focussing on just drugs is not
8 going to resolve the patient's problems.
9 In 1968 Dr. John Tintera published his data where
10 he used adrenal cortical extract and the high protein, low
11 carbohydrate to successfully reverse alcoholism,
12 hypoglycemia, certain schizophrenias and certain arthritis
13 cases. He was very critical of prednisone, documenting it
14 as being very toxic and the only time he ever experienced
15 failure in his patients was if people had had prednisone
17 In 1970, Dr. Ben Feingold documented his ability
18 to reverse learning and behavior disorders by taking
19 children off of all but organic foods, eliminating sugars
20 and eliminating artificial chemicals, dyes and additives,
21 all approved by the FDA, USDA and EPA, including pesticides.
22 Studies claiming to refute these doctors were paid
23 for often by the chemical or sugar industries and were shown
24 to have serious design flaws.
25 Dr. Linus Pauling, who won the Nobel Prize for his
1 chemistry, was also critical of claims that high dose
2 Vitamin C caused harm and said chemically it just was not
4 In 1978, the FDA submitted false information
5 characterized by then-Congressman Barry Goldwater, Jr. as
6 sloppy and suspect to take adrenal cortical extract off the
7 market and make the public a captive audience for
8 prednisone. In mainstream medical literature today
9 prednisone is identified as one of the most toxic drugs, and
10 yet the FDA was promoting it as safe. Even in the
11 Physician's Desk Reference, over 40 years of use of adrenal
12 cortical extract documented no incidence of adverse
14 In 1988, the FDA consumer publication stated that
15 intravenous vitamin treatments were useless. In 1989 the
16 FDA released a health fraud kit where they also misinformed
17 the public about the safety and efficacy of vitamins.
18 The FDA also evidence about folic acid until 1993
19 and '94, which could have saved we'll never know how many
20 birth defects in babies.
21 And in the 1990s when the FDA took the L-
22 Tryptophan off the market, they never really told the public
23 that what caused the harm was the genetically modified L-
25 The FDA recall rate in a 10-year period is 52
1 percent. In November 1994 Newsweek documented that because
2 something is FDA approved it does not mean it is either safe
3 or effective. In June 1998 JAMA revealed hundreds of
4 thousands of deaths from FDA-approved drugs taken as
5 directed. This is the gold standard. This is good science.
6 People are dying as a result of FDA's betrayal of
7 its mandate for safety, which has been subsumed by the more
8 ambitious and ambiguous standard for efficacy in the FDA's
9 power grab on behalf of the chemical, food and drug
10 industries, well documented in the 1993 expose "Raqueteering
11 and Medicine" by Tulane Medical School professor Dr. James
13 My suggestions to the FDA are that they become a
14 clearinghouse of information submitted by practitioners, by
15 scientists, by patients documenting the research and outcome
16 data for these nutritional supplements and natural
17 treatments and that they release that information and the
18 label should reflect that information and the FDA should
19 really care more about the hundreds of thousands of people
20 dying from the drugs for which there are, in just about
21 every case, a nontoxic natural alternative. Thank you.
22 MR. LEVITT: Thank you.
23 We have, on my list, one more speaker.
24 DR. SIMONE: Good afternoon. My name is Charles
25 Simone. I'm an internist trained at the Cleveland Clinic, a
1 medical oncologist trained at the National Cancer Institute,
2 immunologist and also a radiation oncologist trained at the
3 University of Pennsylvania.
4 I've written a number of books, "Cancer and
5 Nutrition," "Breast Health," and I've authored over 50 peer-
6 reviewed papers.
7 In 1993 I was called upon to help frame the
8 language that led to the ultimate DSHEA Act and then I was
9 called upon again to help with the work that led to Pearson.
10 I have a written testimony that you have there and
11 I'm going to skip over some of the things to address a few
12 other things.
13 As a director of a nonprofit cancer institute,
14 I've devoted my entire life to teaching professionals and
15 lay people about diseases and disease prevention through
16 lifestyle modification. We know that since 1930 we've made
17 little progress in the treatment of cancers--adult cancers,
18 not children's cancers--despite a number of things you may
19 have heard.
20 I translate scientific information into a language
21 that is understandable by most people. Treating thousands
22 of patients and speaking with tens of thousands of people,
23 I'm convinced that when people are given accurate
24 information, they can comprehend it and make good decisions
25 accordingly. We all have a right to this accurate
1 information. Since food supplement products are already in
2 the marketplace, people should be given accurate information
3 so that they can choose wisely as to which products they
4 should have.
5 People make choices all the time but armed with
6 accurate information, they can make informed choices.
7 The FDA really can't continue to be paternalistic
8 about these issues. They must change their mind-set and
9 allow people to trust and make the right decisions once they
10 have information. Disclosure over suppression of
11 information allows people to become better educated. The
12 FDA can no longer suppress information that is truthful,
13 nonmisleading and substantiated. The FDA cannot mislead
14 people by restricting information or being arbitrary and
15 capricious in defining terms.
16 I learned that people realize that their lifestyle
17 is a major factor for their good health. People generally
18 modify their lifestyle and incorporate proper food
19 supplements as an overall strategy for good health. I have
20 found that people do not rely on the food supplement solely
21 and with accurate information, instances of harm can
23 I'm also convinced that once people have
24 information that is truthful, nonmisleading and
25 substantiated, they will integrate this information by
1 modifying their lifestyles accordingly and properly choosing
2 products that fit their needs. The American public deserves
3 this information and the American public is guaranteed this
4 information by the Constitution.
5 I would also point out that our mission as
6 physicians is to provide information to people--informed
7 consent. I've written extensively about that. In fact, the
8 American Urological Association has told people in their
9 journals and in their throw-away papers that Saw Palmetto,
10 for instance, is as effective as prescription medications.
11 We must, as physicians, inform people. We must provide
12 information. There's enough information to give good
13 information to people, accurate, nonmisleading information.
14 So we need to change all of our mindsets and provide people
15 with information.
16 We have not made tremendous strides in the
17 treatment of cancer since 1930 for adults. We need to do
18 something else. We need to look at other avenues, other
19 issues, and help people get information to help prevent
20 these problems. Thank you.
21 MR. LEVITT: Thank you very much.
22 I'm just checking with our staff to be sure there
23 are no other registered speakers that are here.
24 Okay, with that, that will bring our meeting to a
25 close. I want to thank all of the staff that worked to put
1 on this meeting. These things don't happen magically.
2 People work hard and put those together and I thank all of
3 you, as well as the--is there anybody here from this
4 building?--for letting us use the facility here for this
6 I thank the panelists from the FDA and all the
7 speakers and the audience that maintained wonderful decorum
8 through a day with a lot of strong views being expressed.
9 VOICE: Could you explain when and how the
10 transcripts will be made available?
11 MR. LEVITT: The question is if I could explain
12 when and how the transcripts of this meeting will be made
14 The general process is it takes usually a couple
15 of weeks and then we put it up on our website. Is that
16 right? Do we have an exact date for that? No. But I would
17 say usually two to three weeks--within three weeks is what's
18 a safe bet.
19 Okay, again I thank everybody here. This
20 concludes our meeting.
21 [Whereupon, at 5:26 p.m. the meeting was