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					September 14, 2010

Division of Dockets Management
Food and Drug Administration
Department of Health and Human Services
5630 Fishers Lane, Room 1061
Rockville, MD 20852

                                        CITIZEN PETITION


               The Corn Refiners Association, a national trade association representing the corn

refining (wet milling) industry of the United States, submits this petition under sections 201(s),

402, 409 and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(s) 342, 348 and

371) to request the Commissioner of Food and Drugs to revise the Generally Recognized As

Safe (GRAS) affirmation regulation for high fructose corn syrup, 21 C.F.R. 184.1866, to

recognize “corn sugar” as an alternate common or usual name for high fructose corn syrup.

                                   A. ACTION REQUESTED

               The Corn Refiners Association proposes that:

               (1)     21 C.F.R. 184.1866, the GRAS affirmation regulation for high fructose

corn syrup, be revised to read as follows:

                              § 184.1866 High Fructose Corn Syrup

                (a)    High fructose corn syrup, also known as corn sugar, a sweet nutritive

           saccharide mixture . . . .

               (2)     21 C.F.R. 168.111, the standard of identity for dextrose monohydrate, be

revised to read as follows:

                                § 168.111 Dextrose Monohydrate


                 1701 Pennsylvania Ave., NW, Suite 950, Washington, D.C. 20006-5805
                   Phone: (202) 331-1634 Facsimile (202) 331-2054 www.corn.org
                (c)     The name of the food is “Dextrose monohydrate or “Dextrose”.

                                B. STATEMENT OF GROUNDS

               Although high fructose corn syrup has been safely used as a food ingredient in the

United States for decades, there is compelling evidence that many consumers are confused and

misled by the ingredient name. Contrary to its name, and contrary to what many consumers

believe, high fructose corn syrup is not high in fructose compared to other commonly used

nutritive sweeteners, such as sugar, honey, fruit juice concentrates, and agave nectar. The

proposed alternate name “corn sugar” more closely reflects reasonable consumer expectations

and more accurately describes the basic nature of the ingredient and its characterizing properties.

Accordingly, revision of the high fructose corn syrup GRAS affirmation regulation to recognize

“corn sugar” as an alternate common or usual name would promote honesty and fair dealing in

the interest of consumers.

         1. EQUIVALENCE OF HIGH FRUCTOSE CORN SYRUP AND SUGAR

               High fructose corn syrup and sugar are equivalent by every parameter of

relevance to consumers. High fructose corn syrup and sugar have equivalent ratios of fructose

and glucose. The most widely-used high fructose corn syrup products in the United States

contain 42% fructose (HFCS-42) and 55% fructose (HFCS-55). Many packaged foods contain

HFCS-42 which is lower in fructose than all other caloric sweeteners. The remaining

carbohydrates in high fructose corn syrup are free glucose and minor amounts of other simple

glucose-based carbohydrates. Sugar (sucrose) is a mixture of 50% glucose and 50% fructose. 1

Thus, the glucose-to-fructose ratio in high fructose corn syrup and sugar is similar, nearly 1:1. A

similar ratio is also found in many fruits, fruit juices, and vegetables.

1
 John S. White, Straight talk about high-fructose corn syrup: what it is and what it ain’t, Am. J.
Clin. Nutr. 2008; 88(suppl): 1716S-21S.
                The only practical distinction in composition between high fructose corn syrup

and sugar is that in sucrose, fructose and glucose are chemically bonded together, while in high

fructose corn syrup, the glucose and fructose are a simple mixture. During digestion and

absorption, however, enzymes in the digestive tract break the chemical bond in sucrose.

Sucrose, thus, enters the bloodstream as free fructose and glucose, just as high fructose corn

syrup does.22

                High fructose corn syrup and sugar have the same number of calories per gram.

High fructose corn syrup and sugar are both simple carbohydrates that contribute about 4

kcal/g.33

                High fructose corn syrup and sugar have the same level of sweetness. Studies

measuring sweetness intensities found that in syrup form at 10% solids (the approximate

sweetener concentration in most carbonated beverages), HFCS-55 and sugar yielded the same

relative sweetness. 44 In addition, one study that measured, among other things, perceived

sweetness of three cola beverages (sweetened with sugar, HFCS-55, and HFCS-42) found that

the three beverages were perceived by study subjects as equally sweet. 55

                High fructose corn syrup and fructose are metabolized the same way by the body.

For example, one study examined the effects in normal-weight women of high fructose corn

syrup and sugar on circulating levels of insulin, leptin, and ghrelin, hormones that regulate body

weight and appetite. The study found no significant differences between the sweeteners with

2
 Schorin MD. 2005. High Fructose Corn Syrups, Part 1: Composition, Consumption, and
Metabolism. Nutrition Today 40(6):248-252.
3
    Ibid.
4
 White, infra note 1. Under the same experimental conditions, HFCS-42 was found to be less
sweet than sugar.
5
  Pablo Monsivais, et al., Sugars and satiety: does the type of sweetener make a difference?, Am.
J. Clin. Nutr. 2007; 86: 116-23.
respect to circulating levels of these hormones.66 Studies in young men and in men and women

demonstrated similar results. 7,87, In the same way, studies comparing effects of sucrose and high

fructose corn syrup on triglycerides and uric acid showed no discernable differences in normal

weight women. 9,108, 9

                Recent expert scientific panels convened by the American Medical Association,11      10




the International Life Sciences Institute (ILSI) and the United States Department of Agriculture

(USDA), 12 Experimental Biology, 13 and the Center of Food Nutrition and Agriculture Policy1413
           11
                                     12




uniformly concluded that high fructose corn syrup and sucrose are compositionally similar and

metabolically equivalent. And the just-published recommendations of the 2010 Dietary



6
  Kathleen J. Melanson, et al., Effects of high-fructose corn syrup and sucrose consumption on
circulating glucose, insulin, leptin, and ghrelin and on appetite in normal-weight women,
Nutrition 23 (2007) 103-112.
7
 Kimber L. Stanhope, et al., Twenty-four-hour endocrine and metabolic profiles following
consumption of high-fructose corn syrup-, sucrose-, fructose-, and glucose-sweetened beverages
with meals. Am. J. Clin. Nutr. 2008, Vol 87:1194-203
8
 Tina Akhavan and G. Harvey Anderson, Effects of glucose-to-fructose ratios in solutions on
subjective satiety, food intake, and satiety hormones in young men, Am. J. Clin. Nutr. 2007;
86:1354-63; Stijn Soenen and Margriet S. Westerterp-Plantenga, No differences in satiety or
energy intake after high-fructose corn syrup, sucrose, or milk preloads, Am. J. Clin. Nutr. 2007;
86:1586-94.
9
 Joshua Lowndes, et al., The effect of high-fructose corn syrup on uric acid levels in normal
weight women, Program Abstract #P2-45 (June 2007 meeting of the Endocrine Society).
10
   Zukley L, et al. June 2007. The Effect of High Fructose Corn Syrup on Post-Prandial Lipemia
in Normal Weight Females. Presented at the June 2007 meeting of The Endocrine Society.
Program Abstract #P2-46. Abstract available
11
  American Medical Association. 2008. Report 3 of the Council on Science and Public Health
(A-08): The Health Effects of High Fructose Syrup.
12
  Julie M. Jones, Dietary Sweeteners Containing Fructose: Overview of a Workshop on the
State of the Science, J. Nutr. 2009; 139: 1210S-1213S.
13
  Victor Fulgoni, High-fructose corn syrup: everything you wanted to know, but were afraid to
ask, Am. J. Clin. Nutr. 2008; 88(suppl): 1715S.
14
  Richard Forshee, et al., A Critical Examination of the Evidence Relating High Fructose Corn
Syrup and Weight Gain, Critical Reviews in Food Science and Nutrition, 2007; 47:561-582.
Guidelines Committee made no distinction between sucrose and high fructose corn syrup. 1514

Published studies and reviews conducted by researchers and experts on high fructose corn syrup

are collected in Appendix A.

               In affirming the GRAS status of high fructose corn syrup, FDA confirmed that the

saccharide composition (glucose to fructose ratio) of HFCS is approximately the same as that of

honey and sucrose and that HFCS is as safe as other commonly used sweeteners, including

sucrose and honey. 61 Fed. Reg. 43447; August 23, 1996.

                                  2. MSR GROUP SURVEY

               This petition is supported by a consumer research study conducted in 2010 by The

MSR Group on behalf of the Corn Refiners Association. The full report of the research study,

including the survey questionnaire, design and methodology, and detailed results, is attached as

Appendix B to this petition.

               The purpose of the research was to determine if consumers are confused about the

nature and content of high fructose corn syrup, the extent to which the name contributes to

consumer confusion, and whether an alternate name more accurately describes the product. The

strong conclusions from The MSR Group research are that (1) consumers incorrectly perceive

that high fructose corn syrup is significantly higher in calories, fructose and sweetness than

sugar, and (2) the term “corn sugar” more accurately reflects the actual properties of high

fructose corn syrup than its current name.

               The survey was weighted to represent United States adults age 18 and older on

key demographic characteristics. The internet was used for data collection, and the survey was



15
  See Table D5.1 Carbohydrates: nomenclature and special issues; Report of the DGAC on the
Dietary Guidelines for Americans, 2010, at D5-3.
conducted in accordance with Office of Management and Budget (OMB) recommendations and

consistent with the design of recent FDA consumer surveys.

               The results show that 40% - 60% of respondents are confused about the properties

of high fructose corn syrup compared to sugar. Although high fructose corn syrup and sugar

have the same number of calories per gram, contain approximately equal proportions of fructose

and glucose, and are the same sweetness, 57% of respondents say that high fructose corn syrup

has more fructose compared to table sugar. Also, over 40% of respondents incorrectly believe

that high fructose corn syrup has more calories than sugar and 45% believe it to be sweeter than

sugar.

               The MSR survey also demonstrates that the term “corn sugar” more accurately

reflects the actual properties of high fructose corn syrup than its current name based on consumer

ratings of this alternate name on the same attributes compared to sugar (i.e. fructose content,

calories per gram, and sweetness). Additionally, after reading a description of high fructose corn

syrup’s properties, 69.6% of the consumers surveyed did not pick “high fructose corn syrup” as

the best name for the product described.

                  3. OTHER EVIDENCE OF CONSUMER CONFUSION

               In addition to the MSR survey, there is ample evidence of substantial (and

growing) consumer confusion regarding the characteristics of high fructose corn syrup. As

noted, contrary to the implication of its name, high fructose corn syrup is not high in fructose.

The two commonly sold forms of high fructose corn syrup, HFCS-42 and HFCS-55, are

metabolized similarly to sugar and honey in the body. Moreover, high fructose corn syrup, like

sugar, has been affirmed by FDA as GRAS. 21 C.F.R. 184.1866.

               In spite of these fundamental similarities between high fructose corn syrup and

sugar, growing numbers of consumers incorrectly believe that high fructose corn syrup contains
significantly more fructose than sugar and is less safe than sugar. Consumer confusion regarding

the basic properties of high fructose corn syrup is reflected in the proliferation of erroneous

statements regarding high fructose corn syrup in the popular press, on the internet and in

scientific journals. Samples of typical statements reflecting confusion and misunderstanding

regarding high fructose corn syrup are collected in Appendix C.

             4. RECOGNITION OF “CORN SUGAR” AS AN ALTERNATE
           COMMON OR USUAL NAME FOR HIGH FRUCTOSE CORN SYRUP
         IS SUPPORTED BY FDA’S COMMON OR USUAL NAME REGULATION

               The FDA common or usual name regulation provides that “the common or usual

name of a food, which may be a coined term, shall accurately identify or describe, in as simple

and direct terms as possible, the basic nature of the food or its characterizing properties or

ingredients.” 21 C.F.R. 102.5(a). In the preamble to the final regulation, FDA indicated that a

common or usual name should “accurately reflect the reasonable expectations of consumers.” 37

Fed. Reg. 12327; June 22, 1972.

               Recognition of the term “corn sugar” as an alternate common or usual name for

high fructose corn syrup would fully satisfy the criteria for a common or usual name when used

to describe high fructose corn syrup. The name “corn sugar” more accurately reflects the source

of the food (corn), identifies the basic nature of the food (a sugar), and discloses the food’s

function (a sweetener). Also, as shown in the MSR survey, the name “corn sugar” more

accurately reflects the reasonable expectation of consumers with respect to the basic properties

of high fructose corn syrup than does the name high fructose corn syrup, and would reduce the

pervasive consumer confusion and misunderstanding associated with the name “high fructose

corn syrup”.

               In 1988, FDA amended the GRAS affirmation regulation for “low erucic acid

rapeseed oil” to permit use of the term “canola oil” as an alternate common or usual name. 53
Fed. Reg. 36067, September 16, 1988. The Petitioner contended that the term “low erucic acid

rapeseed oil” is unappealing and distasteful to many consumers, and FDA ultimately concluded

that the term “canola oil” “is the name preferred by industry, and the name that would be most

favorably perceived and easily understood by all consumers.” 53 Fed. Reg. 36068. There is an

equal or stronger justification to authorize use of the term “corn sugar” as an alternate common

or usual name for “high fructose corn syrup” based on the compelling evidence provided in

support of this petition that consumers are misled by the term “high fructose corn syrup” and

more favorably perceive and easily understand the name “corn sugar”.

               In 2000, FDA approved the use of “dried plums” as an alternative name to prunes

for labeling purposes. 16 The California Prune Board (the Board) contended that consumers
                        15




associated the name “prunes” with negative imagery, which acted as a barrier to trial and

purchase. The Board submitted two consumer research studies to support its contention that the

term “prunes” is associated with negative imagery and that the name “dried plums” would be

received more favorably by consumers and without confusion. Similar justification to authorize

use of the term “corn sugar” as an alternate common or usual name for “high fructose corn

syrup” exists in this case. The evidence provided in support of this petition demonstrates that

consumers are confused and misled by the term “high fructose corn syrup,” which has resulted in

an increasingly negative connotation associated with the term. In contrast, evidence

demonstrates that consumers more favorably perceive and easily understand the name “corn

sugar”.

     5. CONFORMING AMENDMENT TO DEXTROSE STANDARD OF IDENTITY


16
  Letter from Christine J. Lewis, Ph.D., Director, Office of Nutritional Products, Labeling and
Dietary Supplements, Center for Food Safety and Applied Nutrition, FDA, to Richard Peterson,
Executive Director, California Prune Board (Jun. 6, 2000).
               In order to provide for use of the term “corn sugar” as an alternate name for high

fructose corn syrup, the CRA is petitioning for a conforming amendment to the standard of

identity for dextrose monohydrate. 21 C.F.R. 168.111.

               The standard of identity for dextrose monohydrate, defined as “purified and

crystallized D-glucose containing one molecule of water of crystallization with each molecule of

D-glucose,” provides that the name of the food is “dextrose monohydrate” or “dextrose” or

alternatively, “________ sugar monohydrate” or “________ sugar, with the blank to be filled in

with the name of the food source, for example “corn sugar monohydrate” or “corn sugar”. 21

C.F.R. 168.111(c).

               It is appropriate to amend the standard of identity for dextrose monohydrate to

eliminate reference to the names “corn sugar” and “corn sugar monohydrate” in order to provide

the option of using “corn sugar” as an alternate common or usual name for high fructose corn

syrup. The terms “corn sugar” and “corn sugar monohydrate” have rarely been used to describe

dextrose, and these terms are not commonly associated with dextrose by consumers. Rather, as

shown in the MSR survey, consumers regard the name “corn sugar” as more accurately

describing the basic characteristics of high fructose corn syrup.

               This petition is supported by an extensive label survey performed by Mintel, a

prominent market research firm, documenting that the terms “corn sugar” and “corn sugar

monohydrate” are rarely used to describe dextrose on food labels. (Appendix D). Mintel’s

database covers all new food products, including new formulations, brand extensions and new

packaging, introduced in the United States since January 1, 2004. Mintel’s survey shows that of

128,993 new food and beverage products launched in the United States from January 1, 2004 to

June 16, 2010, none used the term “corn sugar monohydrate” on the label. Of 8,840 food and
beverage products containing dextrose introduced during this timeframe, only 51 (about 0.56%)

used the term “corn sugar” on the label. By contrast, 8,789 of these products used the term

“dextrose” on the label. The Mintel survey provides strong evidence that the term “dextrose” is

widely used on food labels to describe ingredients covered by the dextrose standard of identity;

the terms “corn sugar” and “corn sugar monohydrate” are seldom used on food labels, and “corn

sugar” is not commonly associated with dextrose by consumers.

                               C. ENVIRONMENTAL IMPACT

               This petition is subject to categorical exclusion under 21 C.F.R. 25.32(F).

                                 D. ECONOMICAL IMPACT

               Information will be provided to the extent requested by the Commissioner.

                                     E. CERTIFICATION

               The undersigned certifies that, to the best knowledge and belief of the

undersigned, this petition includes all information and views on which the petition relies, and

that it includes representative data and information known to the petitioner which are

unfavorable to the petition.



Respectfully Submitted




Audrae Erickson
President
Corn Refiners Association

				
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