Paula M. Nothofer Regulatory Compliance-Labeling Kraft Foods, Inc. 555 by smx43008

VIEWS: 17 PAGES: 10

									                                                                                                       .- ‘.
             I
 DEPARTMEF            OF HEALTH 81 HUMAN SERVICES                           Public Health Service


                 \                                                          Food and Drug Administration
                     __
                                                                            Washington DC 20204




Paula M. Nothofer
Regulatory Compliance-Labeling
Kraft Foods, Inc.
555 South Broadway
Tarrytown, New York 10591

Dear Ms. Nothofer:

This is to acknowledge your letter of January2,200 1, to the Food and Drug
Administration (FDA), accepting the agency’s invitation to participate in the extended
temporary market testing of “white chocolate” that was granted to Hersey Foods
Corporation (59 FR 67302, December29 1994). Previously, in a letter dated
September25, 1995, FDA granted a permit to Kraft Foods to participate in the extended
temporary market testing of white chocolate under Docket No. 93P-0310. That permit
allowed for the market testing of a product named “Premium White Chocolate Baking
Squares.” The permit was amendedon August 23, 1996, to provide for an additional
total of 30,391 kilograms (67,000 pounds) of other white chocolate products. The agency
is granting a further amendmentto the permit of September25,1995. The amendment
will allow for the market test of anotherproduct that contains white chocolate. The
product will bear the name “Baker’s Brand Premium White Chocolate Chunks.”

The white chocolate component of the product differs from the standardizedchocolate
products in that it is preparedwithout the nonfat components of the ground cacaonibs,
but contains the fat (cocoa butter) expressedfrom the ground cacaonibs. In all other
respects,the white chocolate component would conform to the cacaoproduct standards.

Relying on the representationsmade in your application, we are hereby granting
permission to make interstate shipments,for market testing purposesof 88,000 pounds
(39,909 kg) of new test product. The product will be manufactured at Barry Callebaut
USA, Inc., 400 Industrial Park Road, St. Albans, VT 05478-1875 and will be distributed
throughout the United States.

The draft label that you submitted for the test food is acceptablefor the purpose of this
market test. A finished label must be submitted to the Director, Division of Standards
and Labeling Regulations, Office of Nutritional Products, Labeling and Dietary
Supplements(HFS-820), before the product is shipped in interstate commerce. Each of
the ingredients used in the food must be declared on the label as required by the
applicable sections of 2 1 CFR Part 101.

While this permit is in effect, FDA will refrain from recommending regulatory action.
against shipments of “Baker’s Brand Premium White Chocolate Chunks” coveredby this
Page 2 - Ms. Paula M. Nothofer

permit on the grounds that the food fails to comply with the standardsof identity for
certain chocolate products, e.g., chocolate liquor (2 1 CFR 163.11l), sweet chocolate
(21 CFR 163.123),milk chocolate (21 CFR 163.130), buttermilk chocolate (21 CFR
163.135), skim milk chocolate (2 1 CFR 163.140), or mixed dairy product chocolates
(21 CFR 163.145).




                                     Christine . ewis, Ph.D.
                                     Director v
                                     Office of Nutritional Products, Labeling
                                       and Dietary Supplements
                                     Center for Food Safety
                                       and Applied Nutrition
   ANDREA M.BRUCE                   DIRECTDIAL
      ATTORNEY   AT LAW          (202)6374X6




HOGAN& HARTSONL.L.P.
   555THrRIEENM%TGET,b4%'
     WASHINC~ON,DC~OOO~
      TEL.(202)637-5600
      FAX (202) 637-5910       AMBRUCE@HHLAW.COM


                 January2,200l



                 LorettaA. Carey
                 FoodStandards  Branch(HFS-158)
                                     and
                 Divisionof Programs Enforcement Policy
                 Officeof Food Labeling
                 Centerfor FoodSafetyandAppliedNutrition
                 Foodand DrugAdministration
                 200 C Street,S.W.
                             D.C.
                 Washington, 20204


                                          Re:        Docket Numbers 93P-0310,94P-OU7
                                                     21 CFR 130.17(i)-Notice of Participation In
                                                     Extended Market Test Of White Chocolate

                 DearMs. Carey:

                                                                                    that
                        On July 20,1995,we notifiedthe Foodand DrugAdministration KraftFoods,Inc.
                                                to         in
                 acceptsthe agency’sinvitation participate the extended   markettestof whitechocolate,
                             in                     on
                 announced the FederalRegister December       29,1994;59 Fed.Reg.67302(DocketNo. 93P-
                                                     the                                           product,
                 0310). At this time,we are notifying agencythat Kraftintendsto includean additional
                 Bakers BrandPremiumWhiteChocolate       Chunks,in the ongoingmarkettest

                                             57
                         DocketNo. 94-P-01 (JulyI, 1994;59 Fed.Reg.33976) the docketnumberfor the
                 temporary permitto marketwhitechocolate   originallyissuedto Kraltin 1994,containsrelevant
                 procedural                               of              test
                            historyas well as a description the proposed product The productdescription
                 has not changed,but is repeatedherefor convenient   reference.

                 1.                              is                               addressis Three Lakes
                          The nameof the applicant KraftFoods,Inc. The headquarters
                                          IL
                          Drive,Northfield, 60091.

                 2.                                    in          of            and
                          KraftFoodsis regularlyengaged the business manufacturing marketingcacao
                          products.

                 3.                             we                                                 of
                          The “whitechocolate” proposeto markettest differsfromthe existingstandards
                          identityfor chocolate        e.g.,
                                               products, chocolate                     I),
                                                                  liquor(21 CFR163.11 sweetchocolate
                                           milk          (21
                          (21 CFR63.123), chocolate CFR 163.130)buttermilk       chocolate



                                           Kraft   Foods   555 Soutll Broadway   l   Twrytown,   NY 10591
1 LorettaA. Carey
  January2,200l
  Page2


                                           (21
         (21 CFR 163.135)skim milkchocolate CFR 163.140)and mixeddairyproduct
                   (21
         chocolates CFR163.145).

  4.                            from                      of                that
         The proposeddifference the existingstandards identityrecognizes the product
                                           and
         commonlyknownamongconsumers in othercountriesas ‘white chocolate“ made   is
         with cocoabutter. The cocoabutteris producedby filteringgroundcocoanibsto remove
         the darkcocoasolids.

                         of                    we
         The composition the “whitechocolate” proposeto markettest is consistent thewith
                                                       in
         standardof identityfor Whitechocolate’proposed citizen’spetitionsfiled by Hershey
                            and
         FoodsCorporation the Chocolate     Manufacturers           (Docketnumbers
                                                          Association
                       and
         86-PO2971CP2 86P-02971CP3).

                          the                   we
         Morespecifically, “whitechocolate” proposeto markettest is the solidor semi-
         plasticfood preparedby intimatelymixingand grindingcocoabutterwith oneor more
         nutritivecarbohydrate             and
                               sweeteners one or moreof the optionaldairy ingredients
         specifiedin 21 CFRpart 163. The productcontainsnot lessthan 20 percentcocoabutter,
         not lessthan 14 percenttotal milk solids,not lessthan 3.5 percentmilk fat, and not more
         than 55 percentnutritivecarbohydrate  sweetener.It containsno coloringmaterial,but
         may containemulsifying  agents,spices,naturaland artificialflavoringandother
                      and
         seasonings, antioxidants               for
                                      approved food use.

  5.                              is                 and                 as
         The food “whitechocolate” just as wholesome non-deleterious the cacao
                                                                                 or
         productsthat aresubjectto existingstandards identity. No novelingredients
                                                   of
                   are                      of
         processes usedin the production “whitechocolate”.

  6.                          for              and              and
         The existingstandards sweetchocolate milk chocolate, for theotherchocolate
                                                       for
         productscited above,includeminimumrequirements the additionof chocolate  liquor,
         whichcontainsgroundcacaonibs. ‘Whitechocolate” containsthe cacaofat from ground
                                          solidsfoundin chocolateliquor.
         cacaonibs,but notthe darkchocolate

  7.     The purposeof effectingthe proposed    variationis to facilitatethe markettestingof ‘white
                                                               of
         chocolate”in the UnitedStates,underthe statement identitythat is in commonuse in
                                                                                  the
         othercountriesandis mostinformative the consumer.Additionally, markettest will
                                                 to
                                 of
         facilitatethe collection dataon consumer                  of
                                                     acceptance the productto support      the
         petitionsfor a standardof identityfor “whitechocolate”   alreadyon file withthe Foodand
                                as
         DrugAdministration, citedabove.                                         cc

         A soundlegal casecan be madethat no permitor newstandardis neededto authorize   the
                                 in                                   almostcertainlyis an
         sale of “whitechocolate” this country. Indeed,“whitechocolate”
         appropriately           statement identity,independent the existingstandards.
                       descriptive        of                    of
LorettaA. Carey
January2,200l
Page3


                     we           the
       Nevertheless, acknowledge Agency’sapparent                for
                                                      preference the useof the
                                      in
       temporarymarketingpermitprocess this case. Forthat reason,we arefilingthis
       notification.

8.                                       wouldbenefitconsumers makingit easyfor them
       The variationfrom existingstandards                       by
                     real
       to distinguish &hite chocolate”  products from productsmadewith cheapercacaofat
                                the      of
       substitutes.Additionally, removal darkcocoasolidsfrom the chocolate   formula
       resultsin a uniquemilkywhitecolorand a strongmilkyflavorthat seemsto be preferred
       by manyconsumers.

9.                                                           -          Chunksthat
       The labelfor the Baker’sBrandPremiumBakingChocolate WhiteChocolate
       Kraftplansto addto the ongoingmarkettest is attached.

IO.                                               on
       Duringthe markettest we expectto distribute an annualbasis88,000Lb. of Baker’s
       12oz. Premiumwhitechocolate chunks.

11.                                 throughout UnitedStates.
       The productwill be distributed        the

12.                                   by
       The productwill be manufactured Ban-y CallebautUSA,inc., 400 IndustrialParkRoad,
       St Albans,VT 05478-1875.Thetelephone                                       I.
                                             numberfor this facilityis (802)524-971 At
                                                  and
       this time,the plantmanageris ChrisDemambro the QualityManageris Stuart
       Redfield.


                                                or                              at
Pleasedo not hesitateto contactme at 914-335-6548 in my absence,SherryMarcouiller 847-
         if
646-4206, you needadditional  information.Thankyou for yourcooperation.

           submitted,
Respectfully



KraftFoods,Inc.
PaulaM. Nothofer
         Compliance Labeling
Regulatory        -

cc: SherylA. Marcouiller
    SeniorFoodand DrugCounsel

Attachment
                                                                                                                                                                 ..
I.


                                                       HoGAN&HARTSON
                                                                                                                                      7 yp-u
                                                                            L.L.F!
      Writer’s   Direct Dial:
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           202-636-6466
                                                                                                                                 555 THIRTEENTH     STREET, NW a
                                                                                                                                 WASHINGTON,      DC 200941109
                                                                                                                                      TEL (202) cm-5600
                                                                 February 2,200l                                                      FAX (202) 637-5910
                                                                                                                                      WWW.HiBAW.COM




      BY HAND            DELIVERY

      Loretta A. Carey
      Food Standards Branch (HFS-158)
      Division of Programs and Enforcement .Policy
      Office of Food Labeling
      Center for Food Safety and Applied Nutrition
      Food and Drug Administration
      200 C Street, S.W.
      Washington, DC 20204

                             Re:         Baker’s Brand Premium                            White Chocolate    Chunks -
                                         Notice of Participation                        in Extended   Market   Test of White
                                         Chocolate

       Dear Ms. Carey:

                     As a follow-up to our conversation earlier today, I am providing some
       additional information with regard to the above-referenced notice of participation
       for Baker’s Brand Premium White Chocolate Chunks, submitted by Kraft Foods,
       Inc. @raft) on January 2,200l. First, I have enclosed a copy of the revised label for
       the product. As we discussed, it bears the words “Distributed by” fully spelled out
       on the information panel.

                    Second, I understand that you will be talking with CFSAN colleagues
       about the appropriateness of using the abbreviation “Dist.” in place of the words
       “Distributed by”. To facilitate your discussions, I thought it might be helpful to
       share some information as to why Kraft believes this abbreviation is fully consistent
       with FDA regulations and policy.                                    w
                     Specifically, I have attached a copy of Section 201.1(h) of the agency’s
       drug labeling rules, and the corresponding preamble discussion. These documents
       reflect a determination by the agency to permit abbreviations of the phrases used to
     ? identify a product’s packer or distributor so long as those abbreviations are cle.ar
       and unambiguous. Because no consumer reasonably could misconstrue the letters


                                     BRUSEL§       LONDON    PARIS’    EXJDAPEST    PRAGUE*     WARSAW   MOSCOW    TORY0   -.
       \\\DC.60685/4   -#126059$vl
                               NEWYORK    BALTlhfOBE    McLBAN    bIIAMI   DENVER    BOULLtER    COLORADOSPRINGS    UISANGEIXS
      HOGAN & HAIUSONL.L.P
       Loretta A. Carey
       February 2,200l
       Page 2


       “Dist.” as indicating that Kraft is the product’s manufacturer (rather than
       distributor), Kraft is confident that this abbreviation meets that standard. As you
       can see from the attached correspondence, USDA reached the same conclusion
       many years ago with regard to the labeling of meat products.

                      Section 101.5 - the pertinent regulation with regard to the labeling of
      foods - is fully consistent with Section 2Ol.l(h)‘s allowance for abbreviations.
      Although the phrase “Distributed by” is spelled out in that regulation, it is offered
      only as an example of the phrases that meet the regulatory requirement.

                      When Kraft submitted its notice of participation for Baker’s Brand
       Premium White Chocolate Chunks last month, it had every reason to believe that
       CFSAN would follow the logic reflected in the agency’s drug labeling rules. The
       policy objectives of Sections 201.1(h) and 101.5 are, after all, identical, namely to
       identify for regulators and consumers the entity responsible for a product in the
       event of problems or concerns. CFSAN’s sudden objection to the “Dist.”
       abbreviation - which Kraft has used for many years on a wide variety of food
       products - simply was not and could not have been anticipated.

                     As the enclosed label demonstrates, Kraft has proceeded to revise the
       label for Baker’s Brand Premium White Chocolate Chunks to spell out the words
       “Distributed by”. An inventory of labels bearing the abbreviation “Dist.“, however,
       does exist. I look forward to speaking with you and your colleagues about those
       labels, as well as the status of the notice of participation for Baker’s Brand
       Premium White Chocolate Chunks on Monday, February 5.




                                                       Andrea M. Bruce      ’




       Enclosures

       cc:         Sheryl A. Marcouiller,   Esq.




. .    \\\DC-6068514   -#126059’7vl
‘9201.1                                                  21 CFR Ch. I (4-l-00 Edliion)              Food and Dnig ~dmWtmtlon,               HHS
    (2) If the person performs at least one    used in this paragraph, person, when it                     (4) If a trademark appears on the               (m) This section does not apply to bi-
applicable operation listed in para-           identifies a corporation, includes a par-              drug or drug product label or appears              ological drug products that axe subject
graph (b) of this section and identifies       ent, subsidiary, or affiliate company                  as a mark directly on the drug product             to the requirements of section 361 of
by appropriate designation all other           where the related companies are under                  (e.g., tablet or capsule), the label may           the Public Health Service Act, 42
persons who .have performed the re-            common ownership and control.                          identify the holder or licensee of the             U.S.C. 262.
maining applicable operations, e.g.,              (f) The name of the person rep-                     trademark. The label may also state                            Apr. 15, 1990; FR 72118, Oct.
                                                                                                                                                         145 FR 95’775,           45
“Made by (Person A), Filled by (Person         resented as manufacturer under para-                   whether the person identified holds the            31, 1980, as amended   at 48 FR 37620. Aug.    19,
B), Sterilized by (Person C)“; or              graph (b) or (c) of this section must be               trademark or is licensee of the trade-             19931
    (3) If the person performs at least one    the same as either (1) the name of the               . mark.
applicable operation listed in para-           establishment (as defined in $207.3(b)of                    (5) If the distributor is named on the        #zOlS              and devices;      National
graph (b) of this section and the person       this chapter) under which that person                  label. the name shall be aualified by                  Drug 3 C    e number~3.
is listed along with all other persons         is registered at the time the labeled                  one of the following phraeea: “Manu-                 The National Drug Code (NDC) num-
who have performed the remaining ap-           product is produced or (2) the reg-                    factured for                  ‘* “Distributed      ber is requested but not required to ap-
 plicable operations as “joint manufac-        istered establishment name of a par-                                         ,, “Man;factured       by    pear on all drug labels and in all drug
 turers.” A list of joint manufacturers        ent, subsidiary, or affiliate company                  by                                  $9 “Manu-
                                                                                                                        for ’               ,            labeling, including the label of any pre-
 shall be qualified by the phrase “Joint-      where the related companies are under                  factured for                                  1,   scription drug container furnished to a
 ly Manufactured By                    " and   common ownership and control. In ad-                                                byB, -
                                                                                            \          6”Distributor:                   , “Marketed      consumer. If the ND0 number is shown
 the names of all of the manufacturers         dition, the name shall meet the re-                                        3%. qualifging phrases
                                                                                                                             The                         on a drug label, it shall be displayed as
 shall be printed together in the same         quirements of paragraph (g) of this sec-                by
                                                                                                \      may be abbreviated.                               required in !j26735(b)(3) of this chapter.
 type size and style; or                       tion.
    (4) If the person performs all applica-       (g) The requirement for declaration                      (6) If the packer is identified on the        140 FR 52902, Nov. 7.19751
 ble operations listed in paragraph (b) of     of the name of the manufacturer, pack-                  label, the name shall be qualified by
 this section except for those operations      er, or distributor shall be deemed to be                the phrase “Packed by                     9’ or   #201.6 Drugq       adequate    directiona     for
 listed in paragraph (d) of this section.      satisfied, in the case of a corporate per-              “Packaged by                    *‘. The quali-        use.
 For purposes of this paragraph, person,       son, only by the actual corporate                       fsing phrases may be abbreviated.                    Adequate directions for use means di-
 when it identifies a corporation, in-         name, except that the corporate name                        (i) The statement of the place of busi-       rections under which the layman can
 cludes a parent, subsidiary, or affiliate     may be the name of a parent, sub-                       ness shall include the street address,            use a drug safely and for the purposes
 company where the related companies           sidiary, or affiliate company where the                 city, State, and ZIP Code. For a foreign          for which it is intended. (Section
 are under common ownership and con-           related companies are under common                       manufacturer, the statement of the               261.l26 defines “intended use.“) Direc-
 trol.                                         ownership and control. The corporate                    place of business shall include the               tions for use may be inadequate be-
    (d) The Food and Drug Administra-          name may be preceded or followed by                     street address, city, country, and any            cause, among other reasons, of omis-
 tion finds that it is the common prac-        the name of the particular division of                   applicable mailing code. The street ad-          sion, in whole or in part, or incorrect
 tice in the drug industry to contract         the corporation. LICompany.” “Incor-                     dress may be omitted if it is shown in           specification of:
 out the performance of certain manu-          porated” etc., may be abbreviated or                     a current city directory or telephone                (a) Statements of all conditione, pur-
 facturing operations listed in para-          omitted and “The” may be omitted. In                     direotorg. The requirement for inolu-            poses, or uses for which such drug is in-
 graph (b) of this section. These oper-        the case of an individual, partnership,                  sion of the ZIP Code shall apply to con-         tended, including conditions, purposes,
 ations include: (1) Soft-gelatin encap-       or association, the name under which                     sumer commodity labels developed or              or uses for which it is prescribed, rec-
 sulating, (2) aerosol filling, (3) steri-     the business is conducted shall be used.                 revised after July 1.1969. In the case of        ommended, or suggested in its oral,
 lizing by irradiation, (4) lyophilizing,         (h)(l) Except as provided in this sec-                nonconsumer packages, the ZIP Code               written, printed, or graphic adver-
 and (6) ethylene oxide sterilization.         tion, no person other than the manu-                     shall appear either on the label or the          tising, and conditions, purposes, or
    (e) A person performs an operation         facturer, packer, or distributor may be                  labeling (including the invoice).                uses for which the drug is commonly
 listed in paragraph (b) of this section       identifled on the label of a drug or drug                    (j) If a person manufactures, packs,         used; except that such statements shall
 only if the operation is performed, in-       product.                                                 or distrfbutes a drug or drug product at         not refer to conditions, uses. or pur-
 cluding the performance o&he appro-              (2) The appearance on a drug product                  a place other than the person’s prin-            poses for which the drug can be safely
‘prlate in-process quality control oper-       label of a person’s name without quali-                  cipal place of business, the label may           used only under the supervision of a
 ations, except laboratory testing of          fication is a representation that the                    state the principal place of business in         practitioner licensed by law and for
 samples taken during processing, as           named person is the sole manufacturer                    lieu of the actual place where such              which it is advertised solely to such
 follows:                                      of the product. That representation is                   drug or drug product -was manufactured           practitioner.
    (1) By individuals, a majority of          false and misleading, and the drug                       or packed or is to be distributed, unless            (b) Quantity of dose. including usual
 whom are employees of the person and,         product is misbranded under section                      such statement would be misleading.              quantities for each of the uses for
  throughout the performance of the op-        502(a) of the act, if the person is not                      (k) Paragraphs (b), (c), (d), (eh and (f)    which it is intended and usual quan-
  eration, are ‘subject to the person’s di-    the manufacturer of the product in ac-                   of this section. do not apply to the la-         titiea for persons of different ages and
  rection and control;                         cordance with this seotion.                              beling of drug components.                       different physical conditions.
     (2) On premises that are continuously        (3) If the names of two or more per-                      (1) A drug product is misbranded                 (c) Frequency of administration     or
  owned or leased by the person and sub-       sons appear on the label of a drug or                     under section 562(a) of the act if its la-      application.
  ject to the person’s direction and con-      drug product, the label may identify                      beling identifies a person as manufac-              (d) Duration of administration or ap-
  trol; and                                    which of the persons is to be contacted                   turer, packer, or distributor, and that         plication.
     (3) On equipment that is continu-         for further information about the prod-                   identification does not meet the re-               (e) Time of administration or appli-
  ously owned or leased by the person. As      uct.                                                     .quirements of this section.                     cation (in relation to time of meals,
                                                                                                                                  -
       .-           Fedetal Register J Vol. 45, No. 74 / Tuesday, April 15. 1980 / Rules and Regulations                                25769
                                                                      r
  * %&&a~             to the Spedfketions of      would not fully dlscloet the extent OF         abbreviations is mMe&ing is itaeif
t -“.         ate any mote likely to mleleed a that pemon’econtribution.                         funds to invalidate the pmvisian
    cormuwn as to the identity of the                 Although thu agencyacognize8 the           under Ahnay, hc v. Colifano, 568F.2d
    manufacturer than the phreScN, ’              veJuablacontribution that a product         . 874,932 p.c. citw 1977).
    permitted by the tinatregulatioa the          developer(or innovator) make@,     and             The agmcy agreesthat abb&viatlo
 . epncy believes that thesephrereo cm4 agreesthat Adistributor identification, of should be pennttted of thae phrauzs
    be mirleadiog in rugetrting that 8 :          a developermey be Mmewhat                       that 0 ZO~.I@)    ellowe in Identifying the
    product madeto one dirtributor’o              inedequate.it believe, that to permft a         diettibotot and PAdWt. Such            .
    6pedficatioar Ir eupetiar in quality to                                                                         of
                                                  devsIoperto be identified an ouchon the abbreviattolonn, course.should be clear
    quivplent products marketedby other           product label would detract f&n the             and unambiguoue./              .
    firms. As noted in the posedrule on           prominenceand conspicuousness         that      Tmdemark                                 ?
    2herapeudwKyaquiv r ent drug                  must under rection ~ZO(C) the act be
                                                                               of
    moducte. “&ceot for identified                                   and
                                                  accordedword@ stat&tents that am                    35.Several comment8noted that
    $oble& of bioiaequivalenca,FDA ie             resuired to appearon the label                  6 ZJJl,l(hJ (i ZOl.l(fl an propoeed)would
    not aware&at any therapeutically              Q&ding atiiementa nquired to appear &nit the persoasidentified on the &g
    .igadGcantdufeteacur CuttentIy mint       t under section602(b)(i] of the act).           - pproductlabel to the menuf8ct~er,
    among ph4umaceuticaUy       equivalent *      Therefore.the agencyreject8these                packet, or dielributor of the drug
    ptoducts    whkh mdt from differenwe          WfQUl8d8.                                       product. The commentsurged that the
    .between public compendia1 (or                    33.One wmment stated that            .      owner of a trademark who liceneesthe
    antibiotic1 rtandards end htier internal g xn.i(h? (8 zcn.l(r] ae pmpowd] ia                 .trademarkto another company should
    l tnndarde of manufactwers? FDA thue          defident in that It allowo the .                also be allowed to be identified on the
     bdievw that even when the written             identification of the manufacturerwith         label as the owner of the trademark The
     ipedficetiom for a product aremore            the opdon to omit the name of ths              commentsargued that iderdfiwtion of
    damanding than thoeeof genuiwlty               padqer or di&ibutor who actually                the licen~n, of the trademark on the
    qufvalent producte,the difference8in           delivers the product hto interutete             Mel ia regardedis good aademark
    l pedficatioos do not ordinatily produce wmmerce.The commentcontendedthat practice. One commentstated that a that                         .
                                                                                                   recent Canedten court decision
    a cKfference product queiity‘ Became U A manufacturer prwhcer a product for a trademarkowner may lore hisheld
                   ia                                                                                                                   or ber
     the phrasesdted in the commenthave - reveral distributors who are not                         tights in the trademark if the liceused
     the ~tentiat to mislead comwmem to            Identified on the product label+li, the
    b&eve that A uroduct msde to the               event of a retail or mislabeling, It might      product label does not rtete who owns
    epedfiwdons bf one,distributor la              be impossibleto ascertain who was               the trademark.The cdmmentclaimed
    superior to equivalent productr, the           responsiblefor the product.                     tiat other countries follow the Canadian
     agency wncludea that thesepliraaes               Thir commentinwrrectly eaumes                practice. Finally, one comment
    should not be allowed.                         that the egeocybes the authority to             e-ted        that along with permitting the
                                                   require the distributor or packer to be         ldentificetion of the trademark licenser,
        si. One wmment askedfor                    Identified on the drug product label. No        the proposal rhou!d permit the
     clntUicetlon of the provldon fn               statutory pmvision gives the agency             tdentificetiou 011 lube1 of the iicensee
                                                                                                                        the
     ) zm.i(h) fQZ&I(~) a# proposed)which such aullqily. What is required under                    a8 a licenwe.
     states that “No parson except the             the Federallaw ie that the drug product            The qency did not intend to
    manufacturer, packer, or gliirtributor my                                                                     the
                                                   lnbel beer the ntxw of the manufacturer, &ompromise rightg of a trademark
    be identi5ed on the label of a drue or         packer, ot diitributor. The choice of       z bolder in itr trademark. Suction 2Cfl.l(h~
    drug product”. !Z’he   comment#tat& itu        which of thesepemonr or which -                 has beenrevised to etete that both the-
     assumption that any one.or any                 combination of thesepersonaam to be            licenaor and licensee of a trademark
    cqmbinatioa of tbwe three persons,may fdentifted is left to the labeler of the                 that eppeerr on the drag product or          .
    appear on the label. The commentnoted            mduct and to the mquirementr of State product label may he appropriately
     tbst olany stetyl ~ntl;vrequim          . . E W.                                              identi6ed on the dng product IabeL.
    identicalion on a w product label.of              Even wltbut thu authority to requim
     both Qe manufactwr and distributor, if that e drug product label identify the                .cdgas.                ’:
    the product is di~trihuted by a person         person who is diredly maponslblefor                ~6.Sevemi Gents          recommended
     other then the madechu+                        bbrodudrg the pmduct Into interstate           that proposed 62ul.s(g) be deleted.That
        The applicable rtatute (u&i@’ : C          wmmeme, the agencybebe that                     m~ctibn   Gould requireyif a person’~
     w2(h)(i) of ihe act) and re@;txyn (y        . ,&era am adequatemechaninun to .                name mark, lmprlnt, or other identify@
   .CFR ZOl.l), while                               determlnc who, in fact, war eo                  written, printed or graphic matter (Le..
                         -y$!
    identi6cation of the man actumr. .:             nsponrible end thus to trace products          product “logos appeareddirectly on the
    packer, or distclbutor, do not prohibit a       that em iublect to a nxaU or to an              drug pmduct that the label state
     fin0 horn identifying any lwo or all           action to wmed a n&branding.               1 whether the person identified on the
     ~ofthesepemollsonthe8anl8~                                         ..,“‘.            -    - pmduct is the manufactumr, packer, ot
                                                                                                    distributor. One commentmed that
                                                                                                    the ptovision would diswura@ the use
                                                                                                    of logoaby personswho might not
                                                                                                    qualify au the manufacturer under thu
                                                                                                    terms of the regulation. Another
                                                                                                    commmt took issue with the stated    -
                                                                                                    justification for the requirement.The
                                                                                                    commentnoted that the preamble
                                                                                                    juatifiea the proposedrequirement by
                                                                                                    stating that uw of 8 logo has the
                                                                                                    potential to mielead consumeraby
                                                                                               - * leading consumersto baLievethat the
     SENT BY:M S THOMPSON P C   ; 10-   5-89   2:2SPM   ;   3124549636+

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