LET HFS to Kraft Foods Inc Vol 3/30

.- ‘. 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 ATTORNEY AT LAW DIRECTDIAL (202)6374X6 HOGAN& HARTSON L.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) Divisionof Programs Enforcement and Policy Officeof Food Labeling Centerfor FoodSafetyandAppliedNutrition Foodand DrugAdministration 200 C Street,S.W. Washington, 20204 D.C. Re: Docket Numbers 93P-0310,94P-OU7 21 CFR 130.17(i)-Notice of Participation In Extended Market Test Of White Chocolate DearMs. Carey: On July 20,1995,we notifiedthe Foodand DrugAdministration KraftFoods,Inc. that acceptsthe agency’sinvitation participate the extended to in markettestof whitechocolate, announced the FederalRegister December in on 29,1994;59 Fed.Reg.67302(DocketNo. 93P0310). At this time,we are notifying agencythat Kraftintendsto includean additional the product, Bakers BrandPremiumWhiteChocolate Chunks,in the ongoingmarkettest DocketNo. 94-P-01 (JulyI, 1994;59 Fed.Reg.33976) the docketnumberfor the 57 temporary permitto marketwhitechocolate originallyissuedto Kraltin 1994,containsrelevant procedural historyas well as a description the proposed product The productdescription of test has not changed,but is repeatedherefor convenient reference. 1. 2. 3. The nameof the applicant KraftFoods,Inc. The headquarters is addressis Three Lakes Drive,Northfield, 60091. IL KraftFoodsis regularlyengaged the business manufacturing marketing in of and cacao products. The “whitechocolate” proposeto markettest differsfromthe existingstandards we of identityfor chocolate products, chocolate e.g., liquor(21 CFR163.11 sweetchocolate I), (21 CFR63.123), chocolate CFR 163.130)buttermilk milk (21 chocolate Kraft Foods 555 Soutll Broadway l Twrytown, NY 10591 1 LorettaA. Carey January2,200l Page2 (21 CFR 163.135)skim milkchocolate CFR 163.140)and mixeddairyproduct (21 chocolates CFR163.145). (21 4. The proposeddifference the existingstandards identityrecognizes the product from of that commonlyknownamongconsumers in othercountriesas ‘white chocolate“ made and is with cocoabutter. The cocoabutteris producedby filteringgroundcocoanibsto remove the darkcocoasolids. The composition the “whitechocolate” proposeto markettest is consistent the of we with standardof identityfor Whitechocolate’proposed citizen’spetitionsfiled by Hershey in FoodsCorporation the Chocolate and Manufacturers Association (Docketnumbers 86-PO2971CP2 86P-02971CP3). and Morespecifically, “whitechocolate” proposeto markettest is the solidor semithe we plasticfood preparedby intimatelymixingand grindingcocoabutterwith oneor more nutritivecarbohydrate sweeteners one or moreof the optionaldairy ingredients and 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 seasonings, antioxidants and approved food use. for 5. The food “whitechocolate” just as wholesome non-deleterious the cacao is and as or productsthat aresubjectto existingstandards identity. No novelingredients of processes usedin the production “whitechocolate”. are of The existingstandards sweetchocolate milk chocolate, for theotherchocolate for and and productscited above,includeminimumrequirements the additionof chocolate for liquor, whichcontainsgroundcacaonibs. ‘Whitechocolate” containsthe cacaofat from ground cacaonibs,but notthe darkchocolate solidsfoundin chocolateliquor. The purposeof effectingthe proposed variationis to facilitatethe markettestingof ‘white chocolate”in the UnitedStates,underthe statement identitythat is in commonuse in of the othercountriesandis mostinformative the consumer.Additionally, markettest will to facilitatethe collection dataon consumer of acceptance the productto support of the petitionsfor a standardof identityfor “whitechocolate” alreadyon file withthe Foodand DrugAdministration, citedabove. as cc A soundlegal casecan be madethat no permitor newstandardis neededto authorize the sale of “whitechocolate” this country. Indeed,“whitechocolate” in almostcertainlyis an appropriately descriptive statement identity,independent the existingstandards. of of 6. 7. LorettaA. Carey January2,200l Page3 Nevertheless, acknowledge Agency’sapparent we the preference the useof the for temporarymarketingpermitprocess this case. Forthat reason,we arefilingthis in notification. 8. The variationfrom existingstandards wouldbenefitconsumers makingit easyfor them by to distinguish &hite chocolate” real products from products madewith cheapercacaofat substitutes.Additionally, removal darkcocoasolidsfrom the chocolate the of formula resultsin a uniquemilkywhitecolorand a strongmilkyflavorthat seemsto be preferred by manyconsumers. The labelfor the Baker’sBrandPremiumBakingChocolate WhiteChocolate Chunksthat Kraftplansto addto the ongoingmarkettest is attached. Duringthe markettest we expectto distribute an annualbasis88,000Lb. of Baker’s on 12oz. Premiumwhitechocolate chunks. The productwill be distributed throughout UnitedStates. the The productwill be manufactured Ban-y by Callebaut USA,inc., 400 IndustrialParkRoad, St Albans,VT 05478-1875.Thetelephone numberfor this facilityis (802)524-971 At I. this time,the plantmanageris ChrisDemambro the QualityManageris Stuart and Redfield. 9. IO. 11. 12. Pleasedo not hesitateto contactme at 914-335-6548 in my absence,SherryMarcouiller 847or at 646-4206, you needadditional if information.Thankyou for yourcooperation. Respectfully submitted, KraftFoods,Inc. PaulaM. Nothofer Regulatory Compliance Labeling cc: SherylA. Marcouiller SeniorFoodand DrugCounsel Attachment .. I. HoGAN&HARTSON L.L.F! Writer’s Direct Dial: 202-636-6466 7 yp-u COLUMBIA 555 THIRTEENTH WASHINGTON, SQUARE STREET, NW a DC 200941109 February 2,200l TEL (202) cm-5600 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 Notice of Participation Chocolate White Chocolate Chunks in Extended Market Test of White 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 DENVER PRAGUE* BOULLtER WARSAW MOSCOW \\\DC.60685/4 -#126059$vl NEWYORK TORY0 -. BALTlhfOBE McLBAN bIIAMI 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 (2) If the person performs at least one applicable operation listed in paragraph (b) of this section and identifies by appropriate designation all other persons who .have performed the remaining applicable operations, e.g., “Made by (Person A), Filled by (Person B), Sterilized by (Person C)“; or (3) If the person performs at least one applicable operation listed in paragraph (b) of this section and the person is listed along with all other persons who have performed the remaining applicable operations as “joint manufacturers.” A list of joint manufacturers shall be qualified by the phrase “Joint" and ly Manufactured By the names of all of the manufacturers shall be printed together in the same type size and style; or (4) If the person performs all applicable operations listed in paragraph (b) of this section except for those operations listed in paragraph (d) of this section. For purposes of this paragraph, person, when it identifies a corporation, includes a parent, subsidiary, or affiliate company where the related companies are under common ownership and control. (d) The Food and Drug Administration finds that it is the common practice in the drug industry to contract out the performance of certain manufacturing operations listed in paragraph (b) of this section. These operations include: (1) Soft-gelatin encapsulating, (2) aerosol filling, (3) sterilizing by irradiation, (4) lyophilizing, and (6) ethylene oxide sterilization. (e) A person performs an operation listed in paragraph (b) of this section only if the operation is performed, including the performance o&he appro‘prlate in-process quality control operations, except laboratory testing of samples taken during processing, as follows: (1) By individuals, a majority of whom are employees of the person and, throughout the performance of the operation, are ‘subject to the person’s direction and control; (2) On premises that are continuously owned or leased by the person and subject to the person’s direction and control; and (3) On equipment that is continuously owned or leased by the person. As 21 CFR Ch. I (4-l-00 Edliion) used in this paragraph, person, when it identifies a corporation, includes a parent, subsidiary, or affiliate company where the related companies are under common ownership and control. (f) The name of the person represented as manufacturer under paragraph (b) or (c) of this section must be the same as either (1) the name of the establishment (as defined in $207.3(b)of this chapter) under which that person is registered at the time the labeled product is produced or (2) the registered establishment name of a parent, subsidiary, or affiliate company where the related companies are under common ownership and control. In addition, the name shall meet the requirements of paragraph (g) of this section. (g) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the case of a corporate person, only by the actual corporate name, except that the corporate name may be the name of a parent, subsidiary, or affiliate company where the related companies are under common ownership and control. The corporate name may be preceded or followed by the name of the particular division of the corporation. LICompany.” “Incorporated” etc., may be abbreviated or omitted and “The” may be omitted. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used. (h)(l) Except as provided in this section, no person other than the manufacturer, packer, or distributor may be identifled on the label of a drug or drug product. (2) The appearance on a drug product label of a person’s name without qualification is a representation that the named person is the sole manufacturer of the product. That representation is false and misleading, and the drug product is misbranded under section 502(a) of the act, if the person is not the manufacturer of the product in accordance with this seotion. (3) If the names of two or more persons appear on the label of a drug or drug product, the label may identify which of the persons is to be contacted for further information about the product. Food and Dnig ~dmWtmtlon, HHS (m) This section does not apply to biological drug products that axe subject to the requirements of section 361 of the Public Health Service Act, 42 U.S.C. 262. 145 FR 95’775, Apr. 15, 1990; FR 72118, Oct. 45 31, 1980, as amended at 48 FR 37620. Aug. 19, \ \ (4) If a trademark appears on the drug or drug product label or appears as a mark directly on the drug product (e.g., tablet or capsule), the label may identify the holder or licensee of the trademark. The label may also state whether the person identified holds the trademark or is licensee of the trade. mark. (5) If the distributor is named on the label. the name shall be aualified by one of the following phraeea: “Manu‘* “Distributed factured for ,, “Man;factured by by $9 “Manu, for ’ 1, factured for byB, , “Marketed 6”Distributor: 3%. qualifging phrases The by may be abbreviated. (6) If the packer is identified on the label, the name shall be qualified by 9’ or the phrase “Packed by *‘. The quali“Packaged by fsing phrases may be abbreviated. (i) The statement of the place of business shall include the street address, city, State, and ZIP Code. For a foreign manufacturer, the statement of the place of business shall include the street address, city, country, and any applicable mailing code. The street address may be omitted if it is shown in a current city directory or telephone direotorg. The requirement for inolusion of the ZIP Code shall apply to consumer commodity labels developed or revised after July 1.1969. In the case of nonconsumer packages, the ZIP Code shall appear either on the label or the labeling (including the invoice). (j) If a person manufactures, packs, or distrfbutes a drug or drug product at a place other than the person’s principal place of business, the label may state the principal place of business in lieu of the actual place where such drug or drug product -was manufactured or packed or is to be distributed, unless such statement would be misleading. (k) Paragraphs (b), (c), (d), (eh and (f) of this section. do not apply to the labeling of drug components. (1) A drug product is misbranded under section 562(a) of the act if its labeling identifies a person as manufacturer, packer, or distributor, and that identification does not meet the re.quirements of this section. 19931 #zOlS Drug 3 C and devices; e number~3. National The National Drug Code (NDC) number is requested but not required to appear on all drug labels and in all drug labeling, including the label of any prescription drug container furnished to a consumer. If the ND0 number is shown on a drug label, it shall be displayed as required in !j26735(b)(3) of this chapter. 140 FR 52902, Nov. 7.19751 #201.6 Drugq use. adequate directiona for Adequate directions for use means directions under which the layman can use a drug safely and for the purposes for which it is intended. (Section 261.l26 defines “intended use.“) Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specification of: (a) Statements of all conditione, purposes, or uses for which such drug is intended, including conditions, purposes, or uses for which it is prescribed, recommended, or suggested in its oral, written, printed, or graphic advertising, and conditions, purposes, or uses for which the drug is commonly used; except that such statements shall not refer to conditions, uses. or purposes for which the drug can be safely used only under the supervision of a practitioner licensed by law and for which it is advertised solely to such practitioner. (b) Quantity of dose. including usual quantities for each of the uses for which it is intended and usual quantitiea for persons of different ages and different physical conditions. (c) Frequency of administration or application. (d) Duration of administration or application. (e) Time of administration or application (in relation to time of meals, Fedetal Register J Vol. 45, No. 74 / Tuesday, April 15. 1980 / Rules and Regulations 25769 r abbreviations is mMe&ing is itaeif would not fully dlscloet the extent OF * %&&a~ to the Spedfketions of funds to invalidate the pmvisian t -“. ate any mote likely to mleleed a that pemon’econtribution. under Ahnay, hc v. Colifano, 568F.2d Although thu agencyacognize8 the cormuwn as to the identity of the . 874,932 p.c. citw 1977). veJuablacontribution that a product manufacturer than the phreScN, ’ The agmcy agreesthat abb&viatlo developer(or innovator) make@, and permitted by the tinatregulatioa the . epncy believes that thesephrereo cm4 agreesthat Adistributor identification, of should be pennttted of thae phrauzs that 0 ZO~.I@) ellowe in Identifying the a developermey be Mmewhat be mirleadiog in rugetrting that 8 : diettibotot and PAdWt. Such inedequate.it believe, that to permft a . product madeto one dirtributor’o of devsIoperto be identified an ouchon the abbreviattolonn, course.should be clear 6pedficatioar Ir eupetiar in quality to and unambiguoue./ . product label would detract f&n the quivplent products marketedby other prominenceand conspicuousness that firms. As noted in the posedrule on ? Tmdemark must under rection ~ZO(C) the act be of 2herapeudwKyaquiv r ent drug 35.Several comment8noted that accordedword@ stat&tents that am and moducte. “&ceot for identified 6 ZJJl,l(hJ (i ZOl.l(fl an propoeed)would resuired to appearon the label $oble& of bioiaequivalenca,FDA ie Q&ding atiiementa nquired to appear &nit the persoasidentified on the &g not aware&at any therapeutically - pproductlabel to the menuf8ct~er, .igadGcantdufeteacur CuttentIy mint t under section602(b)(i] of the act). packet, or dielributor of the drug Therefore.the agencyreject8these among ph4umaceuticaUy equivalent * product. The commentsurged that the WfQUl8d8. ptoducts whkh mdt from differenwe owner of a trademark who liceneesthe 33.One wmment stated that . .between public compendia1 (or .trademarkto another company should antibiotic1 rtandards end htier internal g xn.i(h? (8 zcn.l(r] ae pmpowd] ia also be allowed to be identified on the defident in that It allowo the . l tnndarde of manufactwers? FDA thue label as the owner of the trademark The identification of the manufacturerwith bdievw that even when the written commentsargued that iderdfiwtion of the opdon to omit the name of ths ipedficetiom for a product aremore the licen~n, of the trademark on the padqer or di&ibutor who actually damanding than thoeeof genuiwlty Mel ia regardedis good aademark delivers the product hto interutete qufvalent producte,the difference8in . 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 Identified on the product label+li, the the ~tentiat to mislead comwmem to product label does not rtete who owns event of a retail or mislabeling, It might b&eve that A uroduct msde to the the trademark.The cdmmentclaimed be impossibleto ascertain who was epedfiwdons bf one,distributor la tiat other countries follow the Canadian responsiblefor the product. superior to equivalent productr, the practice. Finally, one comment Thir commentinwrrectly eaumes agency wncludea that thesepliraaes e-ted that along with permitting the that the egeocybes the authority to should not be allowed. ldentificetion of the trademark licenser, require the distributor or packer to be si. One wmment askedfor the proposal rhou!d permit the Identified on the drug product label. No clntUicetlon of the provldon fn tdentificetiou 011 lube1 of the iicensee the statutory pmvision gives the agency ) zm.i(h) fQZ&I(~) a# proposed)which such aullqily. What is required under a8 a licenwe. states that “No parson except the The qency did not intend to the Federallaw ie that the drug product 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 has beenrevised to etete that both thewhich of thesepemonr or which assumption that any one.or any licenaor and licensee of a trademark combination of thesepersonaam to be 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 ~6.Sevemi Gents recommended person who is diredly maponslblefor other then the madechu+ that proposed 62ul.s(g) be deleted.That bbrodudrg the pmduct Into interstate The applicable rtatute (u&i@’ : C m~ctibn Gould requireyif a person’~ wmmeme, the agencybebe that w2(h)(i) of ihe act) and re@;txyn (y name mark, lmprlnt, or other identify@ . ,&era am adequatemechaninun to . .CFR ZOl.l), while written, printed or graphic matter (Le.. determlnc who, in fact, war eo -y$! identi6cation of the man actumr. .: product “logos appeareddirectly on the nsponrible end thus to trace products packer, or distclbutor, do not prohibit a drug pmduct that the label state that em iublect to a nxaU or to an 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+ bl t’ 1.