ABSTRACT

LegalDepartment,TheCosmetic,ToiletryandFragranceAssociation, Inc.,Washington,D.C.

I.HISTORYOFTHEVOLUNTARYREPORTINGPROGRAMS177 A.CTFAPetitions177 B.FDAProposals178 c.ScreeningReportableProductExperiences179 D.TheCTFA'sSuggestedScreeningProcedure

forCosmeticProductExperiences180

II.CONFIDENTIALITYOFREPORTEDDATA181 Ill.CURRENTREPORTINGPROCEDURES183

A.VoluntaryRegistrationofCosmeticProduct Establishments(21C.F.R.710)184

B.VoluntaryFilingofCosmeticProductIngredient andCosmeticRa wMaterialCompositionStatements (21C.F.R.720)184

c.VoluntaryFilingofCosmeticProductExperiences (21C.F.R.730)186

A.CTFAPetitions

ThecosmeticindustryparticipatesinthreevoluntaryprogramsdesignedtoprovidetheFoodandDrugAdministration(FDA)informationaboutcosmeticproductestablishments,ingredients,andproduct experiences.Theprogramswereinitiatedin1971and1972bypeti-

tions to the FDA filed by the Cosmetic, Toiletry and Fragrance Association (CTFA) on behalf of its members. The programs, which have been incorporated into the Code of Federal Regulations (C. F. R.) include: ( 1) voluntary registration of cosmetic manufacturing and packing establishments; 1 ( 1) voluntary filing of cosmetic raw material composition and cosmetic product ingredient statements; 2 and ( 3) voluntary filing of cosmetic product experiences. 3

At the time the association petitions proposing the voluntary regulations were submitted to the FDA, the CTFA characterized the programs as "a desirable and innovative example of industry cooperation with government to better consumer protection. "4 The CTFA stated that the programs were conceived and developed in the public interest to support efficient enforcement of the Federal Food, Drug, and Cosmetic Act (FDC Act). 5 Several interested parties assisted the CTFA in developing the proposed regulations, including the Commissioner of Food and Drugs and his staff, the President's Special Assistant for Consumer Affairs, and former Congressman Paul Rogers (D.-Fla.) , Chairman of the Subcommittee on Public Health and Welfare, Committee on Interstate and Foreign Commerce.