The Voluntary Cosmetic Registration Program

The FD&C Act does not require cosmetic firms to register manufacturing establishments or formulations with the FDA, nor does it mandate that companies submit product adverse reaction report data. Nevertheless, the FDA has encouraged the voluntary registration of such data as being in the public interest and consistent with the spirit of responsible ''self-regulation'' advocated by the cosmetic industry. In the early 1970s, the FDA developed a three-part system of regulations, under which manufacturers or distributors of cosmetics may submit this information to the agency on a voluntary basis [33]. The three parts of the Voluntary Cosmetic Registration Program (VCRP) originally comprised the following:

Part I Cosmetic Establishment Registration Program (CERP), requests that cosmetic manufacturing sites be registered with the FDA (see 21 CFR 710)

Part II Cosmetic Product Ingredient Statements (CPIS), requests that cosmetic formulations and cosmetic raw material composition statements be registered with the FDA (see 21 CFR 720). This regulation also set forth the 13 product category codes (PCC) at 21 CFR 720.4 recognized by the FDA as ''cosmetic'' functions. Semi-quantitative raw material disclosures were abandoned and purged from the VCRP database in the early 1990s [34].

Part III Product Experience Reports (PER), discontinued in 1996 (35), requested the annual filing of ''reportable'' adverse reactions (see 21 CFR 700.3 [q]) to the use of cosmetic products by manufacturers which the FDA (euphemistically called 'product experiences' (see 21 CFR 730). The use of optional 'screening' |

protocols to be filed with the FDA, designed by individual manufacturers, for use in determining the 'reportability' of experiences, was also provided for in the PER Program (see 21 CFR 700.3 (p), 730.4 (d)(2)). This data was collected, |

tabulated, and analyzed for statistical deviations of individual products from industry-wide adverse reaction trends by product category.

Despite its voluntary nature, the VCRP has never enjoyed full industry participation. Table 5 illustrates the VCRP registration statistics for the years 1992-1996, the last five |

fiscal years during which all parts of the VCRP were in operation. Part III (PER) annual filings by firms considered by the FDA to be eligible to participate in the program have

Table 5 FDA Voluntary Cosmetic Registration Program (VCRP), FY 1992-FY 1996

FY 1992 FY 1993 FY 1994 FY 1995 FY 1996

Table 5 FDA Voluntary Cosmetic Registration Program (VCRP), FY 1992-FY 1996

FY 1992 FY 1993 FY 1994 FY 1995 FY 1996

Establishments

939

969

954

757

773

registered

Companies filing

800

782

810

806

684

formulations

Formulations

18,012

18,369

16,929

18,558

15,982

registered

Companies filing

114

116

113

97

75

product

experience

reports

Source: J. E. Bailey, Ph.D., personal communication, July 7, 2000.

FY, Fiscal Year

Source: J. E. Bailey, Ph.D., personal communication, July 7, 2000.

historically been the lowest of the three parts of the VCRP. Part III (PER) was discontinued in 1996 [35] and the VCRP itself was temporarily put into operational abeyance in 1998 due to resource re-allocations within the FDA [36]. With partial funding restoration by the Congress ''earmarked'' specifically for the FDA's Cosmetics Program, Parts I and II of the VCRP were restarted in 1999 [37], and a new, streamlined electronic World Wide Web-based system to facilitate industry participation is being developed at the time of this writing [38].

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