Source: https://www.npanational.org/regulatory/food-and-drug-administration-fda/cosmetics-and-colors/
Timestamp: 2019-04-24 07:12:09+00:00

Document:
The Federal Food, Drug, and Cosmetic Act (FFDCA) and the Fair Packaging and Labeling Act (FPLA) are the two most important laws pertaining to cosmetic regulations in the U.S.
What does the statute say about the safety of cosmetics?
The FFDCA prohibits the marketing of adulterated cosmetics in interstate commerce.
Color Additive Petitions are evaluated by CFSAN FDA’s Office of Cosmetics and Colors (OCAC).
Allowable Color Additives for Use in the U.S. in Food, Drugs, Cosmetics, and Medical Devices.
§73.2030 Annatto 1977 Cosmetics generally(5) including eye area use.
§73.2085 Caramel 1981 Cosmetics generally(5) including eye area use.
§73.2087 Carmine 1977 Cosmetics generally(5) including eye area use.
§73.2095 ß-Carotene 1977 Cosmetics generally(5) including eye area use.
§73.2110 Bismuth citrate(3) 1978 Cosmetics intended for coloring hair on the scalp only NTE(7) 0.5 percent.
2010 Cosmetics intended for coloring hair on the scalp only NTE(7) 2.0 percent.
§73.2120 Disodium EDTA-copper 1974 Coloring of shampoos that are cosmetics.
§73.2150 Dihydroxyacetone 1973 Externally applied cosmetics(6) intended solely or in part to impart color to the human body.
§73.2162 Bismuth oxychloride 1977 Cosmetics generally(5) including eye area use.
§73.2180 Guaiazulene 1977 Externally applied cosmetics(6).
§73.2190 Henna(3) 1965 Coloring hair but not eyelashes, eyebrows, or eye area.
§73.2250 Iron oxides 1977 Cosmetics generally(5) including eye area use.
§73.2298 Ferric ammonium ferrocyanide 1977 Externally applied cosmetics(6) including eye area use.
§73.2299 Ferric ferrocyanide 1978 Externally applied cosmetics(6) including eye area use.
§73.2329 Guanine 1977 Cosmetics generally(5) including eye area use.
§73.2396 Lead acetate(3) 1981 Cosmetics intended for coloring hair on the scalp only, NTE(7) 0.6 percent Pb (weight/volume).
§73.2400 Pyrophyllite 1973 Externally applied cosmetics(6).
§73.2496 Mica 1977 Cosmetics generally(5) including eye area use.
§73.2500 Silver (3) 1979 Coloring fingernail polish NTE(7) 1% of final product.
§73.2575 Titanium dioxide 1973 Cosmetics including eye area use.
§73.2645 Aluminum powder 1977 Externally applied cosmetics(6) including eye area use.
§73.2646 Bronze powder 1977 Cosmetics generally(5) including eye area use.
§73.2647 Copper powder 1977 Cosmetics generally(5) including eye area use.
§73.2725 Ultramarines 1976 Externally applied cosmetics(6) including eye area use.
§73.2775 Manganese violet 1976 Cosmetics generally(5) including eye area use.
§73.2991 Zinc oxide 1977 Cosmetics including eye area use.
§73.2995 Luminescent zinc sulfide (3) 2000 Nail polish and externally applied facial makeup(6) NTE(7) 10% of final product for limited, occasional use.
§74.2052 D&C Black No. 2 2004 Eyeliner, brush-on-brow, eye shadow, mascara, lipstick, blushers and rouge, makeup and foundation, and nail enamel.
§74.2053 D&C Black No. 3 (3) 2007 Eyeliner, eye shadow, mascara, and face powder.
§74.2151 D&C Brown No. 1 1976 Externally applied cosmetics(6) .
§74.2254 D&C Orange No. 4 1977 Externally applied cosmetics(6) .
§74.2255 D&C Orange No. 5 1984 Externally applied cosmetics(6) .
1982 Mouthwashes, dentifrices, lipsticks, and other lip cosmetics NTE(7) 5 percent.
§74.2260 D&C Orange No. 10 1981 Externally applied cosmetics(6) .
§74.2261 D&C Orange No. 11 1981 Externally applied cosmetics(6) .
§74.2602 D&C Violet No. 2 1976 Externally applied cosmetics(6) .
§74.2602a Ext. D&C Violet No. 2 1976 Externally applied cosmetics(6) .
§74.2705 FD&C Yellow No. 5 1985 Cosmetics generally(5).
1994 Eye area use (includes Al lake).
§74.2706 FD&C Yellow No. 6 1986 Cosmetics generally (5).
§74.2707 D&C Yellow No. 7 1976 Externally applied cosmetics(6).
§74.2707a Ext. D&C Yellow No. 7 1976 Externally applied cosmetics(6).
§74.2708 D&C Yellow No. 8 1976 Externally applied cosmetics(6).
§74.2710 D&C Yellow No. 10 1983 Cosmetics generally (5).
1984 Modification of uses and restrictions.
§74.2711 D&C Yellow No. 11 1976 Externally applied cosmetics(6).
Do Cosmetic firms need to register with FDA or receive an FDA license to operate?
No, but there is a voluntary FDA program called Voluntary Cosmetic Registration Program (VCRP).

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