Cosmetics and Colors

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.

THE FFDCA defines cosmetics by their intended use. They are “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” (FFDCA, sec. 201(i)). These include the following products:

skin moisturizers
fingernail polishes
lipsticks
perfumes
eye/facial makeup
cleansing shampoos
hair colors
permanent waves
deodorants
any substance intended for use as a component of a cosmetic product
does NOT include soap.

Can FDA order the recall of a hazardous cosmetic from the market?

YES. Recalls of cosmetics are voluntary actions taken by manufacturers or distributors to remove from the marketplace products that represent a hazard or gross deception, or that are somehow defective (21 CFR 7.40(a). FDA is not authorized to order recalls of cosmetics, but we do monitor companies that conduct a product recall and may request a product recall if the firm is not willing to remove dangerous products from the market without FDA’s written request. To learn more, see “FDA Recall Policy for Cosmetics.”

What does the statute say about the safety of cosmetics?

The FFDCA prohibits the marketing of adulterated cosmetics in interstate commerce.

Adulteration” refers to violations involving product composition–whether they result from ingredients, contaminants, processing, packaging, or shipping and handling. Under the FD&C Act, a cosmetic is adulterated if–

“it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under conditions of use as are customary and usual” (with an exception made for coal-tar hair dyes);
“it consists in whole or in part of any filthy, putrid, or decomposed substance”;
“it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health”;
“its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health”; or
except for coal-tar hair dyes, “it is, or it bears or contains, acolor additive which is unsafe within the meaning of section 721(a)” of the FD&C Act. (FD&C Act, sec. 601)

Color Additives in Cosmetics (Color Additive Petitions)

Under the Federal Food, Drug, and Cosmetic Act (Chapter VII, section 721), color additives, except for coal tar hair dyes, are subject to FDA approval before they may be used in food, drugs, or cosmetics, or in medical devices that come in contact with the bodies of people or animals for a significant period of time. The following resources are related to the use of color additives in FDA-regulated products.

Color Additive Petitions

Color Additive Petitions are evaluated by CFSAN FDA’s Office of Cosmetics and Colors (OCAC).

FDA has guidance on submitted Color Additive Petitions

Food and Color Additive Petitions Under Review

Petitions Currently Held in Abeyance (filed and found after review to be deficient)

Allowable Color Additives for Use in the U.S. in Food, Drugs, Cosmetics, and Medical Devices.

Table of Contents (21 CFR Citation Provided)

Color Additives Approved for Use in Human Food

Part 73, Subpart A:Color additives exempt from batch certification
Part 74, Subpart A:Color additives subject to batch certification

Color Additives Approved for Use in Drugs

Part 73, Subpart B:Color additives exempt from batch certification
Part 74, Subpart B:Color additives subject to batch certification

Color Additives Approved for Use in Cosmetics

Part 73, Subpart C:Color additives exempt from batch certification
Part 74, Subpart C:Color additives subject to batch certification

Color Additives Approved for Use in Medical Devices

Part 73, Subpart D:Color additives exempt from batch certification
Part 74, Subpart D:Color additives subject to batch certification

Allowable Color Additives Approved for Use in Cosmetics

Color Additives Approved for Use in Cosmetics Part 73, Subpart C: Color additives exempt from batch certification
21 CFR Section	Straight Color	Year⁽²⁾Approved	Uses and Restrictions
§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.
§73.2110	Bismuth citrate⁽³⁾	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.
§73.2125	Potassium sodium copper chlorophyllin (chlorophyllin copper-complex)	1969	Coloring dentifrices that are cosmetics NTE⁽⁷⁾ 0.1% in combination with a list of substances.
§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.
§73.2326	Chromium hydroxide green	1977	Externally applied cosmetics⁽⁶⁾ including eye area use.
§73.2327	Chromium oxide greens	1977	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.

Color Additives Approved for Use in Cosmetics Part 74, Subpart C: Color additives subject to batch certification⁽⁴⁾
21 CFR Section	Straight Color	Year⁽²⁾Approved	Uses and Restrictions
§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.
§74.2101	FD&C Blue No. 1	1982	Cosmetics generally⁽⁵⁾.
		1993	Allows MnO₂ in manufacture.
		1994	Eye area use (includes lake).
§74.2104	D&C Blue No. 4	1977	Externally applied cosmetics⁽⁶⁾ .
§74.2151	D&C Brown No. 1	1976	Externally applied cosmetics⁽⁶⁾ .
§74.2203	FD&C Green No. 3	1982	Cosmetics generally ⁽⁵⁾.
§74.2205	D&C Green No. 5	1982	Cosmetics generally⁽⁵⁾.
§74.2205	D&C Green No. 5	1994	Eye area use.
§74.2206	D&C Green No. 6	1982	Externally applied cosmetics⁽⁶⁾ .
§74.2208	D&C Green No. 8	1976	Externally applied cosmetics⁽⁶⁾ (NTE⁽⁷⁾ 0.01% (by wt) of finished cosmetic product).
§74.2254	D&C Orange No. 4	1977	Externally applied cosmetics⁽⁶⁾ .
§74.2255	D&C Orange No. 5	1984	Externally applied cosmetics⁽⁶⁾ .
§74.2255	D&C Orange No. 5	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⁾ .
§74.2304	FD&C Red No. 4	1976	Externally applied cosmetics⁽⁶⁾ .
§74.2306	D&C Red No. 6	1983	Cosmetics generally ⁽⁵⁾.
§74.2306	D&C Red No. 6	2012	Ether-soluble matter specification changed to 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent.
§74.2307	D&C Red No. 7	1983	Cosmetics generally ⁽⁵⁾.
§74.2307	D&C Red No. 7	2012	Ether-soluble matter specification changed to 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent.
§74.2317	D&C Red No. 17	1976	Externally applied cosmetics⁽⁶⁾ .
§74.2321	D&C Red No. 21	1982	Cosmetics generally ⁽⁵⁾.
§74.2322	D&C Red No. 22	1982	Cosmetics generally ⁽⁵⁾.
§74.2327	D&C Red No. 27	1982	Cosmetics generally ⁽⁵⁾.
§74.2328	D&C Red No. 28	1982	Cosmetics generally ⁽⁵⁾.
§74.2330	D&C Red No. 30	1982	Cosmetics generally ⁽⁵⁾.
§74.2331	D&C Red No. 31	1976	Externally applied cosmetics⁽⁶⁾ .
§74.2333	D&C Red No. 33	1988	Externally applied cosmetics⁽⁶⁾ ; mouthwashes, dentifrices; cosmetic lip products (NTE⁽⁷⁾ 3% (by wt) of finished cosmetic product).
§74.2334	D&C Red No. 34	1976	Externally applied cosmetics⁽⁶⁾ .
§74.2336	D&C Red No. 36	1988	Externally applied cosmetics⁽⁶⁾; cosmetic lip products (NTE⁽⁷⁾ 3% (by wt) of finished cosmetic product).
§74.2340	FD&C Red No. 40⁽³⁾	1975	Cosmetics generally⁽⁵⁾.
§74.2340	FD&C Red No. 40⁽³⁾	1994	Eye area use (includes Al lake). No oxidizing or reducing agents that may affect integrity.
§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⁾.
§74.2705	FD&C Yellow No. 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⁾.
§74.2710	D&C Yellow No. 10	1984	Modification of uses and restrictions.
§74.2711	D&C Yellow No. 11	1976	Externally applied cosmetics⁽⁶⁾.