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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

Color Additives Approved for Use in Drugs

Color Additives Approved for Use in Cosmetics

Color Additives Approved for Use in Medical Devices

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.
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).
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) .
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).
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).
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).
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).
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).

 

Prohibitions on the use of several ingredients in cosmetic products

Required Warning Statements on the labels of certain types of cosmetics

FDA Inspectional Authority of Cosmetic Manufacturing Facilities

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).

Helpful Information for Importers of Cosmetic Products

Cosmetics and Colors: Compliance and Enforcement

Warning and Untitled Letters

Import Alerts & Refusals Involving Color Additives

Color Additive Status List

Food and Color Additives: Final Rules by Year