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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 SectionStraight ColorYear(2)ApprovedUses and Restrictions
§73.2030Annatto1977Cosmetics generally(5) including eye area use.
§73.2085Caramel1981Cosmetics generally(5) including eye area use.
§73.2087Carmine1977Cosmetics generally(5) including eye area use.
§73.2095ß-Carotene1977Cosmetics generally(5) including eye area use.
§73.2110Bismuth citrate(3)1978Cosmetics intended for coloring hair on the scalp only NTE(7) 0.5 percent.
2010Cosmetics intended for coloring hair on the scalp only NTE(7) 2.0 percent.
§73.2120Disodium EDTA-copper1974Coloring of shampoos that are cosmetics.
§73.2125Potassium sodium copper chlorophyllin (chlorophyllin copper-complex)1969Coloring dentifrices that are cosmetics NTE(7) 0.1% in combination with a list of substances.
§73.2150Dihydroxyacetone1973Externally applied cosmetics(6) intended solely or in part to impart color to the human body.
§73.2162Bismuth oxychloride1977Cosmetics generally(5) including eye area use.
§73.2180Guaiazulene1977Externally applied cosmetics(6).
§73.2190Henna(3)1965Coloring hair but not eyelashes, eyebrows, or eye area.
§73.2250Iron oxides1977Cosmetics generally(5) including eye area use.
§73.2298Ferric ammonium ferrocyanide1977Externally applied cosmetics(6) including eye area use.
§73.2299Ferric ferrocyanide1978Externally applied cosmetics(6) including eye area use.
§73.2326Chromium hydroxide green1977Externally applied cosmetics(6) including eye area use.
§73.2327Chromium oxide greens1977Externally applied cosmetics(6) including eye area use.
§73.2329Guanine1977Cosmetics generally(5) including eye area use.
§73.2396Lead acetate(3)1981Cosmetics intended for coloring hair on the scalp only, NTE(7) 0.6 percent Pb (weight/volume).
§73.2400Pyrophyllite1973Externally applied cosmetics(6).
§73.2496Mica1977Cosmetics generally(5) including eye area use.
§73.2500Silver (3)1979Coloring fingernail polish NTE(7) 1% of final product.
§73.2575Titanium dioxide1973Cosmetics including eye area use.
§73.2645Aluminum powder1977Externally applied cosmetics(6) including eye area use.
§73.2646Bronze powder1977Cosmetics generally(5) including eye area use.
§73.2647Copper powder1977Cosmetics generally(5) including eye area use.
§73.2725Ultramarines1976Externally applied cosmetics(6) including eye area use.
§73.2775Manganese violet1976Cosmetics generally(5) including eye area use.
§73.2991Zinc oxide1977Cosmetics including eye area use.
§73.2995Luminescent zinc sulfide (3)2000Nail 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 SectionStraight ColorYear(2)ApprovedUses and Restrictions
§74.2052D&C Black No. 22004Eyeliner, brush-on-brow, eye shadow, mascara, lipstick, blushers and rouge, makeup and foundation, and nail enamel.
§74.2053D&C Black No. 3 (3)2007Eyeliner, eye shadow, mascara, and face powder.
§74.2101FD&C Blue No. 11982Cosmetics generally(5).
1993Allows MnO2 in manufacture.
1994Eye area use (includes lake).
§74.2104D&C Blue No. 41977Externally applied cosmetics(6) .
§74.2151D&C Brown No. 11976Externally applied cosmetics(6) .
§74.2203FD&C Green No. 31982Cosmetics generally (5).
§74.2205D&C Green No. 51982Cosmetics generally(5).
1994Eye area use.
§74.2206D&C Green No. 61982Externally applied cosmetics(6) .
§74.2208D&C Green No. 81976Externally applied cosmetics(6) (NTE(7) 0.01% (by wt) of finished cosmetic product).
§74.2254D&C Orange No. 41977Externally applied cosmetics(6) .
§74.2255D&C Orange No. 51984Externally applied cosmetics(6) .
1982Mouthwashes, dentifrices, lipsticks, and other lip cosmetics NTE(7) 5 percent.
§74.2260D&C Orange No. 101981Externally applied cosmetics(6) .
§74.2261D&C Orange No. 111981Externally applied cosmetics(6) .
§74.2304FD&C Red No. 41976Externally applied cosmetics(6) .
§74.2306D&C Red No. 61983Cosmetics generally (5).
2012Ether-soluble matter specification changed to 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent.
§74.2307D&C Red No. 71983Cosmetics generally (5).
2012Ether-soluble matter specification changed to 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent.
§74.2317D&C Red No. 171976Externally applied cosmetics(6) .
§74.2321D&C Red No. 211982Cosmetics generally (5).
§74.2322D&C Red No. 221982Cosmetics generally (5).
§74.2327D&C Red No. 271982Cosmetics generally (5).
§74.2328D&C Red No. 281982Cosmetics generally (5).
§74.2330D&C Red No. 301982Cosmetics generally (5).
§74.2331D&C Red No. 311976Externally applied cosmetics(6) .
§74.2333D&C Red No. 331988Externally applied cosmetics(6) ; mouthwashes, dentifrices; cosmetic lip products (NTE(7) 3% (by wt) of finished cosmetic product).
§74.2334D&C Red No. 341976Externally applied cosmetics(6) .
§74.2336D&C Red No. 361988Externally applied cosmetics(6); cosmetic lip products (NTE(7) 3% (by wt) of finished cosmetic product).
§74.2340FD&C Red No. 40(3)1975Cosmetics generally(5).
1994Eye area use (includes Al lake). No oxidizing or reducing agents that may affect integrity.
§74.2602D&C Violet No. 21976Externally applied cosmetics(6) .
§74.2602aExt. D&C Violet No. 21976Externally applied cosmetics(6) .
§74.2705FD&C Yellow No. 51985Cosmetics generally(5).
1994Eye area use (includes Al lake).
§74.2706FD&C Yellow No. 61986Cosmetics generally (5).
§74.2707D&C Yellow No. 71976Externally applied cosmetics(6).
§74.2707aExt. D&C Yellow No. 71976Externally applied cosmetics(6).
§74.2708D&C Yellow No. 81976Externally applied cosmetics(6).
§74.2710D&C Yellow No. 101983Cosmetics generally (5).
1984Modification of uses and restrictions.
§74.2711D&C Yellow No. 111976Externally 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