The FDA does not approve cosmetic products and ingredients before they go on the market, except for color additives that are not intended for use as coal tar hair dyes. However, cosmetic products and ingredients must be safe for consumers under labeled or customary conditions of use. Companies and individuals who market cosmetics have a legal responsibility for the safety of their products and ingredients. The FDA has regulations that specifically prohibit or restrict the use of certain ingredients in cosmetics, such as bithionol, which is prohibited because it may cause photocontact sensitization.
The following resources provide information on cosmetic products, ingredients, and potential contaminants:
- Hair Products: Dyes, Relaxers, Removal, Hair Smoothing Products That Release Formaldehyde
- Makeup: Eye Products, Lipstick, Novelty Makeup, and Permanent Makeup
- Nail Products
- "Organic" Cosmetics
- Soaps & Lotions
- Tanning Products: "Tanning Pills," Self-tanners, and Bronzers
- Tattoos & Permanent Makeup: Also Includes Temporary Tattoos and Henna/Mehndi
The FDA also provides information on allergens found in cosmetic products, possible symptoms of allergic reactions, and testing for allergens. The FDA focuses its efforts on monitoring adverse event reporting, conducting scientific research on the mechanisms of allergic reactions and how allergens interact with the body’s immune system, and conducting research on consumer practices, the frequency of adverse reactions, and consumer awareness of allergens in cosmetics.
The FDA has a cosmetics labeling guide that provides information on labeling requirements for cosmetic products. The guide includes information on petitioning for trade secrecy, drug ingredients, color additives added for color matching, incidental ingredients, dissimilar product assortments, similar product assortments, branded shade lines, direct mail cosmetics, and off-package ingredient labeling. If a cosmetic is also a drug, the label must list first the established name of the drug ingredient(s) and the quantity, kind, and proportion of any alcohol, in compliance with sec. 502(e) of the FD&C Act, as "Active Ingredients" and then the remaining ingredients, in compliance with § 701.3.
