Resources for You
The Federal Food, Drug, and Cosmetic Act does not require cosmetic products and ingredients to be approved by FDA before they go on the market, except for color additives that are not intended for use as coal tar hair dyes. However, they 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.
Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients. Rather, FDA has consistently advised manufacturers to use whatever testing is necessary to ensure the safety of their products and ingredients. Firms may substantiate safety in a number of ways. FDA has stated that "the safety of a product can be adequately substantiated through (a) reliance on already available toxicological test data on individual ingredients and on product formulations that are similar in composition to the particular cosmetic, and (b) performance of any additional toxicological and other tests that are appropriate in light of such existing data and information." (Federal Register, March 3, 1975, page 8916).
The resources listed below provide information to consumers and industry on ensuring cosmetic safety.