What Does the Law Say About Cosmetic Safety and Labeling?

The FD&C Act prohibits the sale of adulterated or misbranded cosmetics in interstate commerce. "Adulteration" refers to violations involving product composition, regardless of whether such violations result from product 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 its labeling, or under such conditions of use as are customary or usual" (except 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, a color additive which is unsafe within the meaning of Section 721(a) of the FD&C Act." (FD&C Act, Section 601) "Misbranding" refers to violations involving products that are improperly labeled or deceptively packaged. Under the FD&C Act, a cosmetic is misbranded if: - "its labeling is false or misleading in any particular"; - its labeling does not contain all required information. (This may not apply to cosmetics intended to be processed, labeled, or repackaged at an establishment other than the original processor or packer. See CFR Title 21, Section 701.9.); - the required information is present on the labeling but is not conspicuous; - "its container is so made, formed, or filled as to be misleading"; - it is a color additive that does not conform to applicable regulations issued under Section 721 of the FD&C Act, except for hair dyes; and - "its packaging or labeling is in violation of an applicable regulation issued under Section 3 or 4 of the Poison Prevention Packaging Act of 1970." (FD&C Act, Section 602) Under the FD&C Act, a product may also be deemed misbranded if its labeling fails to reveal material facts. For example, this means that product labels need safe-use directions and warning statements to ensure the product's safe use. In addition, under the authority of the FPLA, the FDA requires manufacturers to provide an ingredient list for cosmetics sold at retail to consumers (CFR Title 21, Section 701.3). Cosmetics that do not comply with the FPLA are considered misbranded under the FD&C Act. (FPLA, Section 1456) This requirement does not apply to cosmetics used only for professional use or only by institutions (such as schools or workplaces), or used as free samples or hotel amenities. The FDA can take action against cosmetics marketed in violation of the above laws and against the companies and individuals that sell such cosmetics. Who is responsible for proving the safety of cosmetics? Companies and individuals who manufacture or sell cosmetics have a legal responsibility to ensure the safety of their products. Neither the law nor FDA regulations require specific testing of individual cosmetics or ingredients to prove that such cosmetics or ingredients are safe. The law also does not require cosmetic companies to share their safety information with the FDA. The FDA has consistently advised manufacturers to conduct the testing necessary to ensure the safety of their products and product ingredients. Companies can substantiate the safety of their products and product ingredients in various ways. The FDA stipulates that "the following methods are sufficient to substantiate the safety of a product: (a) using toxicity test data already available on individual ingredients and on product formulations similar to the particular cosmetic, and (b) conducting additional toxicity tests and other appropriate tests based on existing data and information." (Federal Register, March 3, 1975, p. 8916) In addition, relevant regulations prohibit or restrict the use of several ingredients in cosmetics and require warning statements on the labels of certain types of cosmetics.