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The FD&C Act prohibits the sale of adulterated or misbranded cosmetics in interstate commerce.

"Adulteration" means any violation of the law involving the composition of a product, regardless of whether such violation is the result of product ingredients, contaminants, processing, packaging, or shipping and handling. Under the FD&C Act, a cosmetic is adulterated if:

 • “It contains or contains any toxic or hazardous substance that may be harmful to the user under the conditions of use specified on its label or under conditions of ordinary use (except coal tar hair dye);

 • “composed in whole or in part of any unclean, putrefactive or putrefactively degraded matter”;

 • “it has been manufactured, packed or held under unsanitary conditions whereby it may have become contaminated with filth or be rendered injurious to health”;

 • “its container consists 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 dye, “is, or has or contains an unsafe color additive as defined in section 721(a) of the FD&C Act.” (Section 601 of the FD&C Act) “Misbranding” refers to violations involving products that are improperly labeled or packaged in a deceptive manner. Under the FD&C Act, a cosmetic is misbranded if:

 • “its labeling is false or misleading in any respect”;

 • Its label does not contain all the required information. (This requirement does not apply to cosmetics that are intended to be processed, labeled, or repackaged at a facility other than the original processor or packer. See 21 CFR 701.9.)

 • The necessary information is on the label but not prominently enough;

 • “its container is made, constructed or filled in a manner that is misleading”;

 • is a color additive that does not comply with applicable regulations promulgated under section 721 of the FD&C Act, except for hair dyes; and

 • “Packaged or labeled in violation of applicable regulations promulgated under section 3 or 4 of the Dangerous Goods Packaging Act of 1970.” (Section 602 of the FD&C Act)

according toUnder the FD&C Act, products that fail to provide material facts in their product descriptions can also be considered misbranded. For example, this means that product labels must include safe use instructions and cautionary statements to ensure the product's safe use. Furthermore, under the authority of the FPLA, the FDA requires manufacturers to provide ingredient lists for cosmetics sold retail to consumers (21 CFR 701.3). Cosmetics that fail to comply with the FPLA are considered misbranded under the FD&C Act (Section 1456 of the FPLA). This requirement does not apply to cosmetics intended solely for professional use or for institutional use (such as schools or workplaces), or to cosmetics used as free samples or hotel supplies.

The FDA can take action against cosmetics that are marketed in violation of these laws, as well as against companies and individuals that sell such cosmetics.

Who is responsible for certifying the safety of cosmetics?

Companies and individuals who manufacture or sell cosmetics have a legal responsibility to ensure the safety of their products.No FDA regulations require specific testing of individual cosmetics or ingredients to prove they are safe, nor do cosmetic companies have a legal requirement to share their safety information with the FDA.

The FDA consistently recommends that manufacturers conduct necessary testing on their products and ingredients to ensure their safety. Companies can demonstrate the safety of their products and ingredients in a variety of ways. The FDA stipulates that "the following methods are sufficient to demonstrate product safety:

（a）Use of already available individual ingredients and similar ingredients to specific cosmetic ingredients Product formulation toxicity test data, and

（b）Conduct additional toxicity testing and other appropriate tests based on available data and information try.” (Federal Register, March 3, 1975, p. 8916).

In addition, relevant regulations prohibit or restrict the use of certain ingredients in cosmetics and require certain types of cosmetics to be marked on their labels. Cautionary Statement.