Do cosmetics and their ingredients need FDA approval before going on the market in the U.S.?

Under traditional U.S. law, cosmetics and their ingredients generally do not require FDA approval before they go on the market — the only exception being color additives (other than the coloring materials used in coal-tar hair dyes), which must be approved for their intended use. Companies and individuals who market cosmetics have a legal responsibility to ensure their products are safe. Important update: since 1 July 2024, the FDA has begun enforcing the cosmetic “facility registration” and “product listing” requirements under the Modernization of Cosmetics Regulation Act (MoCRA), so the statement that cosmetics need no FDA approval before marketing no longer fully applies. FDA scientists continue to conduct cosmetic-safety research (covering microbiological safety, nanotechnology, alpha hydroxy acids, lipstick and lead, talc and more).

FDA Science and Research on Cosmetics

FDA scientists conduct cosmetic-safety research and monitor the work of scientists at other agencies, because any FDA action on cosmetic safety must be based on reliable information. Note: since 1 July 2024, the FDA has begun enforcing the cosmetic “facility registration” and “product listing” requirements under MoCRA, so the older statement that cosmetics need no FDA approval before marketing no longer fully applies.

Scientists at the U.S. Food and Drug Administration (FDA) conduct cosmetic-safety research and pay attention to the research of scientists at other agencies, because any action the FDA takes on cosmetic safety must be based on reliable information. Under U.S. law, cosmetics and their ingredients generally do not require FDA approval before they go on the market. The only exception is color additives (other than the coloring materials used in coal-tar hair dyes), which must be approved for their intended use. Companies and individuals who market cosmetics have a legal responsibility to ensure that their products are safe. To take safety action on cosmetics already on the market, the FDA needs reliable information showing that a product is unsafe when consumers use it according to the label directions or in the customary or expected way. Important note: The statement that “cosmetic products and ingredients do not need FDA approval before they go on the market” no longer applies, because since 1 July 2024 the FDA has begun enforcing the cosmetic “facility registration” and “product listing” requirements under the Modernization of Cosmetics Regulation Act (MoCRA). In this section, you will find: • Product testing: an overview of cosmetic testing for consumers and industry • Microbiological safety of cosmetics: information for consumers and industry, with links to more resources • Nanotechnology: information and resource links for consumers and industry • Research programs: an overview of FDA research related to cosmetic safety FDA science and research resources related to cosmetics • Alpha Hydroxy Acids: Guidance on labeling for cosmetics containing alpha hydroxy acids • Color additives: the chemistry of color additives • Lipstick and lead: Q&A • The FDA's method for testing lead in lipstick • FDA testing of arsenic, cadmium, chromium, cobalt, lead, mercury and nickel content in cosmetics • Nanotechnology: industry guidance on the safety of nanomaterials in cosmetics • Nanotechnology in cosmetics and food: webinar • Potential contaminants • Phthalates • Talc in cosmetics • Tattoos and permanent makeup: market and chemistry

FAQ

Do cosmetics and their ingredients need FDA approval before going on the market in the U.S.?: Under traditional U.S. law, cosmetics and their ingredients generally do not require FDA approval before they go on the market — the only exception being color additives (other than the coloring materials used in coal-tar hair dyes), which must be approved for their intended use. Companies and individuals who market cosmetics have a legal responsibility to ensure their products are safe. Important update: since 1 July 2024, the FDA has begun enforcing the cosmetic “facility registration” and “product listing” requirements under the Modernization of Cosmetics Regulation Act (MoCRA), so the statement that cosmetics need no FDA approval before marketing no longer fully applies. FDA scientists continue to conduct cosmetic-safety research (covering microbiological safety, nanotechnology, alpha hydroxy acids, lipstick and lead, talc and more).

FAQ

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