Under the law, cosmetic products and ingredients do not need FDA pre-market approval, except for color additives. However, the FDA can pursue enforcement action against products on the market that are not in compliance with the law, or against firms or individuals who violate the law.

In general, except for color additives and those ingredients that are prohibited or restricted by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic, provided that:

  • PThe ingredient and the finished cosmetic are safe under labeled or customary conditions of use.
  • PThe product is properly labeled.
  • PThe use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces.
It is also important make sure your cosmetic is not a drug.

Although the Federal Food, Drug, and Cosmetic Act does not subject cosmetics to pre-market approval, we do collect samples for examination and analysis as part of our cosmetic facility inspections, import inspections, and follow-up to complaints of adverse events associated with their use.

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