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Federal Food, Drug, and Cosmetic Act

1938 U.S. law that sets the rules for drugs and cosmetics.

2 links, 2 backed by primary records

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Also known as
FD&C Act

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enacted by

  • U.S. Congress 1938 Primary record 1234

    The quotes are the FDA describing what the Act gives it; Congress alone can change that.

includes

Timeline 1 date
  1. 1938 U.S. Congress signed into law Federal Food, Drug, and Cosmetic Act
Proof 5 sources
  1. FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated, U.S. Food and Drug Administration. Primary record
    A change in FDA's legal authority over cosmetics would require Congress to change the law.
    Under the law, cosmetic products and ingredients do not need FDA premarket approval, with the exception of color additives.
    FDA is not authorized to order recalls of cosmetics, but we do monitor companies that conduct a product recall
  2. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?), U.S. Food and Drug Administration. Primary record
    Whether a product is a cosmetic or a drug under the law is determined by a product's intended use.
  3. Prohibited & Restricted Ingredients in Cosmetics, U.S. Food and Drug Administration. Primary record
    It’s against the law for a cosmetic to contain any ingredient that makes the product harmful when consumers use it according to directions on the label, or in the customary or expected way.
    Under U.S. law, FDA does not have the authority to require cosmetic manufacturers to submit their safety data to FDA, and the burden is on FDA to prove that a particular product or ingredient is harmful when used as intended.
  4. Using Cosmetics Safely, U.S. Food and Drug Administration. Primary record
    However, there is no formal USDA or FDA definition for “natural.”
  5. Modernization of Cosmetics Regulation Act of 2022 (MoCRA), U.S. Food and Drug Administration. Primary record
    The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938.
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