ChemLinked Cosmetic Ingredient Search

Cosmetic Ingredient Search

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How does the U.S. regulate cosmetic ingredients?

Unlike the European Union or ASEAN, the U.S. does not maintain comprehensive positive or negative lists of cosmetic ingredients. Instead, ingredient use is governed primarily through provisions in federal law and supplemented by state-level legislation.

At the federal level, the FDA enforces requirements mainly through the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR. Currently, only 11 ingredients are explicitly prohibited or restricted.

Beyond federal requirements, several states have introduced additional restrictions. For example:

- California Assembly Bill No. 2762 prohibits 24 chemicals of concern, including mercury and formaldehyde, in cosmetics sold in the state (effective January 1, 2025).
- California Assembly Bill No. 496 further bans the manufacture and sale of cosmetics containing 26 additional high-risk ingredients (effective January 1, 2027).

Do cosmetic ingredients require FDA approval?

No. Except for color additives, cosmetic ingredients do not need premarket approval from the FDA. Manufacturers are responsible for ensuring their products are safe for consumers under labeled or customary conditions of use.

Are there differences between federal and state requirements?

Yes. Federal law establishes a baseline for cosmetic safety, but individual states can impose stricter requirements. When differences arise, federal regulations generally take precedence. Companies selling cosmetics nationwide must comply with both federal and applicable state-level rules.

How does the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) affect cosmetic ingredients?

Enacted in 2022, MoCRA is the most significant update to U.S. cosmetic law in over 80 years. It enhances FDA oversight by requiring facility registration, product listing, adverse event reporting, and safety substantiation. However, it does not expand the list of prohibited or restricted ingredients.

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