Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
Every company in the world which is responsible for a cosmetic product which is on sale in the US is now covered by this new regulation.
On December 29, 2022, the President signed the Consolidated Appropriations Act, 2023 (Pub. L. 117-328) into law, which included the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Among other provisions, MoCRA added section 607 to the FD&C Act (21 U.S.C. 364c), establishing requirements for cosmetic product facility registration and cosmetic product listing. Enforcement begins on July 1, 2024.
Section 607(a) of the FD&C Act requires every person that owns or operates a facility that “engages in the manufacturing or processing of a cosmetic product for distribution in the United States” to register each facility with FDA.
Section 607(c) of the FD&C Act requires that for each cosmetic product, the responsible person must submit to FDA “a cosmetic product listing” or ensure that such submission is made.
FDA has developed an electronic submission portal, Cosmetics Direct, to streamline submission and receipt of facility registration and product listing information under section 607 of the FD&C Act.
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Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
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