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U.S. FDA Issues Draft Guidance on Mandatory Cosmetics Recalls Under MoCRA

The draft guidance explains the legal basis, decision-making criteria, and procedural steps associated with mandatory cosmetic recalls.

On December 18, 2025, the U.S. Food and Drug Administration (FDA) released a draft guidance document clarifying its authority to order mandatory recalls for cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The document, titled Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry, explains the legal basis, decision-making criteria, and procedural steps associated with mandatory cosmetic recalls. Public comments on the draft guidance are being accepted until February 17, 2026.

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