Federal Register #2026-21679

FDA Final Guidance on Mandatory Cosmetics Recalls

The U.S. Food and Drug Administration (FDA), within the Department of Health and Human Services, issued final guidance on mandatory cosmetics recalls. - Government agency: Department of Health and Human Services, Food and Drug Administration (FDA). - Purpose: Explains FDA’s current thinking and addresses common questions about recall criteria, processes, and expectations under the mandatory cosmetics recall provisions of the Federal Food, Drug, and Cosmetic Act. - Finalization: FDA considered seven comments on the draft guidance and finalized it without substantive changes. - Procurement status: This is a guidance announcement, not a procurement or contract award; no products or services are requested, and no OEMs or vendors are named.

Description

The FDA announced the availability of its final guidance, “Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry.” The guidance provides answers to common questions about FDA’s mandatory recall authority for cosmetics and describes the agency’s current thinking on criteria, process, and expectations for mandatory recalls of cosmetic products. It finalizes draft guidance published on December 18, 2025, with no substantive changes after FDA considered seven comments. The guidance concerns implementation of section 611 of the Federal Food, Drug, and Cosmetic Act.

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