Health and Human Services Department Docket FDA-2025-D-2246 Notice

2026-21679: Questions and Answers Regarding Mandatory Cosmetics Recalls; Guidance for Industry; Availability

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Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry." The guidance document provides answers to common questions that might arise about FDA's mandatory recall authority for cosmetics. It is intended to inform regulated industry about the Agency's current thinking on implementation of certain aspects, including the criteria, process, and expectations, for mandatory recalls of cosmetic products. The guidance announced in this notice finalizes the draft guidance of the same title published on December 18, 2025.

The agency’s own summary, as published.

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