Health and Human Services Department Docket FDA-2025-D-2243 Notice

2026-01159: FDA Records Access Authority for Cosmetics; Draft Guidance for Industry; Availability

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Summary

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled "FDA Records Access Authority for Cosmetics: Guidance for Industry." The draft guidance document provides answers to frequently asked questions about certain authorities for FDA to access records related to cosmetic products. It is intended to inform regulated industry about the Agency's current thinking regarding the criteria, process, and expectations for FDA's access to these records.

The agency’s own summary, as published.

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