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GUIDANCE DOCUMENT

Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry Draft Guidance for Industry December 2025

Download the Draft Guidance Document
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2025-D-2246
Issued by:
Guidance Issuing Office
Office of Inspections and Investigations

The purpose of this document is to provide guidance to industry on the implementation of the mandatory cosmetics recall provisions of section 611 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act). The guidance in this document is in the form of Questions and Answers and provides answers to common questions that might arise about these mandatory recall provisions and FDA’s current thinking regarding their implementation.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2025-D-2246.

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