FDA Issues Draft Guidance for Industry: Questions and Answers Regarding Mandatory Cosmetics Recalls

Cosmetics Constituent Update

12/18/2025  

Today, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance document entitled "Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry." This draft guidance aims to provide clarity on FDA's mandatory recall authority for cosmetics under section 611 of the Federal Food, Drug, and Cosmetic (FD&C) Act, as added by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

The draft guidance provides information on:

• Criteria for determining when a mandatory recall may be necessary;
• The process FDA will follow when implementing a mandatory recall;
• Expectations for industry compliance with mandatory recall orders;

The guidance aims to clarify FDA's approach to this new authority and help industry and interested parties understand their responsibilities.

FDA encourages all interested parties to review the draft guidance and submit comments. The Agency will consider all feedback received by the public within the comment timeframe before finalizing the guidance document.  

How to Access and Comment

The draft guidance is available for public review and comment:

1. Access the document at FDA Guidance Documents
2. Submit comments by 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER:
   • Electronic submissions: Visit www.regulations.gov and follow the instructions for submitting comments.
   • Written/paper submissions: Send to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
   • Include the Docket No. FDA-2025-D-2246

Additional Information

• This draft guidance, when finalized, will represent FDA's current thinking on mandatory cosmetics recalls but is not binding on FDA or the public.
• For further information, contact Patrick Clouser, Office of Inspections and Investigations, at 240-402-5276 or Patrick.Clouser@fda.hhs.gov.

FDA encourages all interested parties to review the draft guidance and submit comments. Your input will help shape the final guidance document and ensure it best serves the needs of the cosmetics industry and public health.

For more information on cosmetics regulation and guidance, visit the FDA Cosmetics page.