The US Food and Drug Administration (FDA) has made available a draft guidance document entitled  “Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry.” It provides clarity on FDA’s mandatory recall authority for cosmetics under section 611 of the Federal Food, Drug, and Cosmetic (FD&C) Act, as established by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

What’s Covered?

The draft guidance addresses critical aspects of mandatory cosmetics recalls, including:

• Criteria for determining when a mandatory recall may be necessary. FDA says this is designed for helping industry understand the circumstances that could trigger FDA action.
  
• The process FDA will follow when implementing a mandatory recall. This provides transparency on Agency procedures and timelines.
  
• Expectations for industry compliance with mandatory recall orders. This clarifies responsibilities and required actions for regulated entities.

The draft guidance is available on the FDA site. 

FDA encourages all interested parties to review the draft guidance and submit comments during the public comment period.

Submissions: Electronic & Written

Comments can be submitted electronically at www.regulations.gov. Mailed comments can be sent to: Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852. FDA asks that Docket No. FDA-2025-D-2246 is included in all submissions.

The submissions are due 60 days after date of publication in Federal Register.

This draft guidance represents the Association’s current thinking on mandatory cosmetics recalls but is not binding on FDA or the public when finalized, according to the agency.