The FDA has announced the availability of a draft guidance document entitled “Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry.” This guidance provides important clarification 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).
The draft guidance addresses several key aspects of mandatory cosmetics recalls. These include the criteria FDA will consider when determining whether a mandatory recall may be necessary, helping industry understand the circumstances that could trigger Agency action. The guidance also explains the process FDA will follow when implementing a mandatory recall, providing transparency regarding the agency's procedures and timelines. In addition, it outlines expectations for industry compliance with mandatory recall orders, clarifying the responsibilities and required actions of regulated entities.
This draft guidance is available through FDA Guidance Documents. Interested parties may submit comments within 60 days of publication in the Federal Register. Electronic submissions are preferred and may be submitted through www.regulations.gov by following the instructions provided. Written or paper submissions may be mailed to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All submissions must reference Docket No. FDA-2025-D-2246.
For additional information on cosmetics regulation and related guidance, please visit the FDA Cosmetics webpage.
Full details of the draft guidance can be found at the link below: