Key Takeaways:

• The FDA issued draft guidance clarifying triggers, process, and industry expectations for mandatory cosmetics recalls under MoCRA.
• MoCRA grants the FDA authority to mandate recalls of adulterated or misbranded cosmetics that pose serious health risks.
• The FDA seeks public comments on the draft guidance through February 17, 2026, including cost-related impacts.

On December 18, the Food and Drug Administration (FDA) announced the availability of a draft guidance document, “Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry.” The guidance, once finalized, is intended to help answer common questions around what could trigger the FDA to issue a mandatory recall of a cosmetic, the FDA’s process if a mandatory recall is issued, and the FDA’s expectations of the industry.

As directed by section 611 of the Federal Food, Drug, and Cosmetic (FD&C) Act, established by the Modernization of Cosmetics Regulation Act (MoCRA) of 2022, the FDA has new authority for mandating cosmetics recalls. Such recalls could be triggered “when a product poses a risk of serious adverse health consequences or is adulterated/misbranded, outlining the criteria, process (like notices and public announcements), and industry compliance for such actions, as detailed in recent FDA draft guidance documents,” according to the FDA website. 

The FDA welcomes public comments on the draft guidance until February 17, 2026. As the agency develops final guidance on this topic, it will consider comments on costs or cost savings the guidance may generate, relevant to Executive Order 14192, according to the FDA’s site.

To comment on the draft guidance, the FDA is accepting electronic submissions, and written/paper submissions can be sent to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Reference Docket No. FDA-2025-D-2246.