On December 16, 2025, the US FDA opened a 60-day consultation on its draft Guidance for Industry on the on the implementation of the mandatory cosmetics recall provisions.
Mandatory recalls are a new power granted to the FDA by the Modernization of Cosmetics Regulation Act (MoCRA).
This document, in the form of 16 questions and answers, is intended to provide answers to common questions that may arise about these mandatory recall provisions and the FDA’s current position regarding their implementation.
The US Administration details:
• the products concerned,
• the reasons for a recall (product “adulterated” or likely to cause serious health consequences, with details of the different cases that fall under these categories),
• the process followed (an initial request for voluntary withdrawal to the Responsible Person, before, in case of refusal, ordering a mandatory withdrawal),
• the actions expected of the Responsible Person,
• the penalties incurred in case of failure by the Responsible Person.
The FDA specifies that, once finalized, this document will not confer any rights on anyone and will not be binding on the FDA or the public. Alternative approaches may be chosen if they meet the requirements of applicable laws and regulations.
The Administration also notes that comments on this document may be submitted at any time, but advises that they be submitted within 60 days (by February 17, …
