FDA Releases Draft Guidance on Mandatory Cosmetics Recalls under MoCRA

by | Feb 13, 2026 | FDA, MoCRA, U.S. Regulatory

The U.S. Food and Drug Administration (FDA) has published a significant new draft guidance document titled ‘Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry.’

This release is a key step in implementing the Modernization of Cosmetics Regulation Act (MoCRA), aimed at providing the industry with clarity regarding the FDA’s new mandatory recall authority.

What the Guidance Covers

The draft document outlines the specifics of how and when the FDA will exercise its power to force a recall. Key areas of focus include:

Decision Criteria: The specific criteria the FDA will use to determine if a mandatory recall is necessary.

The Process: A step-by-step look at the procedure the FDA will follow when implementing a mandatory recall.

Industry Expectations: Clear guidelines on what is expected from companies regarding compliance with these orders.

Call to Action

Industry stakeholders are encouraged to review the document to understand their new obligations. The draft guidance is currently open for public comment.

Deadline: You must submit your comments by February 17.