FDA's Guide: Recalling That Sketchy Lipstick Fast
Published Date: 12/18/2025
Notice
Summary
The FDA just dropped a draft guide to help cosmetic companies understand how mandatory recalls work and what to expect if their products need to be pulled from shelves. This guide answers common questions about the recall process, making it easier for businesses to stay safe and compliant. Companies should send their feedback by February 17, 2026, so the FDA can finalize the rules—keeping everyone on track and avoiding costly surprises.
Analyzed Economic Effects
5 provisions identified: 5 benefits, 0 costs, 0 mixed.
Draft Q&A on Mandatory Cosmetics Recalls
The FDA released a draft guidance titled "Questions and Answers Regarding Mandatory Cosmetics Recalls" that explains its current thinking on how mandatory cosmetics recalls will work, including the criteria, process, and expectations under section 611 of the FD&C Act (added by section 3502 of MoCRA). The document is presented as questions and answers to help regulated cosmetic industry members understand recall implementation.
Guidance Is Nonbinding; Alternatives Allowed
The draft guidance says it does not establish any rights and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
No New Information-Collection Burden
FDA tentatively concluded that the draft guidance contains no collection of information, so Office of Management and Budget clearance under the Paperwork Reduction Act of 1995 is not required. This means the draft guidance does not add new paperwork requirements as written.
Deadline to Comment on Draft Guidance
If you want FDA to consider your feedback before it begins work on the final guidance, submit electronic or written comments by February 17, 2026. Comments submitted to https://www.regulations.gov will be posted publicly unless submitted as confidential written/paper submissions following FDA instructions.
FDA Will Consider Comments on Costs
As FDA develops final guidance, the Agency will consider comments on costs or cost savings the guidance may generate, which is relevant to Executive Order 14192. Stakeholders can submit such cost-related comments for FDA to review when finalizing the guidance.
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