FDA Releases New Draft Guidance on Mandatory Cosmetic Recalls
- M. DuBose
- Jan 20
- 3 min read
What Industry Needs to Know About Draft Cosmetic Recalls
The cosmetics industry is continuing to evolve under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), and one of the most significant shifts is the FDA’s expanded authority to mandate recalls. To support industry understanding and preparedness, the U.S. Food and Drug Administration has released a new draft guidance: “Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry.”
This draft guidance is designed to help companies navigate FDA’s recall authority under section 611 of the Federal Food, Drug, and Cosmetic Act, and it serves as a practical resource for any cosmetic manufacturer, distributor, or brand owner responsible for product safety.
Why does this guidance matter? Recalls in the cosmetics sector have historically been voluntary, but MoCRA changed that landscape. FDA now has the power to order a mandatory recall when a cosmetic product is adulterated or misbranded and poses a risk of serious adverse health consequences. For companies, this means greater accountability, higher expectations for safety oversight, and a stronger need for recall readiness. The new draft guidance provides clarity on how FDA will use this authority, and how companies should respond if a recall becomes necessary.
What the Draft Guidance Covers
The guidance is structured as a FAQ-style resource, making it easy for industry professionals to quickly find answers during high‑pressure situations such as a recall event. Key areas include:
1. When a Mandatory Recall May Be Necessary
FDA outlines the criteria it uses to determine whether a product poses a serious health risk. Understanding these triggers helps companies assess issues early and take voluntary action before FDA steps in.
2. How FDA Implements a Mandatory Recall
The guidance explains the steps FDA follows, from notifying the responsible party to issuing a public recall announcement. This transparency helps companies anticipate timelines and required documentation.
3. What FDA Expects from Industry
Clear expectations are provided regarding:
Response timelines
Required corrective actions
Communication responsibilities
Documentation and reporting
For companies navigating a recall, these details can serve as a roadmap to ensure compliance and minimize disruption.
Why This FAQ Is a Valuable Tool During a Recall
Recalls are stressful, time‑sensitive, and often complex. Having a structured, FDA‑authored FAQ available can:
Reduce confusion by clarifying regulatory expectations
Improve decision‑making during early risk assessments
Support compliance by outlining required steps
Strengthening communication between companies and FDA
Help teams prepare before a recall ever occurs
For organizations building or updating their recall plans under MoCRA, this guidance is an essential reference.
How do you access and comment on the draft guidance? The draft guidance is available on FDA’s website through the Search for FDA Guidance Documents page. Public comments are open for 60 days after publication in the Federal Register. Here is a PDF on commenting guidance from regulations.gov. You can also read other comments Regulations.gov
How to Submit Comments
Electronically (preferred): Visit Regulations.gov and follow the instructions
By mail: Dockets Management Staff (HFA‑305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Be sure to include Docket No. FDA‑2025‑D‑2246 in all submission.
FDA encourages all stakeholders, manufacturers, safety professionals, consumer groups, and consultants, to provide feedback. Industry input helps ensure the final guidance is practical, clear, and aligned with real‑world needs.
For more information on cosmetics regulation under MoCRA, visit the Cosmetics Guidance & Regulation | FDA, which provides updates on:
Facility registration
Product listing
Safety substantiation
Adverse event reporting
Labeling requirements
These resources, combined with the new recall FAQ, give companies a stronger foundation for compliance and consumer protection.
As MoCRA continues to reshape the cosmetics regulatory landscape, tools like this draft guidance are invaluable. Whether you are preparing your recall procedures or responding to an active issue, the FDA’s FAQ offers clarity, structure, and insight into what the Agency expects.
Staying informed and participating in the comment process helps ensure your organization is ready, compliant, and aligned with the future of cosmetics safety.
References & Useful Links:
-Cosmetics | FDA
-Regulations.gov – Comments, Dockets, and Documents
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