FDA Draft Guidance on Mandatory Cosmetic Recalls Under MoCRA: What Brands Must Know

On 18 December 2025, the U.S. Food and Drug Administration announced the availability of a new draft guidance document titled “Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry.”
This guidance represents a critical enforcement clarification under the Modernization of Cosmetics Regulation Act (MoCRA) and directly impacts cosmetic brands, manufacturers, and Responsible Persons selling products in the United States.

Why This FDA Draft Guidance Matters

Historically, cosmetic recalls in the U.S. have been largely voluntary. Under MoCRA, FDA now has explicit authority to mandate cosmetic recalls when products pose a serious health risk and voluntary actions are not taken.

The draft guidance explains:

When FDA may require a mandatory cosmetic recall
The procedural steps FDA must follow
The rights and obligations of the Responsible Person
FDA expectations for recall execution and reporting

This development significantly elevates post-market compliance responsibilities for cosmetic companies operating in or exporting to the U.S.

Criteria for Mandatory Cosmetic Recalls

According to the draft guidance, FDA may initiate a mandatory recall process when it determines that:

There is a reasonable probability that a cosmetic is:
- Adulterated under Section 601 of the FD&C Act, or
- Misbranded under Section 602 of the FD&C Act; and
There is a reasonable probability that use of, or exposure to, the cosmetic may cause Serious Adverse Health Consequences or Death (SAHCOD).

If both conditions are met, FDA must first provide the Responsible Person with a written opportunity to voluntarily cease distribution and conduct a recall, in accordance with Section 611(a) of the FD&C Act.

FDA Enforcement Process Explained

If the Responsible Person does not voluntarily comply within the timeframe specified by FDA, the Agency may:

Order the immediate cessation of distribution of the cosmetic product.

The Responsible Person is then entitled to an informal regulatory hearing, which:

Must be held within 10 days of the order; and
Is conducted under 21 CFR Part 16 procedures.

Following this process, FDA may:

Vacate the order if insufficient evidence exists;
Continue the distribution-cease order; or
Amend the order to require a mandatory cosmetic recall, including:
- Notification requirements,
- Recall timelines, and
- Ongoing progress reports to FDA.

Regulatory Impact for Cosmetic Brands and Responsible Persons

This draft guidance reinforces that recall readiness is no longer optional under U.S. cosmetic regulations. Companies must now demonstrate:

Robust post-market surveillance systems
Timely adverse event reporting
Clear recall procedures and documentation
Active oversight by a qualified MoCRA Responsible Person

Failure to comply can result in enforced recalls, regulatory actions, reputational damage, and commercial disruption.

How Cosmereg Can Assist

Cosmereg supports cosmetic brands worldwide with end-to-end MoCRA compliance and FDA regulatory services, including:

MoCRA Responsible Person services
Recall readiness and recall procedure development
Adverse event reporting systems
FDA cosmetic compliance audits
Risk assessments for adulteration and misbranding
Regulatory strategy and authority response support

Our team helps ensure your cosmetic products remain compliant, market-ready, and protected against enforcement risk in the U.S.

Public Comment Deadline

FDA is accepting public comments on this draft guidance until 17 February 2026. Industry feedback at this stage may influence how mandatory cosmetic recalls are enforced once the guidance is finalized.

If you require support reviewing the draft guidance, submitting comments, or strengthening your MoCRA compliance framework, Cosmereg is ready to assist.