NEWS & BLOGS

FDA’s New Guidance on Mandatory Cosmetic Recalls: What Brands Need to Know

Provision Consulting Group
11 minutes ago
3 min read

How has the FDA cosmetic recall system evolved since MoCRA?

In the past, even when issues arose with cosmetics sold in the U.S., they were primarily managed through voluntary recalls by companies. However, with the enactment of MoCRA (Modernization of Cosmetics Regulation Act) in late 2022, the FDA’s legal authority to intervene in the cosmetics sector has become significantly clearer.

Recently, the FDA released a Draft Guidance on Mandatory Cosmetics Recalls, outlining the specific standards and procedures they will use to exercise this newfound authority.

Does this mean the FDA can now force a recall?

Yes. In this guidance, the FDA explains that it can order a cessation of distribution or a recall if certain conditions are met. However, it is important to note that the FDA still prioritizes voluntary corrective actions. Mandatory recalls are described as a step taken only when specific criteria are satisfied.

Criteria for an FDA Mandatory Cosmetic Recall

1. Potential Regulatory Violations

The FDA cites several scenarios where a product may be deemed in violation, such as:

Products manufactured or stored under unsanitary conditions.
Potential contamination or lack of adequate safety substantiation.
Labeling that is misleading to consumers or missing required information.

Under the FD&C Act, these cases may fall under "adulterated" or "misbranded" categories.

2. Risk of Serious Adverse Health Consequences

The FDA uses the term SAHCOD (Serious Adverse Health Consequences or Death) as a threshold. A simple quality issue is not enough; there must be a reasonable probability that the product will cause severe health issues, such as:

Severe skin damage or chemical burns
Infections or cases requiring hospitalization
Permanent disfigurement
Adverse events requiring medical intervention

Will a recall order be issued immediately upon finding a problem?

Not necessarily. The guidance describes a phased approach involving internal reviews and specific procedures. First, the FDA provides the Responsible Person (the manufacturer, packer, or distributor listed on the label) an opportunity to voluntarily cease distribution and initiate a recall. If the response is inadequate, the FDA may then issue a formal order to cease distribution, which can escalate to a mandatory recall order if necessary.

(※The Draft Guidance also details informal hearing procedures, the scope of possible decisions, and the authority of the FDA Commissioner.)

What changes for the industry?

The shift in the FDA’s recall policy is less about "stricter regulation" and more about a structural shift toward proactive consumer protection. This new framework reduces the likelihood of harmful products remaining on the market and ensures the FDA can promptly inform the public through press releases and official notifications.

Since MoCRA, FDA cosmetic regulations have moved from "formal registration" to "real-world consumer safety." This Draft Guidance serves as a roadmap for understanding exactly what types of products the FDA may scrutinize in the future.

The core takeaways are clear:

Is your safety substantiation sufficient? Does your labeling avoid any misleading claims? Is your adverse event reporting system ready?

Regardless of a mandatory recall, these are the fundamental pillars of compliance for the U.S. market. Whether you are preparing to launch or are already selling in the U.S., now is the time to audit your recall risks and regulatory response systems.

※ This post is based on the FDA’s Draft Guidance for Industry (2025) and is subject to change before finalization.

※ This content is for informational purposes only and does not substitute for legal or regulatory advice regarding specific products or situations.