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FDA Draft Guidance on Cosmetic Recalls under MoCRA
- Daniel Jiménez
- 1 hour ago
- 3 min read
The publication of the Draft Guidance on mandatory cosmetic recalls by the US Food and Drug Administration represents one of the most relevant interpretative developments since the entry into force of MoCRA.
Although the document does not introduce new legal requirements, it does constitute the first structured explanation of how the agency plans to apply, in operational terms, the mandatory recall authority incorporated into the US legal framework.
From a regulatory point of view, these types of documents usually anticipate the enforcement model that will later be consolidated in final guidelines, inspections and administrative actions.
Table of contents
Regulatory Context: MoCRA and the Legal Authority for Mandatory Recall
The legal authority does not originate from the Draft Guidance, but from the Modernization of Cosmetics Regulation Act (MoCRA) itself, which introduced section 611 in the FD&C Act.
Under this legal basis, the FDA can order a mandatory recall when it determines that there is a reasonable probability that a cosmetic is adulterated or mislabeled and that its use could cause serious health consequences or death, especially if the Responsible Person does not conduct a voluntary recall after being given the opportunity to do so.
Historically, cosmetic recall policies in the US have been based on voluntary mechanisms, and the
The FDA continues to indicate that it expects most recalls to continue occurring under this model.
The real change, therefore, is not the replacement of the voluntary system, but the introduction of a coercive tool when the health risk justifies it.
Legal Nature of Draft Guidance
The draft published in December 2025 is presented in a Q&A format and aims to clarify the agency's approach to:
The criteria that could justify a mandatory recall
The regulatory procedure that the FDA would follow
Industry compliance expectations
Like any FDA guidance, the document reflects the agency's current thinking , is not legally binding, and may be modified before its final version following the public comment process.
From a compliance perspective, this does not diminish its relevance: in practice, this type of guide usually anticipates the inspection and enforcement behavior of the authority.
Operational Interpretation: What the Draft Guidance Really Explains
The document does not expand the law, but it does add clarity on regulatory operations.
For example, it describes how, before issuing a mandatory recall order, the FDA will provide the Responsible Person with the opportunity, in writing, to voluntarily cease distribution of the product. It also contemplates the possibility of informal hearings to discuss the scientific or regulatory basis for the agency's decision.
This approach reinforces a progressive enforcement model:
Health risk assessment
Opportunity for voluntary action
Escalation to mandatory measures if the risk persists
From a comparative regulatory perspective, this model is consistent with other FDA sectors (e.g., medical devices or food safety).
Regulatory Implications for the Cosmetics Industry
The Draft Guidance should be interpreted within a broader context: MoCRA has significantly strengthened post-market control over cosmetics.
Among other elements, the legislation introduced:
Obligation to report serious adverse events within 15 days
Greater FDA access to safety records
Expanded monitoring capabilities over facilities and products
Taken together, this points to a regulatory model focused on the entire product lifecycle, not just the initial marketing phase.
Strategic Reading: What Regulatory Signal Is the FDA Sending
From a regulatory strategy perspective, the main message of the Draft Guidance is regulatory predictability.
The FDA is:
Formalizing decision criteria
Standardizing performance processes
Preparing the ground for more consistent enforcement
It does not imply an immediate increase in mandatory recalls, but it does reduce uncertainty about when and how they might be applied.
Regulatory Conclusion
The Draft Guidance on cosmetic recalls should be interpreted as a transitional document between the legal basis created by MoCRA and its future consolidated operational application.
For the industry, the real impact lies not only in the authority for mandatory recalls, but also in the consolidation of a supervisory model based on:
Continuous risk assessment
Defensible security evidence
Actual operational capacity for post-market management
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