MoCRA Marches On: FDA Issues Draft Guidance on Mandatory Cosmetic Recalls

MoCRA’s Mandatory Recall Authority

As we have explained previously, MoCRA authorizes the FDA to order a mandatory recall of a cosmetic product if both of the following are true: (1) the FDA determines there is a reasonable probability that the cosmetic is adulterated or misbranded and use of or exposure to it will cause serious adverse health consequences or death (SAHCOD); and (2) the company declines to voluntarily cease distribution or recall the product after being given the opportunity to do so.

Notably, the FDA does not have mandatory recall authority across all products under its jurisdiction. For example, it has mandatory recall authority for medical devices but not drugs or conventional foods and beverages. MoCRA’s grant of mandatory recall authority for cosmetics significantly expands the FDA’s enforcement toolkit.

What the Draft Guidance Covers

In December 2025, the FDA issued a draft guidance providing additional clarity on this new authority. The guidance confirms that the FDA’s mandatory recall authority applies to all products that meet the definition of “cosmetic,” but does not extend to products regulated as combination drug-cosmetic products.

How a Mandatory Recall Would Proceed

The draft guidance outlines the FDA’s process for ordering a mandatory recall.

• The FDA will first provide written notice to the company and an opportunity to voluntarily cease distribution and recall the cosmetic.

• If the company does not act in the time and manner prescribed, the FDA may order an immediate cessation of distribution and provide an opportunity for an informal hearing within 10 days to address whether adequate evidence exists to justify the order.

• After the hearing, the FDA may either vacate the order, continue the order to cease distribution until a specified date, or amend the order to require a recall, including notification requirements, an implementation timetable, and a schedule for FDA updates.

How the FDA Will Evaluate Evidence

When considering a mandatory recall, the FDA will evaluate all relevant evidence to determine if there is a reasonable probability that the cosmetic is adulterated or misbranded and that its use or exposure will cause SAHCOD. Evidence may include significant inspection observations, analytical results for raw materials, finished products, or environment swabs, epidemiological data, vulnerability of the exposed population, serious adverse event data, consumer and trade complaints, and whether the company declined to voluntarily cease distribution or initiate a voluntary recall. The FDA will evaluate evidence and context to assess whether the product poses a SAHCOD risk.

Notifications and Public Communications

If the FDA issues or amends an order to recall, the agency may require notice to appropriate parties, including manufacturers, distributors, importers, and retailers, as well as the public. Where a recall is ordered, the FDA will issue a press release that includes, at minimum, the product name, a description of the risk, and, to the extent practical, information about similar products that are not affected. If available, the FDA will also post an image of the cosmetic on its website and use other alerts and public notices to reach consumers and retailers.

Termination and Enforcement

If the FDA continues an order to cease distribution, the order will remain in effect until the specified date. A mandatory recall generally terminates when the FDA determines all requirements of the recall order have been satisfied and reasonable efforts have been made to remove or correct the product commensurate with the hazard. The FDA will provide written notification of termination to the recalling company.

A company’s failure or refusal to comply with a mandatory recall order may result in the FDA seeking an injunction or criminal prosecution. While the FDA expects most companies will continue to conduct voluntary recalls, the agency emphasizes it will use its mandatory authority where the statutory criteria are met to mitigate SAHCOD risks.

What Cosmetic Companies Should Do Now

• Strengthen cGMP Compliance: Maintain robust compliance with good manufacturing practice requirements.

• Substantiate Safety: Adequately substantiate the safety of each cosmetic and ingredient.

• Validate Labeling: Confirm cosmetic labeling complies with statutory and regulatory requirements.

• Bolster Surveillance and Readiness: Maintain effective adverse event monitoring and recall readiness to respond promptly to any communications from the FDA.

Comment Deadline

The FDA is accepting comments on the draft guidance until February 17.

ArentFox Schiff will continue to closely monitor developments related to MoCRA compliance.

If you are interested in more information about MoCRA or are seeking guidance on any cosmetic-related requirements, please contact the authors.