When the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was passed, it marked the most significant expansion of the Food and Drug Administration’s (FDA) authority over cosmetics in more than 80 years. Now, the agency has finalized guidance explaining how it may require companies to recall cosmetic products that pose serious health risks.
On October 22, the FDA published Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry, finalizing a draft first issued in December 2025. The guidance outlines when the FDA can order a mandatory recall, the process it will follow, and what it expects from companies subject to these orders. According to the FDA, the final guidance contains no substantive changes from the original draft.
It’s important to note that the guidance does not introduce a new law. Rather, it explains how the FDA intends to implement the mandatory recall authority established under MoCRA.
MoCRA added section 611 to the Federal Food, Drug, and Cosmetic Act, giving the FDA authority to halt distribution and require cosmetic recalls under specified conditions if companies did not act voluntarily.
To invoke this authority, the FDA must determine there is a reasonable probability that the cosmetic is adulterated or misbranded and that using it or being exposed to it will cause serious adverse health consequences or death. A product defect or complaint alone does not establish grounds for a mandatory recall; the statutory health risk threshold must also be met.
The guidance also highlights the evidence the FDA considers when assessing potential risks, including inspection findings, product testing, adverse-event reports, and consumer and trade complaints.
But how does the mandatory recall process actually work?
The FDA says the process begins with written notice to the responsible person, who could be the manufacturer, packer, or distributor whose name appears on the product label, giving the company an opportunity to voluntarily stop distribution and recall the product.
If the company refuses or fails to act within the time and manner specified by the FDA, the agency can issue an order requiring distribution to stop. The company must provide an opportunity for an informal hearing, which, if granted, must take place no later than 10 days after the order is issued. Following the hearing, the FDA will proceed as it sees fit, either vacating the order, continuing the distribution restriction, or requiring a recall.
Although this authority gives the FDA greater power to intervene, the agency still encourages companies to recall cosmetics on a voluntary basis, and expects most recalls to remain this way.
For the beauty industry, the guidance highlights the importance of having clear procedures in place when product safety issues arise. Brands should be prepared to identify affected batches, trace product distribution, and have access to safety and testing records, among other precautions.
This guidance does not impose a universal plan for recall requirements. It simply clarifies the FDA’s approach to how the existing mandate can be used in practice, as part of the agency’s broader implementation of MoCRA.