Cosmetic products that are also drugs or devices are not subject to Section 611 but may be subject to other mandatory recall authorities such as Section 613 of the FDCA.

The U.S. Food and Drug Administration (FDA) recently released a draft guidance Q&A offering clarity to the industry on FDA’s implementation of its new authority to order mandatory cosmetics recalls. The Modernization of Cosmetics Regulation Act of 2022 added Section 611 to the Federal Food, Drug and Cosmetic Act (FDCA), which provides FDA the authority to order mandatory recalls for certain cosmetics.

The draft guidance touches on potential points of concern:

Scope of Recall Authority

Cosmetic products that are also drugs or devices are not subject to Section 611 but may be subject to other mandatory recall authorities such as Section 613 of the FDCA.

Issuing a Recall Order

To use its mandatory recall authority, FDA will determine whether (1) there is a reasonable probability that the cosmetic is adulterated or misbranded under Sections 601 or 602 of the FDCA and (2) there is a “reasonable probability that the use of or exposure to the cosmetic will cause serious adverse health consequences or death.”

To make such a determination, FDA will look at evidence including:

• “significant cosmetic safety observations made during establishment inspections;
• results from sample analyses, which may include those for raw materials or finished cosmetics, and sample swabs from the cosmetic facility manufacturing environment;
• epidemiological data (e.g., data directly related to the cosmetic that suggest disease or injuries have already occurred from the use of/exposure to the product);
• vulnerability of the population that normally uses or is exposed to the cosmetic (the assessment of the hazard will consider the segment of the population, e.g., infants, toddlers, the elderly, pregnant women, medically compromised individuals);
• available serious adverse event data;
• consumer and trade complaints; and
• whether the responsible person has failed to voluntarily cease distribution of the cosmetic or initiate a voluntary recall.”

Post-Receipt of a Recall Order

Before FDA issues an order for a mandatory recall, it will make the above determination using the two listed criteria, then notify the “responsible person” under the FDCA in writing. If the responsible person does not voluntarily cease distribution or recall the cosmetic, then FDA may order a recall.

Recipients of this order must immediately cease distribution and may have to provide notice of the order to the public and “appropriate persons” including manufacturers, distributors and importers. FDA intends to include this instruction in the order to cease distribution.

Recipients of a recall order have an opportunity for an informal hearing, which, if granted, will be held no less than 10 days after date of issuance of the order per Section 611(b) of the FDCA. The hearing will follow 21 C.F.R. Part 16 procedures and provide an opportunity to address whether there is adequate evidence to justify the recall order.

If a recall order is amended after an informal hearing, FDA will issue a press release detailing the name of the cosmetic, a description of the risk and information about similar cosmetics not affected by the recall, as well as an image of the cosmetic, if available.

FDA will issue alerts and public notices, as appropriate, to notify consumers and retailers who may have received the cosmetic at issue.

Termination of a Recall Order

A mandatory recall order would terminate when FDA determines that all of the order’s requirements are satisfied. FDA would follow the termination procedures included in 21 C.F.R. § 7.55, which allows termination when FDA determines that a firm has made reasonable efforts to remove or correct the product in accordance with the recall strategy and when it is reasonable to assume the recalled product has been removed and proper correction has been made commensurate with the product’s degree of hazard.

The appropriate FDA office will issue notice of the recall termination.

The comment period on FDA’s draft guidance is open until February 17, 2026.

For More Information

If you have any questions about this Alert, please contact Frederick R. Ball, Victoria (Tori) Hawekotte any of the attorneys in our Life Sciences and Medical Technologies Industry Group or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.