When FDA Can Make You Recall That Mascara

On December 18, 2025, the U.S. Food and Drug Administration (FDA or the Agency) published clarification on its enforcement approach under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) with the release of a draft guidance titled “Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry.”  See also here (“FDA Recall Policy for Cosmetics”).  This draft guidance is now available for public review and comment and provides cosmetic companies, including distributors and packers, with insight into how FDA’s mandatory recall authority will work in real day-to-day practice.

Interestingly, MoCRA was passed in December  2022 and included many different requirements some of which were self-executing (e.g., mandatory recall authority).  Thus far, FDA has missed all or virtually all deadlines set by MoCRA including rulemaking for fragrance allergen disclosures, cosmetic good manufacturing practices, and talc asbestos testing.  In light of the Agency’s long to-do list, it took us by surprise that FDA issued a draft guidance regarding its mandatory recall authority—especially because MoCRA does not require that FDA issue guidance on this provision.

Why This Matters

Historically, FDA did not have the statutory authority to order cosmetic product recalls.While the Agency could request that companies voluntarily recall unsafe or violative products per 21 C.F.R. Part 7, it could not compel them to do so.  That changed with MoCRA, which granted the FDA formal mandatory recall authority for Class I recalls of cosmetics under FDCA Section 611.  See 21 U.S.C. § 364g.  FDA may order a recall when the Agency determines there is a reasonable probability that a product is adulterated or misbranded and could cause serious adverse health consequences or death (SAHCOD) (i.e., the standard for a Class 1 recall).

What Does the Draft Guidance Say?

The draft guidance is structured as a series of questions and answers—a common framework for clarifying guidances (see, e.g., here)—designed to explain FDA’s current thinking on several aspects of mandatory cosmetics recalls including:

• Criteria for Mandatory Recalls:  Outlines the circumstances under which FDA might determine a recall is necessary.  While the guidance doesn’t promulgate rules (because it isn’t legally binding as opposed to statutes/regulations), it emphasizes the Agency’s focus on potential serious adverse health consequences including, inter alia, chemical burns, infections, and patient safety signals.  Notably, adverse events for cosmetics are defined differently from those for drugs.  The industry would benefit from further clarification regarding this definition; however, unfortunately, the draft guidance does not address this expanded definition.
• Process:  Explains procedural steps, beginning with an opportunity for responsible parties (manufacturers, packers, distributors) to voluntarily cease distribution and conduct a recall.  If voluntary actions are inadequate, FDA can escalate its concerns and issue a formal recall order.
• Industry Expectations:  Clarifies what FDA expects from companies regarding compliance with recall orders including communication with both the Agency and the public.

Implications for Cosmetic Brands

For industry leaders and compliance teams, this draft guidance has several practical implications:

• Preparation Is Essential:  Because FDA is now able to mandate recalls, brands should revisit their recall readiness plans, ensuring they can rapidly identify and remove unsafe products from the market.  These efforts should include proceduralizing recall steps per standard operating procedures and training employees on the same as well as paying increased attention to potential safety signals.
• Risk Assessment and Documentation:  Prepare and maintain consistent internal safety assessments, thorough documentation, and transparent adverse event reporting.  As FDA inspectors love to quip, “if it isn’t documented, it didn’t happen.”
• Strategic Engagement:  Provide feedback on the draft guidance—we can’t emphasize this enough!

What’s Ahead

As mentioned earlier, FDA has been slow in implementing MoCRA.  It has missed all or virtually all deadlines set by the law.  Since the enactment of the law, FDA’s Office of Cosmetics and Colors has been moved from the Human Foods Program (formerly the Center for Food Safety and Applied Nutrition) to the Office of the Chief Scientist and we have seen little activity on MoCRA and related issues.  It remains to be seen if the issuance of the draft guidance is a sign of more activities and rulemaking to come.

FDA is actively seeking feedback from stakeholders, so GIVE IT!  Interested parties can review the draft guidance and submit comments through the regulations.gov portal or by written submission to the FDA Dockets Management Staff.  As is unique to FDA guidance documents (regardless of whether it’s the draft or final iteration), comments can be provided anytime.  21 C.F.R. § 10.115(g)(5); see also link.  However, FDA requested that comments be submitted by February 17, 2026 “to ensure that the Agency considers your comment . . . before it begins work on the final version of the guidance.”

This comment period presents a key opportunity for cosmetic companies, trade associations, and compliance professionals to raise any concerns and shape the final guidance document.

HPM will be monitoring further developments and is available to assist with drafting and submitting comments.