What’s New With MoCRA?

By Carolyn A. Blessing and David B. Abramowitz, Buchanan Ingersoll & Rooney PC

With the first two-year deadlines for renewing facility registrations and product submissions coming in FY 2026 and 2027, now is a good time to look at the latest developments with respect to the Food and Drug Administration’s (FDA) implementation and enforcement of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

Much has been written about how the FDA is currently re-evaluating many of its positions and policies. As part of this multi-year process, FDA’s Office of Cosmetics and Colors has obtained new oversight by moving from the Center for Food Safety and Nutrition to the Office of Chief Scientist, as well as transitioning to new leadership within the Office itself.

While these changes have delayed FDA’s efforts to implement MoCRA and provide further guidance, the Office has issued a few guidance documents and policy statements for industry. We present updates on several key issues of concern below.

Mandatory Recalls

MoCRA added Section 611 to the Federal Food, Drug, and Cosmetics Act (21 U.S.C. § 364g), which granted FDA the authority to issue mandatory recalls of cosmetic products in certain circumstances.

In December 2025, FDA issued a draft guidance, “Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry,” which is designed to provide the Industry with information regarding what factors FDA will consider when determining whether a mandatory recall of a cosmetic product is appropriate.

This Draft Guidance notes that before taking such drastic action FDA will: (1) offer the responsible person (manufacturer or distributor) the opportunity to conduct a voluntary recall; and (2) provide the opportunity for an informal hearing where the responsible person can present evidence concerning whether the recall is justified.

Industry stakeholders, especially in management, should review the Draft Guidance to understand how FDA will handle the recall process should issues arise with their products.

FDA Records Access

MoCRA requires responsible persons to maintain records of all reports of adverse events (Section 605; 21 U.S.C. § 364a) and serious adverse events (Section 610; 21 U.S.C. § 364a) that may be attributed to a cosmetic product.

In January 2026, FDA issued a Draft Guidance entitled “FDA Records Access Authority for Cosmetics Products: Guidance for Industry” that identifies what records must be retained by responsible persons and when FDA may request access to those records.

Importantly, the Draft Guidance identifies for the first time FDA’s position on which types of records FDA may access pursuant to a request under Section 605 or 610 (adverse event reports, recall documentation and consumer complaints) and which types of records FDA may not access pursuant to such a request (recipes or formulations, financial and pricing data, sales data and personnel information).

Industry stakeholders should become familiar with this Draft Guidance and conform their documentation retention policies to the FDA’s instructions.

Safety Substantiation

Although Section 608 of MoCRA (21 U.S.C. § 364d) requires that the responsible person maintain records supporting “adequate substantiation of the safety” of a cosmetic product, FDA still has not issued any guidelines interpreting that requirement three years later.

While Industry waits for fulsome guidance from FDA, FDA has assembled a website concerning product testing of cosmetics that identifies some types of documentation that may be part of substantiating safety, including: (1) data on ingredients obtained by manufacturer testing; (2) data reported in scientific journals; and (3) information published by the Cosmetic Ingredient Review (CIR) panel.

Apart from this information, FDA suggests that independent testing of cosmetic products would be appropriate, including testing for microbiological contamination, but provides no official recommendations or suggestions for what testing should be undertaken.

Industry stakeholders should continue to monitor FDA for any updates on these issues.

Current Good Manufacturing Practices

Section 606 of MoCRA (21 U.S.C. § 364b) requires FDA to establish regulations setting forth Current Good Manufacturing Practice for cosmetic products. FDA has yet to promulgate any proposed regulations and has not provided any recent updates as to when such proposals may be forthcoming.

Carolyn Blessing concentrates her practice in IP pharmaceutical matters, Hatch-Waxman litigation, and FDA regulatory counseling. She represents pharmaceutical and biotechnology companies in all aspects of federal intellectual property litigation, and she has significant experience counseling generic pharmaceutical companies in federal intellectual property litigation, and counseling food, drug and cosmetic companies in connection with regulatory issues.

David Abramowitz focuses his practice on complex patent litigation brought under the Hatch-Waxman amendments to the Federal Food, Drug and Cosmetic Act and the Biologics Price, Competition and Innovation Act, where he has significant experience representing and counseling generic pharmaceutical and biotechnology companies in federal intellectual property litigation, and counseling food, drug and cosmetic clients in connection with regulatory issues.