Health Law Update

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On August 7, 2023, the U.S. Food and Drug Administration (FDA, the Agency) published draft guidance aimed at assisting cosmetics companies with achieving and maintaining compliance with new cosmetic product facility registrations and product listings requirements. This forward-looking framework encompasses a wide array of products, as provided for by Section 604(2) of the Food, Drug, and Cosmetic Act, from makeup essentials and nail polishes to grooming products, perfumes, cleansers, haircare items and skincare solutions.

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Namandjé Bumpus, Ph.D., the FDA’s chief scientist, underscores the transformative nature of this draft guidance: “On average, consumers in the U.S. use six to twelve cosmetic products daily. Until recently, the FDA lacked the authority to mandate manufacturers to furnish cosmetic product listings, including ingredient lists and facility registration.” The passage of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has ushered in a new era, giving the FDA the capacity to demand these vital details. As the year progresses, mandatory registration and listing of cosmetic product facilities and products will be enacted, ensuring that information regarding cosmetics, including ingredients and production facilities, is readily available to the Agency.

The draft guidance, “Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry,” serves as an essential guide for MoCRA’s stipulations for facility registration, product listings and the exemptions tailored for specific small businesses. Compliance emerges as a cornerstone, as MoCRA requires the submission of existing cosmetic product facility and product information no later than December 29, 2023. The guidance explicitly states that any modifications to facility registration data should be updated within a 60-day window from the change. Additionally, facility registration renewal becomes obligatory every two years. Furthermore, the draft guidance spotlights that any adjustments to product listings, encompassing changes in ingredient composition, must be submitted annually.

Linda Katz, M.D., M.P.H., director of the FDA’s Office of Cosmetics and Colors, points to the manifold benefits of this forward-looking initiative. “The FDA is steadfast in bolstering its oversight of cosmetics safety,” she says. Registration and listing data will serve as essential tools to achieve multifaceted goals, including identifying facilities potentially linked to adverse events, facilitating the recall of products that fall short of safety standards, administering product testing and surveillance programs, orchestrating strategic inspections, and pinpointing products that diverge from regulatory guidelines.

Anticipating the evolving landscape, the FDA’s draft guidance marks a significant shift from voluntary to mandatory compliance. Until March 2023, the FDA operated the Voluntary Cosmetic Registration Program, which, while insightful, provided only a partial view of cosmetic products, ingredients, their prevalence and the businesses involved in their production and distribution. Separately, the Fair Packaging and Labeling Act provides the FDA and Federal Trade Commission specific authority to prevent consumer deception related to ingredient descriptions, and class actions frequently address the safety of ingredients, but this authority is inherently responsive as opposed to proactive. This new guidance stands as a testament to the FDA’s commitment to consumer safety, as it seeks to elevate not just beauty but also transparency, accountability and safety across the cosmetics industry.

Stakeholders seeking additional clarity on product facility registrations and product listings required under MoCRA may submit comments to the FDA by September 7, 2023.

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Transforming Cosmetics Regulation: FDA’s Mandatory Compliance Shift for Safer Beauty