The Office of Information and Regulatory Affairs (OIRA) published this week the Fall 2024 edition of its Unified Agenda of Federal Regulatory and Deregulatory Actions. The FDA Agenda, which is the final unified agenda of the Biden Administration, includes four proposed rules specific to cosmetic products, including three proposed rules that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) directed FDA to issue.
Three of these proposed rules appeared on the Spring 2024 Unified Agenda and FDA has pushed back the anticipated NPRM date for each of these rules; this marks the first time that the GMP Rule has appeared on a unified agenda.
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Proposed Rule
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Summary
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Anticipated NPRM Date (Update from Spring 2024 Agenda)
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Disclosure of Fragrance Allergens in Cosmetic Labeling (i.e., the Fragrance Allergen Disclosure Rule)
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Would identify certain substances as fragrance allergens and require their disclosure on labels of cosmetic products, as required by MoCRA.
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January 2025 (updated from October 2024 in prior unified agenda)
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Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products (i.e., the Talc Rule)
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Would require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products, as required by MoCRA.
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December 2024 (updated from July 2024 in prior unified agenda)
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Use of Formaldehyde and Formaldehyde-Releasing Chemicals as an Ingredient in Hair Smoothing Products or Hair Straightening Products (i.e., Rule Banning Formaldehyde From Hair Smoothing/Straightening Products)
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Would ban formaldehyde (FA) and other FA-releasing chemicals (e.g., methylene glycol) as an ingredient in hair smoothing or hair straightening products marketed in the United States.
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March 2025 (updated from September 2024 in prior unified agenda)
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Good Manufacturing Practice for Cosmetic Product Facilities (i.e., the GMP Rule)
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Would establish good manufacturing practices for cosmetic product facilities to help ensure the safety of cosmetic products.
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October 2025 (new to the unified agenda)
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The anticipated NPRM publication dates are aspirational. FDA often misses these targets, and this is even more likely this year given the transition to the incoming Trump Administration next month. Notably, only one of these four rules, the Talc Rule, has been sent to OIRA for review (a prerequisite before the rule can be issued). We do not expect any of these proposed rules to issue before inauguration in January, but we will continue to monitor their status closely.
If you have any questions concerning the material discussed in this client alert or any aspects of FDA’s implementation of MoCRA, please contact the members of our Cosmetics practice.
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