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Proposed Rules Implementing MoCRA: FDA Unified Agenda Update

Alert July 9, 2024

Proposed Rules Implementing MoCRA: FDA Unified Agenda Update

July 9, 2024, Covington Alert

The Office of Information and Regulatory Affairs (OIRA) published this week the Spring 2024 edition of its Unified Agenda of Federal Regulatory and Deregulatory Actions. The FDA Agenda includes three proposed rules specific to cosmetic products, including two proposed rules that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) directed FDA to issue: 

 Proposed Rule  Summary  Anticipated NPRM Date (Update from Fall 2023 Agenda)

Disclosure of Fragrance Allergens in Cosmetic Labeling (i.e., the Fragrance Allergen Disclosure Rule)

Would identify certain substances as fragrance allergens and require their disclosure on labels of cosmetic products, as required by MoCRA.

October 2024 (new entry in unified agenda)

Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products (i.e., the Talc Rule)

Would require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products, as required by MoCRA. 

July 2024 (updated from December 2023 in prior unified agenda)

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)

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.

September 2024 (updated from July 2024 in prior unified agenda)

 

Although two of these proposed rules appeared on the Fall 2023 Unified Agenda, this marks the first time that the Fragrance Allergen Disclosure Rule has appeared on a unified agenda.

The anticipated NPRM publication dates are aspirational. FDA often misses these targets, and this is even more likely this year given that rulemaking tends to slow down leading up to a federal election. It would be out of the ordinary for any of these proposed rules to actually issue until after this year’s election, but we will continue to monitor their status closely.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice.

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