FDA Pushes Back Deadlines for Key Cosmetic Regulations on Fragrance and Asbestos Testing

On July 5, 2024, the Office of Information and Regulatory Affairs (OIRA) published the "Spring 2024 Unified Agenda of Regulatory and Deregulatory Actions," which provides updates on various proposed rules affecting cosmetics in the U.S. Two key proposed rules under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) have been delayed, with further delays possible:

• Disclosure of Fragrance Allergens in Cosmetic Labeling: MoCRA initially required the FDA to issue a proposed rule by June 29, 2024, mandating the disclosure of fragrance allergens on cosmetic labels. The Unified Agenda now indicates that this rule will be issued in October 2024.
• Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetics: The FDA was expected to propose standardized testing methods for detecting asbestos in talc-containing cosmetics by December 29, 2023. This proposal has been delayed to July 2024, but no rule has yet been released.

The Unified Agenda also updated the timeline for a proposed rule to ban formaldehyde and formaldehyde-releasing ingredients in hair straightening and smoothing products. Originally expected in October 2023, the proposal is now expected to be released in September 2024.

FDA Announces Enhancements to Cosmetics Direct Submission Portal

On July 29, 2024, the U.S. Food and Drug Administration (FDA) introduced updates aimed at helping the cosmetics industry maintain its registration and listing submissions. The most significant updates include two new features in Cosmetics Direct, the electronic submission portal established by MoCRA.

The new features allow for the discontinuation and relisting of cosmetic product listings. The discontinuation feature enables responsible persons - manufacturers, packers, or distributors of cosmetic products - to discontinue products that are no longer on the market. The relisting feature allows previously discontinued products to be reintroduced to the market.

Discontinuation is different from deletion in Cosmetics Direct. Discontinued products remain in the Structured Product Labeling (SPL) file and can be relisted, whereas deleted products are permanently removed and cannot be retrieved. For more details, please refer to the updated User's Guide to Cosmetics Direct.