U.S. FDA Delays Rulemaking on Fragrance Allergens and Asbestos Testing Methods Under MoCRA

On July 5, 2024, the Office of Information and Regulatory Affairs (OIRA) released the "Spring 2024 Unified Agenda of Regulatory and Deregulatory Actions" (the Unified Agenda), which includes updates on several proposed rules concerning cosmetics in the United States.

Among these updates, the rulemaking of two notable proposed rules under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) have been delayed from their original timelines, with further delays possible:

• Disclosure of Fragrance Allergens in Cosmetic Labeling: MoCRA initially mandated the FDA to issue a proposed rule establishing a list of fragrance allergens and requiring their disclosure on product labels by June 29, 2024. The Unified Agenda now indicates this proposed rule will be issued in October 2024.

• Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetics: Under MoCRA, the FDA was required to propose a rule establishing standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products by December 29, 2023. This proposed rule has been delayed to July 2024, but as of now, no relevant proposal has been released.

In addition to these MoCRA-related delays, the Unified Agenda also updated the timeline for a proposed rule to ban the use of formaldehyde and formaldehyde-releasing ingredients in hair straightening products and hair smoothing products. This proposed regulation, initially announced by the FDA in October 2023, is now scheduled for release in September 2024.

Despite these delays, several MoCRA provisions have already taken effect since the law's enactment in December 2023. These include requirements for facility registration, product listing, safety substantiation, labeling for professional-use cosmetics, adverse event recordkeeping, and serious adverse event reporting. The labeling requirement to include U.S. contact information for receiving adverse event reports is set to take effect by the end of 2024. ChemLinked advises cosmetics industry stakeholders to closely monitor the ongoing updates and requirements under MoCRA to ensure timely compliance and avoid potential penalties.

Relevant Resources

• US Passes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) to Overhaul Cosmetics Regulatory Framework

• FDA Releases the Final Guidance on Cosmetic Facility Registration and Product Listing for MoCRA 

• US MoCRA Compliance Focus: Major Updates and Steps for Being Prepared