U.S. FDA Sets New Schedules for MoCRA Rulemakings: GMP, Fragrance Allergens, and Asbestos Testing Included

The notice of proposed rulemaking (NPRM) for good manufacturing practices (GMPs) for cosmetics is now expected by October 2025, while the anticipated NPRM date for fragrance allergen labeling requirements is scheduled for January 2025.

In July 2024, the Office of Information and Regulatory Affairs (OIRA) issued the Spring 2024 Unified Agenda of Regulatory and Deregulatory Actions, announcing delays in the rulemaking for fragrance allergens and asbestos testing methods directed by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

On December 13, 2024, the OIRA published the Fall 2024 Unified Agenda of Regulatory and Deregulatory Actions, further revising and delaying the target dates for four proposed cosmetic rules, including three MoCRA-mandated rules.¹

Proposed Rule	Summary	Initial NPRM Date	Spring 2024 Agenda	Fall 2024 Agenda
MoCRA Rule: Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetics	Establishes standardized testing methods for detecting asbestos in talc-based cosmetics.	December 29, 2023	July 2024	December 2024
MoCRA Rule: Disclosure of Fragrance Allergens in Cosmetic Labeling	Requires the disclosure of certain fragrance allergens on the labels of cosmetic products.	June 29, 2024	October 2024	January 2025
MoCRA Rule: Good Manufacturing Practice for Cosmetic Product Facilities	Establishes GMPs for cosmetic product facilities to ensure product safety.	December 29, 2024	Not listed	October 2025
Use of Formaldehyde and Formaldehyde-Releasing Chemicals as an Ingredient in Hair Smoothing Products or Hair Straightening Products	Proposes a ban on formaldehyde (FA) and FA-releasing chemicals in hair smoothing and straightening products.	October 2023	September 2024	March 2025

The revised timelines provide the cosmetics industry additional time to prepare for compliance. This includes revising production processes, updating product labeling, and adopting new safety measures.

However, it is important to note that these anticipated NPRM publication dates remain expected targets, and may face further delays. ChemLinked advises cosmetic stakeholders to closely monitor the FDA’s developments to ensure readiness for compliance and avoid potential penalties.