Since the Modernization of Cosmetic Regulation Act (MoCRA) was announced in December of 2022, the FDA has delivered on some of their obligations and deadlines included in the original Act. However, much of their most important work is still to come, or is it?
Key Takeaways:
Looking back at MoCRA
The requirement for on-hand safety substantiation for all cosmetic products placed on the US market as well as for adverse event record keeping and reporting becomes effective
The FDA creates additional functionality in the Cosmetics Direct portal for the relisting and discontinuation of product listings
The FDA Releases Data from the Agency’s 2023 Testing of Talc-Containing Cosmetic Products for Asbestos. No products tested are shown to contain asbestos
July 1, 2024 - Initial Manufacturer Registrations and Product Listings are due
1: The FDA Updates their Guidance for the industry on the Registration and Listing of Cosmetic Product Facilities and Products. Additional details were added to the FAQs to explain the role of the US Agent, discuss the sharing of FEI numbers based on facility locations, and address listings for free samples and gifts.
2: The FDA Issues the Proposed Rule on Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products.
3: Announcement of the exit of the FDA Cosmetics Director and Principal Deputy Commissioner who had been leading the MoCRA efforts.
Looking to 2025 and beyond
Current timelines for remaining provisions of MoCRA
Changes and gaps in leadership
Changes in federal administration
Continued due diligence needed
Impacts
The overall trajectory of MoCRA now hangs in the balance between the spirit of the regulation – to bring US cosmetics more in-line with other, more scrupulous jurisdictions such as the EU – versus the current headwinds which may continue to delay timelines or derail this regulatory movement altogether.
If the Office of Cosmetics and Colors is able and rightly staffed to complete the provisions and enforcement mechanisms of MoCRA, cosmetic brands and manufacturers can expect further scrutiny and requests for information, safety substantiation questioning, audit of brands and manufacturers, and overall FDA oversight. However, MoCRA may not progress further and only the current requirements may remain. In the end, companies should consider their obligations to their customers to continue to provide safe, quality, truthful, and substantiated products and build their company culture around that priority.
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