The Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) was signed into law on December 29, 2022. MoCRA expands the authority of the U.S. Food and Drug Administration (“FDA”) to regulate cosmetics and serves as the most significant change to the regulation of cosmetics since the passage of the Federal Food, Drug, and Cosmetic (FD&C) Act in 1938. MoCRA is a seismic shift in the world of cosmetic regulation, bringing new authorities to the FDA that are similar to those that currently exist for food, drugs and medical devices, among other regulated products. MoCRA has sweeping implications for domestic and international cosmetics manufacturers that market products in the U.S.

In the pre-MoCRA world, cosmetic manufacturers seeking to sell their products in the U.S. were responsible for ensuring product safety, but the FDA’s enforcement authority was limited.  Cosmetics determined to be hazardous by the FDA required legal action through the FDA’s seizure or injunction authorities. Further, cosmetic manufacturers were not required to submit information to the FDA about production facilities, distribution chains, or product formulations. The FDA did establish the Voluntary Cosmetic Registration Program (“VCRP”) which was, as the name suggests, voluntary, and which is now suspended. This left most cosmetic products unregulated.

In the post-MoCRA world, the cosmetic industry will need to comply with a variety of new mandatory requirements including, but not limited to, the following:  

Additional information can be found on the FDA’s website. Stay tuned for the upcoming Product Perspective’s posts discussing MoCRA in detail and for updates on the FDA’s rulemaking. Meanwhile, here are the deadlines to keep in mind as MoCRA is implemented:

DateDeadline to:Steps you can take now:
July 1, 2024Register facilities
Submit product listings
Submit product information  
– Assemble facility registration information
– Prepare product listing and ingredient information
– Perform safety substantiation testing and assemble relevant records
December 29, 2024Disclose known allergens
Disclose “responsible person’s” contact information
– Participate in FDA hearings on allergen and fragrance disclosure rulemaking Identify “responsible person”
– Evaluate contracts within your supply chain to allocate “responsible person’s” duties and compliance costs
December 29, 2025Comply with Good Manufacturing Practices– Participate in FDA hearings on GMPs and submit public comments
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Photo of Magda Patitsas Magda Patitsas

Magda has extensive experience in complex product liability litigation defending manufactures of talc products, consumer products, medical devices, and mechanical devices in state and federal courts. She handles product liability, personal injury and premises liability cases including multi-district litigation, class actions and individual

Magda has extensive experience in complex product liability litigation defending manufactures of talc products, consumer products, medical devices, and mechanical devices in state and federal courts. She handles product liability, personal injury and premises liability cases including multi-district litigation, class actions and individual product defense. As national coordinating counsel in widespread toxic tort litigation, Magda works with a network of internal and external counsel and experts to achieve clients’ business objectives through the optimal litigation strategy.

Photo of Jen Dlugosz Jen Dlugosz

Jen focuses her practice on defending businesses in toxic tort and product liability matters in some of the most dangerous jurisdictions across the United States. In addition to product liability and toxic tort experience, Jen’s broad range of litigation experience…

Jen focuses her practice on defending businesses in toxic tort and product liability matters in some of the most dangerous jurisdictions across the United States. In addition to product liability and toxic tort experience, Jen’s broad range of litigation experience includes commercial litigation, white collar investigations, qui tam litigation, insurance litigation and contract disputes. Jen also maintains an active pro bono practice.

Photo of Seth Mailhot Seth Mailhot

With an education in chemical engineering and a prior career at the U.S. Food and Drug Administration, Seth brings clients rare regulatory insight on food, medical device and drug matters. As Leader of the firm’s FDA group, Seth handles a broad array…

With an education in chemical engineering and a prior career at the U.S. Food and Drug Administration, Seth brings clients rare regulatory insight on food, medical device and drug matters. As Leader of the firm’s FDA group, Seth handles a broad array of matters involving FDA-regulated products and services including food, medical devices, pharmaceuticals, biotechnology, tobacco, radiation-emitting electronic products and cosmetics.