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:
- The label of each cosmetic product must disclose the name and U.S. contact information of a “responsible person” (either the manufacturer, packer, or distributor of the product). The “responsible person” will serve as the point of contact for adverse event reporting and, among other duties, will be responsible for safety substantiation.
- Each marketed cosmetic product, along with its ingredients, must be submitted to the FDA in an annual listing. Similar product listing systems exist for drugs and medical devices. The FDA is currently seeking comments for its proposed online and paper format for product listing.
- Cosmetic manufacturing facilities will need to register with the FDA and update their facility registration every two (2) years. The FDA now has the authority to withdraw a facility’s registration where there is a reasonable probability that a cosmetic product poses serious adverse health consequences or death. This is similar to the food facility registration requirements. Like with product listings, the FDA is currently seeking comments for its proposed online and paper format for facility registration.
- Cosmetic product labels will have to disclose “fragrance allergens,” although details pertaining to what exactly will have to be disclosed are to be established by the FDA in 2024. This is expected to potentially implicate disclosure of information previously regarded as trade secret and it is bound to be subject of vigorous public comment.
- The FDA will issue mandatory good manufacturing practices (“GMPs”) for cosmetic manufacturers. The GMPs are expected to be generally consistent with national and international standards, and the first public comment pertaining to the GMPs is scheduled for June 1, 2023.
- The FDA will require “adequate safety substantiation,” or support for the claims that a product is safe. Serious adverse events associated with the use of cosmetic products in the U.S. will have to be reported to the FDA. The FDA will have the authority to request access to records and issue mandatory recalls of cosmetic products. This record access authority for cosmetics is similar to other authorities granted to the FDA with respect to foods and drugs.
- The FDA is also expected to issue rules pertaining to standard testing and detection methods for the purported presence of asbestos in talc, and regulations pertaining to PFAS that may implicate preemption considerations in future litigation.
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:
|Steps you can take now:
|July 1, 2024
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, 2024
|Disclose 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, 2025
|Comply with Good Manufacturing Practices
|– Participate in FDA hearings on GMPs and submit public comments