New FDA Regulatory Framework for Cosmetics

MoCRA – What is it?

MoCRA, the Modernization of Cosmetics Regulation Act, was signed into law by the US government on Dec 29, 2022, as part of the omnibus spending bill. This is the first major update to the US Food and Drug Administration’s (FDA) authority over cosmetic products since 1938.

MoCRA pre-empts state law requirements differing from, or in addition to, those relating to registration and product listing, good manufacturing practice, recordkeeping, recalls, adverse event reporting, and safety substantiation. Some state laws (such as California’s Prop 65) are pre-empted.

Congress appropriated $14,200,000 for fiscal year 2023, $25,960,000 for fiscal year 2024, and $41,890,000 for each of fiscal years 2025 through 2027 to FDA for developing regulations and performing the other activities under MoCRA.

What can we expect?

• Establishment Registration – mandatory for manufacturers
• Product listing requirement
• Responsible Person – the manufacturer, packer, or distributor of a cosmetic product
• Reporting of Adverse Events & recordkeeping of such events
• Ingredient labelling requirement for professional products
• Good Manufacturing Practices (GMP) to be established
• Substantiation of Safety – businesses must maintain records (tests, research, etc.) that demonstrate product is safe
• Mandatory recall authority
• Additional regulations for products containing talc
• Further investigation into the safety of per- and polyfluoroalkyl substances (PFAS) in cosmetics

When can we expect it?

The requirements become effective one year after enactment of the legislation – Dec 29, 2023. It’s expected that Registration and Product Listing will be the first requirements implemented. Currently this is voluntary, so the system is already in place.

Some cosmetic manufacturers may already be in compliance as there is a similar facility registration in place for OTC drugs which includes sunscreen and acne products.

Each product must be registered separately – companies with a wide assortment of products will have a larger burden. Every time a new product is launched it will need to be registered.

DSV will continue to monitor CBP and FDA communications for additional details as they become available. If you have any further questions or concerns, please reach out to your local DSV representative.