Will Modernization of Cosmetic Regulation Finally Happen?

On June 14, 2022, the Senate Health, Education, Labor and Pensions Committee voted to pass the FDA Safety and Landmark Advancements (FDASLA) Act (S.4348).   While FDASLA focuses on user fees and includes several other provisions regarding drugs and devices, it also includes provisions related to cosmetics.  Specifically, FDASLA includes the Modernization of Cosmetics Regulation Act of 2022 proposing significant amendments to the FDC Act, intended to modernize safety standards for cosmetics in the United States.

Efforts to update safety standards for cosmetics have been ongoing since 2013, with the proposed Personal Care Products Safety Act of 2021 being the most recent iteration prior to FDASLA.  The Modernization of Cosmetics Regulation Act of 2022 addresses much of what was included in previous bills, including:

• adverse event reporting requirements;
• a labeling requirement to include contact information for adverse event reporting;
• ingredient labeling requirement for cosmetic products for professional use (these products are currently exempt from ingredient labeling requirements);
• mandatory recall authority;
• establishment of good manufacturing practices (GMPs) for cosmetics facilities;
• registration and product listing requirements; and
• a requirement for FDA to issue regulations to establish standardized testing methods for detecting and identifying asbestos in talc-containing products

The bill includes certain exemptions for small businesses.

The current bill is not as sweeping as the Personal Care Products Safety Act of 2021.   Among other things, rather than requiring that FDA promulgate a rule banning the addition of perfluoroalkyl and polyfluoralkyl substances (PFAS), the current bill only requires that FDA assess the use and safety of PFAS in cosmetics and prepare a report within two years of the enactment of the law.  Other provisions from the 2021 bill that are absent in the 2022 bill include the mandate for FDA to annually review the safety of at least five cosmetic ingredients or non-functional constituents, and registration fees.

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 would be preempted, but other prohibitions and limitations on the use or amount of an ingredient in a cosmetic product, state tort laws, and state laws and referendums, such as California’s Proposition 65 are carved out from preemption.

The current House bill does not include the cosmetic provisions and it remains to be seen which riders will survive and which will be eliminated.