FDA Goes Modern: Modernization of Cosmetics Regulation Act of 2022
The US cosmetics industry is getting a face-lift with the recent passage of the Modernization of Cosmetics Regulation Act on December 29, 2022. MoCRA is attempting to create a more regulated framework for cosmetics production and manufacturing, a feat not prioritized for decades. Amendments have been made specifically to Chapter VI of the Federal Food, Drug, and Cosmetic Act which was originally passed in 1938. The changes that have been made primarily target manufacturers of cosmetics with flexibility for small businesses. The law imposes the following requirements:
Product and facilities registration
The introduction of good manufacturing practices (GMP) for facilities
Safety testing and serious adverse event documentation
Labeling changes for adverse event reporting
Additional regulations for products containing talc
Further investigation into the safety of per- and polyfluoroalkyl substances (PFAS) in cosmetics
In contrast to the decades prior, MoCRA grants the FDA mandatory recall authority for those products that are “adulterated, misbranded, or the cause of adverse health consequences or death.” Such authority will also be accompanied by a framework establishing good manufacturing practices in line with global and national industry standards. The FDA previously had no authority to demand recalls but instead they were voluntary. It remains to be seen what this framework will end up looking like and the effect it may have on smaller businesses compared to larger cosmetics companies. However, the regulations regarding listing products with the FDA will go into effect in December 2023.
There also exists an exemption for small businesses which are defined as those businesses whose average gross annual sales in the United States of cosmetic products for the previous three-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of certain enumerated cosmetic products. These businesses are not subject to the MoCRA requirements regarding good manufacturing practices, facility registration, and product listing. Small businesses are still responsible for safety testing, serious adverse event documentation/reporting and labeling changes for adverse event reporting.
The US Cosmetics industry is generally known for liberally regulating products and manufacturers of cosmetics. MoCRA will hopefully begin a new era of taking product testing and cosmetic consumer safety more seriously with the implementation of these new regulatory frameworks. Additionally, the Act will require standardization of testing for Talc-Containing Cosmetics and research on PFAS (per-and polyfluoroalkyl substances) and discourages the use of animal testing in the cosmetic industry (but doesn’t restrict it).
While the details of MoCRA’s implementation are still nebulous, we do know that MoCRA has implications for both small and larger businesses. Please reach out to us to discuss how to get in compliance before December 2023.