For the first time in over 80 years, cosmetic companies are expected to report any adverse events to the FDA (food and drug administration) as part of MOCRA (modernization of the of cosmetics regulation act of 2022) which is part of the Food and Drug Omnibus Reform Act of 2022 passed on December 23, 2022. It was signed into law by President Joe Biden on December 29, 2022.
What does this mean for consumers? All brands will be held to a higher standard as they will be required to adhere to manufacturing regulations, can’t use chemical additives and undergo asbestos testing for products made with talc. MOCRA provides FDA mandatory recall authority (on products which cause serious adverse health consequences) and increases FDA’s access to a number of records.
According to FDALawBlog.com “ MOCRA preempts 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. However, 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. Although the preemption provision certainly is not as strong as industry would prefer, industry has generally supported modernization of cosmetic regulation as it will advance innovation, modernize oversight and (presumably) bolster consumer confidence. At least for now, industry has been successful in preventing user fees for cosmetic companies. 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.
The passing of MOCRA does not change matters for industry overnight. The requirements for registration and listing and new enforcement provisions become effective one year after enactment of the legislation. A client memo prepared in early 2023 will address MOCRA and other major provisions of FDORA in further detail.”
“Although more is needed to ensure the safety of chemicals used in cosmetics, this update is a welcome step in the right direction,” said Scott Faber (Environmental Working Group senior vice president for government affairs).