Azariah Dileo, Class of 2024, Belmont Law
Until December 29th of this past year, the Federal Food, Drug, and Cosmetic Act (FD&C) and the Fair Packaging and Labeling Act (FPLA) were the only federal laws that regulated cosmetic manufacturing and distribution processes within the United States. Section 201(i) of the FD&C Act defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Cosmetics, according to the FD&C Act, do not include soaps, dietary supplements, or products that are used for therapy purposes.
Last month, President Biden signed a bill that added one more federal law that would govern the manufacturing and selling of cosmetics within the United States: the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)—the first update to cosmetics regulations within the United States in eighty years. MoCRA’s purpose is to regulate the manufacturing and processing of cosmetics that are distributed and sold within the country. To meet MoCRA’s initial requirements, every existing cosmetic manufacturing or processing facility must register with the Food and Drug Administration (FDA) no later than December 29, 2023. Any new manufacturing or processing facilities that come into existence after December 29, 2023, must register with the FDA within sixty days after commencing operations.
MoCRA also tasks the FDA with creating regulations for cosmetic production facilities. To minimize any undue economic burdens, MoCRA requires the FDA to formulate its regulations flexibly, keeping in mind that what might be practicable for a larger business may not be practicable for a small business. The FDA has a three-year deadline (2025) by which it must formulate MoCRA regulations for good manufacturing practices.
In addition to enabling the FDA to promulgate regulations, MoCRA sets requirements for cosmetic manufacturers, packers, or distributors who are listed on a product’s label—MoCRA names such an entity a “reasonable person”. A reasonable person must meet several of MoCRA’s requirements, but here are a few. A reasonable person is responsible for providing the FDA with a list of each cosmetic product and corresponding cosmetic ingredient lists. Additionally, a reasonable person must provide an “adequate substantiation of [the] safety” of their cosmetic products. A reasonable person typically meets this requirement by providing the FDA with research or other evidence that the ingredients in their product are safe for the expected use. If a consumer experiences a “serious adverse event” related to using the cosmetic within fifteen days of receiving the cosmetic product, the reasonable person has a duty to report the event to the FDA.
With MoCRA being the first update in federal laws governing cosmetic production in eighty years, its impact is vast. In addition to the changes that MoCRA brings, described above, it has additional implications for the FDA, preemption of state laws, and other production practices.