The U.S. Food and Drug Administration (“FDA”) oversees the regulation and safety of drugs, medical devices, many food items, and cosmetic products. Until recently, the FDA’s regulation of cosmetic products was minimal. There were very few measures in place to ensure the public’s safety when using cosmetics.
What products are defined as cosmetics?
As defined by the FDA, “cosmetic products” include more than just makeup. They also include hair and hair removal products, nail products, soaps, lotions, and tanning products.
How is the FDA’s regulatory process for cosmetics changing?
Historically, regulation of cosmetic products was not stringent at all. Notably, cosmetic product manufacturers were not required to register their products or ingredients with the FDA. Registration was voluntary. Therefore, the FDA was unaware of what cosmetic products were on the market. As such, it was unable to ensure products were safe. Further, the FDA refused to regulate per- and polyfluoroalkyl substances, also known as PFAS and forever chemicals,” in cosmetics.
But, in December 2022, the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) was enacted. MoCRA is the first update to the FDA’s cosmetic regulations since 1938, and makes the FDA’s regulatory framework for cosmetics much more stringent. Importantly, per MoCRA, the FDA must now assess the use safety and risks of PFAS in cosmetics.
When do the new MoCRA regulations begin?
The first step in enacting MoCRA is a registration process with a December 2023 deadline. Last month, the FDA issued detailed draft guidance to registrants in order to help them navigate the process. Cosmetic product manufacturers and processers must register their facilities with the FDA. Additionally, cosmetic product manufacturers and processors must submit cosmetic product lists to the FDA.
Does this apply to all manufacturers?
Small businesses whose average gross annual sales are less than one million dollars do not have to register. Additionally, manufacturers or processors whose cosmetic products are also drugs or medical devices do not have to register.
How does this impact cosmetic regulations?
The goal of MoCRA is to increase consumer safety and ingredient transparency. Cosmetic products, as broadly defined, are used by a large percentage of the public. The FDA’s recent draft guidance is a good sign that it is finally taking cosmetic regulations seriously.