Cosmetics, as regulated by the U.S. Food and Drug Administration (FDA), encompass a wide range of products intended for beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions. This includes items like skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, cleansing shampoos, hair colors, and deodorants.
Unlike drugs or medical devices, cosmetics do not require FDA premarket approval, except for color additives. However, they must adhere to the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA), which mandate safety, proper labeling, and prohibit the sale of adulterated or misbranded products. The Modernization of Cosmetics Regulation Act (MoCRA), signed into law on December 29, 2022, introduces significant new regulatory requirements intended to enhance the safety, traceability, and quality of cosmetics and skincare products sold in the U.S.
Under MoCRA, cosmetic companies will be required, for the first time, to register their facilities and list their products with the FDA beginning on July 1, 2024. Additional requirements include record-keeping, adverse event reporting, product safety substantiation, and updated labeling requirements. The FDA now has the authority to order mandatory recalls of cosmetics and will publish final regulations regarding good manufacturing practices (GMP) for cosmetics by the end of 2025.
Manufacturers bear the responsibility for ensuring the safety of their cosmetics, and while specific tests are not mandated, they must ensure their products are safe under customary conditions of use. The regulatory landscape for cosmetics emphasizes compliance and safety without the stringent premarket approval processes required for other FDA-regulated products.
At Asebey Life Science Law, we provide expert legal guidance to help clients navigate the complexities of cosmetic regulation. We assist companies in identifying and meeting their MoCRA compliance requirements, ensuring that their products meet all federal standards for safety and labeling, thereby supporting market success and consumer trust.