On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act, 2023 which includes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This long-awaited move significantly changes the current regulatory framework for the cosmetics industry, bringing the federal regulation into the 21st century.
The 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act) is a set of laws in the United States that authorizes the Food and Drug Administration (FDA) to oversee and regulate the production, sale, and distribution of food, drugs, medical devices, and cosmetics. The overarching purpose of the FD&C Act, with enforcement from the FDA, is to “protect the general public from adulterated and misbranded products manufactured and sold in the US” (Lam et al., 2022).
MoCRA is one of the first major amendments to the FDA’s cosmetics authority since the FD&C Act was first enacted in 1938. Essentially, MoCRA grants FDA the authority to impose new regulations for cosmetics. This act represents a combination of efforts from lawmakers, the FDA, consumer and environmental groups, and the beauty and personal care industry to ensure that cosmetics remain safe for consumer use.
FDA’s New Authority
Under MoCRA, the FDA now has the authority to:
- Suspend a facility’s registration if it determines that a cosmetic product manufactured by that facility has a reasonable probability of causing serious adverse health consequences.
- Access records relating to a cosmetic product if it reasonably believes that a product or its ingredients are adulterated and present a threat of serious adverse health consequences.
- Issue a mandatory recall of a product if it determines that there is a reasonable probability that a cosmetic product is adulterated, misbranded, or poses a serious adverse health effect.
New Requirements for Cosmetic Companies
Under MoCRA, cosmetic companies must now meet the following requirements:
- Records of health-related adverse events associated with a cosmetic product must be maintained for 6 years and FDA must be notified of any serious adverse event within 15 days of learning of the event.
- Facilities must be registered with the FDA and must submit product listings (including ingredients, responsible party, and where it is manufactured).
- The safety of a cosmetic must be substantiated (tests, studies, research, etc.).
- Product labels must list fragrance allergens, and products intended for professional use must be labeled as such.
The new requirements regarding substantiation of cosmetic safety claims, facility registration, adverse event recordkeeping, and submission of a list of cosmetics products on the market must be implemented by the end of 2023 or the company will be subject to FDA’s new authority to recall products.
Our team of scientists at EHS Support is ready to help you meet these new regulations and requirements. Visit our website to learn more or contact Damani Parran, so we can help to ensure your company is compliant with the new MoCRA regulations.
- Lam C, Patel P. Food, Drug, and Cosmetic Act. [Updated 2022 Aug 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan. Available from: https://www.ncbi.nlm.nih.gov/books/NBK585046/