Submission of Information to the FDA About Existing Cosmetic Product Facilities and Ingredients Is Required No Later Than December 29, 2023
Cosmetics: FDA-Regulated, but Not FDA-Approved
On August 7, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance on new requirements for registration and listing of cosmetic product facilities and products. The draft guidance follows the signing of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) into law on December 29, 2022, as part of the year-end Consolidated Appropriations Act for 2023. A majority of the new MoCRA requirements, including the provision requiring manufacturers and processors of cosmetic products to register with the FDA, are set to take effect on December 29, 2023, with the exception of a few requirements that will take effect one to two years thereafter. Until the signing of MoCRA last year, there were no laws requiring the registration of cosmetics products and listing of ingredients (besides color additives) before they were marketed. MoCRA will apply to those personal care products which under The Federal Food, Drug, and Cosmetic Act (FDCA) are "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." These products include not only makeup but also skin moisturizers, perfumes, lipsticks, nail polishes, shampoos, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.
MoCRA Recap
As we previously reported, MoCRA added significant new requirements for manufacturers, packers, and distributers of cosmetic products (“responsible persons” under the Act) to Chapter VI of the FDCA. MoCRA, which was years in the making, marked the first significant U.S. cosmetics regulation reform since the FDCA was first enacted in 1938 and the FPLA in 1966. MoCRA contains the following key provisions: 1) serious adverse events related to cosmetics products must be reported to the FDA; 2) manufacturers and processors of cosmetic products will be required to register within one year; 3) the safety of cosmetic products must be substantiated; 4) cosmetic labels must include new information, including for products intended for professional use; 5) the FDA has the authority to order mandatory recalls and suspend manufacturing facilities registration; and 6) the FDA must create regulations establishing good manufacturing practices.
Draft Guidance for Registration and Listing
As relevant to the draft guidance, the newly added section 607 of the FDCA provides that domestic and foreign facilities that manufacture or process cosmetic products for distribution in the U.S. must register with the FDA. (Note that firms that solely perform labeling, relabeling, packaging, repackaging, holding, and/or distributing of cosmetic products; entities that manufacture or process cosmetic products solely for use in research or evaluation; and establishments that manufacture only cosmetic ingredients are not required to register). In addition, responsible persons also must annually submit a list for each cosmetic product with the FDA, including its ingredients and information about where the cosmetic product is manufactured.
The draft guidance describes MoCRA requirements for facility registration and product listing, and the exemptions under MoCRA for certain small businesses. Submission of information about existing cosmetic product facilities and products is required no later than December 29, 2023. Thereafter, facility registration information must be updated within 60 days of a change and registration must be renewed every two years. Any updates to a product listing, such as a change in product ingredients, must be provided annually.
While there was previously no mandatory registration program for cosmetic manufacturers, the FDA did encourage participation in the Voluntary Cosmetic Registration Program (VCRP). Up until earlier this year, cosmetic manufacturers, distributors, and packers could file information on their products being marketed to consumers in the U.S. and register their manufacturing and/or packaging facility locations in the VCRP database. The FDA confirmed in the draft guidance announcement that prior participation in the VCRP does not exempt entities from mandatory MoCRA registration requirements because the information in the VCRP differs from the information required to be submitted under MoCRA. Accordingly, the FDA concluded its use of the VCRP on March 27, 2023. The FDA noted that information in the VCRP will not be transferred to the new MoCRA-initiated system.
Next Steps for Manufacturers
The FDA is accepting comments on the draft guidance until September 7, 2023. In the meantime, cosmetic product manufacturers should prepare their registration and listing information submissions to the FDA in order to meet the December 29, 2023 deadline. While electronic submission of registration and listing information is not required, the FDA is strongly encouraging electronic submission to facilitate efficiency and timeliness of data submission and management by the FDA. However, the FDA has not yet created the electronic portal for registration and product listing.
Wilson Sonsini provides cross-functional legal support to help companies navigate complex legal issues in connection with regulation reform. If you are interested in submitting comments to the FDA or have questions, please contact Georgia Ravitz, James Ravitz, Eva Yin, Paul Gadiock, Scott Cohn, Shawn Lichaa, Marissa Hill Daley, or any member of the firm’s FDA regulatory, healthcare, and consumer products practice.
Georgia Ravitz and Marissa Hill Daley contributed to the preparation of this alert.