On December 29, 2022, President Biden signed into law the “Consolidated Appropriations Act, 2023.” The Act includes the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”), which increased the authority of the United States Food and Drug Administration (FDA) to regulate cosmetics products and provide enhanced cosmetics protections for consumers. For insight, please see our prior blog post, Revamping of Cosmetics Regulation and Safety (January 23, 2023).
FDA previously announced that it will no longer accept facility registration and product listing submissions to the Voluntary Cosmetic Registration Program (VCRP) beginning March 27, 2023. Formerly, cosmetic companies had the option of participating in the Voluntary Cosmetic Registration Program (“VCRP”) for products sold in domestic commerce. The purpose of VCRP was to help FDA gather information on cosmetics, including ingredients, frequency of use, etc.
Most recently, in August 2023, the FDA released draft guidance, entitled Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry, on upcoming regulatory changes pursuant to MOCRA, including guidance on cosmetic product facility registrations and product listings. Importantly, because MOCRA imposes requirements that are different from those required under the VCRP, the FDA emphasizes in this guidance that it will not consider previous submissions to the VCRP as satisfying the facility reporting and product listing requirements under MOCRA. Comments on the draft guidance were due by September 7, 2023 and can be viewed on Docket No. FDA-2023-D-1716-002.
Several commenters, including multiple industry associations, requested that the FDA keep cosmetic facility registration and product listing information protected from public disclosure under the Freedom of Information Act (FOIA) and refrain from publicizing FDA’s database of facility registrations and product listings. For example, industry groups requested that FDA (1) define the information within public facility registrations and product listings that would be considered “relevant information” under FOIA and therefore disclosable, and (2) provide clear confirmation that the identity of responsible parties remain confidential.
Some groups requested FDA to continue to use the same product listing categories that were used under the VCRP until the initial registration and listing period ends. This would allow industries to have more time to update their internal categorization systems to match with FDA’s final guidance. Other groups have requested FDA go back to using the VCRP’s categories permanently, explaining that the new list of categories could place several products in more than one category.
Additionally, a few foreign-based cosmetics companies provided comments seeking FDA clarification on whether a “Responsible Person” under MoCRA may be a foreign entity.