The U.S. Food and Drug Administration (FDA) recently updated its guidance titled “Registration and Listing of Cosmetic Product Facilities and Products.” This document aims to help cosmetic businesses understand the requirements for registering their facilities and listing their products with the FDA. The updated guidance includes finalized frequently asked questions (FAQ) in Appendix B, specifically questions 1 through 19, which were first introduced in a previous version of the guidance. Additionally, three new questions, labeled as Q20 to Q22, have been added to Appendix B. However, these new questions are marked as drafts to allow stakeholders the opportunity to provide feedback before they are finalized. These updates reflect the FDA’s ongoing efforts to clarify compliance requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
The FDA initially issued its final guidance on cosmetic facility registrations and product listings in December 2023, as mandated by MoCRA. This law introduced significant changes to the way cosmetic products are regulated in the United States. The guidance provides detailed instructions on several key aspects of the registration and listing process. For instance, it explains who is responsible for submitting the required information, what details need to be included in the submissions, how businesses should submit their information, and when these submissions must be made. It also outlines certain exemptions that may apply to specific businesses or products. The FDA has designed this guidance to make the process as straightforward as possible while ensuring compliance with the law.
To facilitate these submissions, the FDA has developed an electronic system called Cosmetics Direct. This online portal streamlines the process of submitting and managing registration and product listing information. For businesses that prefer not to use electronic tools, the FDA provides paper forms, specifically Forms 5066 and 5067, as an alternative. Additionally, businesses can submit their information through the FDA’s Electronic Submissions Gateway (ESG), another secure online platform. However, the FDA strongly encourages the use of electronic submissions, as they are more efficient and allow for faster processing of data.
The guidance highlights the importance of submitting accurate and timely information to the FDA. This ensures that cosmetic products are properly regulated, which helps protect consumer safety. By providing detailed instructions and multiple submission options, the FDA aims to make it easier for businesses to comply with the law while improving the overall efficiency of the regulatory process. For more information, including specific exemptions and additional resources, businesses are encouraged to refer to the “Additional Information” section of the guidance.
Three new FAQs about specific topics related to the registration and listing process are also included for public feedback. First, they clarify the responsibilities of a U.S. Agent who represents cosmetic facilities located outside the United States. Second, they explain situations where one Facility Establishment Identifier (FEI) number may be associated with multiple buildings that manufacture or process cosmetic products. Third, they provide guidance on how to list cosmetic products that are distributed as free samples or gifts. By addressing these topics, the FDA aims to ensure that businesses have a clear understanding of their obligations and how to comply with federal regulations.
