- On December 11, 2024, the U.S. Food & Drug Administration (FDA) issued updated guidance for industry on the registration and listing of cosmetic product facilities and products. The guidance provides recommendations and instructions to help individuals and companies comply with the Modernization of Cosmetics Regulations Act of 2022 (MoCRA).
- MoCRA mandates that cosmetic companies report serious adverse events to FDA within 15 business days, register their facilities and list their products, ensure product safety before marketing, and comply with FDA’s authority to access records and order recalls if products are found to be unsafe or misbranded.
- The updated guidance outlines the statutory requirements for submitting cosmetic product facility registrations and product listings. It finalizes the frequently asked questions (FAQs) in Appendix B (Q1-19) and introduces three new FAQs (Q20-22) for public comment.
- Q20 outlines the responsibilities of a U.S agent, which includes assisting FDA with communications, responding to product inquiries, helping schedule inspections, and receiving documents on behalf of the foreign establishment;
- Q21 explains that multiple buildings within three miles can share one FEI number if they are part of the same establishment and management, and can be inspected together; and
- Q22 indicates that a product listing is generally required for all cosmetic products, including free samples or gifts, unless specific exemptions apply.
- The comment period is open until January 13, 2024, and comments can be submitted through the docket.
© 2025 Keller and Heckman LLP
National Law Review, Volume XIV, Number 348