FDA Issues Final Guidance on Facility Registration and Product Listing Under MoCRA

On December 11, 2024, the Food and Drug Administration (FDA) released a final guidance concerning the Modernization of Cosmetics Regulation Act (“MoCRA”)’s facility registration and product listing submission requirements, which FDA began enforcing on July 1, 2024. This guidance includes key FDA recommendations and instructions, including the following:

• The “responsible person” is required to submit both the facility registration and product listing information. The responsible person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of the product.
• The facility registration requires the responsible person to include the name of the facility’s owner, the address and contact information of the facility, the FDA Establishment Identifier (“FEI”), all brand names for the products manufactured or processed at the facility, and the product categories for each cosmetic product manufactured or processed at the facility.
• The product listing requires the responsible person to identify all FEIs for facilities where the product is being manufactured or processed, the name and contact of the responsible person, the product categories for the cosmetic product, a list of ingredients (including any fragrances, flavors, or colors), and the product listing number (if one was previously assigned).
• FDA launched Cosmetics Direct, an electronic submission portal for facility registration and product listing submissions. FDA strongly recommends electronic submissions through this platform.
• In response to a request under the Freedom of Information Act (FOIA), FDA will not disclose the product listing number (a number FDA will generate for each unique product) or information from a facility on the brand names of products manufactured or processed at the facility. All other information from the facility registration and product listings will be available for public disclosure under FOIA.
• Facility registration and product listing is not required for a cosmetic product that is also defined as a drug. But a facility that manufactures and processes cosmetic products that are not drugs must ensure that both the facility registration and product listing submission requirements are met.

The finalized guidance also includes two Appendices. Appendix A lists the cosmetic product categories and codes that must be submitted with the facility registration and product listing submissions—e.g., baby products, bath preparations, eye makeup preparations, etc. Appendix B is frequently asked questions and answers about MoCRA requirements. The finalized guidance includes three new FAQs:

1. The responsibilities of U.S. agents for foreign establishments or facilities include: (1) assisting FDA in communications with the foreign establishment; (2) responding to questions concerning the foreign establishment’s products that are imported or offered in the U.S.; (3) assisting FDA in scheduling inspections of the foreign establishment; and (4) receiving information or documents from FDA on behalf of the foreign establishment.
   
   
2. A cosmetic facility that includes multiple buildings with different physical addresses but within three miles of each other are considered to be one facility with one FEI number if the following conditions are met: (1) the activities of the buildings are all closely related to the same business enterprise; (2) the buildings are under the supervision of the same local management; and (3) the buildings can all be inspected by FDA during a single inspection. Registering for an FEI number must be completed before starting the facility registration submission.
   
   
3. A responsible person must submit a product listing for each cosmetic product, even those that are provided as free samples or gifts, unless another exemption applies. However, FDA does not require a product listing for a cosmetic sample that is provided within the industry for research and product development where the product is not intended for consumer consumption—g., free finished product samples for industry participants.  

The deadline for public comments on the finalized guidance, and specifically the three new FAQs, was January 13, 2025, but the Regulations.gov docket states that FDA is allowing late comments. Interested stakeholders should consider submitting comments as soon as possible.