FDA Publishes Final and Draft Registration/Product Listing FAQs

By Percy Doufou-Shafiq, regulatory affairs lead, Supply Chain team, UL Solutions

On Dec. 12, 2024, the Department of Health and Human Services of the United States Federal Food and Drug Administration (U.S. FDA) announced the availability of guidance to the industry regarding the “Registration and Listing of Cosmetic Product Facilities and Products” that included a finalized version of frequently asked questions (FAQs). It also added three new draft questions open to public comment.

The FDA has published various guidance documents following the enactment of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) on Dec. 12, 2022. The purpose of the guidance documents is to assist cosmetic companies with the various requirements of MoCRA, such as their facility registration and product listing obligations, and to answer questions that may frequently arise.

The latest guidance‚ “Registration and Listing of Cosmetic Product Facilities and Products,” finalized the draft frequently asked questions (FAQs) that were released in December 2023 and presented three new draft FAQs open to public comment.

The three FAQs open for comments are the following:

1. What are the responsibilities of the U.S. agent?

   According to the answer from the FDA, a U.S. agent acts as a liaison between foreign establishments and FDA. The Agency expects the U.S. agent to answer questions about the foreign establishment, help with scheduling inspections, respond to questions about foreign products being imported to the U.S., and communicate information between the FDA and the foreign company. The FDA considers providing the U.S agent with information or documents equivalent to providing them directly to the foreign establishment.

2. Can multiple buildings that are in close proximity (within 3 miles of each other) be  associated with one FDA Establishment Identifier (FEI) number, or are two FEI numbers needed?

   An FEI number is a unique identifier used by the FDA to identify firms associated with FDA regulated products. Obtaining an FEI is a necessary first step to register a cosmetic facility with the FDA. According to the FDA, a single FEI number can be used for cosmetic product facilities that have the same physical address (multiple buildings within the same site) or buildings that are within 3 miles of each other if the buildings are closely related to the same business, under the same management and capable of being inspected by the FDA in a single inspection.

3. Does a product listing need to be submitted for free samples or gifts?

   The FDA answered that the responsible person must submit to the FDA a product listing for each cosmetic product, even for those considered free samples or gifts, unless an exception applies (e.g., small business exemption). Products provided within industry for research and development and that are not intended for consumer use do not require product listing.

Comments for these three draft questions must be submitted either electronically or in writing through contact information given in the guidance document within 30 days of publication, which is until Jan. 13, 2025. After this deadline, the FDA will work on finalizing the answers to these questions.

For a quick summary of the specific requirements under MoCRA please refer to the article “Newly Passed Law Tightens US Cosmetics Regulations,” which was previously published by UL Solutions.

References

Modernization of Cosmetics Regulation Act of 2022

FDA - Cosmetics

Registration & Listing of Cosmetic Product Facilities and Products