MoCRA Updates: FDA Releases the Final Guidance on Cosmetic Facility Registration and Product Listing for MoCRA

Following a public consultation on the draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products on August 7, 2023, the U.S. Food and Drug Administration (FDA) officially issued the final Guidance on December 18, 2023. This comprehensive document offers instructions for submitting cosmetic facility registrations and product listings to the FDA. To be specific, the document covers term explanations, responsible entities for application submission, necessary dossiers, submission methods, submission deadlines, and more.

Compared to the draft version unveiled in August 2023, the final Guidance has undergone several updates and additions, with key points highlighted below:

1. Further clarification of the submission methods accepted by the FDA.

The primary submission method recommended is "Cosmetics Direct," an online portal exclusively dedicated to electronic submissions for cosmetic facility registration and product listing. Following this, paper form submission using FDA Forms 5066 and 5067 is also accepted. Additionally, the FDA's Electronic Submission Gateway (ESG) can be utilized as an alternative tool to complement the aforementioned methods.

2. The use of FDA Establishment Identifier (FEI) number as the cosmetic product facility’s registration number, and the provision of detailed instructions for FEI application.

The acquisition of an FEI number marks the initial step in facility registration and product listing, with the application typically processed within 7-10 working days. Enterprises are strongly advised to apply for their own FEI number in advance.

Facility owners or operators already possessing an FEI number can directly employ it, whose existence can be determined through the FEI Search Portal. For those without an assigned FEI number from the FDA, they shall submit an application request to [email protected] and provide the following information:

• Legal firm name

• Any alternate firm names, including those used for "doing business as" purposes

• Physical address

• Designated mailing address

• Name and contact information of the designated contact person

• A comprehensive list of activities conducted at this specific location (e.g., drug manufacturing, food packaging, etc.)

• Any registration numbers associated with other FDA Center(s), if applicable

• Any former names the firm was known by

• Any previous addresses linked to the firm

3. Introduction of criteria for appointing an appropriate “U.S. agent”.

Foreign facilities are required to designate a U.S. agent during the facility registration process. The Guidance specifies that the U.S. agent must be an individual or business entity residing in the U.S. or maintaining a U.S. place of business with a physical presence in the country. Importantly, it cannot be a mailbox, answering machine, service, or any location where the designated individual acting as the agent is not physically present.

4. Update of the compliance deadlines for cosmetic facility registration and product listing in line with the FDA’s latest announcement on delayed enforcement.

5. Introduction of a New FAQ Attachment—Appendix B to the Guidance.

This appendix addresses questions of key concern to enterprises. It is noteworthy that it is open for public comments. Stakeholders with any comments can submit electronic feedback to http://www/regulations.gov within 30 days from the publication in the Federal Register (by January 18, 2024).

Among the 19 FAQs covered, two key points deserve attention. The FDA clarifies the identification of "small businesses", stating that it generally does not require companies to submit relevant documentation, nor does it issue small business exemption certificates for cosmetic product facilities or responsible persons.

Furthermore, the FDA emphasizes that laboratories conducting testing on cosmetics solely for research and development purposes do not need to be registered. However, if these laboratories engage in cosmetic product batch release testing, they are subject to the registration requirements, as batch release testing is considered part of manufacturing and processing.

For further insights into MoCRA, please explore ChemLinked's new Featured page: Navigating US Cosmetic Regulations: MoCRA and Beyond.

Further Reading

• U.S. FDA Launches Cosmetic Direct Electronic Portal for MoCRA
  

• U.S. FDA Updates Instructions for Filing out Serious Adverse Event Reports for Cosmetics