FDA Issues Final Guidance on Registration and Listing of Cosmetic Product Facilities&Products Required under MoCRA, and Launched Cosmetic Direct.

On December 18, 2023, the U.S. Food and Drug Administration (FDA) issued two announcements regarding the law of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), specifically concerning the requirements for cosmetic facility registration and cosmetic product listing. First of all, the FDA launched the "Cosmetics Direct" electronic submission portal to accept information about product listings and cosmetic facility registrations. Second, the FDA published its final guidelines regarding the information that must be submitted with listings and registrations.

The Agency is not enforcing facility registration or product listing requirements until July 1, 2024, as noted in a compliance policy announced on November 8, 2023. However, companies should start following the new regulations. More details are discussed below.

1. Cosmetics Direct for Electronic Registration

According to the FDA's announcement, companies can now submit facility registration, product listing, and labeling information to the FDA by using the Cosmetics Direct electronic portal. Cosmetics Direct is accessed at https://direct.fda.gov/.

As the FDA described the portal is a "Structured Product Labeling (SPL) authoring tool, for cosmetic product facility registration and cosmetic product listing. It includes user-friendly data entry forms, creates and saves the SPL submission, performs initial validations, and submits the SPL to FDA for internal processing." Information about cosmetic labeling must be sent in SPL format. There's also a detailed user's guide for Cosmetics Direct available. In general, creating an account is required for every party wanting to submit information through the portal.

The portal is now available for businesses that submit this information electronically, even though the FDA declared that it would not enforce the facility registration and product listing requirements for an extra six months after the December 29, 2023, statutory deadline (until July 1, 2024). Significantly, the other MoCRA requirements that go into effect on December 29, 2023, such as the requirement to report serious adverse events and to keep records confirming the safety of cosmetics, are not impacted by this enforcement delay.

2. Final Guidance on Cosmetic Facility Registration and Product Listing

The FDA also issued final guidance with suggestions and instructions to help stakeholders with cosmetic product facility registration and product listing submissions to the FDA. The guidance provides information about
1) who is responsible for making registration and listing submissions
2) what information to include
3) how to submit
4) when to submit
5) certain exemptions to the registration and listing requirements

Other important points are noted in the guidance

When registering for the first time, a cosmetic company must include its facility registration number. The facility registration number assigned by the Agency will be the FDA Establishment Identifier (FEI) number.

• A cosmetic facility's registration process is required to include
  1) The name of the owner/operator of the facility
  2) The complete name of the facility and its physical address
  3) Information for a US agent contact person (for the facility located outside of the U.S.): name, telephone number, email address
  4) The facility registration number (or Establishment Identifier (FEI) number)
  5) Type of submission
  6) A list of all brand names of cosmetic products manufactured or processed at the facility
  7) The responsible person listed on the cosmetic product labels
  8) The product category or categories into which each product falls

• The product listing submission is required to include
  1) The facility registration number (FEI) of each facility where the cosmetic product is manufactured or processed
  2) The name and contact number of the responsible person, as well as the name of the cosmetic product as it appears on the label
  3) Information about the product category or categories that cover it (as described in Appendix A of the Final Guidance)
  4) A list of ingredients in the cosmetic product (including fragrances, flavors, or colors)
  5) The product listing number
  6) Type of submission

Appendix B of the Final Guidance has a section titled "Frequently Asked Questions" (FAQs). This part is being released "for comment purposes only," meaning it is effectively a draft version. However, it's important to read these FAQs since they provide more insight into how the FDA is interpreting specific parts of the registration and listing standards.

If you have questions about the registration or listing requirements, or any other provisions of MoCRA, or want to apply for FEI numbers please feel free to contact us.

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