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MoCRA Update: FDA Responds to Public Comments Regarding the Registration and Listing of Cosmetic Product Facilities and Products — Guidance for Industry

In response to FDA’s August 2023 draft Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry (“draft guidance”), FDA received 49 public comments by the Sept. 5, 2023, deadline. The comments included requests to update the accuracy of FDA’s burden estimates; suggestions regarding ways to enhance the quality, utility, and clarity of the information to be collected; suggestions on ways to minimize the burden of the collection of information; requests to clarify the scope for confidentiality of information to be submitted; and requests that the deadline for product listings and facility registration be extended. In addition, FDA released screenshots of the cosmetic facility registration and product listing portals, and draft forms for paper submissions ̶ though electronic submissions are encouraged.

On September 15, FDA announced updates to the draft guidance, responded to the public comments, and provided further explanation of the requirements for obtaining a facility identification number (“FEI”).

Burden Estimates

While FDA increased the burden estimates it attributes to product listing reporting activities in response to the public comments, it made no further modifications to the burden estimates previously presented in the draft guidance related to the time needed to perform the following: updating product labels with the new MoCRA elements; third-party disclosure requirements; reporting serious adverse events; and record keeping.

Confidentiality

FDA did not directly respond to concerns regarding the confidentiality of the information submitted with facility registrations or product listings, e.g., the identity of the product manufacturers for specific brands. Instead, FDA’s response was merely to point out that “[p]rivacy and trade-secret, commercial confidential information is governed by the Privacy Act of 1974 and part 20 of our regulations (21 CFR part 20).”

Will the December 29, 2023, Product Listing and Facility Registration Deadlines be Extended?

No. In response to requests that the deadlines be extended, FDA acknowledged that “[t]he registration and listing requirements set forth in section 605 of the FD&C Act (21 U.S.C. 364(c)) require that FDA begin receiving registration and listing information no later than December 29, 2023.” As such, because it is a legislative mandate, FDA made no other modifications to the proposed collections of information.

Notably, FDA did not mention when enforcement for failure to meet the Dec. 29, 2023, would begin. However, in my opinion, it does seem FDA has enough to focus on over the next two years that it is likely enforcement may be slow to begin.

FEI  ̶  What Is it and How Do You Get One?

A FEI is an FDA Establishment Identifier or Firm Establishment Identifier. It is an FDA system-generated number used to identify a firm. The FEI will be required in the process for submitting product listings and facility registrations. As such, we suggest confirming your company already has an FEI. If not, we suggest requesting one today! Here’s how you go about doing so:

1. To determine whether your company already has a FEI, you will need to request access to the FEI portal. To do so, create an account at https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=portal.login
2. You will receive an email that provides you with a password to log into the FEI portal
3. Log into the portal and search for your company by entering its name and address
4. If you can’t find an FEI for your company using the FEI portal, you can request one by emailing feiportal@fda.hhs.gov and providing the following information:

• The legal name of the firm being registered.
• Are you representing the firm as an Agent (third party)?
• Any alternate firm names, including those used for “doing business as” purposes.
• The physical address of the firm being registered.
• The designated mailing address for the firm being registered.
• The name and contact information of the designated contact person at the facility being registered.
• A comprehensive list of activities conducted at this specific location (e.g., drug manufacturing, food packaging, etc.).
• Any registration numbers associated with other FDA Centers, if applicable.
• Any former names the firm was known by.
• Any previous addresses linked to the firm.

If you would like assistance with preparing for and submitting product listings or facility registration, or just have questions regarding MoCRA, please do not hesitate to contact us. Our Cosmetics Industry Practice Group attorneys are here to support you.

• Angela Diesch
• Ashish Talati
• Rend Al-Mondhiry
• Lauren Aronson
• Abhishek Gurnani
• Ivan Wasserman
• Jennifer Adams
• Karmina Fefferman
• Natascia Taken