news September 15, 2023

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FDA’s August 2023 draft Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry (“draft guidance”), FDA received 49 public comments by the Sept. 5, 2023, deadline.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On September 15, FDA announced updates to the draft guidance, responded to the public comments, and provided further explanation of the requirements for obtaining a facility identification number (“FEI”).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response to the public comments, it made no further modifications to the burden estimates previously presented in the draft guidance related to the time needed to perform the following: updating product labels with the new MoCRA elements; third-party disclosure requirements; reporting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.


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?

Extended Till July 1, 2024

Although MoCRA’s deadline for product listings and facility registrations is technically not extended, earlier this month FDA announced it intends to exercise its enforcement discretion until July 1, 2024. This decision is due to the delayed launch of the listing/registration portal as well as the industry’s feedback that they need more time. Despite delayed enforcement, FDA encourages companies to still try to submit their listings and registrations by the end of this year:

FDA will be ready to accept registration and listing information by the statutory deadline of December 29, 2023, and we encourage companies to meet that deadline if they are able to do so. However, FDA does not intend to enforce the requirements under section 607 of the FD&C Act related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements. In addition, FDA does not intend to enforce the registration requirement for owners or operators of facilities that first engaged in manufacturing or processing a cosmetic product after December 29, 2022, or the listing requirement for cosmetic products first marketed after December 29, 2022, until July 1, 2024.

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
  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 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.