Draft guidance on cosmetic product and facility registration under MoCRA – Some clarifications from the FDA

August 24, 2023. On August 7, 2023, the US Food and Drug Administration (FDA) published a long-awaited draft guidance on cosmetic product listing and facility registration. These are new requirements set by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

The Guidance aims at helping the cosmetic industry to get ready to comply. It is not legally binding, but it provides the current thinking of the FDA on the registration requirements.

The draft Guidance is open for comments until September 7, 2023. After this date, the FDA will issue a finalized version.

Key points from the FDA draft Guidance

The FDA confirms they are working on a new electronic submission portal for product listing and facility registration that will be operational in October 2023. Although they encourage electronic submissions, the FDA is working on an alternative paper application form.

Facilities registration

Any facility that, on December 29, 2022, manufactures or processes cosmetic products for distribution in the United States must register with the FDA by December 29, 2023. If a facility engages in such activities after December 29, 2022, it has to register within 60 days after the start of the operations or by February 27, 2024, whichever is later. The registration must be updated every two years (abbreviated renewal if there are no updates). Additionally, the facility must communicate any changes to the registration information within 60 days.

Concerning the facility registration, the draft Guidance clarifies the following:

  • Only one registration is needed for each facility, even if that facility manufactures or processes cosmetic products on behalf of more than one responsible person.
  • The facility registration consists of two steps. Firstly, the facility must obtain a facility registration number: an FDA Establishment Identifier (FEI). Secondly, the facility must submit the registration information.
  • Small businesses do not need to register unless they produce certain type of cosmetic products (e.g., products that are injected, intended for internal use, come into contact with mucus membrane of the eye). At the same time, the registration requirement does not apply to facilities that manufacture or process cosmetics that are also drugs unless they also manufacture or process products classified exclusively as cosmetics.

Product listing

MoCRA requires that the responsible person submits to the FDA a cosmetic product listing for each product by December 29, 2023, or within 120 days of marketing the product in the United States. The product listing must be updated every year; however, the FDA is developing an abbreviated renewal in case there are no changes to the product.

According to MoCRA, the cosmetic product listing must include the following information:

  • Facility registration number for each facility where the product is manufactured or processed
  • Name of the product as it appears on the labels
  • Responsible person’s name and contact number
  • Cosmetic category — Appendix A to the draft Guidance lists such categories and the related codes
  • List of ingredients, including fragrances, flavors, and colors
  • Product listing number (if any)

In the Guidance, the FDA expands the list of data to be submitted, adding the mandatory type of submission (initial, annual update, abbreviated renewal) and the following optional elements:

  • Parent company name (if any)
  • Type of business as it appears on the labels (manufacturer, packer, distributor)
  • Image of the label
  • Product webpage link
  • Statement that the product is for professional use only (if applicable)
  • Responsible person DUNS Number
  • Unique Ingredient Identifiers (UNIIs)
  • Additional contact information

Furthermore, the FDA confirms that small businesses do not need to list their products. Additionally, if a product is both a drug and a cosmetic, the cosmetic product listing is not required.


If you want to know more about the FDA draft Guidance, you can check our dedicated 30-minute webinar.




FDA. (2023). Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry. Retrieved on 23/08/2023

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