FDA issues Guidance for Registration and Listing of Cosmetic Product Facilities and Products

The FDA is currently working on approaches to strengthen its oversight in regard to the safety of cosmetic products. Therefore, the agency issued a draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products. According to the FDA, the guidance will help to accomplish several objectives, such as

  • identifying facilities producing products potentially causing adverse events,
  • facilitating the recall of unsanitary products,
  • administering product testing and surveillance programs,
  • planning GMP inspections and identifying products marketed in violation of the law.

In March 2023, the agency has stopped accepting submissions to the voluntary cosmetic registration program (VCRP) as a result of the facility registration and product listing mandated by the Modernization of Cosmetics Regulation Act (MoCRA). Therefore, the agency is developing a new system for receiving the required registration and listing information.

When finalized, the draft guidance will assist stakeholders with cosmetic product facility registration and product listing submissions to FDA, by describing

  • who is responsible for making the registration and listing submissions,
  • what information to include,
  • how to submit, and when to submit,
  • as well as certain exemptions for small businesses to the registration and listing requirements.

In addition, the MoCRA provided new authorities to FDA including:

  • Facility Registration: Cosmetic product manufacturers and processors must register their facilities with FDA, update content within 60 days of any changes, and renew their registration every two years.
  • Product Listing: A Responsible Person (i.e. the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product) must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates (such as a change in product ingredients) annually. 

The Responsible Person will need to obtain the relevant FDA Establishment Identifier (FEI) (the FDA intends to use the FEI as the required facility registration number) for each facility where the cosmetic product is manufactured or processed, because the facility registration number is required for the product listing submission. If the facility is a small business that is exempt from registration and has no facility registration number, then facility name/address can be provided instead for the product listing.

Submission of information about existing cosmetic product facilities and products is required no later than 29 December 2023.

For more information please see FDA's draft guidance Registration and Listing of Cosmetic Product Facilities and Products.

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