Is a US Agent Required for Cosmetic Facility Registration?

Yes, a U.S. agent is required for cosmetic facility registration with the U.S. Food and Drug Administration (FDA) if the establishment is located outside of the United States. A US FDA agent is a person or entity that can act on behalf of a foreign cosmetic manufacturer or processor to register their facility with the FDA under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The agent must be located in the United States and be authorized by the foreign manufacturer or processor to act on their behalf.

Using a US FDA agent to register your cosmetic facility under MoCRA brings significant advantages. Firstly, it saves time and money. The agent knows FDA requirements and helps you complete the process correctly. Secondly, it prevents penalties for not following FDA rules. Thirdly, knowing a professional is handling your facility's registration provides peace of mind.

Information Required for Cosmetic Facility FDA Registration

  • The name of the owner and/or operator of the facility.
  • The facility’s name, physical address, email address, and telephone number.
  • US FDA agent information for foreign facilities.
  • The facility registration number (FEI number).
  • All brand names under which cosmetic products are manufactured or processed in the facility.
  • The product category or categories ( MoCRA Product Category) and Responsible Person for each cosmetic product manufactured or processed at the facility.
  • Type of submission (initial, amended, biennial renewal, or abbreviated renewal).
  • Parent company name (if applicable).
  • Facility duns number.
  • Additional contact information for individuals associated with the registration.

LMG assists cosmetic manufacturers with US FDA registration, Listing and US FDA agent service to foreign cosmetic manufacturers at a reasonable price.

The above information is based on FDA draft guidance; the requirements may change once finalized. Please refer to the FDA’s final guidance for any changes.