USA: FDA Drafts Guidelines for Facilities Registration and Listing of Cosmetic Products

ARQon
Sep 13, 2023
2 min read

As mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the FDA was designated new authorities for Cosmetics which are Facility Registration and Product Listing. This designation brought the FDA to draft guidance on cosmetic product facility registration and product listings. This finalized guidance is intended to assist stakeholders with the requirements and information needed for cosmetic facility registration and cosmetic product listing submission.

The new authority duty for the FDA includes:

Facility Registration: Required for all cosmetic manufacturers or processors to register their facilities with FDA, within 60 days of any changes, and apply registration renewal for every 2 years
Product Listing: Responsible persons are compulsory to submit the list of marketed cosmetic product information and annual updates to the FDA

**Responsible Person: Manufacturer, packer, or distributor of a cosmetic product, whose name stated on the label of the cosmetic product

Previously in March 2023, MoCRA was mandated for the facility registration and product listing authorities upon the Constituent Update by FDA, which caused FDA to discontinue accepting submissions to the Voluntary Cosmetic Registration Program (VCRP).

The draft guidance mentioned the intention of applying the FDA Establishment Identifier (FEI) as the required facility registration number for the registration process. This means that the facility owners are required to obtain an FEI number before the facility registration submission. The Responsible persons must obtain the FEI numbers from their cosmetic products’ facilities for the product listing submission.

There are few exemptions given for small businesses from facility registration and product listing requirements except:

Facilities that manufacture products that regularly come into contact with the mucus membrane of the eye under customary or usual conditions of use
Facilities that manufacture products that are injected
Facilities that manufacture products intended for internal use
Facilities that manufacture products intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer are not part of such conditions of use

Apart from that, the FDA is planning to implement the electronic registration and listing submission portal, which is intended to be available in October 2023. Hence, FDA motivates electronic submissions to facilitate efficiency and timeliness of data submission. FDA encourages members from the cosmetic industry to participate in the User Acceptance Testing (UAT) for potential evaluation of the new electronic portal.

For the obligation of the FEI numbers, the stakeholders are advised to plan well on the registration and listing as the statutory deadline will be on 29 December 2023.

Source: Food and Drug Administration (FDA)