US FDA Issued Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products

On August 7, 2023, the US Food and Drug Administration (FDA) published draft guidance on cosmetic product facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

When finalized, the draft guidance will assist stakeholders with cosmetic product facility registration and product listing submissions to the FDA, by describing:

• who is responsible for making the registration and listing submissions;
• what information to include;
• how to submit it;
• when to submit; and
• certain exemptions to the registration and listing requirements.

MoCRA provided new authorities to the FDA including:

• Facility Registration: Cosmetic product manufacturers and processors must register their facilities with the FDA, update content within 60 days of any changes, and renew their registration every two years.
• Product Listing: A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.

Exemptions

MoCRA exempts certain small businesses from facility registration and product listing requirements.

However, such exemptions do not apply to facilities that manufacture or process, or responsible persons for, the following cosmetic products:

• Products that regularly come into contact with the mucus membrane of the eye under customary or usual conditions of use;
• Products that are injected;
• Products that are intended for internal use; and
• Products intended to alter the 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.

Exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices.

A new electronic registration and listing submission portal

The draft guidance also contains information about a new electronic registration and listing submission portal. The FDA intends to make the new electronic submission portal available in October 2023. The FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency. The FDA is also developing a paper form as an alternative submission tool to the electronic submission portal.

The FDA Establishment Identifier (FEI) number

As described in the draft guidance, the FDA intends to use the FDA Establishment Identifier (FEI) as the required facility registration number. To facilitate the registration process, the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration. To determine if an entity already has an FEI number, please refer to the FEI Search Portal. If your firm does not have an FEI number assigned by the FDA, send a request to feiportal@fda.hhs.gov.

The responsible person will need to obtain the relevant facility registration (FEI) number(s) for each facility where their cosmetic products are 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 the facility name/address can be provided instead for the product listing.

Stakeholders should plan to register and list well in advance of the December 29, 2023, statutory deadline.

If you need any assistance or have any questions, please contact us via service@cirs-group.com.

Further Information

FDA News

CIRS Group will hold a free webinar to interpret the "Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry" on September 7, 2023. This webinar will introduce the latest developments in the US cosmetics regulations to enterprises exporting cosmetic products to the United States and assist enterprises in preparing for regulatory compliance as soon as possible. Click here to find out more.