FDA Issues Final Guidance for MoCRA Cosmetic Product Facility Registration and Listings

On December 18, 2023, the U.S. Food and Drug Administration (FDA) released the final guidance for the industry regarding cosmetic product facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The guidance supports stakeholders in submitting cosmetic product facility registrations and product listings to the FDA. It outlines submission responsibilities, necessary information, submission procedures, timelines, and specific exemptions from registration and listing requirements.

Portal

The guidance provides details about a newly launched electronic registration and listing portal called Cosmetics Direct. This portal is now accessible. Additionally, the FDA is in the process of creating paper forms, Form FDA 5066 and Form FDA 5067, to serve as alternative tools for submitting cosmetic product registration and listing information. These forms are expected to be available soon on the Registration & Listing of Cosmetic Product Facilities and Products platform.

The FDA will use the FDA Establishment Identifier (FEI) as the mandatory facility registration number. To streamline the registration process, facility owners or operators are required to obtain an FEI number before submitting their facility registration. To check for an existing FEI number, please use the FEI Search Portal.

It is important for the responsible person to obtain the relevant FEI number(s) for each facility where their cosmetic products are manufactured or processed, as these facility registration number(s) are necessary for product listing submissions. In the case of a small business that is exempt from registration and does not have a facility registration number, the product listing can be submitted using the facility name and address.

Exemptions

MoCRA provides exemptions from facility registration and product listing for specific small businesses.

However, these exemptions do not apply to facilities or responsible persons associated with the manufacture or processing of certain cosmetic products, including the following:

• Products that regularly come into contact with the mucus membranes of the eye under customary or usual conditions of use.
• Products that are injected.
• Products that are intended for internal use.
• Products that, under customary or usual conditions of use, are intended to change the appearance for more than 24 hours and removal by the consumer is not part of such conditions of use. 

Delayed Enforcement 

The FDA will not enforce the cosmetic product facility registration and product listing requirements for an additional six months after the December 29, 2023 deadline, until July 1, 2024. During this period, regulated industries will have more time to meet these obligations.

Additionally, the FDA will not enforce the registration requirement for facilities that begin cosmetic product manufacturing or processing after December 29, 2022, and the listing requirement for products first marketed after that date until July 1, 2024.