Facilities and Products: What Does the Deadline Mean to You, and How is FDA Helping You Comply?
the U.S. Food and Drug Administration (FDA) reminds industry of the resources available to help firms comply with the new registration and listing requirements established by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by July 1, 2024, consistent with FDA’s Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing.
FDA established a dedicated Registration & Listing of Cosmetic Product Facilities and Products Web page that consolidates links to all resources.
Reminder: Generally, a cosmetic product listing must include the facility registration number of each facility where the cosmetic product is manufactured or processed. Thus, it is important for facilities to register before the product listing is completed.
MoCRA provided new authorities to FDA and requirements for industry including:
- Facility Registration: Cosmetic product manufacturers and processors must register their facilities with FDA, update their registration to reflect changes to their registration information 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.
Responsible person means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the Federal Food, Drug, and Cosmetic Act or section 4(a) of the Fair Packaging and Labeling Act.
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 mucus membrane of the eye under customary or usual conditions of use.
- Products that are injected.
- Products that are intended for internal use.
- Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use.
Exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices.
In November 2023, FDA issued guidance on its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements under MoCRA for six months until July 1, 2024 to help ensure that industry has sufficient time to submit facility registration and product listing information.
In December 2023, FDA issued final guidance on cosmetic product facility registrations and product listings, as mandated by MoCRA. The guidance provides recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA.
FDA has made available several options for facility registration and product listing:
- In October 2023, FDA published a Structured Product Labeling (SPL) Implementation Guide with Validation Procedures, which was updated in December, 2023. The Implementation Guide can be used to develop SPL authoring tools to transmit SPL-formatted submissions through FDA’s Electronic Submissions Gateway (ESG).
- In December 2023, FDA also announced the launch of its Cosmetics Direct electronic submission portal, at https://direct.fda.gov/, for registration and listing of cosmetic product facilities and products. We have also developed a user’s guide to Cosmetics Direct, a facility registration tutorial, and a product listing tutorial (See links in Related Resources section below).
- In January 2024, FDA announced the availability of Xforms, an SPL authoring tool for cosmetic product facility registration and cosmetic product listing. FDA also announced the availability of Form FDA 5066 and Form FDA 5067 as an additional submission tool for providing cosmetic product facility registration and cosmetic product listing information to FDA. These paper forms are available at Registration & Listing of Cosmetic Product Facilities and Products.
For More Information
- Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing
- Federal Register Notice: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing; Guidance for Industry; Availability
- Final Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products
- Federal Register Notice: Registration and Listing of Cosmetic Product Facilities and Products; Final Guidance for Industry