13/14 March 2024
The U.S. Food and Drug Administration (FDA) announced the launch of its Cosmetics Direct electronic submission portal for registration of cosmetic product facilities and listing of cosmetic products, as mandated by the Modernization of Cosmetics Regulation Act (MoCRA). In addition, the agency issued the final guidance on cosmetic product facility registrations and product listings. The document also includes a new draft section, for public comment, that describes frequently asked questions and answers. The guidance assists stakeholders with cosmetic product facility registration and product listing submissions to FDA, by describing who is responsible for making the submissions, what information to include, how to submit, when to submit, and certain exemptions to the registration and listing requirements.
The Cosmetics Direct portal, is dedicated exclusively to cosmetic product facility registration and cosmetic product listing electronic submissions to FDA. Cosmetics Direct is an FDA Structured Product Labeling (SPL) authoring tool, for cosmetic product facility registration and cosmetic product listing, with user-friendly data entry forms that creates, validates, saves, submits, processes, and automatically transmits the SPL submission to FDA for internal processing without having to use the Electronic Submissions Gateway (ESG). The agency strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency. However, the agency is also developing paper forms as an alternative submission tool.
As described in the guidance, the agency will be using 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. 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.
The guidance also includes a new draft guidance section, Appendix B, for comment purposes only, that describes frequently asked questions and answers. Aside from that section, this guidance finalizes the draft guidance that was published in August last year. Comments on Appendix B should be submitted to the agency - either electronically or in written form - by 18 January 2024.
On November 8, 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 to help ensure that industry has sufficient time to submit such facility registration and product listing information.
More information is available in the Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products.