FDA is actively seeking input on its recently developed draft electronic submission platform known as “Cosmetics Direct,” alongside traditional paper submission forms (Forms FDA 5066 and 5067).
Cosmetics Direct simplifies the process by converting the essential registration and listing data found in paper forms into a standardized electronic format. This feature aids respondents in structuring their registration and listing submissions, ensuring they contain the necessary information required by the FDA. Additionally, it grants respondents access to their historical Cosmetic Direct registrations and listing submissions.
In a bid to enhance efficiency and promptness in data submission and management, the FDA strongly advocates for electronic submissions. However, for those who prefer the traditional approach, the option to submit paper registrations and listings remains available.
Draft screenshots of the electronic system are available below for review and comments. For more information, see the Federal Register Notice and Registration & Listing of Cosmetic Product Facilities and Products.
- Draft Cosmetics Direct Electronic Submissions Portal
- Draft FDA Form 5066 -Registration of Product Facility
- Draft FDA Form 5067 – Cosmetic Product Listing
Original Constituent Update
August 7, 2023
The U.S. Food and Drug Administration, today, issued draft guidance on cosmetic product facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
When finalized, the draft guidance will assist stakeholders with cosmetic product facility registration and product listing submissions to FDA, by describing who is responsible for making the registration and listing submissions, what information to include, how to submit, and when to submit, as well as certain exemptions to the registration and listing requirements.
MoCRA provided new authorities to FDA including:
- Facility Registration: Cosmetic product manufacturers and processors must register their facilities with 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.
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 FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.
MoCRA provides exemptions for certain small businesses from the obligations of facility registration and product listing.
However, it’s important to note that these exemptions do not extend to facilities engaged in the manufacturing or processing of certain types of cosmetic products, nor do they apply to the responsible persons overseeing these products. Specifically, exemptions do not cover:
- Products intended for regular contact with the mucous membranes of the eye under typical conditions of use.
- Injectable products.
- Products designed for internal use.
- Products intended to alter one’s appearance for more than 24 hours under customary conditions of use, where consumer removal is not a part of those conditions.
- Certain products and facilities subject to regulations governing drugs and devices.
In March 2023, the FDA issued a Constituent Update, announcing the suspension of submissions to the Voluntary Cosmetic Registration Program (VCRP). This suspension was a direct result of the facility registration and product listing requirements mandated by MoCRA.
The draft guidance also includes information about a forthcoming electronic registration and listing submission portal. The FDA plans to launch this new electronic submission portal in October 2023. The agency strongly encourages electronic submissions to enhance efficiency and timeliness in data submission and management. Additionally, the FDA is developing a paper-based alternative submission method to complement the electronic portal.
As outlined in the draft guidance, the FDA intends to implement the FDA Establishment Identifier (FEI) as the required facility registration number. To simplify the registration process, facility owners or operators will need to obtain an FEI number before submitting their facility registration. Entities can verify the existence of an FEI number through the FEI Search Portal. For those without an FDA-assigned FEI number, instructions for requesting one can be found on the FEI Search Portal website.
The responsible person will also need to acquire the relevant facility registration (FEI) number(s) for each facility where their cosmetic products are manufactured or processed. These registration numbers are a prerequisite for product listing submissions. In cases where a facility is a small business exempt from registration and lacks an FEI number, the product listing can include the facility’s name and address as an alternative.
Stakeholders are advised to initiate the registration and listing process well in advance of the statutory deadline on December 29, 2023.
Furthermore, the FDA is actively seeking applications from members of the cosmetic product industry interested in participating in a voluntary pilot program focused on User Acceptance Testing (UAT). This program aims to evaluate a potential new electronic submissions portal for cosmetic product facility registration and listing in accordance with MoCRA. The FDA intends to accept up to nine participants for this pilot program, with the goal of gathering valuable input to inform the evaluation of the new electronic submission portal. For additional information, please consult the Federal Register Notice: Pilot Program for Cosmetic Product Facility Registration and Listing Electronic Submissions User Acceptance Testing.
