As we previously discussed, MoCRA requires cosmetic product manufacturer and processors to register their facilities with the U.S. Food and Drug Administration (FDA). On August 7, 2023, FDA announced that it had published a draft guidance on cosmetic product facility registration and product listings, as required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The draft guidance intends to help the industry by providing relevant requirements and definitions, explaining who is responsible for making submissions, what details to include, and how and when to make the submissions. It also provides information on exemptions, such as those for certain small businesses.
The Product Perspective previously discussed the facility registration requirement under MoCRA. The FDA’s recent guidance clarifies that the following information must be submitted as part of facility registration:
- the name of the owner and/or operator of the facility;
- the facility’s name, physical address, email address, and telephone number;
- with respect to any foreign facility, the contact for the United States agent of the facility;
- the facility registration number, if any, previously assigned;
- all brand names under which cosmetic products manufactured or processed in the facility are sold;
- the product category or categories and responsible person for each cosmetic product manufactured or processed at the facility; and
- whether the submission is the initial submission, an amended submission, the biennial renewal, or an abbreviated renewal.
Note that a facility must obtain a facility registration number before initiating the registration submission. FDA intends to use its FDA Establishment Identifier (FEI) for the facility registration number. Applicants should search FDA’s “FEI Search Portal” to determine if an FEI has been assigned for their facility. If an FEI has not already been assigned, applicants should request an FEI from email@example.com.
Under the current guidance, facilities can, but do not have to, submit the parent company name and the facility’s Dun & Bradstreet Data Universal Numbering System (DUNS) Number. In other facility registration systems, such as those for pharmaceuticals and food, the DUNS number is required and can pose delays in the registration process. Making the DUNS Number’s submission optional under MoCRA should make the facility registration process more seamless.
In addition to the facility registration requirement, MoCRA requires that each marketed cosmetic product be listed with the FDA. Pursuant to the recently announced guidance, the following information must be submitted with a cosmetic product listing:
- the facility registration number of each facility where the cosmetic product is manufactured or processed;
- the name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label;
- the applicable cosmetic category or categories for the cosmetic product;
- a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by the name or by the common or usual name of the ingredient;
- the product listing number, if any previously assigned; and
- whether the submission is an initial listing, an annual update with revisions to content, or an abbreviated renewal.
FDA also requests that certain optional information be submitted, including the type of business, a website link, responsible person, DUNS number for the address on the product label, and any unique ingredient identifiers. Please note that information provided under the voluntary cosmetics registration program, which ended on March 27, 2023, will not be transferred to the new system and will not satisfy the MoCRA registration and listing requirements.
Product listing and facility registration will be available via paper form on online portal, both of which are under development. FDA is currently seeking public comments on its proposed online portal and on the paper form. All constituents are encouraged to weigh in.
The initial registration and product listings must be submitted no later than December 29, 2023 for persons that, as of December 29, 2022, own or operate a facility engaged in the manufacturing or processing of cosmetic products for distribution in the United States. Amendments must be made within 60 days of any changes to the previously submitted information, and renewals occur every two years. An abbreviated renewal process will be available if the registrant’s information is not changing. This abbreviated process is expected to be similar to the abbreviated processes used in the drug registration and listing system.
FDA is also accepting comments on the draft guidance pertaining to the registration requirements until September 7, 2023. Comments may be submitted online at regulations.gov and identified by docket number FDA-2023-D-1716.
Husch Blackwell LLP has experience working with clients on preparing FDA registration and listing submissions, including those involving FDA’s electronic systems, as well as serving as the U.S. Agent for foreign manufacturers and other companies. Should you have any questions regarding these proposed requirements, feel free to reach out to one of the authors of this article.