The U.S. Food and Drug Administration issued a draft guidance for the cosmetics industry outlining the new upcoming process that will require cosmetic product facilities and products to be registered with the agency by December 29, 2023.
BACKGROUND INFORMATION
On December 29, 2022, the President signed the Consolidated Appropriations Act, 2023 (Pub. L. 117-328) into law, which included the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Among other provisions, MoCRA added section 607 to the Federal Food, Drug, and Cosmetic Act (FD&C Act), establishing requirements for cosmetic product facility registration and product listing.
- Section 607(a) of the FD&C Act requires every person that owns or operates a facility that “engages in the manufacturing or processing of a cosmetic product for distribution in the United States” to register each facility with FDA.
- Section 607(c) of the FD&C Act requires that for each cosmetic product, the responsible person must submit to FDA “a cosmetic product listing.”
The guidance included definitions of terms used in the instruction and outlined who is responsible for making the submissions, what information to include in the submissions, how to make the submissions, and upcoming deadlines for the community.
SUBMISSION & DEADLINES FOR FD&C ACT REGISTRATION
The FDA is developing an electronic submission portal to streamline submission and receipt of registration and product listing information required by section 607 of the FD&C Act. Registration and listing data can be submitted electronically using structured product labeling (SPL) format; alternatively the FDA is also developing a paper form submission tool. Both the electronic submission portal and the paper form will be accessible at https://www.fda.gov/. Instructions for submission will also be provided on this webpage.
For initial registration, every person that owned or operated a facility on or before December 29, 2022 must register by December 29, 2023. For those that took ownership of a facility after December 29, 2022, must register within 60 days or by February 27, 2024, whoever is later.
For product listings, if a cosmetic product is marketed on or before December 29, 2022, the registration deadline is December 29, 2023. If the product was first marketed after December 29, 2022, it must be registered within 120 days of marketing such product in interstate commerce. There is no fee to submit a registration or product listing to FDA under section 607 of the FD&C Act.
WHAT INFORMATION IS NEEDED FOR FD&C ACT REGISTRATION?
For facility registration, the following information will be required:
- 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 (name and phone number), and, if available, the electronic contact information (email);
- 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 (refer to Appendix A below) and responsible person for each cosmetic product manufactured or processed at the facility; and
- type of submission (initial, amended, biennial renewal, or abbreviated renewal)
- parent company name (if applicable);
- facility DUNS Number; and
- additional contact information for individuals associated with the registration.
The following information is needed for product listing registration:
- 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 (required under Section 701.3 of Title 21 Code of Federal Regulations) or by the common or usual name of the ingredient;
- the product listing number, if any previously assigned; and
- type of submission (initial, update to content (annual), abbreviated renewal)
- parent company name (if applicable);
- type of business (as listed on the label), i.e., manufacturer, packer, or distributor;
- image of the label;
- product webpage link;
- whether the cosmetic product is for professional use only;
- responsible person DUNS Number for address listed on product label;
- Unique Ingredient Identifiers (UNIIs); and
- additional contact information for individuals associated with the listing.
WILL THIS BE PUBLIC INFORMATION?
The product listing number will not be available for public disclosure (section 607(d) of the FD&C Act). Further, under section 607(e) of the FD&C Act, FDA will not disclose information from a facility registration on the brand names under which cosmetic products manufactured or processed in the facility are sold, or from a product listing on the facility registration number of the facility where the cosmetic product is manufactured or processed, in response to a request under the Freedom of Information Act (FOIA) (5 U.S.C. 552).
All other information from cosmetic product facility registration and listing would be available for public disclosure consistent with the FOIA, FDA’s disclosure regulations under 21 CFR Part 20, and other applicable federal law. FDA intends to make relevant information from cosmetic product facility registration and listing available to the public to the extent permitted by law.
For more information, visit the complete FDA guidance document: Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry
For questions regarding this draft document, contact the Office of Cosmetics and Colors at 240-402-1130.
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