On August 7, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on cosmetic facility registrations and product listings (draft guidance). This document, available for public consultation until September 7, 2023, holds significant relevance under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
The draft guidance refines the requirements for cosmetic facility registration and product listing. It brings clarity to essential terms like “contract manufacturer,” “responsible person,” “facility,” and “Data Universal Numbering System (DUNS) number.” Moreover, it provides comprehensive guidance for the entities responsible for submitting the application for registration and listing, as well as necessary documentation, submission methods, submission deadlines, and exemptions from registration and listing requirements.
Below are the key requirements for product listing.
Entities Requiring Product Listing
Cosmetic responsible person, i.e., the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label, is mandated to submit the product listing.
Much like the exemptions applicable to facility registration, there are two scenarios where product listing exemptions apply:
“Small business” cosmetic responsible persons, provided their average gross annual cosmetics sales within the U.S. for the preceding three years remain below $1 million, and their products do not include mucus-membrane-contacting cosmetics, injected cosmetics, or some cosmetics categorized as high-risk.
Enterprises whose product categories satisfy the definitions of both cosmetics and drugs.
Required Information
Mandatory Information
- Facility registration number of each manufacturing or processing facility for the cosmetic product;
- Name and contact number of the responsible person, as well as the product name as it appears on the label;
- Applicable cosmetic category or categories for the product;
- A list of ingredients in the cosmetic product, including any fragrances, flavors, and colors. Each ingredient should be identified by the name required in the Code of Federal Regulations (21 CFR Part 701.30), or any successor regulations, or by its common or usual name;
- Product listing number, if previously assigned by FDA.
- Type of submission (initial, update to content, and abbreviated renewal).
Optional Information
- Parent company name (if applicable);
- Type of business (as listed on the label, i.e., manufacturer, packer, or distributor);
- Label image;
- Product webpage link;
- Whether the cosmetic product is for professional use only;
- Responsible person DUNS number for address listed on the product label;
- Unique ingredient identifiers (UNIIs);
- Additional contact details for associated individuals.
Public Accessibility of Product Listing Information
As outlined in the draft guidance, the product listing number and details of the manufacturing and processing enterprise associated with the product will remain confidential and will not be publicly disclosed. However, other relevant information will be made accessible to the public.
Submission Methods
The FDA is currently in the process of developing a new electronic submission portal for facility registration and product listing, projected for launch in October 2023. Once operational, enterprises will opt for either electronic or paper form submission. For international companies, electronic submission is recommended due to the convenience.
Furthermore, the FDA is recruiting cosmetics companies for participation in the internal test of the electronic submission portal. This initiative aims to gather valuable insights from participants to improve the submission portal. Interested stakeholders can submit an electronic application to eRLC.testing@fda.hhs.gov.
Product Listing Fees
FDA does not impose any fees for the product listing process.
Recommended Preparations
Given the current situation, initiating product listing submission is not feasible as of now, as the official release of the electronic submission platform and paper submission form is slated for October 2023.
In light of this, enterprises are strongly advised to proactively undertake preliminary measures in anticipation of the upcoming product listing. These steps may encompass securing a business FEI number, designating a U.S. agent, and sorting out product information.
