In December 2023, the U.S. Food and Drug Administration (FDA) released final guidance on cosmetic facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
This comprehensive document clarifies requirements, defines key terms such as “contract manufacturer,” “responsible person,” “facility,” and “Data Universal Numbering System (DUNS) number,” and provides detailed instructions on submission responsibilities, necessary documentation, submission methods, deadlines, and exemptions. The FDA has also launched “Cosmetics Direct,” an electronic portal designed to streamline the submission process for facility registrations and product listings.
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 offers several options for submitting cosmetic facility registrations and product listings under MoCRA:
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Cosmetics Direct Portal – A user-friendly electronic platform for submitting registrations and listings without using the Electronic Submissions Gateway (ESG).
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Electronic Submissions Gateway (ESG) – An alternative electronic method for submitting Structured Product Labeling (SPL) files.
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SPL Xforms – An FDA-provided tool to assist in creating and submitting SPL files.
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Paper Forms – Facilities can submit Form FDA 5066 (facility registration) and Form FDA 5067 (product listing) by mail or email:
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Mail: FDA Office of Cosmetics and Colors, 5001 Campus Drive, College Park, MD 20740-3835
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Product Listing Fees
FDA does not impose any fees for the product listing process.
Recommendations
Since the launch of Cosmetics Direct on December 18, 2023, the FDA has officially started accepting facility registrations and product listings under the MoCRA. While the FDA has extended enforcement to July 1, 2024, companies are strongly advised to begin the process as soon as possible to ensure compliance.
- Review MoCRA’s guidelines on facility registration and product listing to determine your company’s obligations.
- Regularly review and update your product listings to maintain accuracy and compliance.
- Prepare key details such as product names, categories, ingredient lists, and manufacturing facility addresses.
- Submit facility registrations and product listings electronically through the Cosmetics Direct Portal for a streamlined process