FDA Launches Cosmetics Direct and Issues Final Guidance on Facility Registration & Product Listings Required under MoCRA

On December 18, 2023, the U.S. Food and Drug Administration (FDA) launched Cosmetics Direct, the electronic submission portal for facility registration and product listing required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and published a User Guide for the portal.[1] Cosmetics Direct contains user friendly data entry forms, performs initial validations, creates and saves the structured product labeling (SPL) submission, and submits the SPL to FDA.

The agency also issued final guidance with recommendations and instructions to assist those who are submitting facility registration and product listing information to the FDA. Among other things, this guidance covers who is responsible for making submissions, how and when to make submissions, and the information that must be included.[2]

The following information will need to be submitted as part of the facility registration process:

• The name of the owner and/or operator of the facility;
• The complete name of the facility;
• The country, street address, city, state or province, and zip/postal code where the facility is physically located;
• The facility email address and telephone number (including area or country code);
• The contact information for the United States agent (for facilities located outside the U.S.): name, telephone number, email address, and (optional) U.S. agent phone extension;
• The facility registration number (or FDA Establishment Identifier (FEI));
• All brands names under which cosmetic products manufactured or processed in the facility are sold;
• The product category or categories and codes[3] for each cosmetic product manufactured or processed at the facility;
• The responsible person listed on the cosmetic product labels;
• Type of submission;
• (Optional) Additional contact information for individuals associated with the registration.
• (Optional) Parent company name (if applicable);
• (Optional) Facility DUNS Number; and

The following information will need to be submitted as part of the product listing submission:

• The facility registration number (FEI) 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[4] for the cosmetic product(s);
• A list of ingredients in the cosmetic product(s), including any fragrance, flavors, or colors, with each ingredient identified by the name, or by the common or usual name of the ingredient;
• The product listing number (a number that FDA will generate for each unique product and needs to be included only if previously assigned);
• Type of submission (initial, update to content (annual), abbreviated renewal);
• (Optional) Parent company name (if applicable);
• (Optional) Type of business listed on the label (i.e., manufacturer, packer, or distributor);
• (Optional) Image of the label;
• (Optional) Product webpage link;
• (Optional) Whether the cosmetic product is for professional use only;
• (Optional) Responsible person DUNS Number for address listed on product label;
• (Optional) Unique Ingredient Identifiers[5] (UNIIs); and
• (Optional) Additional contact information for individuals associated with the listing.

Before starting the submission process, companies must first obtain a facility registration number. The facility registration number is the same as the FDA Establishment Identifier (FEI), a unique, 7-to-10-digit identifier assigned by the FDA to identify companies associated with FDA-regulated products. To determine if an entity already has an FEI number, companies should use the FEI Search Portal. To request an FEI, contact feiportal@fda.hhs.gov and provide the following information:

1. Legal name of the company;
2. Whether the requestor is acting as an agent;
3. Any alternative company names, including those used for “doing business as” purposes;
4. Physical address of the company;
5. Designated mailing address for the company;
6. Name and contact information of the designated contact person at the facility being registered;
7. A comprehensive list of activities conducted at the specific, facility location;
8. Any registration numbers associated with other FDA Center(s) (if applicable);
9. Any former names for the company; and
10. Any previous addresses linked to the company.

Per FDA’s guidance, requests for FEI numbers may take approximately 7-to-10 business days to process.

Although FDA previously announced that it does not intend to enforce the facility registration and product listing requirements for an additional six months after the December 29, 2023 statutory deadline (until July 1, 2024), the portal is now open for companies who choose to submit this information electronically. Notably too, this enforcement delay does not impact the other provisions of MoCRA that become effective December 29, 2023, including the requirements to report serious adverse events, and ensure and maintain records supporting the safety substantiation of cosmetic products.