Cosmetic Product Listing Under MoCRA: Responsible Person, Grouping and Updates

Under FD&C Act section 607, cosmetic facility registration and product listing are distinct. The owner or operator of a covered facility handles registration; the manufacturer, packer or distributor whose name appears on the cosmetic label is the responsible person for a covered product listing. First check product classification, actual market status and applicable small-business or drug/device exceptions. Listing is a submission to FDA, not product approval or certification. See FDA’s current registration and listing overview: https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products .

Identify the responsible person and any exemption

The label-named responsible person, which may be a manufacturer, packer or distributor, submits the listing. A contract manufacturer’s facility owner/operator normally has a different registration duty. Certain small businesses are exempt from listing and registration, but not for specified products that regularly contact the eye mucous membrane, are injected, are intended for internal use, or alter appearance for more than 24 hours without customary consumer removal. Some drug/device products and facilities fall under different requirements. A U.S. agent for a foreign facility is not automatically the responsible person.

Information and facility identifiers

Form FDA 5067 and FDA’s final guidance describe the product name, cosmetic category, ingredients, responsible-person information and manufacturing/processing facility information for listing. Where a facility must register, its FEI-based facility registration number connects it to the listing. If the facility is exempt from registration and therefore has no required facility number, the listing may use its name and address instead. DUNS is optional information in the facility-registration context, not the required cosmetic facility identifier. Safety-substantiation records, label compliance and adverse-event records are separate responsibilities; do not confuse them with universal fields in the listing form. See https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-registration-and-listing-cosmetic-product-facilities-and-products .

When variants may be grouped

FDA permits one listing to include multiple cosmetic products with identical formulations, or formulations differing only in colors, fragrances, flavors or quantity of contents. A universal one-FDA-listing-per-SKU rule is therefore wrong. Review actual formulations, labels and scope before choosing a listing group. FDABridge’s approved $75 professional price per product and any bundle price are commercial billing units, not a statement that FDA always requires one submission per SKU.

Initial listing and updates

A responsible person generally lists a newly marketed cosmetic product within 120 days of marketing it, subject to the applicable statutory transition provisions. Product-listing updates are provided annually. There is no universal 60- or 90-day deadline to report every formulation change; assess whether an updated or new listing is appropriate and include the required information in the annual update. The facility owner/operator has a different generally 60-day amendment clock for required registration-information changes, and required facility registration renews every two years from its initial date.

Practical preparation and service scope

Confirm the label-named responsible person, actual product categories and ingredients, each manufacturing facility’s FEI or exempt-facility name/address, grouping eligibility, first-marketing date and existing listing status. FDABridge offers a scoped $75 per-product listing service and separate label-review, facility-registration and bundle services; scope and professional fees are distinct from FDA filing rules. Review https://fdabridge.com/cosmetic-product-listing and https://fdabridge.com/cosmetics . A request or payment does not establish that FDA has processed a listing, approved the product or admitted a shipment.