Under the Modernization of Cosmetics Regulation Act, facility registration and product listing are two separate mandatory obligations — and many foreign cosmetic manufacturers who completed their facility registration assumed they were done. They were not. Product listing requires the responsible person to submit detailed information about each cosmetic product sold in the US market, and the listing must be updated whenever product information changes. As of early 2026, the FDA's Cosmetics Direct system shows nearly one million active product listings, reflecting the scale of the compliance effort across the industry.
Who must list cosmetic products
The product listing obligation falls on the responsible person — defined under MoCRA as the manufacturer, packer, or distributor whose name appears on the product label. For foreign cosmetic brands, this is typically the brand owner or the US distributor, depending on whose name and address appear on the US market label. If the foreign manufacturer's name appears on the label, the foreign manufacturer is the responsible person and must submit the listing. If a US distributor's name appears on the label with a distributed by or manufactured for qualifier, the US distributor is the responsible person. Getting this determination wrong means either no one files the listing or the wrong entity files it — both create compliance problems.
What information is required in a product listing
Each product listing must include the product name as it appears on the label, the product category using the FDA's cosmetic product category codes, the responsible person's name and contact information, the facility registration number of every facility where the product is manufactured or processed, and the complete ingredient list. If the product is marketed under multiple brand names or in multiple formulations, each variation requires a separate listing. The ingredient list must match the actual formulation — not a generic or approximate version. The FDA uses product listing data for post-market surveillance, adverse event tracking, and inspection planning, so accuracy is not optional.
How product listing connects to facility registration
Product listing and facility registration are linked through the facility registration number. When you submit a product listing, you must identify the manufacturing facility by its registration number. If the facility is not registered — or if the registration has lapsed — the product listing cannot be properly associated with a registered facility. This means that facility registration must be completed and active before product listings can be submitted. For brands that use contract manufacturers, each contract manufacturing facility must be separately registered, and the product listing must reference the correct facility for each product.
Updating and maintaining product listings
Product listings are not static. Under MoCRA, the responsible person must update a product listing within 60 days of any change to the information previously submitted. This includes changes to the product name, formulation, manufacturing facility, or responsible person information. Products that are discontinued must also be updated to reflect their discontinued status. The FDA expects product listing data to be current at all times — not just at the time of initial submission. For foreign brands with large product portfolios, maintaining accurate listings across dozens or hundreds of SKUs requires a systematic approach to change management.
How FDABridge handles product listing for foreign brands
FDABridge manages MoCRA product listing for foreign cosmetic brands alongside facility registration. We determine responsible person status, prepare product listing submissions through Cosmetics Direct, and maintain listings as products and formulations change. Visit fdabridge.com/cosmetics to learn about our cosmetics compliance services or fdabridge.com/contact to get started.
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