A marketplace listing can put a foreign food or cosmetic brand in front of US customers within days, but it does not change what FDA requires. The same rules apply whether a product is sold to a supermarket chain, through a distributor or directly to consumers on Amazon or a brand's own web shop. Marketplaces also set their own document requests, which can differ from FDA's requirements and from one product category to another. This guide separates the two: what FDA requires, and what to prepare when a marketplace asks for evidence.
Food: facility registration rules do not change online
Under 21 CFR part 1, subpart H, facilities that manufacture or process, pack, or hold food for consumption in the United States must register with FDA unless an exemption applies. For a foreign brand, that usually means the factory that makes the food and any foreign facility that packs or stores it before export. A foreign facility is exempt only when its food undergoes further manufacturing or processing, including packaging, by another facility outside the United States, and that exemption does not apply when the later facility only adds labeling or performs a similarly minor activity. Each registered foreign facility must designate a U.S. agent who resides or maintains a place of business in the United States.
Online selling raises one question that store-based selling usually does not: whether the seller itself is a retail food establishment. FDA's definition covers an establishment whose primary function is selling food directly to consumers, measured by whether the annual value of its direct-to-consumer food sales exceeds its sales to all other buyers, and businesses do not count as consumers. Retail food establishments are exempt from registration. Whether a particular online seller meets that definition depends on the facts, and the exemption never covers the foreign facility that made the food.
Labels, Prior Notice and FSVP
Food sold online must meet the same labeling requirements as food sold in stores, including the statement of identity, net quantity, ingredient list, major food allergen declaration, nutrition labeling where required, and the name and place of business of the manufacturer, packer or distributor. If the food is imported, FDA must receive Prior Notice for each shipment, including commercial parcels sent by courier or international mail. If a US importer brings the food in, that importer must also meet the Foreign Supplier Verification Program (FSVP) requirements, which include verifying the foreign supplier. See Prior Notice for imported food and the FSVP gap analysis for foreign food suppliers.
Cosmetics: MoCRA registration, listing and label contact details
For cosmetics, MoCRA requires the owner or operator of a facility that manufactures or processes cosmetic products for US distribution to register that facility with FDA, and requires the responsible person, meaning the manufacturer, packer or distributor whose name appears on the label, to list each cosmetic product. Facility registrations are renewed every two years and product listings are updated annually. The label must also carry domestic contact information through which the responsible person can receive adverse event reports. If your company's name appears on the label as manufacturer, packer or distributor, your company is the responsible person for that product. Certain small businesses are exempt from registration and listing, with exceptions for some product types; see who qualifies for the MoCRA small business exemption.
Listing and label details are covered in how to list cosmetic products under MoCRA and the MoCRA label contact requirement. The responsible person must also keep records supporting each product's safety, as explained in MoCRA section 608 safety substantiation.
When a marketplace asks for documents
Marketplaces may ask sellers for evidence of FDA registration, product listing, label artwork or ingredient information, and their requests change over time. FDA does not issue registration certificates, so the right evidence for food is the facility's registration number and a copy of its valid registration, and for cosmetics the facility registration number and product listing numbers from Cosmetics Direct. Avoid presenting a registration as an FDA approval: FDA states that a registration number does not convey approval or endorsement. What FDA does and does not issue is explained in our guide to FDA registration certificates and proof of registration.
Pre-launch checklist
- Identify every facility in the supply chain that manufactures or processes, packs, or holds the food, and confirm each one's registration status and U.S. agent.
- Have the label reviewed against US requirements before printing, including allergens and the net quantity declaration.
- Set up Prior Notice for every food shipment, including samples and small parcels.
- For cosmetics, confirm facility registration, product listing and the label's domestic contact information.
- Keep registration numbers, listing numbers and confirmations in one place so you can answer marketplace and importer requests quickly.
How FDABridge helps
FDABridge registers food and cosmetic facilities, lists cosmetic products, reviews food and cosmetic labels against US requirements and prepares Prior Notice for agreed shipments. Service scope is set out on the pages for food facility registration, food label review, Prior Notice, cosmetic facility registration, cosmetic product listing and cosmetic label review, with U.S. agent coverage in selected registration services described on the U.S. Agent page. FDABridge is not affiliated with FDA or with any marketplace, and registration or listing does not mean that FDA has approved a product.