Selling food, supplements, or consumer goods on Amazon USA as a foreign manufacturer means clearing FDA compliance first. Orionex handles the registration, the paperwork, and the ongoing compliance — so your products reach Amazon's fulfillment centers without delays.
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Yes. Any foreign facility that manufactures, processes, packs, or holds food for U.S. consumption — including Amazon FBA inventory — must be registered with the FDA under the Bioterrorism Act and FSMA. Without FDA registration, your products can be refused entry at U.S. customs before reaching Amazon's fulfillment centers. You also need a U.S. Agent physically located in the United States.
FSVP stands for Foreign Supplier Verification Program. Under FDA's FSMA rules, the U.S. importer of record — often the Amazon FBA seller or their nominated importer — must have an FSVP in place. This means conducting hazard analysis, verifying your foreign supplier's compliance, and maintaining records. Without FSVP, your shipments can be refused at the border. Orionex provides complete FSVP program development and acts as your FSVP Qualified Individual.
Through Orionex, FDA food facility registration is typically completed in 3–7 business days. Work begins within 1 business day of payment. You will receive your official FDA FEI number and Certificate of Registration — ready to use for Amazon Seller Central and U.S. customs documentation.
Yes, but dietary supplements face additional FDA requirements beyond standard food facility registration. Your labels must comply with FDA supplement labeling rules including a Supplement Facts panel, structure/function claim disclaimers, and correct net quantity declarations. Orionex handles FDA registration, label review, FSVP, and U.S. Agent services for supplement exporters selling on Amazon USA.
The minimum requirement is FDA Food Facility Registration plus a U.S. Agent. Amazon FBA sellers typically also need FSVP compliance and a compliant product label. Orionex combines these into a single Amazon FBA compliance engagement rather than billing each piece separately — see our Services & Pricing page for current rates, or reach out for a quote tailored to your product line.