FDA Registration & FSVP
for Amazon FBA Sellers

FSVP (Foreign Supplier Verification Program) is a mandatory FDA requirement under FSMA for any U.S. importer of food or dietary supplements — including Amazon FBA sellers sourcing from foreign manufacturers. FSVP requires a hazard analysis of each foreign supplier, ongoing verification activities, and records maintained by a Qualified Individual (QI). Without FSVP, your shipments can be detained at U.S. ports. Orionex acts as your Qualified Individual and handles all FSVP documentation.

Your shipment will be held by U.S. Customs and Border Protection. FDA holds result in storage fees, delays, and potential refusal of entry — meaning your inventory is returned or destroyed at your cost. Your Amazon seller account may also be flagged or suspended. Prior Notice must be filed with the FDA for every food shipment entering the United States, typically 2–5 days before arrival at the U.S. port.

Yes — exporters from India, Sri Lanka, Thailand, Vietnam, Malaysia, Indonesia, and other countries can legally sell food and dietary supplements on Amazon USA, provided they meet FDA compliance requirements: FDA food facility registration, a U.S. Agent, FSVP program compliance, FDA-compliant English labeling, and Prior Notice for each shipment. Orionex serves exporters in 60+ countries worldwide — including India, Sri Lanka, Thailand, Vietnam, Turkey, UAE, Brazil, Colombia, EU member states, and more — with complete compliance packages starting from $990.

FDA food facility registration is typically acknowledged within 2–5 business days. Orionex begins work within 1 business day of payment and required information — most clients receive their FDA registration number and Certificate of Registration within 5–10 business days. FSVP program development takes an additional 5–7 business days. Full package turnaround is typically 10–14 business days.

Yes. All food and dietary supplement labels sold in the United States — including on Amazon — must be in English and comply with FDA labeling regulations. This includes a compliant Nutrition Facts or Supplement Facts panel, ingredient list in descending order of weight, allergen declarations, net quantity, and manufacturer or distributor statement. Amazon's compliance team flags labels that don't meet these standards. Our label review service checks all of this before your first shipment.