Every food or supplement shipment entering the U.S. must name an FSVP importer — often called an FSVP agent. If you sell from abroad, including through Amazon FBA or your own web store, Orionex Trading LLC (Casper, Wyoming) can take the role. We build and keep your FSVP program, and give your broker our importer details for every entry.
Quick answer: Under FDA's FSVP rule (21 CFR 1.500), the FSVP importer is the U.S. owner or consignee of the food when it enters. When there is no U.S. owner or consignee, the foreign owner must appoint a U.S. agent or representative, with written consent, as FSVP importer. Orionex fills that role for food, beverage and dietary supplement exporters. Customs clearance, duties and the bond still go through your own broker or courier.
Sellers in Canada, the UK, the EU, Japan, Australia and elsewhere sending food or supplements to FBA warehouses. Brokers and couriers can stop or return shipments that name no FSVP importer.
Brands selling from their own web store and shipping by DHL, FedEx or UPS, where the U.S. customer cannot be the FSVP importer.
When your U.S. distributor or buyer does not want the FSVP responsibility, or you sell to many small U.S. buyers.
If a broker or courier stopped your goods because no FSVP importer was on file, we can set one up and send your broker the details.
Both plans start with a one-time FSVP program set-up for your supplier and products. Then pay yearly or per shipment.
Example: annual plan, first year $1,000 ($400 set-up + $600), then $600 per year. We review your supplier documents before we accept the importer role, so you may prefer to send your products for review first.
As FSVP importer we take legal responsibility for your products, so we accept a product only after reviewing the supplier's documents. Have these ready:
📎 No supplier login is needed. We send a secure upload link by email, which you can forward to your supplier.
Tell us what you ship, who makes it and how often, using the form below.
We check the supplier documents and confirm by email, with the agreement and invoice.
Hazard analysis, supplier approval and QI sign-off. Your FSVP file is ready.
Your broker files the entry with Orionex as FSVP importer. We keep the records up to date.
Tell us about your products and supplier. We reply by email with what we need and the next steps.
Or email fsvp@orionexregulatory.com.
Yes, in practice. FDA’s rule uses the term FSVP importer. When a food has no U.S. owner or consignee at entry, the foreign owner appoints a U.S. agent or representative to take that role, and many people call this an “FSVP agent”. It is the same job: verifying foreign suppliers and keeping the FSVP records.
No. A U.S. Agent is named in a foreign facility’s FDA registration and is FDA’s contact for that facility. The FSVP agent or importer is responsible for verifying foreign suppliers for the food being imported. A facility can need both, and Orionex provides both: see U.S. Agent service.
When FDA-regulated human or animal food is imported and there is no U.S. owner or consignee at the time of entry, for example when a foreign brand ships to Amazon warehouses or sells directly to U.S. customers. If a U.S. company buys and owns the food at entry, that company is normally the FSVP importer instead. Some foods are exempt, such as certain juice and seafood made under HACCP rules, food for personal use and most alcoholic beverages.
Usually yes. For food and supplements sent to Amazon fulfillment centers, the seller normally owns the goods at entry. A seller with no U.S. company needs a U.S. FSVP agent or importer whose name, email and D-U-N-S number the broker files with each entry. Without one, couriers and brokers can hold or return shipments.
FDA checks that each food entry names an FSVP importer and can ask for FSVP records, which must be provided within 24 hours of a request. FDA also carries out FSVP inspections. Problems can lead to warning letters, held or refused shipments and placement on an FSVP import alert, which blocks entries until the issue is fixed.
The FSVP importer is the company responsible for verifying that imported food or supplements were made to U.S. safety standards. Under 21 CFR 1.500 it is the U.S. owner or consignee of the food when it enters. If there is none, the foreign owner must appoint a U.S. agent or representative, with written consent, to act as the FSVP importer. Their name, email and D-U-N-S number are filed with every customs entry.
No. The FSVP importer must be in the United States. A foreign manufacturer, exporter or Amazon seller with no U.S. company needs a U.S. business to take the role, such as its U.S. buyer or a service like Orionex.
No. The importer of record is a customs role: it files the entry and pays duties, taxes and the customs bond, usually through a broker or courier. The FSVP importer is an FDA role for supplier verification. They can be different companies. Orionex acts as FSVP importer only; your broker or courier still handles customs.
At $80 per shipment, the annual plan ($600) costs less once you ship 8 or more times a year. Amazon FBA sellers who send monthly usually choose annual. Occasional exporters choose per shipment.
Yes, if the manufacturer is not already registered. Food facility registration (with a U.S. Agent) is the manufacturer's obligation, and FSVP is the importer's. Orionex can do both, and Prior Notice for each shipment.
Human food, beverages and dietary supplements regulated by FDA. Some products are fully or partly exempt from FSVP, such as juice and seafood made under FDA's HACCP rules, some alcoholic beverages, food for personal use and meat, poultry and egg products regulated by USDA. Ask us and we will confirm.
Work begins within one business day of payment. How fast the program is ready depends mainly on how quickly your supplier sends the documents.
Send your products and supplier details. We reply within one business day.