U.S. FDA registration & U.S. Agent services · Casper, Wyoming, USA info@regovant.com+1 307-301-7465
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FDA Food Facility Registration for Australian Companies

Exporting honey, macadamias, wine, snacks and supplements from Australia to the U.S.? Each facility that makes, packs or stores them must be registered with the U.S. FDA and name a U.S. Agent, in addition to your food business registration with your state or territory authority and your export registration with the Department of Agriculture. We do it for $269 a year.

  • Registration filed in 1 to 5 business days once we have your details
  • U.S. Agent service in the United States included
  • Certificate of registration your U.S. buyers can verify online
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Pricing for Australian companies

USD
Registration + U.S. AgentPer facility, per year$269
Additional facilitySame owner$169
Prior NoticePer shipment$25
FDA charges no fee for food registrationCard or PayPal

Do Australian food companies need FDA registration?

Yes. Under U.S. law, every facility that manufactures, processes, packs or holds food for people or animals in the United States must be registered with the U.S. Food and Drug Administration. This applies to facilities in Australia exactly as it does to U.S. facilities. Typical Australian products we register include honey, macadamias, wine, dairy, snacks and supplements.

Your food business registration with your state or territory authority and your export registration with the Department of Agriculture are still needed at home, but they do not replace FDA registration. Without a valid FDA registration, your shipments can be held at the U.S. port and your importer cannot file Prior Notice correctly.

What you need

  • The facility's legal name and exact physical address
  • A D-U-N-S number for that address. It is free from Dun & Bradstreet but can take several weeks, so request it early.
  • An emergency contact phone answered 24 hours a day
  • A list of the foods made, packed or stored at the facility

Complementary medicines sold as supplements

Complementary medicines sold in the U.S. as dietary supplements must follow FDA's supplement rules, including U.S.-format labels and no claims to treat or cure disease. See our label reviews.

Wine, beer and spirits

Wineries, breweries and distilleries must register with FDA too. Separately, your U.S. importer needs label approval from the Alcohol and Tobacco Tax and Trade Bureau (TTB).

How Regovant helps

  1. Order online and pay by card or PayPal in U.S. dollars. $269 per facility per year.
  2. Send your details through one short registration form.
  3. We check and file. We check your D-U-N-S details, file with FDA and act as your U.S. Agent.
  4. You receive your FDA registration number and a Regovant certificate of registration your buyers can verify.

Food facility registrations are renewed between October 1 and December 31 of every even-numbered year. We email you before each renewal. See the 2026 renewal guide or our step-by-step registration guide.

Questions

We are approved by your state authority. Do we still need FDA registration?

Yes. Approvals at home cover Australia. For the U.S., each facility that makes, packs or stores the food must be registered with the U.S. FDA.

Do Australian facilities need a U.S. Agent?

Yes. Every food facility outside the U.S. must name a U.S. Agent located in the United States. It is included in our $269 price.

Can you register more than one of our facilities?

Yes. Each address is registered separately. Additional facilities with the same owner are $169 each.

Registering from another country? See FDA registration by country.