The short answer
Pet food and treats are regulated by FDA’s Center for Veterinary Medicine. Foreign plants making pet food for the U.S. must register with FDA like any food facility — and treats made from animal parts usually need USDA permits as well.
What exporters should watch for
🏭 Registration and preventive controls
Pet food and treat factories must register with FDA as animal food facilities, name a U.S. Agent and, unless exempt, follow FDA’s Current Good Manufacturing Practice and Preventive Controls for Animal Food rule (21 CFR Part 507).
🦠 Salmonella
FDA keeps Import Alert 71-04 for animal food contaminated with Salmonella, updated in October 2026. Pet treats such as chews and jerky are tested, because people handle them too.
🐄 Animal-origin ingredients
Treats and foods containing meat, bones, hides or other animal products usually need USDA APHIS veterinary import permits or certificates, in addition to FDA rules — check before the first shipment.
🏷️ Labels
Pet food labels must show the product name, net quantity, guaranteed analysis, ingredient list in descending order and the manufacturer or distributor. Claims to treat or prevent disease make it an animal drug.
Common reasons shipments are stopped
- Salmonella in treats and chews
- Animal-origin ingredients without USDA permits
- Disease claims on pet food or supplements
- Facility not registered as an animal food facility
- Labeling — missing guaranteed analysis or ingredient list
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP agent service for food and dietary supplements — from $80 per shipment, with the program and Qualified Individual included.
What you need to register — and what it costs
| Product type | FDA requirement | Orionex price |
|---|---|---|
| Food, beverages, supplements | Food facility registration + U.S. Agent, renewed every 2 years; Prior Notice for each shipment | $300/year or $450 for 2 years |
| Cosmetics | MoCRA facility registration (every 2 years) + product listing + U.S. Agent | $300/year or $450 for 2 years; listing $150/product |
| Medical devices | Establishment registration (yearly, FDA fee paid separately) + device listing; 510(k) for many Class II devices | $550/year; listing $50/device |
| Drugs (incl. OTC) | Drug establishment registration (yearly) + NDC labeler code + drug listing | $550/year; listing $350/product |
Every Orionex registration includes the U.S. Agent service, D-U-N-S number set-up where needed and a Certificate of Registration. All prices →
Tell us your product — we’ll confirm what FDA requires, in writing, by email.
Frequently asked questions
Do pet food manufacturers need FDA registration?
Yes. Facilities that manufacture, process, pack or hold animal food — including pet food and treats — for the U.S. must register with FDA and name a U.S. Agent, and each shipment needs Prior Notice. Most also need a written animal food safety plan under 21 CFR Part 507.
Do dog chews made from animal parts need USDA approval?
Usually, yes. Products made from animal hides, bones or meat generally need USDA APHIS import permits or veterinary certificates to control animal diseases, in addition to FDA registration and Salmonella controls.
Sources
- eCFR — 21 CFR Part 507, Current Good Manufacturing Practice and Preventive Controls for Food for Animals
- FDA — Import Alerts by Publish Date
- eCFR — 21 CFR Part 1 Subpart H, Registration of Food Facilities
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.