The short answer
Fresh produce is regulated by two U.S. agencies. USDA APHIS decides whether a fruit or vegetable may enter from your country at all and under what treatment. FDA covers food safety: the Produce Safety Rule on farms, registration of packing houses, pesticide residues and the importer’s FSVP.
What exporters should watch for
🌾 Farms vs packing houses
Farms that grow and pack their own produce are generally exempt from FDA facility registration but must follow the Produce Safety Rule (21 CFR Part 112) for water, soil amendments, worker hygiene and sanitation. Packing houses and cold stores that handle other farms’ produce usually must register.
🛂 USDA APHIS permission first
Before thinking about FDA, check that USDA APHIS allows the fruit or vegetable from your country. Many need an import permit, a phytosanitary certificate and a treatment such as irradiation, cold treatment or hot water. Some commodities also have USDA grade rules (Section 8e).
🧪 Pesticide residues
Residues must be within U.S. EPA tolerances. A pesticide that is legal at home but has no U.S. tolerance for that crop makes the produce violative at any level. FDA tests imported produce and keeps import alerts for repeat pesticide violations.
📋 Traceability and FSVP
Many fresh fruits and vegetables are on FDA’s Food Traceability List. The compliance date for the extra traceability records has been extended to July 20, 2028. The U.S. importer also needs an FSVP that verifies each grower or packer.
Common reasons shipments are stopped
- No USDA APHIS permission or missing phytosanitary treatment
- Pesticide residues without a U.S. tolerance
- Packing house not registered or no Prior Notice
- Pathogens such as Salmonella or Listeria
- No FSVP at the U.S. importer
🏢 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 fruit and vegetable farms need FDA registration?
A farm that only grows, harvests and packs its own produce is usually exempt from food facility registration. Packing houses, cold stores and processors that handle produce from other farms generally must register, name a U.S. Agent and file Prior Notice for each shipment.
What is needed to export mangoes or other fresh fruit to the U.S.?
First, USDA APHIS must allow that fruit from your country. Mangoes from several countries, for example, must be irradiated or hot-water treated under USDA supervision. Then FDA rules apply: registered packing house, Prior Notice, pesticide residues within U.S. tolerances, and an FSVP at the U.S. importer.
When does the food traceability rule apply to fresh produce?
FDA extended the compliance date for the food traceability rule (FSMA Section 204) to July 20, 2028. Exporters of foods on the Food Traceability List, such as leafy greens, fresh herbs, tomatoes, peppers, cucumbers, melons and tropical tree fruits, should start keeping lot-level records now.
Sources
- eCFR — 21 CFR Part 112, Standards for the growing, harvesting, packing and holding of produce
- FDA — FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods
- Federal Register — Food traceability rule compliance date extension (Aug 7, 2025)
- 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.