The short answer
Guatemala ships fresh vegetables, berries, melons, coffee and cardamom to the U.S. Fresh produce gets the closest FDA attention — Guatemalan raspberries were linked to Cyclospora outbreaks in the U.S. in the 1990s, and produce safety has been a focus ever since.
What Guatemalan exporters should watch for
🫐 Berries and vegetables
Farms must meet FDA’s Produce Safety Rule — water quality, worker hygiene and sanitation matter most. Packing houses that are not part of a farm must register with FDA. Pesticide residues must meet U.S. tolerances.
🌿 Cardamom and spices
Guatemala is one of the world’s largest cardamom exporters. Spices are tested for Salmonella (Import Alert 99-19), filth and pesticide residues — test each lot before shipping.
☕ Coffee
Processing plants and warehouses register with FDA and name a U.S. Agent; each shipment needs Prior Notice. Farms that only grow and dry their own coffee are generally exempt.
🍈 Melons
Melons are a higher-risk produce for Salmonella. Growers and packers should expect buyers to ask for food safety plans and test records.
Common reasons Guatemalan shipments are stopped
- Pesticide residues on vegetables and berries
- Salmonella and filth in spices
- Produce safety gaps — water, hygiene, sanitation
- No Prior Notice or packer not registered
- Labeling — Spanish-only labels
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP importer 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 products — we’ll confirm what you need to register, in writing, by email.
Frequently asked questions
Does Guatemalan cardamom need FDA registration?
Yes. The facility that cleans, dries, grades or packs cardamom for the U.S. must register with FDA and name a U.S. Agent, each shipment needs Prior Notice, and lots should be tested for Salmonella and pesticide residues.
Do Guatemalan farms need FDA registration?
Farms are generally exempt from food facility registration but must meet FDA’s Produce Safety Rule. Packing houses and processors that are not part of a farm must register and name a U.S. Agent.
Sources
- FDA — FSMA Final Rule on Produce Safety
- FDA Import Alert 99-19 — Salmonella (notes separate alerts for black pepper from India and Brazil)
- 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.