The short answer
Mushrooms cover three very different routes: fresh mushrooms follow produce rules, dried mushrooms are processed foods, and canned mushrooms are low-acid canned foods. Listeria in enoki mushrooms has caused U.S. outbreaks.
What exporters should watch for
🌿 Fresh mushrooms
Mushroom farms are covered by the Produce Safety Rule, and packers that handle other growers’ mushrooms register with FDA. Enoki mushrooms have been linked to Listeria outbreaks, and FDA has put several suppliers on import alert.
🥫 Canned mushrooms
Canned mushrooms are low-acid canned foods. The cannery needs FCE registration and an SID filing for each product and container size.
🍄 Dried and wild mushrooms
Drying plants register. Wild mushrooms must be correctly identified by species, and buyers test for pesticides and heavy metals.
🏷️ Labels and cooking advice
Labels need the common name of the mushroom and U.S. units. Many enoki packs now carry “cook thoroughly” advice because they are often eaten raw.
Common reasons shipments are stopped
- Listeria in enoki or other fresh mushrooms
- Canned mushrooms without FCE or SID
- Misidentified wild species
- Pesticide residues
- No Prior Notice or FSVP
🏢 No U.S. company to act as FSVP importer? Orionex can be your U.S. FSVP importer (FSVP agent) 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 mushroom farms need FDA registration?
Farms that grow and pack only their own mushrooms are generally exempt from registration but follow the Produce Safety Rule. Packing houses, dryers and canners that handle mushrooms from others must register.
Why are enoki mushrooms on FDA import alert?
Enoki mushrooms from several suppliers tested positive for Listeria monocytogenes and were linked to U.S. illnesses, so FDA detains shipments from those suppliers without examination.
Do canned mushrooms need an FCE and SID?
Yes. Mushrooms are a low-acid food, so canned mushrooms need FCE registration and a Scheduled Process filed for each product and container size before export.
Sources
- eCFR — 21 CFR Part 112, Produce Safety Rule
- FDA — Acidified & Low-Acid Canned Foods (LACF) registration
- 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.