The short answer
“Coconut products” covers very different foods under FDA rules. Coconut water is treated as a juice, canned coconut milk is a low-acid canned food that needs FCE and SID filings, and desiccated coconut is watched for Salmonella. Since January 2025, FDA no longer lists coconut as a tree nut allergen.
What exporters should watch for
🧃 Coconut water is a juice
FDA applies the juice HACCP rule (21 CFR Part 120) to coconut water. Processors need a juice HACCP plan with a 5-log pathogen reduction step. FDA has issued warning letters to coconut water exporters for missing juice HACCP controls.
🥫 Canned coconut milk and cream
Coconut milk in cans or retort pouches is usually a low-acid canned food (21 CFR Part 113). The plant needs a Food Canning Establishment (FCE) number and a Scheduled Process (SID) filed with FDA for each product and pack size before shipping.
🦠 Desiccated coconut and Salmonella
Desiccated and shredded coconut are eaten without cooking, so FDA samples them for Salmonella. Firms with positive results can be placed on import alerts and detained without examination.
🏷️ Labels and the allergen change
FDA’s January 2025 allergen guidance removed coconut from the list of tree nuts, so it no longer needs a “Contains: Tree nuts (coconut)” statement. Labels still need the full ingredient list, Nutrition Facts and U.S. units.
Common reasons shipments are stopped
- No juice HACCP plan for coconut water
- Missing FCE or SID for canned coconut milk
- Salmonella in desiccated coconut
- Sulfites not declared in desiccated or dried coconut
- Facility not registered or no Prior Notice
🏢 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 product — we’ll confirm what FDA requires, in writing, by email.
Frequently asked questions
Does coconut water need juice HACCP?
Yes. FDA treats coconut water as a juice, so processors must follow 21 CFR Part 120, including a hazard analysis and a validated 5-log pathogen reduction. Products that are shelf-stable and low-acid may also fall under the canned food rules.
Is coconut still a tree nut allergen in the U.S.?
No. In its January 2025 final allergen guidance FDA removed coconut from its list of tree nuts. Coconut must still be named in the ingredient list, and many brands keep an informational statement for consumers.
Does canned coconut milk need FCE and SID?
Usually yes. Coconut milk and cream are low-acid foods, so when packed in hermetically sealed containers and heat-treated, the plant must register as a Food Canning Establishment and file a Scheduled Process for each product before export.
Sources
- eCFR — 21 CFR Part 120, Hazard Analysis and Critical Control Point (HACCP) Systems for juice
- FDA warning letter — Harmless Harvest Thailand (coconut water, juice HACCP)
- eCFR — 21 CFR Part 113, Thermally processed low-acid foods packaged in hermetically sealed containers
- Covington — FDA finalizes two guidance documents related to food allergens (Jan 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.