Quick answer: Yes — any Thai facility exporting food, drugs, devices, or cosmetics to the U.S. must register with the FDA and designate a U.S. Agent. Thailand is one of the largest source countries for U.S. seafood imports, and FDA maintains shrimp-specific import alert history for Thai product, including a dedicated alert for canned shrimp. Orionex provides FDA registration and U.S. Agent services for Thai exporters starting at $300/year.
Thailand's Scale in the U.S. Seafood Supply
Thailand consistently ranks among the top countries supplying edible fishery products to the United States, accounting for roughly 9% of total U.S. seafood import volume in recent FDA data — placing it among the largest source countries alongside Canada, India, and Vietnam. Shrimp is the single largest category of U.S. seafood imports by volume overall, and Thailand is a major contributor to that supply.
Shrimp-Specific Import Alert History
This scale comes with dedicated regulatory attention. FDA maintains import alerts that specifically name Thailand among shrimp-exporting countries subject to enforcement scrutiny, and maintains a separate, dedicated import alert specifically for canned shrimp from Thailand — distinct from the broader alerts covering fresh and frozen shrimp from multiple countries at once. This level of product-and-country specificity reflects Thailand's outsized role in the category, not a general concern about Thai food safety broadly.
If you export shrimp from Thailand: check the current status of shrimp-related import alerts before shipping, since these are actively maintained and can be modified. A firm-specific or product-specific detention history elsewhere in your supply chain can affect your own shipments even if your facility hasn't personally had a violation.
Seafood HACCP Still Applies
Beyond import alert history, Thai seafood processors follow the same Seafood HACCP requirements under 21 CFR Part 123 that apply to any country's seafood exporters — a mandatory, facility-specific hazard control plan in addition to standard registration. See our seafood-specific guide for the full HACCP framework, including the enforcement mechanism (Import Alert 16-120) that applies broadly across seafood-exporting countries, Thailand included.
Standard FDA Requirements Still Apply
- FDA Food Facility Registration for food, beverage, and supplement exporters
- Drug Establishment Registration for pharmaceutical manufacturers
- Medical Device Establishment Registration for device manufacturers
- MoCRA Cosmetic Registration for cosmetic manufacturers
- A U.S. Agent for all of the above
U.S. Agent Requirement for Thai Facilities
Every Thai facility registering with the FDA must designate a U.S. Agent physically located in the United States as its official FDA point of contact.
Orionex Regulatory Solutions is a trusted FDA U.S. Agent for Thai exporters, physically based in Casper, Wyoming USA. Learn about our U.S. Agent services →
Thai Exporter Compliance Checklist
Register With the FDA in the Correct Category
Food, drug, device, or cosmetic — requirements differ by product type.
Designate a U.S. Agent
Required for all Thai exporters.
Confirm Seafood HACCP Compliance
Required in addition to registration for any seafood processor.
Check Current Shrimp Import Alert Status
Especially relevant for canned shrimp exporters.
Renew on Schedule
Food facilities renew biennially — next window: October 1 – December 31, 2026. See our renewal guide.
What Orionex Provides for Thai Exporters
The FDA charges no government fee for food facility registration. Orionex's fixed pricing:
- Food Facility Registration + U.S. Agent + Certificate: $300/year
- Drug Establishment Registration + U.S. Agent: $550/year
- Medical Device Establishment Registration + U.S. Agent: $550/year
- MoCRA Cosmetic Registration + U.S. Agent: $650/year
Note: Orionex handles your FDA registration and U.S. Agent designation. Confirming your seafood facility's current standing against active shrimp import alerts is worth doing before shipping — contact us if you'd like guidance.
Why Thai Exporters Choose Orionex
FDA Registration & U.S. Agent for Thai Exporters — From $300/Year
Orionex handles FDA registration and U.S. Agent services for Thai food, drug, device, and cosmetic manufacturers exporting to the United States.