Short answer: every shipment of Vietnamese farm and fishery products entering the United States must come from an FDA-registered foreign facility, carry a Prior Notice, and meet labeling and safety rules. Seafood covered by FDA’s HACCP regulation is exempt from the importer’s Foreign Supplier Verification Program — but shrimp detained for salmonella or banned antibiotics shows how narrow the margin for error is.
The real-world problem
A Vietnamese shrimp packer signs its first US contract, ships a container to Los Angeles, and the lot is held at the port for laboratory examination. Each day of detention burns money; a refusal means re-export or destruction. Almost every hold traces back to one of four missing pieces: facility registration, Prior Notice, HACCP documentation, or labeling.
US legal framework (in force as of 19 October 2026)
Facility registration. Under Section 415 of the Federal Food, Drug, and Cosmetic Act (Bioterrorism Act of 2002), any foreign facility that manufactures, processes, packs, or holds food for US consumption must register with the FDA and designate a US agent. Registration is free but must be renewed between 1 October and 31 December of every even-numbered year — the next window is 1 October to 31 December 2026. Miss it and the FDA cancels the registration; product from that facility cannot enter until it re-registers.
Prior Notice. Every shipment of FDA-regulated food needs Prior Notice filed before arrival, identifying the registered facility. A registered facility with a perfect label can still be refused if Prior Notice is late or names the wrong facility.
Seafood HACCP vs. FSVP. Fish and fishery products subject to FDA’s seafood HACCP regulation (21 CFR Part 123) are exempt from the Foreign Supplier Verification Program that otherwise requires the US importer to maintain a written verification program with a qualified individual. The exemption is conditional: the foreign supplier must actually comply with the HACCP requirements. For non-seafood agri-products (cashews, pepper, coffee, fruit), the US importer must run a full FSVP — importers buying from Vietnam should confirm who holds that duty in the contract.
The pangasius exception. Catfish of the order Siluriformes — which includes Vietnamese pangasius (cá tra) — was transferred from FDA to USDA’s Food Safety and Inspection Service jurisdiction. A pangasius exporter follows FSIS equivalence and inspection rules, not the FDA seafood path. Shrimp, tuna, and other finfish stay with the FDA.
Enforcement teeth. The FDA can place a product on detention without physical examination (an import alert) after repeated violations — later shipments are held automatically until the shipper proves compliance. Common triggers for Vietnamese seafood: salmonella, residues of banned antibiotics (nitrofurans, chloramphenicol), and decomposition.
Vietnamese side
Vietnam’s Food Safety Law 55/2010/QH11 and Decree 15/2018/ND-CP govern domestic production conditions. There is no free trade agreement between Vietnam and the United States — market access runs on the 2001 Bilateral Trade Agreement (MFN treatment) — so tariff and regulatory compliance, not preferences, decide competitiveness. Exporters should also watch US trade-remedy exposure: Vietnamese shrimp and pangasius have long histories of anti-dumping cases.
Pre-shipment checklist
- Confirm the foreign facility’s FDA registration is current and will survive the 31 December 2026 renewal deadline.
- Designate (or confirm) the US agent named in the registration.
- File Prior Notice for every shipment with the correct facility registration number.
- Maintain a written seafood HACCP plan covering hazards reasonably likely to occur (pathogens, drug residues, decomposition), with monitoring records in English or translated.
- For pangasius: follow the USDA-FSIS track, not the FDA track.
- For non-seafood products: allocate FSVP responsibility to the US importer in writing.
- Verify labeling: nutrition facts where required, allergen declaration, country of origin, and no misleading claims.
Frequently asked questions
Does our US buyer need an FSVP for our shrimp?
No — provided your shrimp is subject to and compliant with FDA’s seafood HACCP regulation, the FSVP exemption applies. Keep the HACCP records that prove it; the exemption disappears the moment compliance lapses.
We export pangasius. Do FDA rules apply to us?
No. Pangasius (order Siluriformes) falls under USDA’s Food Safety and Inspection Service. Applying the FDA playbook to pangasius — or vice versa — is one of the most common jurisdictional mistakes Vietnamese exporters make.
What happens if our facility registration lapses?
The FDA cancels it without individual notice, and product from that facility is refused entry until re-registration. Calendar the 1 October–31 December 2026 renewal window now.
Can one failed lab test block all our future shipments?
A single violation rarely does, but a pattern can land the product on detention without physical examination — every later shipment is held automatically. Early corrective action with documented root-cause analysis is far cheaper than an import alert.
Who is legally responsible if Prior Notice is filed late — us or the broker?
The importer of record bears the responsibility, not the broker and not the foreign supplier. Contracts should state explicitly who files Prior Notice and who absorbs detention costs when it goes wrong.
Planning your first FDA-regulated shipment? FLAT Law Firm advises Vietnamese exporters on US market-entry compliance — contact us for a pre-shipment legal review.
This article has been quality-reviewed by the FLAW AI Legal Council