The United States is Ecuador’s fastest-growing mature shrimp market — up 29% year-on-year in 2026 — and every kilogram of it passes through one gatekeeper: the FDA. For American importers, understanding exactly what the agency requires is the difference between routine clearances and containers sitting in detention. This guide covers the complete compliance picture.

FDA jurisdiction over imported seafood

All seafood entering the US falls under FDA authority via the Federal Food, Drug, and Cosmetic Act and the Seafood HACCP regulation (21 CFR Part 123). Unlike meat and poultry, seafood is not inspected shipment-by-shipment at the border; instead, the FDA holds importers responsible for verifying that their foreign suppliers meet US safety standards — and audits that verification aggressively.

Prior Notice: file before the vessel arrives

Under the Bioterrorism Act, every food shipment requires a Prior Notice filed with the FDA before arrival — typically via the Automated Broker Interface alongside the customs entry. No Prior Notice, no entry: the shipment is refused or held at the port at the importer’s expense. Filing is routine when your documentation chain is organized; it becomes a crisis when data on the invoice, packing list and health certificate do not match.

HACCP: the backbone requirement

Every processor shipping shrimp to the US must operate a documented HACCP plan covering hazards from pond to blast freezer — and US importers must maintain written verification that their suppliers comply. Serious Ecuadorian packers run mature HACCP programs as standard; what buyers should request is the plan summary, monitoring records for critical control points, and the plant’s FDA registration number.

Automatic detention: what triggers it

The FDA maintains import alerts that subject specific products, plants or countries to detention without physical examination. For shrimp, the classic triggers are residues of unapproved antibiotics, filth, and sulfite levels above the limit. Once a supplier lands on an import alert, every subsequent shipment is detained until five consecutive clean entries prove compliance — a months-long, expensive process. The way to avoid it is unglamorous: verified suppliers, lot-level testing, and consistent paperwork.

The metabisulfite limit: 100 ppm

The FDA permits sodium metabisulfite in shrimp at up to 100 ppm in the edible portion, and requires sulfites to be declared on the label above 10 ppm. Ecuadorian product meets this standard — the recent trade friction concerns China’s shell-inclusive testing methodology, not US compliance. For the underlying science, see our food safety explainer on sodium metabisulfite.

The document package

  • Commercial invoice with product description matching the entry.
  • Bill of lading and packing list consistent with the invoice.
  • Farm or catch certificate documenting aquaculture origin.
  • Health certificate issued by Ecuador’s competent authority (AGROCALIDAD / Vice Ministry of Aquaculture).
  • FDA foreign facility registration — the processing plant must be registered and renew biennially.

How KATUNA Trade prepares FDA-ready shipments

KATUNA Trade works only with FDA-registered, BASC-certified Ecuadorian plants, assembles the full entry package before the vessel sails, and coordinates Prior Notice data with your broker. Our SENAE-certified customs team makes sure what leaves Guayaquil matches what your entry declares — line by line. Shipping to Europe as well? Our EU sourcing guide covers that lane.

Building a US shrimp program? Contact KATUNA Trade for FDA-compliant sourcing from Ecuador.