Fish-Liver Oils & Their Fractions

The species of origin is the determining factor: cod-liver oil and its fractions are specifically enumerated under 1504102000, while liver oils derived from other fish species — such as halibut or shark — fall under the residual line 1504104000. Importers should have species identification documentation available, as customs may request it to verify the correct line.

The FDA regulates fish-liver oils marketed as dietary supplements under the Dietary Supplement Health and Education Act (DSHEA). Products must comply with FDA labeling requirements and current Good Manufacturing Practice (cGMP) standards. If the oil is intended as a food ingredient or pharmaceutical excipient, additional FDA review pathways may apply. Consult a licensed customs broker or regulatory counsel to confirm the correct admissibility route for your specific product.