Puffer Fish Products in the United States

Puffer fish and products containing puffer fish are highly regulated and restricted in the United States due to the potential presence of the alkaloid toxins tetrodotoxins (TTX) and saxitoxins (STX). Imported and domestic puffer fish are regulated under the U.S. Code of Federal Regulations (21 CFR Part 123 - Fish and Fishery Products) which identifies Hazard Analysis Critical Control Point (HACCP) processes for the control of specific hazards including natural toxins. Additional restrictions are placed on puffer fish depending on the source. The only approved source of imported puffer fish is allowed through an Exchange of Letters between the U.S. Food and Drug Administration and the Japanese Ministry of Health, Labour, and Welfare restricting imported products to the meat, skin, and testicles of Takifugu rubripes. Additional restrictions are placed on domestic puffer fish through specific state bans. Despite these efforts, puffer fish poisoning cases still occasionally occur. Illnesses from imported products have mainly been due to TTX in the meat of illegally imported Lagocephalus lunaris, while illnesses from domestically sourced products have been due to STX in the meat of Sphoeroides nephelus harvested from the Atlantic coast of Florida.