The FDA has made a significant milestone by approving the first safety consultation for lab-grown fish, marking a major step forward in the cultured seafood industry. Wildtype is now only the fourth company to receive this approval from the FDA, allowing it to sell its cultivated salmon in the United States. Currently, the salmon is available for order at a Portland restaurant, bringing innovative, sustainable seafood directly to consumers.
Last week, Wildtype announced that the FDA had issued a “no questions” letter, indicating that the agency found the cultivated salmon to be as safe as comparable traditional foods. This marks the final step in the FDA’s approval process for lab-grown animal products. While the FDA oversees most lab-grown seafood, the USDA shares responsibility for cultivated meat, making this approval particularly noteworthy.
Though the FDA’s pre-market safety consultation is voluntary, it’s considered a valuable step for market acceptance. Industry expert and IP lawyer Dr. Emily Nytko-Lutz explained that this pathway helps brands build credibility and streamline their entry into the market, offering a balanced approach between full regulatory approval and longer review processes.
Wildtype’s cultivated salmon is now featured at Haitian restaurant Kann in Portland, Oregon. The company has also launched a waitlist for five additional restaurants eager to serve this innovative fish. In the broader landscape, Wildtype joins companies like Upside Foods and Good Meat, which have received approval to sell cultivated chicken in the US. Meanwhile, Mission Barns has been cleared by the FDA for its cultivated pork fat but is awaiting USDA approval for its pork products.
However, the regulatory environment remains complex at the state level, with eight states enacting bans on lab-grown meat, reflecting ongoing debates around this emerging technology. As cultivated seafood continues to gain momentum, it’s clear that the future of sustainable, lab-grown protein is taking shape in the American market.
