The FDA has granted its inaugural approval for a safety consultation concerning lab-grown fish. This milestone positions Wildtype as the fourth company to receive the green light from the regulatory body to market cell-cultivated animal products, with its cultivated salmon now available at a restaurant in Portland.
Last week, Wildtype shared that the FDA issued a letter confirming it had “no questions” regarding the safety of its cultivated salmon in comparison to conventional seafood. This communication represents the final step in the FDA’s approval procedure for lab-produced animal products. The FDA oversees most lab-grown seafood regulation, while cultivated meat falls under shared jurisdiction with the United States Department of Agriculture (USDA).
The pre-market safety consultation from the FDA is optional but is deemed beneficial for enhancing market competitiveness. IP attorney Dr. Emily Nytko-Lutz, who focuses on biotechnology patents, advised Technology News that this path is advantageous compared to other options like self-affirming safety or a lengthier food additive review process. The FDA’s “No Questions” letter serves as a balanced alternative.
Wildtype’s salmon has made its debut on the menu at the Haitian restaurant Kann in Portland, Oregon, and the company is now accepting sign-ups for a waitlist for additional restaurants aiming to offer the fish. Wildtype joins the ranks of Upside Foods and Good Meat, both of which have regulatory approval to sell cultivated chicken in the United States. Meanwhile, Mission Barns has received FDA clearance but is still pending USDA approval for its cultivated pork fat. The regulatory landscape varies by state, with eight states enacting bans on lab-grown meat amid increasing political discourse on the subject.
