US-based Wildtype has secured a “no questions” letter from the FDA regarding the safety of its cell cultured salmon, confirming that the firm’s cultivated coho salmon is as safe as conventional seafood. The product has debuted in a US restaurant, with plans to expand to four additional restaurants in the country in the coming months.

“We did not identify any substance uses that would lead us to question Wildtype’s conclusion regarding the safety of its food given available information, existing uses or authorizations in food, and anticipated exposure,” says the FDA in a scientific memo.

Wildtype’s salmon is now the first cultivated seafood available to consumers worldwide, and the firm is the third cultivated protein producer with full approval to sell, after UPSIDE Foods and GOOD Meat.

The clearance also makes Wildtype the first company authorized to sell cultivated seafood in the US amid a string of recent laws prohibiting the manufacture, sale, or distribution of cultivated meat in the country. Economic protection for traditional meat industries and safety and ethical concerns are some of the reasons behind such restrictions.

The San Francisco-based start-up produces its sushi-grade salmon by cultivating cells from Pacific salmon (oncorhynchus kisutch) in food-grade bioreactors. This provides a sustainable alternative to traditional seafood as the industry grapples with issues like overfishing, habitat destruction, and microplastic contamination.

According to the FAO, nearly 90% of global marine stocks are now fully exploited or overexploited, sparking concerns over pressure on global marine ecosystems.

A “watershed moment”

Dr. Suzi Gerber, the executive director of the Association for Meat, Poultry, and Seafood Innovation, calls the approval a “watershed moment” for domestic seafood production and for the cultivated protein industry overall.

“The thoughtful, evidence-driven review proves that innovative food technologies meet the highest safety standards and can play a vital role in healthy American diets while strengthening our food system’s domestic production and resilience, supporting the President’s executive order to expand seafood production in the US.”

In April, President Donald Trump signed an executive order called “Restoring American Seafood Competitiveness.” The aim is to strengthen US seafood production by encouraging innovation and investment, including in cultivated and alternative seafood.

Awaiting retail debut

At present, Wildtype is not planning retail sales of its products. It is focusing on restaurant partnerships to advance sustainable seafood cuisines. The company is focused on introducing the product through partnerships with chefs committed to sustainability.

Its cultivated salmon has been served at Kann, a Portland-based restaurant led by chef Gregory Gourdet since late May. The debut dish features the cell-based served with pickled strawberry, spiced tomato, strawberry juice, and an epis rice cracker (a traditional Haitian seasoning blend) to highlight the ingredient’s versatility and flavor.

“Introducing Wildtype’s cultivated salmon to our menu hits the elevated and sustainable marks we want our menu to offer guests who share a similar value system to ours,” says Gourdet.