StoryRegulatory
FDA completes pre-market consultation for Wildtype's cultivated salmon
WildtypeCultivated coho salmon
On May 28, 2025 the FDA closed consultation with Wildtype with a "no questions" letter, saying it had no concerns about the company's conclusion that its cultured coho salmon cell material is as safe as comparable foods. It was the first cultivated seafood to complete FDA's pre-market review, joining only three other cell-cultured products to receive FDA clearance.
- Consultation began in 2022; Wildtype submitted its initial safety dossier in June 2022 and made eight amendments through early 2025.
- FDA evaluated the production process, cell lines, cell banks, manufacturing controls and all inputs and components.
- Only four cell-cultured products have received FDA "no questions" letters: Wildtype salmon, GOOD Meat chicken, Upside Foods chicken, and Mission Barns pork fat.