by Veronika Kyrylenko, The New American:
The Food and Drug Administration (FDA) has cleared its first-ever lab-grown fish for sale in the United States — based entirely on data submitted by the manufacturer. Wildtype, a California-based food tech company, is now approved to serve its cell-cultivated coho salmon.
This FDA approval makes Wildtype the fourth company cleared to market lab-grown animal products in the country. The salmon is now available on the menu at Kann, a high-profile Haitian restaurant in Portland. The company plans to roll out its “salmon” in four additional restaurants in the coming months, followed by a broader launch into the food-service sector.
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What FDA Said
In its review, the FDA stated that it had “no questions” regarding the safety of Wildtype’s salmon. This bureaucratic phrasing marks the final step in the agency’s voluntary pre-market consultation process. The agency wrote:
Based on the data and information presented in [Wildtype’s pre-market safety submission to the FDA], we have no questions at this time about Wildtype’s conclusion that foods comprising or containing cultured coho salmon cell material resulting from the production process defined in [the submission] are as safe as comparable foods produced by other methods. Furthermore, at this time we have not identified any information indicating that the production process as described in [the submission] would be expected to result in food that bears or contains any substance or microorganism that would adulterate the food.
The FDA did not conduct its own tests. Instead, it based its clearance on Wildtype’s internal safety assessments. The agency said it found no evidence to contradict the company’s conclusions — but, apparently, also made no effort to verify them independently.
How It’s Made
Wildtype begins the process of creating what it calls “the cleanest, most sustainable seafood on the planet” by extracting cells from a single coho salmon. These can come from muscle tissue or even from a fertilized egg, per the company. The cells belong to the mesenchymal lineage, meaning they have the natural ability to turn into muscle, fat, or connective tissue.
Once collected, the cells are placed in a sterile, nutrient-rich environment designed to mimic the conditions inside a living fish. They grow and multiply in stainless steel tanks, similar to the fermenters used in brewing. Over time, the cell mass expands to form the basis of what will become the finished product.
After harvesting, the cells are combined with a small number of plant-based ingredients. These help fine-tune the taste, color, and texture, giving the final product its sushi-grade look and feel. Wildtype previously used a plant-based scaffold to help shape the product, but has since moved away from that approach. The company now applies thermal processing after harvest to ensure food safety.
The result is a fillet that resembles raw fish in appearance and taste. According to Wildtype, it delivers the same amount of omega-3 and omega-6 fatty acids as conventional salmon, but without the harmful levels of mercury, antibiotics, or parasites.
However, many of the details remain undisclosed — such as what gives it its pink color or which agents are used to prevent bacterial contamination. While the process appears clean and carefully controlled, critics point out that the lack of transparency and independent oversight leaves some important questions unanswered.
Safety, Hazards, and Oversight
Wildtype claims it follows a rigorous food-safety protocol. This includes a seafood-specific HACCP (Hazard Analysis and Critical Control Points) plan, good manufacturing practices, allergen controls, verified suppliers, traceability for all inputs, batch testing, sanitation procedures, and employee retraining. On paper, the system checks all the regulatory boxes.
But key questions remain unanswered. Wildtype conducted no animal trials. No human feeding trials. And there is no post-market surveillance to monitor long-term health effects. The FDA didn’t request any of that. Instead, it accepted the company’s internal safety assessment, backed by a legal mechanism known as GRAS — “Generally Recognized as Safe.”
The GRAS designation was originally developed for substances used widely and safely for decades — food ingredients like vinegar or black pepper. As the FDA itself explains, GRAS status applies only when “all data necessary to establish safety” are publicly available and recognized by qualified experts. GRAS ingredients must meet the same standard as food additives: a “reasonable certainty of no harm” with intended use.
In Wildtype’s case, the FDA stretched that standard, to say the least. The cultivated salmon isn’t a familiar pantry item or time-tested seasoning. It’s an entirely new food category created in a lab, using techniques borrowed from pharmaceutical manufacturing. And the only data the FDA relied on came from the company itself.
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