FDA Approves First Lab-Grown Salmon Based Solely on Manufacturer’s Safety Claims

In its approval letter, the FDA said that it understood from Wildtype’s own safety testing that the company had concluded that “foods comprised of or containing the cultured cellular material” made by the company’s production process were “as safe as comparable foods produced by other methods.”

The company, backed by Bezos Expeditions, actor Leonardo DiCaprio, agricultural giant Cargill, and many others, is already selling its lab-grown sushi-grade fish at James Beard award-winning restaurant, Kann in Portland, Oregon.

Over the next four months, the company plans to roll out the product in four more restaurants, then launch the fish in foodservice.

Wildtype is the fourth lab-grown meat company granted permission to sell its product in the U.S. Upside Foods and Good Meat have approval to sell chicken grown in a lab from animal cells.

Another California startup, Mission Barns, got the green light from the FDA to sell its cultivated pork fat in March, but still needs approval from the U.S. Department of Agriculture (USDA).

Unlike chicken and beef, which must also be approved for sale by the USDA, cultivated seafood doesn’t need approval from the USDA — the FDA is the final authority for Wildtype, The Verge reported.

Based on its assessment of Wildtype’s data, the agency said it didn’t find any basis to dispute the company’s safety assessment.

That means that all safety testing of lab-grown fish cells has been conducted by the company seeking to market it.

CEO Justin Kolbeck has been making the rounds in friendly media for several years, promoting his product. He and his lab partners first started cultivating the salmon in 2018, trying different methods to “feed” the cells they took from a real salmon while maintaining a “healthy growing state.”

Kolbeck said it was hard work because little research has been done on fish cell culture.

“Nobody’s ever written a scientific paper about this,” he told Technology Networks. “There’s no starting point. You just have to do the work and test different combinations.”

That was enough for the FDA to approve the fish.

Jaydee Hanson, policy director for the Center for Food Safety (CFS) and expert in synthetic biology, called the FDA’s approval of the lab-grown salmon “outrageous.”

The agency allowed the company’s claims that the additives used don’t need further testing because they fall under the FDA’s “Generally Recognized as Safe” process, originally intended for products whose safety has been established through “a substantial history of consumption for food use by a significant number of consumers.”

“The ‘Generally Recognized as Safe’ designation was never intended for this,” Hanson said. “The FDA is negligent, I would say, in allowing a company to use the self-approved generally recognized as safe method. And then the FDA should have developed its own new guidelines for how to test this new food.”

Hanson said that the USDA and FDA had some discussions about what oversight might look like for such products, but they haven’t made any rules. “The USDA had more public comments on what to call lab-grown meats than on how they should be regulated.”

The process for replicating cultured cells uses techniques borrowed from Big Pharma, which relies on cultured cells to test drugs.

Wildtype’s fish is made from the cultured cells of a living coho salmon and cultivated in steel vats, or cultivators, where the fish are fed a “proprietary cell nutrient blend,” according to the pre-market safety consultation summary the company submitted to the FDA.

The salmon itself is also made from water and other undisclosed ingredients. The cells are harvested and then put onto plant-based scaffolds that help to replicate the look and texture of salmon. They are rinsed, processed and packaged.

Wildtype describes the cultivators as similar to those used for brewing beer or making yogurt. But Hanson said it’s not a simple process, and the information about the process that has been made public raises several concerns.

The details of the “proprietary methods” for making the cells grow and testing them for contaminants aren’t available for public scrutiny. The company doesn’t divulge what it uses to give the salmon its pink color — which in wild salmon comes from a crustacean-rich diet.

Wildtype also likely needs some kind of anti-bacterial product to keep the cells healthy, Hanson said, but it isn’t clear what product the company is using for that.

He also said it’s unclear how much testing the company did on the growth factor it uses — fibroblast growth factor-2 or FGF2 — designed to make cells grow rapidly. The company reports that it washes off the growth factor before the lab-grown salmon goes to market, and it therefore causes no health risk, according to Hanson, who said he’s concerned that FGF2 could promote the development of cancer-like cells.

The company also isn’t required to do any feeding trials in animals before selling its products to humans.

Hanson said the company makes claims about safety, but there isn’t enough data available to verify those claims. He believes the FDA should have a process for feedback from organizations, scientists and the public before approving these products.

For example, CFS is in the process of responding to a request for public input by the U.S. Environmental Protection Agency for a new pesticide that won’t even be directly eaten by humans.

And yet, the FDA is allowing the production of an entirely new type of food without inviting public comment.

Many scientists who work in cell culturing would likely have important insights to share, Hanson said.

Do lab-grown meats really have a future?

Despite all of the hype, lab-grown meats face an uphill battle. Between 2016 and 2022, investors pumped almost $3 billion into cultivated meat and seafood companies.

The New York Times reported that Eat Just and Upside Foods achieved billion-dollar valuations. However, since then, investment has dropped significantly. Greenqueen reported that funding dropped by 75 percent in 2023 and another 40 percent in 2024 to just $139 million.

Greenqueen also reported that Wildtype has raised $120 million, most of which came from a $100 million series B funding round in 2022.

The Times reported that company founders have cut corners, faced significant technological obstacles, dangerous contamination, and never achieved reasonable costs or meaningful scale.

Several states, including Florida, Alabama, Mississippi, Montana and Indiana have banned the sale of lab-grown meat, and several other states are considering similar legislation.

Marketing claims for lab-grown meats celebrate them as more environmentally friendly than typical meat production because they require land, water and ‘fossil fuels’.

However, researchers at the University of California, Davis, assessed the energy needed and ‘greenhouse gases’ emitted by lab-grown meat production and concluded its global warming potential was four to 25 times greater than for beef.

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