FDA Rubber-stamps Approval of Lab-grown Salmon

by Veronika Kyrylenko June 12, 2025

Article audio sponsored by The John Birch Society

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.

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.

Jaydee Hanson, policy director at the Center for Food Safety, told The Defender that the FDA’s move was “outrageous.” He argued that the GRAS pathway was never meant for novel biotech products like this:

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.

Without those guidelines, and without independent testing, critics say, the FDA handed off its regulatory role to the very company seeking approval — leaving consumers to hope the science holds up.

Cultivated Food and Globalism

The push for lab-grown meat and seafood doesn’t exist in a vacuum. It aligns closely with Agenda 2030, the United Nations’ sweeping blueprint for global control. Among its 17 Sustainable Development Goals (SDGs), several specifically target the way food is produced, distributed, and consumed.

Under SDG 2 (“Zero Hunger”) and SDG 12 (“Responsible Consumption and Production”), the UN calls for “sustainable food systems” that reduce environmental impact, use fewer natural resources, and decrease reliance on traditional agriculture. Cultivated meat, at least in theory, promises to do just that: no livestock, no methane, no deforestation.

Global institutions like the World Economic Forum (WEF), which supports cell-cultivated food as a scalable solution to “climate change” and global food insecurity, echo this narrative. Together, the UN and WEF promote a future of food that is lab-made, patent-protected, and centrally controlled.

Needless to say, this approach hands power over what we eat to a narrow set of actors: multinational corporations, unelected global bodies, and venture-backed biotech firms. Traditional farming, food independence, and personal choice are being engineered out of the equation.

from: https://thenewamerican.com/us/tech/fda-rubber-stamps-approval-of-lab-grown-salmon/

News Release: “Bleeding” veggie burger has “no basis for safety,” according to FDA

WASHINGTON, D.C. – Creators of a fake-meat burger made with a high-profile genetically engineered ingredient may have landed their experimental industry in a sizzling food safety mess, casting doubt on a Silicon Valley foodtech investor bubble.

As reported on in today’s New York Times, recently obtained documents from the U.S. Food and Drug Administration (FDA) reveal that Impossible Foods, maker of the Impossible Burger, the meatless burger that supposedly “bleeds,” was told by FDA officials that it hadn’t provided adequate proof of safety for a genetically engineered protein that gives the burger its meat-like taste and color. Impossible Foods put the genetically engineered product on the market for public consumption even though the company privately admitted to the FDA that it had not conducted or designed safety tests. The FOIA-produced documents state that the “FDA believes that the arguments presented, individually and collectively, do not establish the safety of SLH for consumption, nor do they point to a general recognition of safety.”

“The FDA told Impossible Foods that its burger was not going to meet government safety standards, and the company admitted it didn’t know all of its constituents. Yet it sold it anyway to thousands of unwitting consumers. Responsible food companies don’t treat customers this way,” said Jim Thomas of ETC Group. “Impossible Foods should pull the burgers from the market unless and until safety can be established by the FDA and apologize to those whose safety it may have risked.”

“Under no circumstances should any food company ignore FDA safety warnings and put consumers’ health at risk,” Dana Perls, senior food and technology campaigner at Friends of the Earth. “The FDA must be the authority when it comes to determining food safety, and that means overhauling the broken regulatory process so that companies like Impossible Foods cannot self-regulate and rubber stamp their products as safe.”

The FDA’s safety designation of “generally recognized as safe” (GRAS) allows a manufacturer, like Impossible Foods, to decide for itself, without FDA input, whether or not a product is safe. The self-determination does not require notice to the public or the FDA, and may apply to food chemicals regardless of industry conflicts of interest, or whether the chemicals are new or not widely studied.

U.S. government documents, obtained by ETC Group and Friends of the Earth U.S. through the Freedom of Information Act, reveal that Impossible Foods was warned by FDA officials that its key genetically engineered ingredient, “soy leghemeglobin” (SLH), would not meet the basic FDA GRAS status. SLH, or “heme,” is a bio-engineered protein additive that adds meat-like taste and color. Impossible Foods recognizes that SLH has never been widespread in the human diet in its natural or genetically engineered form. Despite touting the color properties of the engineered “heme,” Impossible Foods did not seek FDA approval as a color additive, which has stricter safety regulations.

In discussion with FDA, Impossible Foods also admitted that up to a quarter of its “heme” ingredient was composed of 46 “unexpected” additional proteins, some of which are unidentified and none of which were assessed for safety in the dossier.

The case of Impossible Burger raises concerns that surpass this one patty and implicates the extreme genetic engineering field of synthetic biology, particularly the new high-tech investor trend of “vat-itarian” foods (meat, dairy, and other animal proteins grown in a biotech vat instead of from an animal). While Impossible Burger is the poster child for this vat-grown approach, other companies such as Perfect Day (synthetic biology cow milk) and Clara Foods (synthetic biology egg whites) appear also to be racing to market. Just as biofuels were pitched as a “clean tech” fix to climate change a decade ago, the vat-itarian venture capitalists are now attempting to capitalize on animal welfare concerns through “molecular farming.”

While the health and environmental damage caused by large-scale industrial livestock production should not be minimized, the success of non-animal burgers like the non-GMO Beyond Burger demonstrates that plant-based animal substitutes can succeed without resorting to genetic engineering.

A 2013 US National Survey by Hart Research found that 61% of respondents felt negative about synthetic biology-produced food additives. Polls also show that consumers increasingly want GMOs to be labeled as such, but so far, most companies selling products with synthetic biology ingredients, including Impossible Foods, are not labeling on the products or menus.

Friends of the Earth and ETC Group reached out last week to Impossible Foods, inviting the company to a discussion on the safety of the Impossible Burger.

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Impossible Burger FOIA documents are available here.

For further information and analysis see ETC Group’s on-line searchable database of synthetic biology derived ingredients, including Impossible Food’s “heme”.

See Friends of the Earth’s blog on synthetic biology animal replacement products “Is ‘Food-Tech’ the Future of Food?” and website for additional information on synthetic biology’s risks to our health and environment.

from: http://www.synbiowatch.org/2017/08/bleeding-veggie-burger-has-no-basis-for-safety-according-to-fda/?lores

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