Lab-Grown Salmon Hits Menus in Oregon and Texas After FDA Green Light

A San Francisco cultured meat company has received a “no questions” letter from the FDA and has begun serving its “cultivated” or “lab-grown” salmon product in Portland, Oregon and Austin, TX. Mission Barnes received the approval letter from the FDA in March for its lab-grown pork. Two states, Alabama and Florida, banned the cultivation, sale, and distribution of lab-grown meat products while Tennessee’s labeling law goes into effect prohibiting these products from calling it “meat” or a “meat product.”

“Based on the information Wildtype has presented to FDA, as well as other information available to the agency, we did not identify a basis for concluding that the production process as described in CCC 000005 would be expected to result in food that bears or contains any substance or microorganism that would adulterate the food,” wrote Mark Hartman, Director of the Office of Food Chemical Safety, Dietary Supplements, and Innovation  “We have no questions at this time regarding Wildtype’s conclusion that foods comprised of or containing cultured salmon cell material.”

There are five steps to the manufacturing process of these products – cell isolation, establishment of cell lines, establishment of master cell bank (MCB) and working cell bank (WCB(proliferation phase and harvest of cell material as a “cell mass or paste.” The FDA document details the potential hazards and quality concerns Wildtype identified.

Cell Isolation

“The cells used to establish the cell banks are mesenchymal cells isolated from skeletal muscle and connective tissue of fry stage coho salmon acquired from a Washington state hatchery,” the FDA scientific letter states. For this portion of the manufacturing process, one concern identified by the manufacturer is the “source animal” health prior to “tissue procurement” could cause cells to be contaminated with aquatic microflora, pathogenic bacteria, viruses, parasites, prions or toxic heavy metals. 

Establishment of Cell Lines

A possible hazard is the incorrect source-identification meaning isolated cells are of “incorrect origin.” As with the cell isolation step, bacterial and fungal contamination are possible as well as the introduction of heavy metals.

Establishment of MCB and WCB

The manufacturer said this step could cause residual amounts of reagents, like cryoprotectants in the harvested cell material. Wildtype uses dimethyl sulfoxide (DMSO) and states that it periodically tests for levels of DMSO in the harvested cell material stating that measurements have been well below the allowable 50 parts per million.

In a 2019 study about the use of DMSO in biopharmaceutical applications, the authors wrote “The extreme changes in microRNAs and alterations in the epigenetic landscape indicate that DMSO is not inert. Its use should be reconsidered, especially for cryopreservation of embryos and oocytes, since it may impact embryonic development.”

“While hepatic microtissues demonstrated non-significant changes, findings from cardiac microtissues suggested disruption of DNA methylation mechanisms leading to genome-wide changes,” the study authors wrote. “The extreme changes in microRNAs and alterations in the epigenetic landscape indicate that DMSO is not inert. Its use should be reconsidered, especially for cryopreservation of embryos and oocytes, since it may impact embryonic development.”

The authors concluded that use of DMSO should be avoided when possible because even at low levels, DMSO is not inert.

Wildtype acknowledges that contamination can occur at various stages of the process and could result in residues being present in the harvested cell material. The company details procurement and sterilization processes to minimize the chances that contamination will occur.

The World Health Organization (WHO) released a document in 2023 titled “Food Safety Aspects of Cell Based Food.” The authors note ongoing concerns with the way that this type of food product should be regulated and the labels that would be appropriate.

“While many hazards are already well known and existing equally as well in conventionally produced food, the focus may need to be put on the specific materials, inputs, ingredients (including potential allergens), and equipment that are more unique to cell-based food production,” the WHO document states. The regulatory burden for these foods exists on the same level as other foods despite the use of different forms of technology that have historically not been used for food products.

The WHO document also states, “The term “cell-based” has never been used for food, therefore some food business operators may prefer not to use the term. The terms “cultured” and “cultivated” can be confusing as they are often used in the aquaculture sector to indicate farmed fish and fisheries products.”

The FDA, in its “no questions” letter, used the term “cultured salmon cell material,” but also stated this is not a recommendation that the company use this term when referring to the product. Wildtype, on its website, said it prefers to use the term “cultivated salmon,” to differentiate between plant-based, farm-raised, and wild-caught salmon. Wildtype also refers to the term “lab grown” as a pejorative that isn’t reflective of the process, which the company says is similar to a brewery.

A 2023 survey found 50% of Americans are not interested in trying lab-grown or “cultivated meat” products. 18% are very likely to try it and 30% are somewhat likely to try the product. A Statista survey from 2024 found only 16% of Americans are willing to consume these products.

The primary drive to consume these alternative options to conventional meat is the perceived benefits to the environment and animal welfare. Multiple studies have found that the current processes for producing lab-grown meat products would not be more environmentally sustainable compared to conventional agriculture.

A December study published in ACS Food Science and Technology concluded that cultured meat “may lead to significantly greater environmental impact if the industry is unable to fully transition from pharmaceutical-grade ingredients to food/feed-grade inputs,” which the authors said would be a significant challenge.