(The Defender) Describing the development as “a food revolution,” the U.S. Food and Drug Administration (FDA) on Wednesday declared lab-grown chicken meat developed by Berkeley, California-based food-tech firm Upside Foods is safe for human consumption.
Upside Foods “will use animal cell culture technology to take living cells from chickens and grow the cells in a controlled environment to make the cultured animal cell food,” the FDA said.
The news — widely reported as an FDA “approval” of lab-grown meat — signifies the completion of the first, and biggest, of the three regulatory steps Upside Foods must complete before its “cultivated” chicken attains full approval and can be sold to the public, according to TIME.
Although two more steps must follow before the FDA can grant the product full approval, the agency’s language suggests the approval is a foregone conclusion.
Upside Foods, on its website, all but confirmed that FDA approval is on the way:
“This landmark regulatory decision means the FDA accepts our safety conclusion, and Upside’s cultivated chicken will be available following USDA inspection and label approval.”
The FDA and some media outlets cheered the news — but others, including scientists and food safety advocates, expressed concerns about the adequacy of the FDA’s preliminary review process.
Experts who spoke to The Defender also questioned the safety of lab-grown meat, which is produced with gene-edited cells, and some scientists argued that, despite claims to the contrary, the production process for lab-grown “meats” is energy-intensive and not, as advertised, beneficial to the environment.
Some also questioned Upside Foods’ connections to figures and entities such as Cargill, Bill Gates, Jeff Bezos, Richard Branson, Kimbal Musk, brother of Elon Musk and co-founder of The Kitchen, “a growing family of businesses that pursues an America where everyone has access to real food,” and the World Economic Forum (WEF).
FDA hasn’t yet granted ‘approval’ — but most significant step in that process completed
The Center for Food Safety said this about the FDA’s announcement:
“The U.S. Food and Drug Administration (FDA) recently completed its preliminary review of the first lab grown ‘chicken’ to be sold as food. The FDA and the U.S. Department of Agriculture are both reviewing ‘meats’ which are grown in vats from cells extracted from living animals.
“This week’s announcement by the FDA that it was reviewing a cell-cultured chicken ‘meat’ is the first indication that these products might come to market in the U.S.”
According to the FDA, this first stage — known as a “pre-market consultation” — was the first time the agency completed such a consultation “for a human food made from cultured animal cells.”
As part of this consultation, according to the FDA:
“The FDA’s pre-market consultation with the firm included an evaluation of the firm’s production process and the cultured cell material made by the production process, including the establishment of cell lines and cell banks, manufacturing controls, and all components and inputs.
“The voluntary pre-market consultation is not an approval process. Instead, it means that after our careful evaluation of the data and information shared by the firm, we have no further questions at this time about the firm’s safety conclusion.”
In an exclusive interview with The Defender, Jaydee Hanson, policy director for the Center for Food Safety, questioned the FDA’s “pre-market consultation”:
“The FDA regulatory process in general relies on company testing of their products.
“The FDA, in this case, seemed to mostly review what the company sent them, but did not require additional tests and did not require the company to disclose its methods in a complete and transparent manner.”
The next steps in the regulatory process involve the U.S. Department of Agriculture and its Food Safety and Inspection Service (FSIS) before full approval is granted.
Upside Foods’ Emeryville, California, production facility will be ready to produce more than 50,000 pounds of “cultivated” products, including a chicken fillet, per year, upon receipt of regulatory approval, the company stated.
Upside Foods, FDA, media describe lab-grown meat as a ‘food revolution,’ ‘watershed moment,’ but regulatory process questioned
The FDA described the news of Upside Foods coming a step closer to full approval as part of “a food revolution” that the world is experiencing, in which the FDA “is committed to supporting innovation in the food supply.”
TIME used remarkably similar language in its story, describing the FDA’s announcement as “setting the stage for a new food revolution in which the world’s meat is grown in bioreactors instead of on factory farms.”
Bruce Friedrich, president of the Good Food Institute (GFI), told NPR the FDA’s announcement is “a critical milestone towards the future of food” that will benefit “consumers who desire their favorite foods made more sustainably.”
And Dr. Uma Valeti, CEO and founder of Upside Foods, described the news as “a watershed moment in the history of food” in a statement, adding that “U.S. consumers will soon have the chance to eat delicious meat that’s grown directly from animal cells.”
In the same announcement, Valeti added:
“We started Upside amid a world full of skeptics, and today, we’ve made history again as the first company to receive a ‘No Questions’ letter from the FDA for cultivated meat.
“This milestone marks a major step towards a new era in meat production.”
The Center for Food Safety questioned the FDA’s regulatory process, stating the “experimental product” was “woefully deficient”:
“In short, the documents shared by the FDA and the Upside Foods Co. show us where more research and more transparent data are needed, but this is a woefully deficient review by the FDA.
“In its review of the company’s documents, the FDA states it has ‘no further questions’ about this experimental product’s safety — but we have many more questions. In the name of protecting public health, consumers and policymakers deserve better.”
While the FDA claims that it had “no further questions” regarding Upside Foods’ self-reported safety evaluation, which formed the basis of the FDA’s decision to complete its “pre-market evaluation,” the Center for Food Safety questioned the process by which the cells for lab-grown meat are cultured and the FDA’s oversight of this process:
“The FDA’s review of the first-ever cell-cultured food for U.S. approval is a start, but grossly inadequate. In this ‘pre-market consultation,’ neither the company nor the FDA presented the actual data from tests looking at the effects of raising these cells in fetal bovine serum and enzymes from the intestines and pancreas of animals.
“Likewise, while the company notes that it uses genetic engineering to keep the cells growing, it fails to share which genes are being used. This is vital information that consumers and policymakers need to know to make informed decisions in the best interests of public health. We should make certain that genes linked to cancer are not being used.”
Experts raise alarm about genetically engineered cells and risk of cancer
In his interview with The Defender, Hanson said that far from the company’s claims that cultivating lab-grown meat will save animals, the bovine serum used as part of this process requires that animals be slaughtered:
“The science used by Upside to culture in vats is essentially the same as that used to culture cells for experiments in medical labs.
“Upside is using a mixture of bovine serum (most likely from fetal calves found in cows being slaughtered) and enzymes from the pancreas and intestines of animals. Upside indicates that it is trying to switch to other kinds of growth mediums.”
Hanson also questioned the use of genetically engineered cells as part of the production process, telling The Defender that such cells “can promote cancers” and highlighting that the Upside Foods has not listed the exact genes it is using:
“The company also notes that it is using genetic engineering to promote continuous growth of the cells. This is disturbing, in that it is likely that the genes being manipulated can promote cancers.
“Medical cell cultures use cancer cells for testing of drugs, etc., but cancer-causing genes should not be used in food production. Food additives that cause cancer are illegal. Unfortunately, the company does not list exactly which genes it is using for genetically engineered cells.”
The genetic engineering process employed by Upside Foods appears to involve CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats), a gene-editing technology that acts as a “precise pair of molecular scissors that can cut a target DNA sequence, directed by a customizable guide.”
Put differently, this technology allows scientists to edit sections of DNA by “snipping” specific portions of it and replacing them with new segments. Gene editing is not a new concept, but CRISPR technology is viewed as being cheaper and more accurate.
In 2019, it was revealed that Memphis Meats — the former name of Upside Foods prior to a 2021 rebrand — was employing CRISPR as part of its process for curating lab-grown meat, and even received a patent for this purpose.
As recently reported by The Defender, while CRISPR has been touted as a potential solution to global hunger and food shortages, many scientists question this claim.
“These were also risks with the old-style GMOs [genetically modified organisms], and they are still risks with these gene-edited GM plants with animals.
“The risks, if you’re gene editing them … are that there will be knock-on effects on the animals, welfare or health that we can’t anticipate, such as deformities or changes in the function of certain genes in the animal.”
Michael Antoniou, Ph.D., in an October 2022 interview with The Defender, agreed, stating that, “innately, gene editing also can bring about unintended DNA damage … even at the site of your intended edit or elsewhere in the DNA of your target cells, with unknown downstream consequences.”
A report published in the Journal of Genetics and Genomics in 2020 found CRISPR gene-editing in rice resulted in numerous unintended and undesirable on-target and off-target mutations.
Antoniou described this as “a grave oversight, because we know that gene editing is not precise … the evidence is there to show that you will always have unintended DNA damage in addition to what you want … a whole spectrum of unintended DNA damage that accumulates at the multiple steps of the gene editing process.”
“If you don’t take this into account, as is happening at the moment,” said Antoniou, “you will launch a product that could have marked changes in its biochemistry and therefore composition. And included in that chain-altered composition could be the unintended production of toxins and allergens,” including in food for human consumption.
Robinson and Antoniou also raised ethical concerns regarding CRISPR. “These unexpected effects of CRISPR are very well recognized,” Robinson said. “They’re written about in the scientific literature.”
“Scientists know that these things are not ready yet to go into clinical trials,” she added. “On the whole, they’re certainly not ready to be used on [the public].”
In a Nov. 14 interview on NPR’s “Morning Edition,” Valeti said he launched Memphis Meats in 2015 based on an idea he came up with while previously “working with heart attack patients at the Mayo Clinic more than 15 years ago, growing human heart cells in a lab.”
He realized that “it should be possible to grow meat with similar science,” according to the NPR interview.