FDA approved its first GM pig for consumption, potentially safe for red meat allergy sufferers

Critics say the agency failed to adequately scrutinize whether the pork will cause allergic reactions, or the environmental consequences of a GM pig escape.

After news broke yesterday that the Food and Drug Administration (FDA) approved the first genetically engineered pig for human consumption, overjoyed emails began to flood Dr. Scott Commins’s inbox.

Commins, an associate professor at the University of North Carolina School of Medicine, is one of the nation’s foremost researchers specializing in alpha-gal syndrome, the term for an increasingly common allergy to meat and animal products. Named after the specific sugar that triggers allergic reactions, alpha-gal syndrome is widely believed to be caused by tick bites that introduce the offending molecules into the bloodstream, according to the CDC. In turn, consumption of red meat, which also contains alpha-gal, can then trigger subsequent allergic reactions, ranging in severity from hives to difficulty breathing.

Commins estimated that there are 34,000 people with alpha-gal syndrome today. However, because there’s no cure for it, the only way to manage the allergy is to avoid red meat products. That’s why FDA’s approval—which pertains to a specific genetic alteration that stops the production of alpha-gal—is such good news to many of his patients.

“GalSafe is one step on our journey to address the shortage of transplantable organs in the US.”

“People [are] excited,” he said, of the dozens of emails he’s received from alpha-gal syndrome sufferers. “Some of them even listed what they would like their first order to be.”

But it may be wise to not count our pork chops before they’re plated. FDA’s approval only covers a single hog farm in Iowa with the capacity to produce 1,000 “GalSafe” pigs per year. In addition, it appears that the nutritional element of this approval may be ancillary to the medical possibilities at hand. Revivicor, the company that applied for FDA’s green light, is a developer of pig-based organs for use in human medicine, and yesterday’s approval is the first step in its efforts to develop heart and kidneys that can be transplanted in people.

“GalSafe is one step on our journey to address the shortage of transplantable organs in the US,” said Dewey Steadman, head of investor relations at United Therapeutics Corporation, the parent company of Revivicor. “If there’s other market opportunities along the way, great!” (Use of GalSafe pigs as specific medical products still has to go through further review, Steadman said.)

GalSafe pigs aren’t expected to trigger reactions in people with red meat allergies, but FDA has not scrutinized any allergy-related guarantees.

Here’s another catch: FDA only evaluated Revivicor’s claim that GalSafe pigs are, in fact, free of alpha-gal and safe to eat. But because Revivicor did not provide data or make claims related to food allergies, FDA didn’t “evaluate food safety specific to those with [alpha-gal syndrome].” In other words, GalSafe pigs aren’t expected to trigger reactions in people with red meat allergies, but FDA has not scrutinized any allergy-related guarantees. “People with an alpha-gal allergy that would like to consume meat from these pigs but have questions should talk to their doctor,” an agency spokesperson said in an emailed statement. This caveat is worrisome for some consumer interest advocates, who believe that FDA jumped the gun with its approval.

“It shouldn’t have been approved until they had adequately addressed the allergenicity of the product,” said Jaydee Hanson, policy director for the Center for Food Safety.

He also took issue with Revivicor’s assessment of the environmental risks related to the production of these genetically engineered pigs—specifically the risk it poses to wildlife in the case of escape. Revivicor asserts that this possibility “is extremely low.” However, Hanson drew parallels between yesterday’s announcement and FDA’s 2015 approval of genetically engineered salmon. Last month, a federal judge ruled that the agency failed to fully consider the environmental consequences of an escape, and ordered it to conduct another review. The decision was the result of a lawsuit filed by a coalition of groups including the Center for Food Safety. Hanson said the organization is considering litigation related to yesterday’s approval. 

Commins’s team is set to begin conducting blind allergy tests of GalSafe pork among allergy sufferers within the next three months.

Others still believe that this development could be a major boon for allergy sufferers, and are working to vet its effect on eaters quickly. Commins’s team is set to begin conducting blind allergy tests of GalSafe pork among allergy sufferers within the next three months. Revivicor’s involvement is limited to the supply of the pork, he told me. Commins also added that he himself has previously sampled the pork under an FDA-approved sensory test. “It tastes just like normal pork, so to speak.”

Part of the rising prevalence of alpha-gal syndrome is due to increased awareness of the issue. However, Commins said, it’s also potentially driven by a booming population of tick-carrying deer and a climate crisis that is making more swaths of the United States hospitable to ticks.

For those of you already working up an appetite, there’s a long road ahead before GalSafe sausage hits store shelves. Revivicor is currently “evaluating potential partnerships with pork producers” to raise and distribute products. Maybe keep Benadryl on hand for now?

Update, December 16, 2020, 1:30 p.m.: A previous version of this story mistakenly stated that a judge struck FDA’s 2015 approval of GM salmon down. The approval remains in place while FDA conducts another environmental review.

Note: The feature photo for this story is of non-GM pigs.

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Jessica Fu is a staff writer for The Counter. She previously worked for The Stranger, Seattle's alt-weekly newspaper. Her reporting has won awards from the Association of Food Journalists and the Newswomen’s Club of New York.