Genetically engineered pigs have been approved by the U.S. Food and Drug Administration – the first time a deliberate genomic alteration has been authorized for both food and medical use.
The pigs, called GalSafe pigs, do not have sugar on their skin which can cause a serious allergic reaction in some people.
Without the molecule alpha-gal sugar, these animals can be used for tissue and organ transplants for patients with alpha-gal syndrome, a disease contracted by tick bites, and can consume the white meat without repercussions.
The FDA determined during its review that GalSafe pigs do not pose a threat to the environment and have a low microbial food safety risk.
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Genetically engineered pigs have been approved by the U.S. Food and Drug Administration – the first time a deliberate genomic alteration has been authorized for both food and medical use (stock)
FDA Commissioner Stephen M. Hahn, MD, said in a statement Monday, “The first-ever approval of an animal biotechnology product for both food and as a potential biomedical resource is a huge milestone for scientific innovation.”
“As part of our public health mission, the FDA strongly supports the promotion of innovative animal biotechnology products that are safe for animals, safe for humans, and achieve the intended results.”
“Today’s action underscores the FDA’s success in modernizing our scientific processes to optimize a risk-based approach that fosters breakthrough innovations that consumers can trust.”
Revivicor, a spin-off from PPL Therapeutics that cloned the first adult mammal Dolly the sheep in 1996, grants a license for GalSafe pigs.
The pigs, called GalSafe pigs, do not have sugar on their skin which can cause a severe allergic reaction in some people. Without the alpha-gal sugar molecule, these animals can be used for tissue and organ transplants for patients with Alpha-gal syndrome (stock)
The company is now working with genetic engineering to design pigs that are safe for the general population to consume, as well as for medical purposes.
Pigs have long been used for tissue and organ transplants, but for people who are allergic to alpha gal sugar, the graft is usually rejected by the body.
The company Xenotherapeutics is using GalSafe pigs in three studies for skin grafts for burn victims with Alpha-gal syndrome and plans to conduct three more at Massachusetts General Hospital.
“In the US, the condition most often starts when a Lone Star tick bites someone and transfers alpha-gal sugar into the person’s body,” the FDA said in a statement.
“In some people, this triggers an immune system response that later causes mild to severe allergic reactions to alpha-gal sugar in red meat.”
Revivicor, a spin-off from PPL Therapeutics that cloned the first adult mammal Dolly the sheep in 1996 (photo), licenses GalSafe pigs
During its review, the FDA analyzed the potential impact that the intentional genomic modification (IGA) approval would have on the environment in GalSafe pigs and found that it is no greater than in conventional pigs.
“The conditions under which GalSafe pigs are kept are much stricter than those for conventionally bred pigs,” the FDA shared.
In addition, no animal safety concerns were found for GalSafe pigs other than those that would be expected from well-managed commercial pig operations.
The agency also found that the microbial food safety risk is low.
This isn’t the first time the FDA has approved IGA in animals for medical or food purposes.
In 2009, the lawsuit was awarded for modified goats that produced a drug in their milk that is used to prevent blood clots.
The milk therapy is called ATryn and is given to people with a rare disease called hereditary antithrombin deficiency.
The modification of chickens was approved in 2015 to produce a drug from their eggs to treat a protein deficiency, and in the same year, salmon was the first to be genetically modified as a food.
However, the GalSafe pigs are the first in history to be approved for both nutrition and therapy.