Genetically engineering pigs so they lack a certain sugar on the surface of their cells that triggers meat allergies or organ rejection won approval from the Food and Drug Administration Monday. The regulatory clearance — the first of an intentional genomic alteration in a product with both food and medical uses — means the animals could be safer sources of not just food but also treatments such as the blood-thinner heparin.
“Today’s first ever approval of an animal biotechnology product for both food and as a potential source for biomedical use represents a tremendous milestone for scientific innovation,” FDA Commissioner Stephen Hahn said in a statement.
There have been four previous approvals for such genetic engineering in animals, three for biomedical purposes and one for food, but none for both biomedicine and food, Steven Solomon, director of the FDA’s Center for Veterinary Medicine, said in a conference call with reporters.
GalSafe pigs, named for their lack of detectable alpha-gal sugar, could potentially provide tissues and organs for patients without the danger of rejection caused by the presence of the sugar in cross-species procedures known as xenografts or xenotransplantation. Alpha-gal is considered a primary cause of rejection, Solomon said, but he was hesitant to say it is the only source.
“I think that people need to be careful,” Solomon said. “That’s why in part, it’s going to require further evaluation for xenotransplantation, xenograft, or the other activities by the medical products centers and FDA.”
People with Alpha-gal syndrome, a condition that causes mild to severe allergic reactions to alpha-gal sugar found in the red meats beef, pork, and lamb, might also benefit. The allergic reaction, recently identified in the United States, occurs after a Lone Star tick bites and then transmits alpha-gal sugar into a person’s body. Some people develop an immune reaction that later erupts into mild to severe allergic responses after eating the alpha-gal sugar in meat.
The FDA did not test food safety specifically for people who have the syndrome, nor did the agency evaluate the pigs for use in transplantation or implantation into humans. Any developers hoping to make medical products based on GalSafe pigs would have to seek approval from the FDA before any organs, implants, or drugs could be used in human medicine.