The U.S. Food and Drug Administration has approved on December 14, 2020, a first-of-its-kind intentional genomic alteration (IGA) in domestic pigs, referred to as GalSafe pigs which could be used for food or human therapeutics. The approval is the first IGA in an animal that the FDA has approved for both human food consumption and potential therapeutic uses. The IGA in GalSafe pigs eliminates alpha-gal sugar on the surface of the pigs' cells. People with Alpha-gal syndrome (AGS) may have mild to severe allergic reactions to alpha-gal sugar found in red meat including beef, pork, and lamb.

"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," said FDA Commissioner Stephen M. Hahn, M.D. "As part of our public health mission, the FDA strongly supports advancing innovative animal biotechnology products that are safe for animals, safe for people, and achieve their intended results. Today's action underscores the success of the FDA in modernizing our scientific processes to optimize a risk-based approach that advances cutting-edge innovations in which consumers can have confidence."

GalSafe pigs may potentially provide a source of porcine-based materials to produce human medical products that are free of detectable alpha-gal sugar. For example, GalSafe pigs could potentially be used as a source of the blood-thinning drug heparin, free of detectable alpha-gal sugar. Tissues and organs from GalSafe pigs could potentially address the issue of immune rejection in patients receiving xenotransplants, as alpha-gal sugar is believed to be a cause of rejection in patients.

As part of its review, the FDA evaluated the safety of IGA for animals and humans eating meat from them, as well as the product developer's intention to market the IGA for its ability to eliminate alpha-gal sugar on pigs' cells. The FDA determined that food from GalSafe pigs is safe for the general population to eat. The FDA's review also ensured that there is no detectable level of alpha-gal sugar across multiple generations of GalSafe pigs.

For more details about this approval, read the FDA news release.