Genetically Modified Pigs Approved for Human Consumption by FDA

The U.S. Food and Drug Administration (FDA) recently approved genetically modified pigs as being safe to eat. The approval marks the first that time that an intentional genomic alteration (IGA) in an animal has been approved for both human consumption as well as therapeutic uses. The IGA in what are being referred to as GalSafe pigs is designed to eliminate a type of sugar that is found in the animal.

“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 press release. “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.”

Alpha-gal sugar is eliminated from the surface of the pigs’ cells through the recently approved IGA. The GalSafe pigs could potentially serve as a new protein source for individuals who suffer from Alpha-gal syndrome (AGS). People with AGS can have allergic reactions to the alpha-gal sugar found in red meat. While FDA has determined that GalSafe pigs are safe to consume, the food safety specific to AGS was not evaluated.

The genetically modified pigs are licensed to Revivicor Inc., which is a subsidiary of United Therapeutics. The company has significant experience with biological engineering. Revivicor is a spinoff of the company that produced the first cloned mammal back in 1996, PPL Therapeutics. GalSafe pigs present a great deal of potential in the medical field. Organs and tissues from the animals can help address issues of immune rejection for patients receiving xenotransplants. GalSafe pigs can also be used to produce things such as the blood-thinning drug heparin, that are do not contain alpha-gal sugar.