The Food and Drug Administration (FDA) announced on Monday that it had, for the first time, approved an intentional genomic alteration (IGA) for an animal for both food and therapeutics. The IGA is for domestic pigs, specifically a group called GalSafe pigs.
The genetic alteration will eliminate alpha-gal sugar from pig’s cells. It is designed for people with Alpha-gal syndrome (AGS) who have severe allergic reactions to the sugar, which is found in beef, pork, and lamb. The FDA did not specifically evaluate its use for people with AGS, however. AGS most frequently begins, at least in the United States, after someone has been bit by a Lone Star tick, which triggers an immune system reaction to the sugar.
FDA Commissioner Stephen Hahn said in the press release that this approval is “a tremendous milestone for scientific innovation.” Hahn explained that “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.”
In addition to providing food that is safe for people with AGS, the GalSafe pigs could provide a source for porcine-based materials used in medical products which could benefit from being free of the alpha-gal sugar as well. The press release specifically mentioned potential uses in heparin, a blood-thinning drug, and immune rejection, since alpha-gal sugar is reportedly a cause of rejection in patients receiving xenotransplants. The pigs have not been evaluated for use in xenotransplants yet, and developers will still need to obtain approval from the FDA.
Steven M. Solomon, director of the FDA Center for Veterinary Medicine, said that “the developer of GalSafe pigs participated in this program, proving the impact of this important FDA initiative.” Solomon said that the FDA hopes for more work with developers to innovate biotechnology products.
The FDA’s report on the safety of the IGA determined that it was safe for consumption by the general population and that it is effective for multiple generations of pigs which consistently did not have a detectable level of alpha-gal sugar. Meat from the GalSafe pigs will initially be sold through individual mail orders, not in supermarkets.
