FDA approves biotech-altered pigs for food, therapeutic uses


By Julie Larson Bricher on 12/15/2020


The U.S. Food and Drug Administration has approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs intended for both human food consumption and as a source for potential therapeutic uses.


The IGA animals, tagged with the moniker "GalSafe pigs," have been biotech-engineered to eliminate alpha-gal sugar on the surface of the pigs’ cells. People with Alpha-gal syndrome may have mild to severe allergic reactions to alpha-gal sugar found in red meat.


“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, in a press release.


In addition to its determination that food from GalSafe pigs is safe for the general population to eat, FDA's evaluation data also demonstrated that there is no detectable level of alpha-gal sugar across multiple generations of GalSafe pigs.


The agency also found that the IGA pigs would have no greater impact on the environment than conventional pigs. The conditions under which GalSafe pigs will be kept are far more stringent than those for conventionally farmed pigs. Additionally, no animal safety concerns were noted for GalSafe pigs beyond those that would be expected in well-managed, commercial swine operations, said the agency.


The agency suggested that GalSafe pigs may potentially provide a source of porcine-based materials to produce human medical products that are free from detectable alpha-gal sugar, such as as the blood-thinning drug heparin used in organ transplants.


The FDA granted approval of the IGA in GalSafe pigs to the developer, Revivicor Inc., which participated in the FDA's Veterinary Innovation Program. The company indicated that it initially intends to sell meat from GalSafe pigs by mail order, rather than in supermarkets.

Source : meatingplace.com