The US Food and Drug Administration (FDA) has approved a genetically modified pig for human consumption and therapeutic use. The pig is engineered to be free of a certain sugar molecule responsible for severe allergic reactions in some people.
The FDA approval marks just the second time a genetically modified animal has been approved for human consumption in the United States. This follows the still controversial approval of a fast-growing type of salmon in 2015.
The modified pig is called GalSafe, and it has a single gene tweak designed to eliminate the presence of a sugar molecule called alpha-gal. Allergies to alpha-gal sugars are primarily thought to be triggered by tick bites.
“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,” says FDA Commissioner Stephen Hahn.
While the approval covers medical uses for GalSafe pigs, the FDA suggests further application processes will be necessary before specific human medical products can be commercially deployed. These medical uses could hypothetically involve the pigs being used to grow tissues or organs for transplantation.
XenoTherapeutics, a private research and development company, is already working on a Phase 1 human clinical trial using GalSafe pig products for biomedical applications. The trial is the first to explore the safety of skin transplants for severe burn victims using tissue from GalSafe pigs.
The FDA states in its approval that it determines GalSafe pigs are safe for human consumption. However, despite the genetically modified animals being shown to contain no detectable levels of alpha-gal sugars, there have been no tests on whether the meat prevents allergic reactions in humans with alpha-gal allergies.
A spokesman for the company producing the engineered pig says there are no immediate plans to commercially sell the meat for human consumption. The FDA’s approval statement suggests any initial meat sales will only occur by mail order and there are no current plans for the GalSafe meat to be available in supermarkets.
“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,” says Hahn in the FDA’s approval statement. “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.”
Source: FDA
