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FDA approves genetically modified pigs for food, therapies in U.S.

The biologically altered pigs have been engineered without a naturally produced sugar in their cells that can cause severe allergic reactions in humans, when eaten. File Photo by by Jai79/Pixabay
The biologically altered pigs have been engineered without a naturally produced sugar in their cells that can cause severe allergic reactions in humans, when eaten. File Photo by by Jai79/Pixabay

Dec. 17 (UPI) -- Federal regulators have approved genetically modified pigs for food and medical uses in the United States, marking just the second time they have signed off on a biologically modified animal for a consumer purpose.

The Food and Drug Administration gave approval this week to pigs that have been engineered to cut out "alpha-gal" sugar in their cells that can cause severe allergic reactions in humans if eaten. The sugar is also found in red meat like beef and lamb.

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The FDA determined that the domestic line of "GalSafe" pigs are safe to eat and said the absence of alpha-gal sugar in their tissues and organs would lead to lower rejection rates in patients receiving xenotransplants.

It's the second time the FDA has approved a biologically modified animal for consumption, after Salmon five years ago, but it's the first time the agency has approved a genetically altered animal for therapeutic use.

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"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 Dr. Stephen M. Hahn said in a statement Monday.

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"[This] 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."

The FDA said products made from the pigs -- like the blood thinner heparin and tissue or organ transplant materials -- are safe for use in people with alpha-gal syndrome.

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The regulatory approval, however, has met with some concern in the scientific community.

Walter Sanchez-Suarez, a veterinary scientist and animal welfare expert, warned that the FDA decision brings ethical and practical concerns.

"Unfortunately, this is another example of how sentient non-humans are systematically exploited in the U.S.," said Sanchez-Suarez of the non-profit Mercy for Animals.

The FDA approved genetically modified salmon for consumption in 2015 but blocked the imports until just last year. The first imported eggs to produce genetically modified salmon for consumption arrived in the United States 19 months ago.

United Therapeutics, a developer of biologically engineered pigs, said it has no plans yet to sell genetically modified pork products directly.

"We're looking at the potential for partnering with meat producers, but we have no plans to sell any meat ourselves," company spokesman Dewey Steadman said. "[The] size of the GalSafe herd is limited to one farm and 1,000 head along with one abattoir."

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Revivicor, a subsidiary of United Therapautics, is a spinoff of PPL Therapeutics -- which famously produced the first mammal clone, Dolly the sheep, in 1996.

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