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FDA Approves Genetically Engineered Pigs for Food, Possible Medical Use

MONDAY, Dec. 14, 2020 -- The first genetically engineered pigs for use as food or for potential future biomedical use -- such as transplantation -- in humans have been approved by the U.S. Food and Drug Administration.

These GalSafe pigs were created to eliminate alpha-gal sugar on the surface of the pigs' cells. People with Alpha-gal syndrome (AGS) may have mild-to-severe allergic reactions to alpha-gal sugar found in red meat such as pork, beef, and lamb. In the United States., AGS most often begins when a Lone Star tick bites someone and transmits alpha-gal sugar into the person's body, causing an immune system reaction in some that later produces mild-to-severe allergic reactions to alpha-gal sugar found in red meat.

The product developer, Revivicor Inc., indicated that it initially intends to sell meat from GalSafe pigs by mail order, rather than in supermarkets, according to the FDA.

"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, M.D., said in an agency news release.

The pigs have not been evaluated by the FDA as sources of medical products for transplantation or implantation into people. Developers of such products would first have to obtain approval from the FDA before these products can be used in human medicine, the agency said.

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Posted: December 2020