Gene-Edited Pigs Approved For Human Consumption In The US

The US Food and Drug Administration granted approval yesterday (December 14) for a genetically modified line of pigs that marks the first time a GM animal has been given the regulatory greenlight for both therapeutic development and food consumption, the agency says in a statement.

"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".

"Today's action underscores the success of the FDA in modernising our scientific processes to optimise a risk-based approach that advances cutting-edge innovations in which consumers can have confidence".

The genetically engineered mammals are called GalSafe pigs. Consumption of standard red meat, which also contains alpha-gal, can then trigger allergic reactions, ranging in severity from hives to difficulty breathing.

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Barbecue can return to the menu for individuals with "alpha-gal" syndrome - severe allergic reactions to the alpha-galactose saccharide found in red meat - with FDA approval Monday of pigs engineered to lack an enzyme considered key to the condition. The sugar makes its way into many products - including medications, cosmetics and food - and can cause allergic reactions in some people. For example, GalSafe pigs could potentially be used as a source of medical products, such as the blood-thinning drug heparin, free of detectable alpha-gal sugar. This is particularly important as GalSafe pigs' organs and tissues could potentially address the immune rejection issue among patients who received xenotransplants, which are believed to be triggered by alpha-gal sugar.

The FDA said it had determined that the food from the GM pigs, known as GalSafe pigs, is "safe for the general population to eat", and suggested the meat might be sold by mail order.

In the US, AGS most often begins when a Lone Star * a href="https://alphagalinformation.org/ticks-and-ags/#:~:text=Tick%20Species%20Associated%20with%20Alpha%2Dgal%20Syndrome%20 (AGS)&text=In%20the%20U.S.%2C%20the%20Lone, Texas%20and%20Florida%20 (20)*" target="_blank" rel="noopener noreferrer" *tick bites someone and transmits alpha-gal sugar into the person's body. The pigs are only the second GM animal to be approved for food after GM salmon in 2015. For this and any other use in new human medical products, developers must apply for further approval from the FDA. United Therapeutics Corp. says the primary objective of the pig would be for medical products.

The pig, called GalSafe, also has commercial potential as food, but Steadman said the company doesn't know when it might be able to secure an agreement with a meat producer to process and sell it.