US Food and Drugs Administration approves first genome-altered animal for human consumption

Pink piglets.

US – The US Food and Drug Administration (FDA) has approved genome-altered pigs for human consumption, a first for the food industry in the globe.

The approval was granted to the regenerative medicine company Revivicor, which intends to sell meat by mail order, rather than supermarkets

The pig’s genome is said to be altered through a method called intentional genomic alteration (IGA) for the purpose of eliminating the alpha-gal sugar on the surface of the pigs’ cells,  a substance that people with alpha-gal syndrome (AGS) may have a mild to severe allergic reaction to.

The elimination of the sugar, which also appears in beef and lamb, suggests that the animal may be safer to eat for some populations.

However, the FDA’s review process did not evaluate food safety specific to those with AGS, as the application did not include data regarding the elimination or prevention of food allergies.

The line of pigs is also poised to produce human medical products such as the blood-thinning drug heparin and decrease the risk of immune rejection in transplants.

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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,” says FDA Commissioner Stephen Hahn.

While the move may be hailed as an advancement, recent studies have expressed concern that quickly moving technology may have a greater impact than we are aware of.

The emergence of antimicrobial resistance due to GalSafe pigs has been deemed “highly unlikely” in the FDA’s safety evaluation.

The FDA concluded that the microbial food safety risk is low and is mitigated by the low number of GalSafe pigs entering the food supply and the ongoing surveillance for antimicrobial resistance, among other factors.

Having made the above observations, the FDA determined that food from GalSafe pigs is safe for the general population to eat.

The FDA’s review also examined data across multiple generations of GalSafe pigs, which demonstrated no detectable level of alpha-gal sugar.

The environment was also factored into the safety evaluation and the altered pigs were determined to be no greater threat to the environment than conventional pigs, who would similarly destroy crops if they escaped and turned feral.

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