Regulator approves genetically altered pigs for food, medicine in US

*The Food and Drug Administration remarks it’s first time the US Government has approved an animal biotechnology product for both food and as a potential source for biomedicine, and the animals will lack a molecule that produces allergic reactions in some people

Emmanuel Akosile | ConsumerConnect

For both food and as a potential source for biomedicine, the Food and Drug Administration (FDA) has granted approval for genetically engineered pigs for a medical firm in the United States (US).

ConsumerConnect gathered the medical company and applicant, Revivicor, plans to use the genetically altered animals in a number of different ways.

These methods are to be adopted to produce drugs, to provide organs and tissues for transplants, and to produce meat that’s safe to eat for people with meat allergies, report said.

FDA Commissioner Dr. Stephen Hahn said it was the first time the government has approved an animal biotechnology product for both food and as a potential source for biomedicine.

Dr. Hahn stated: “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.”

It was learnt the pigs have been given the name “GalSafe” because an alpha-gal sugar molecule has been removed from the animals.

That molecule can trigger allergic reactions in some people with food allergies, according to report.

The regulatory agency further explained the GalSafe pigs could also provide materials to produce human medical products that don’t have any detectable alpha-gal sugar.

It said, for instance, the pigs could be used to make a version of the blood-thinning drug heparin that’s free of detectable alpha-gal sugar.

On organs for transplant, the researchers have also suggested that tissues and organs from GalSafe pigs could produce organs for transplant, eliminating or reducing the chances of organ rejection.

Alpha-gal sugar is currently believed to be the cause of organ and tissue rejection in some patients.

The FDA disclosed that it thoroughly reviewed the safety of the genetic alteration before granting approval, and it determined that food from GalSafe pigs is safe for the general population to eat.

The agency’s review also focused on ensuring the effectiveness of the IGA through the evaluation of data demonstrating that there is no detectable level of alpha-gal sugar across multiple generations of GalSafe pigs.

Genetic alteration of food products is not new, but has been limited to plants until now. The technology has been used for decades to produce genetically modified organisms (GMOs) that are more resistant to disease and drought.

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