The U.S. Food and Drug Administration (FDA) has given its first approval on genetically-modified pigs for food and medical use.

In a press release, FDA Commissioner Stephen M. Hahn said that the agency has awarded it "first-ever approval of an animal biotechnology product," which can be used for biomedical purpose and for general consumption. The commissioner noted that this "represents a tremendous milestone for scientific innovation."

The pigs are licensed under Revivicor Inc., which is a subsidiary of United Therapeutics. The company is based in Virginia and was formed in 2003 from the U.K. company that produced Dolly the Sheep, the first cloned animal, in 1996. 

FDA Approves GalSafe Pigs for Food and Medical Use

According to The Verge, the genetically-modified pigs are called GalSafe pigs because they lack alpha-gal sugar molecules, which are found in mammals. They are not superpigs as the only difference between GalSafe and a natural pig is their lack of alpha-gal sugar.

While they are not found in humans, Alpha-gal sugar may trigger allergic reactions called Alpha-gal syndrome (AGS). The AGS causes serious meat allergy that can happen after a deer tick or lone star bite.

The FDA deemed GalSafe pork products to be safe for general consumption, despite the lack of testing for people with AGS. The agency also permitted the use of genetically-modified pigs for human transplant as well as for production of medicines.

While this is not the first time that the FDA approved genetically-modified animals, the GalSafe pigs is the first to have received approval for human consumption as well as for medical use.

In 2009, the FDA approved genetically-modified goats that produce milk that can be prevent blood clots. In 2015, the FDA also granted approval for genetically-engineered chickens that can produce a drug with their eggs. Also in 2015, the U.S. agency gave its approval on a genetically modified salmon, which became the first GMO animal approved for eating.

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Genetically-modified pigs pros and cons

GalSafe may resolve the lack for vital organ transplants resources as 10 patients in the U.S. die every day while waiting for donors. 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.

A xenotransplant refers to the implantation, infusion, or transplantation of live tissues, cells, or organs from an animal source to a human. It also involves contact of human cells, tissues, body fluids, or organs outside human bodies. 

Aside from the great potential for safe human consumption, there are several potential medical uses for GalSafe pigs. They could be used to make safer drugs for people with AGS such as heparin, a common blood-thinner that is derived from animal tissue. these genetically-modified pigs can also supply organs and tissues without the alpha-gal sugar can be a cause of organ rejection.

However, the GalSafe pigs's potential for transplantation has not yet been tested, so further research is necessary. Similarly, there are also still no tests being done on GalSafe ingestion by people with meat allergies, so it is still unclear what effects it would have on them.

Meanwhile, any company or manufacturer that would want to utilize GalSafe pigs would need to get further approval from the FDA before they use new drugs or do implants or transplants on humans.

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Written by CJ Robles

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