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FDA Approves Genetically Modified Pigs!

U.S regulators, FDA, came with a decision groundbreaking for the field of biotechnology. A genetically modified pig is now legal for food and medical products. The biggest use of it will be found in eliminating alpha-gal, a sugar that is found in many mammals and ends up in food, cosmetics, and medications. It has been shown to cause allergic reactions and the genetically modified pig can prevent it.

Genetically Modified Pig Meat Safe For Consumption

Although FDA has confirmed that genetically modified pig meat will be safe for consumption, the company behind it, United Therapeutics Corp,  says they are not planning to sell it for meat production.

Development Of Medical Prdocuts

United Therapeutics plan to start developing medical products using the genetically modified pig in order to avoid alpha-gal and being safe for people that are allergic to this type of sugar. Although it may not appear significant, it will provide very valuable opportunities for anti-allergic blood thinners and other crucial medications. The ultimate goal for the company is, however, much bigger. They plan to eventually be able to transplant the pig’s organs into humans in desperate need of transplantation. 

Center Of Food Safety Sceptical Of FDA’s Decisions Regarding Approving Genetically Modified Animals

The FDA’s decision to approve the GalSafe pig did not go unnoticed by the Center for Food Safety. The group has earlier sued FDA after the regulators decided to give green light to the first genetically modified animal for human consumption – salmon whose growth was altered. The Center for Food Safety spoke out about being in the process of reviewing the FDA’s decision. 

While some believe that the announcement presents new possibilities within biotechnology’s development, others say that it is concerning due to the fact that United Therapeutics never disclosed how the DNA of the pig was altered. 

FDA Says It Is “A Tremendous Milestone”

Dr. Stephen Hahn who is the FDA’s Commissioner commented on the news calling it “a tremendous milestone”. He said, “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,” 

Phase 1 Trial

Currently, three patients that suffered skin burns with alpha-gal allergies will be going through the Phase 1 trial to analyze the opportunities that GalSafe pigs have for treating severe burns. 

“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 modernizing our scientific processes to optimize a risk-based approach that advances cutting-edge innovations in which consumers can have confidence.”, Hahn said in the official FDA statement.

Impact Of The GalSafe Pig On The Environment

The FDA’s review also concluded that the pig would not have any different impact on the environment than what the traditionally farmed pigs do. Although this is not the first genetically modified animal to be approved by the FDA, there were very few previous cases. That is why the decision is significant for the biotechnology field. While solving the shortages of transplantable organs with GalSafe pigs may still be years away, we may be one step closer to it. 

Nel Tomczyk
Nel Tomczyk
Nel is a writer for RegTech Global. From her past experience, she gained a deep understanding of fintech, AI, regulations, and new technologies. She has vast experience in journalism and entrepreneurship.


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