November 27, 2022

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FDA approves the marketing of genetically modified pig products

FDA approves the marketing of genetically modified pig products, which could be used to treat red meat allergy

FDA approves the marketing of genetically modified pig products, which could be used to treat red meat allergy.  US FDA approved genetically modified pig products on December 14th. Patients with red meat allergies can eat them safely and can also be used to manufacture medical biological products that are safe for allergic patients.

FDA approves the marketing of genetically modified pig products

Red meat allergy is alpha-galactose syndrome. In the United States, this particular allergy often stems from a lone star tick bite. During the bite, the tick may transfer α-galactose into the human body, triggering an immune system response. People who are bitten thereafter will have mild to severe allergic reactions to α-galactose in red meats such as beef, pork or lamb, so they are called “red meat allergies.”

This is the first time the FDA has approved genetically modified animal products for both edible and biomedical purposes. Through transgenic technology, there is no alpha-galactose on the surface of the transgenic pig cells, and patients with red meat allergies can eat it safely. Genetically modified pigs can also produce many medical products, such as heparin anticoagulants, biological heart valves, etc., which can effectively avoid more severe immune rejection in allergic patients.

The FDA pointed out in the statement that the FDA has conducted a comprehensive assessment of the safety of genetically modified pork and determined that it is safe for food use. At the same time, the agency also evaluated the offspring of genetically modified pigs and confirmed that alpha-galactose was not detected in the products of these offspring.

The FDA assesses the potential impact of genetically modified pigs on the US environment and determines that it will not have a greater impact than conventional pigs. Except for the common animal safety issues in common pig farms, no other problems were found. The FDA also evaluated the bacteria in pigs, and the results confirmed that the microbiological safety risks associated with genetically modified pork are relatively low, and follow-up issues need to be paid attention to.

FDA Commissioner Dr. Stephen Hanh said that for the first time animal biotechnology products have been approved for food and biomedical purposes at the same time, which is a major event in scientific innovation. The FDA will still strongly support the promotion of innovative animal biotechnology products that are safe for animals and humans.

Prior to this, the FDA approved the first genetically modified animal medical product ATryn in 2009, made from genetically modified goat milk, which can be used to prevent blood clots in patients with hereditary antithrombin deficiency; since then, the FDA also approved genetically modified eggs Kanuma can be used to treat rare protein deficiencies; Sevenfact made from genetically modified rabbit milk can be used to treat certain forms of hemophilia.

Genetically modified salmon is the only genetically modified animal product approved for consumption.

The FDA added that at present, the biological products of this genetically modified pig cannot be used for the treatment of heterogeneous implantation in the human body (such as biological valves). Medical device companies need to submit an application to the FDA and obtain approval before it can be used for clinical treatment.

(source:internet)

Reference:

FDA Approves First-of-its-Kind Intentional Genomic Alteration in Line of Domestic Pigs for Both Human Food, Potential Therapeutic Uses

https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-intentional-genomic-alteration-line-domestic-pigs-both-human-food?utm_medium=email&utm_source= govdelivery


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