FDA has ‘no objections’ to lab-made dairy proteins produced with GMO microbes

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Ice cream and other dairy products can be produced from lab-made proteins, without animals. Credit: Perfect Day

Perfect Day, a startup producing milk proteins via microbial fermentation (minus the cows), has secured a coveted ‘no questions/objections’ letter from the FDA in response to its Generally Recognized as Safe (GRAS) determination for ‘non-animal’ whey protein.

…. [T]he FDA explains that, “Based on the information that Perfect Day provided, as well as other information available to FDA, we have no questions at this time regarding Perfect Day’s conclusion​​ that β-lactoglobulin is GRAS under its intended conditions of use.”​

The GRAS determination covers β-lactoglobulin (the major whey protein in cow’s milk) produced via the fermentation of a genetically engineered strain of the filamentous fungus Trichoderma reesei​.

Related article:  Animal gene-editing researchers leaving US to escape FDA's 'regulatory confusion'

According to FDA’s summary​​, Perfect Day​​ – one of a new wave of startups producing proteins via microbial fermentation – produces β-lactoglobulin by submerged fermentation of a pure culture of the production strain of T. reesei​ under controlled conditions.

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