In the letter - which you can read here - the 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.
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. During the fermentation, the β-lactoglobulin is secreted into the fermentation media. Post-fermentation, the culture is put through a centrifuge to separate the biomass from the fermentation media that contains soluble β-lactoglobulin.
The β-lactoglobulin is then concentrated via ultrafiltration/diafiltration and spray-dried.
According to Perfect Day, protein characterization data show that the final 'non animal' whey protein (which contains no genetically engineered fungi) is "identical to commercially available bovine-produced β-lactoglobulin," and as such presents no additional safety concerns.
The nutrition and functionality of animal protein... minus the cows
Speaking to FoodNavigator-USA in December 2019 after raising $140m in a Series C round, Perfect Day co-founder Ryan Pandya said the firm's dairy proteins (and in future fats) are greener and kinder than those produced via industrialized animal farming, but they also represent a new supply of animal-free ingredients that deliver the unique functionality and nutrition of dairy so that formulators do not have to compromise.
"Typically companies are looking at this as a third category somewhere between plant-based and traditional dairy, where we offer the nutrition and functionality and flavor experience of dairy and the heart and soul of a plant-based protein.”
- Read more about Perfect Day HERE.
- Read a new paper published in Critical Reviews in Food Science and Nutrition by Paul Hanlon and Vincent Sewalt: GEMs: genetically engineered microorganisms and the regulatory oversight of their uses in modern food production.
