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Perfect Day’s animal-free dairy protein earns Generally Recognized as Safe (GRAS) status

The U.S. Food and Drug Administration (FDA) issued a “no objections” letter for the animal-free dairy company Perfect Day’s β-lactoglobulin protein. The letter certifies that the protein has attained Generally Recognized as Safe (GRAS) status.

This whey protein is a flora-based replication of the bovine-based β-lactoglobulin protein. It is made from the fermentation of the genetically modified trichoderma reesei yeast strain. After the yeast ferments, the protein is extracted via the aid of a centrifuge and then combined with water and fat to create a milk-like product for use in dairy products.

Though GRAS is a voluntary designation for companies to pursue, this status is a milestone for companies with novel ingredients or lab-based formulations that companies want to assure consumers through government backing that there is a reasonable certainty that it won’t cause harm.

According to Perfect Day, “β-lactoglobulin produced by fermentation is identical to commercially available bovine-produced β-lactoglobulin.” By issuing the notification with “no questions,” the FDA is signaling that it agrees with the company’s assessment.

Although this approval took nearly a year for the company to receive, its arrival is no surprise. Last year, Impossible Foods received GRAS status for its soy leghemoglobin that creates the burger’s characteristic “bloody” look. Nor will these two companies likely be the last to receive this status as startups like animal-free egg protein producer Clara Foods look to microbial fermentation for a more sustainable solution to produce animal proteins without the animal.

Now that Perfect Day’s central protein ingredient has its GRAS status, the company will likely look toward expanding its animal-free dairy products. Last December, the California-based company closed a $140 million funding round with the intention of accelerating business growth, ramping up production capacity, and increasing its product portfolio. This funding round brought the company’s total funding to $201.5 million.

However, the company will only be able to expand so far. In the FDA approval letter, the governmental regulatory agency specifically prohibits some uses for the protein. The letter said lab-fermented β-lactoglobulin is “not intended for use in infant formula or in products subject to regulation by the United States Department of Agriculture.”

With infant formula off the table, the company will likely focus on more mainstream dairy products like cheese, milk, yogurt and ice cream. Last summer, the company’s first commercial product - animal-free ice cream - appeared on its website. The ice cream came in three flavors: Milky Chocolate, Vanilla Salted Fudge and Vanilla Blackberry Toffee. Despite a $20 per pint price tag, the lab-grown ice cream sold out in 24 hours.

Just this week, Perfect Day announced it teamed up with Silicon Valley’s Smitten Ice Cream to offer $12 pints in four flavors: Brown Sugar Chocolate, Fresh Strawberry, Root Beer Float and Coconut Pecan. Clearly there is interest in the company's animal-free dairy products so whatever the company produces next, will likely also grab consumer attention.