Perfect Day, the startup using fermentation to create animal-free dairy proteins, has officially received approval for its proprietary whey protein from the Food and Drug Administration (FDA). In a letter, the FDA writes that it has “no questions” that β-lactoglobulin — Perfect Day’s proprietary protein for its flora-based products — is Generally Recognized As Safe (GRAS).
Perfect Day submitted the notice to approve β-lactoglobulin to the FDA on May 20, 2019, so it’s taken roughly 10 months for the FDA to officially approve it. The protein is created by fermenting a genetically modified strain of the yeast Trichoderma reesei. Said yeast is submerged in media, where it ferments and excretes the β-lactoglobulin protein. The whole solution is then put through a centrifuge to separate out the protein, which is then filtered and dried to create a raw product. Add fat and water, and you’ve got something that’s essentially animal-free milk — and can be used to make ice cream, cheese, and basically anything that contains dairy.
In the FDA letter, Perfect Day plants an important stake in the ground. The company “concludes that the protein characterization data shows that the sequence of β-lactoglobulin produced by fermentation is identical to commercially available bovine-produced β-lactoglobulin.”
In short, Perfect Day claims that its flora-based milk is essentially the same thing as the milk from a cow you’d buy in the store. The FDA backs that up — at least to some extent — when states in the letter that β-lactoglobulin needs the same allergy labeling as milk. It is, at least for those with dairy allergies, the same thing.
The FDA hasn’t approved Perfect Day to sell its protein willy-nilly. The letter explicitly states that the β-lactoglobulin protein is “not intended for use in infant formula or in products subject to regulation by the United States Department of Agriculture.” But Perfect Day is free to sell its flora-based dairy protein to larger CPG companies to make animal-free products, as it had planned to do all along.
According to Ryan Pandya, Perfect Day’s CEO, this GRAS certification hasn’t affected their go-to-market timeline one way or another. He wrote to me that “we were expecting to secure the certification,” and had essentially been preceding under the assumption that it would be granted. Since the FDA has already approved fermented ingredients to replace animal products in the past — like Impossible Food’s blood-like heme — it’s not a reach that Perfect Day’s dairy proteins are considered GRAS.
Waiting for the GRAS letter may not have been holding up Perfect Day’s plans, but COVID-19 could still wreak havoc on their timeline. Pandya didn’t reveal any specifics about the pandemic’s effects, only noting that they are “adjusting our plans as needed.”
Perfect Day released its first product — animal-free ice cream — last year and plans to announce its first commercial partnerships in early 2020 (as in, any day now).