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FDA Approves Perfect Day’s Animal-Free Whey Protein as Safe to Eat

by Catherine Lamb
April 15, 2020April 15, 2020Filed under:
  • Alternative Protein
  • Featured
  • Future of Drink
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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).


Related

Perfect Day Expands Series C Round to $300M for its Flora-based Dairy

Perfect Day, which creates animal-free, flora-based dairy products, announced today that it has expanded its Series C fundraise to $300 million. The new tranche is led by Canada Pension Plan Investment Board and follows the $140 million C round that initially closed in December of 2019. This brings the total…

MOOLESS: The First Animal-Free Whey Protein Powder Created By Perfect Day & Natreve

Perfect Day, a company that makes animal-identical proteins using precision fermentation, and Natreve, a wellness and nutrition company, have partnered to produce MOOLESS, a protein powder made with animal-free whey protein. In 2020, the FDA approved Perfect Day's animal-free whey protein made from β-lactoglobulin (the company's proprietary protein) for human…

Starbucks is Trialing Animal-Free Milk. I Decided to Try it Out to See If It Tastes & Foams Like Regular Milk

In case you haven't heard, Starbucks is trialing animal-free milk in the Seattle market. No, we're not talking Oatly or another plant-based milk, but a milk with cow milk-identical proteins made in a lab. The alt-milk is from Perfect Day, a company that uses precision fermentation to create its proprietary…

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