Nature’s Fynd Gets FDA GRAS Approval For Its Yellowstone Park Fungi Protein ‘Fy’

Nature’s Fynd has been given the go-ahead from the U.S. Food and Drug Administration (FDA) to use its fungi-based protein Fy in food applications. In response to the company’s GRAS safety application, the regulators issued a “no questions” letter to deem Fy safe for consumption and give the firm tacit approval to sell products containing the novel protein ingredient. 

Nature’s Fynd, the Chicago-based food tech backed by Bill Gates and Jack Ma, has received a “no questions” letter from the FDA in response to its GRAS food safety application. The startup can now use its fungi protein ingredient dubbed Fy to be used and sold in food products, including in meat and dairy alternatives, beverages, ready meals, dried pasta and noodles, baking goods and oils and dressings. 

In the letter explaining the decision to recognise Fy as generally safe, the regulators said: “​Based on the information that Nature’s Fynd​​ provided, as well as other information available to FDA, we have no questions at this time regarding Nature’s Fynd’s conclusion that Fusarium protein is GRAS ​[Generally Recognized as Safe] under its intended conditions of use.”​

Fy protein

Fy is the ingredient developed by Nature’s Fynd, based on microbial research conducted for NASA in the geothermal springs of Yellowstone National Park. The name stands for Fusarium strain flavolapis, a naturally occurring non-GMO microorganism that Nature’s Fynd ferments into its complete fungi-derived protein. 

The process the startup uses involves growing the pure culture of the fungi strain through surface fermentation under lab-controlled conditions. A mycelial “biomat” then forms and can be harvested, while the fungal cells are inactivated through heat. The water content is removed through mechanical pressing, resulting in the final product—Fy—which contains all the essential amino acids. 

Fy can then be used to create a number of meat and dairy analogues for a far smaller carbon footprint than its traditionally farmed animal-based counterparts.

Fungi sausage patties and cream cheese

Nature’s Fynd has already used Fy to create two products: sausage patties and a cream cheese spread. Debuted in January this year, the products were released in limited quantities and were sold out within hours. Both products are vegan and non-GMO, and were designed to give consumers an “exclusive first-taste” of the company’s upcoming breakfast product line. 

With GRAS approval, the company can now speed up the launch of its products to the wider market within this year, a spokesperson for Nature’s Fynd told FoodNavigator. 

Previously, the startup revealed that it has also sought regulatory approval for Fy to be sold in Hong Kong and in mainland China. Nature’s Fynd said at the time of its US$45 debt financing in December 2020 that it will be using Fy to create a number of animal-free Asian dishes to gear up for its expansion into the region. 

Super high-protein, low carbon footprint

In its GRAS application, the startup says that Fy performs even better than other plant-based proteins in terms of nutrition and sustainability. Fy has a PDCAAS protein score of 0.92, a higher concentration than that of pea protein, while also containing “significant amounts of dietary fibre.” 

Based on a life cycle analysis, Fy requires very few resources to produce. Compared to conventional beef, it uses 99% less land, 87% less water, and emits 99% fewer greenhouse gases. 

Alternative protein demand on the rise

If alternative protein sales and investment data are any indication, Nature’s Fynd is likely to benefit from being a first-mover in the fast-growing space. Last year, U.S. plant-based retail sales surged to US$7 billion for the first time. 

While the company’s Fy protein is classified under the fermentation pillar of alternative proteins, a sector that meat-free player Quorn is best known for pioneering, it’s clear that the consumer demand for healthier, safer, and sustainable substitutes is rising. Globally, a Euromonitor survey estimates that 42% of all shoppers now consider themselves flexitarians, opening up an enormous market for all alternative protein players to capitalise on.  

In terms of investment data, an analysis from the Good Food Institute showed that in 2020, fermentation alternative protein companies raised US$590 million, doubling the amount from the year before. Nature’s Fynd’s US$80 million Series B round, which closed in March 2020, represented one of the biggest contributors, alongside precision fermentation dairy company Perfect Day’s US$300 million Series C. 

All images courtesy of Nature’s Fynd.