In the letter, the FDA explains that, “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.”
What is Fy protein and how is it made?
The GRAS determination covers a fungal protein - described on food labels as ‘Fy Protein (nutritional fungi protein)’ - from Fusarium strain flavolapis, a naturally occurring, Non-GMO fungi strain that Chicago-based Nature’s Fynd grows as a whole food ingredient for use in multiple applications from meat and poultry analogs to dairy alternatives, meal replacements, juices, pastas, baked goods, soups, and fats & oils at levels of up to 23.3% dry weight.
According to the GRAS determination (GRN 904), Fusarium protein is 20-30% solids and may also be dried to a product with around 95% solids. On a dry weight basis, it contains more than 45% protein, 25-35% fiber, 5-15% non-fiber carbohydrates, 5-10% fat, and less than 0.5% sugar.
According to the FDA’s summary, Nature’s Fynd grows a pure culture of F. strain flavolapis through surface fermentation under controlled conditions until a mycelial ‘biomat’ is formed. This is then harvested and the fungal cells are inactivated by heat treatment. Water is removed by mechanical pressing to obtain the final Fusarium protein product, which can then be further dried or ground.
Safety and allergenicity
While F. strain flavolapis is a new food ingredient, it is similar to Quorn mycoprotein from Fusarium Venenatum strain PTA-2684, which was subject to a GRAS ‘no questions’ letter in 2002, according to Nature’s Fynd, which also references an unpublished acute toxicology study in Sprague Dawley rats and two genetic toxicology studies performed using Fusarium protein, neither of which showed its potential to produce toxicity.
As for allergenicity, its Fusarium protein has “no homology to the eight major food allergens,” while unpublished results of simulated gastric and intestinal fluid digestion tests indicate that consumption is unlikely to cause an allergic response, says Nature’s Fynd, which notes that that its protein is also “well tolerated in consumption trials and without reports of major gastrointestinal issues.”
Non GMO whole food ingredient with 'all the essential amino acids and significant amounts of dietary fiber'
Part of a third wave of ingredients in the ‘alternative protein’ space that is not plant-based or cell-cultured, but made via microbial fermentation, Nature’s Fynd is not, however, using genetic engineering (eg. synthetic biology to ‘program’ microbes to produce target molecules).
Instead, it is working with Non GMO fungi strains that naturally produce high levels of complete protein when grown in a controlled environment. Rather than extracting the protein to make a concentrate or isolate, Nature’s Fynd is producing a whole food ingredient, said the company, which recently tested the market with a limited edition launch of meatless breakfast patties and dairy-free cream cheese.
Microbes are more efficient than animals and many plants at producing protein
Right now, producing protein – whether from peas and soybeans or cows and chickens – is resource-intensive and time-consuming, requiring large amounts of land, energy and water, according to Nature's Fynd CEO Thomas Jonas, who like to point out that it can take years to grow animals, and months or years to grow plants, while microbes "can double their biomass in a matter of hours and the ‘growing season’ is 24 hours a day, seven days a week, 365 days a year.”
What makes the ‘extremophile’ Fusarium flavolapis strain alluring as a potential food source is that it has evolved to do more with less – that is, it can produce high quality protein with minimal inputs very efficiently in a highly acidic environment, which “drastically reduces” the risk of contamination and enhances food safety, claimed Jonas.
Attractive PDCAAS score, lower environmental inputs
In the GRAS notice, the company explains that Fy protein has a PDCAAS score of 0.92 (higher than plant proteins such as pea), providing "all the essential amino acids and significant amounts of dietary fiber."
According to the company, a life cycle analysis suggests that Fy emits roughly 99% fewer greenhouse gases, and uses 99% less land, and 87% less water than growing beef, with no methane emissions, and minimal waste.
Nature's Fynd (previously known as Sustainable Bioproducts) has raised $158m to date from a range of high-profile backers including Breakthrough Energy Ventures (a $1bn fund backed by high-profile names from Bill Gates (who mentioned the company on 60-Minutes over the weekend), Mike Bloomberg, Richard Branson and Jeff Bezos to Mark Zuckerberg); and sustainable investment firm Generation Investment Management LLP (chairman: Al Gore).
* The strain was previously identified as F. novum yellowstonensis. However, more recent taxonomic characterization and genetic analysis have indicated the organism is a distinct species, says the FDA.