Nature’s Fynd receives GRAS no questions letter from FDA for ‘Fy’ nutritional fungi protein

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 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which was subject to a GRAS ‘no questions’ letter in 2002,​ ​according to Nature’s Fynd, which also references an unpublished acute toxicology study in Sprague Dawley rats and two genetic toxicology studies performed using Fusarium protein, neither of which showed its potential to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.

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