NOMAD submitted an amendment to the supplement on June 9, 2021, providing additional information regarding the cumulative dietary exposure to the ingredient, Thaumatin II. FDA previously evaluated GRN 910 and sent ‘no questions’ letter at that time regarding NOMAD’s conclusion that Thaumatin II is GRAS for use as a non-nutritive sweetener in a variety of food categories at levels ranging from 5 to 400 mg/kg or mg/L food or beverage.

Thaumatins are natural non-caloric sweeteners/flavour modifiers. Thaumatins are intensely sweet-tasting protein mixtures (consisting mainly of Thaumatin I and Thaumatin II), about 2000-3000 times sweeter than sucrose on a weight basis. Thaumatin mixtures purified from its natural source plant Thaumatococcus received regulatory approvals as sweetener or taste modifier decades ago, and they are on the market in US, EU, Japan and many other countries. The wide use of the products as sugar replacements is however limited because of low and unreliable supply of natural plant species and low yield resulting in high price of the product; and the fact that the microbial fermentation production process of Thaumatins is not competitive. NOMAD has developed alternative process of natural Thaumatins, specifically the superior protein Thaumatin II, in alternative plant hosts that opens way to unlimited and economical production of the protein. To date, NOMAD has received four GRAS clearance for Thaumatins made in other plant hosts as sweeteners and taste modifiers in 2018-20 (GRN 738, GRN 910, GRN 920, GRN 910S).