NOMAD Bioscience Receives Its GRAS Regulatory Clearance In USA For Plant-Made Natural Thaumatin II As Sweetener

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 as multiuse noncaloric sweeteners/taste modifiers. The much wider use of the products is however limited because of low and unreliable supply of natural plant species, low yield per hectare resulting in high price of bulk substance; and the fact that the microbial fermentation production of Thaumatins is not competitive. NOMAD has received its first regulatory GRAS clearance for Thaumatins made in other plant hosts as sweeteners in 2018 (GRAS 738). NOMAD’s current petition describes production and characterization of Thaumatin II. This natural Thaumatin version is over 10000 times sweeter than sucrose on a weight basis, it has superior taste attributes and, by using NOMAD manufacturing technology, it can be produced in other plants in unlimited amounts and at significantly lower cost of goods.

NOMAD and its former subsidiary Icon Genetics, have developed a unique process of manufacturing proteins in plants that is based on transient, rather than transgenic, expression of proteins such as Thaumatins. This transient fermentation process is currently being brought to an industrial level by NOMAD and its partners.

Thaumatin II is the NOMAD’s lead product candidate with new superior taste attributes; it aims to reduce sugar and eliminate artificial sweeteners in food products, and it can be produced in many plant crops thus assuring an unlimited substance supply and low commercially viable cost of goods.

“We are very pleased to receive a ‚no questions‘ response from FDA“, said Prof. Yuri Gleba, NOMAD’s CEO. “High consumption of sugars negatively affects health of one third of people globally. The regulatory clearance of our product candidate provides a commercial path to the products that have excellent taste, lower sugar content, and are not relying on artificial sweeteners. Its wide adoption would have a major environmental effect through reduction of sugar cane and sugar beet plantings (currently ca. 16 million hectares), because for production of our sweetener equivalent, we need approximately thousand times less land.”