OptiBiotix Health plc (LON:OPTI) said its cholesterol product had been generally recognised as safe (GRAS) by an independent expert panel in the US.
The company, which is developing products to tackle obesity, cardiovascular disease and diabetes, said sign-off for its Lactobacillus plantarum LPLDL probiotic strain represented a significant milestone.
WATCH: OptiBiotix cholesterol product 'generally recognised as safe' by US independent expert panel
That’s because GRAS designation is required for food additives in the States. In the case of probiotics, it is strain-specific.
Assessment involves submitting an extensive technical dossier for evaluation.
The GRAS panel that reviewed LPLDL concluded the bacteria strain was safe for use in food and beverages at a concentration of up to 10bn colony forming units per serving.
This is more than double the dose found to significantly reduce cholesterol and blood pressure in a human trial conducted by Reading University.
OptiBiotix chief executive Stephen O’Hara said: “This is a significant achievement and a major commercial milestone as it expands the potential applications of LPLDL from use as a supplement to use as a functional ingredient in a wide range of food, dairy, beverage, and high-value medical food applications, across the USA.
“In addition, obtaining GRAS status is increasingly being seen by large US corporates as a key requirement to independently validate the safety of commercial probiotic strains in supplements and as such, is a major point of differentiation from other probiotics, as very few strains currently have this status.”