21st Feb 2019 11:38
LONDON (Alliance News) - OptiBiotix Health PLC on Thursday said the US FDA assigned a GRAS designation to its cholesterol and blood pressure reducing probiotic strain.
The Lactobacillus plantarum LPLDL product, developed by OptiBiotix's subsidiary ProBiotix Health Ltd, has been defined as "Generally Recognized As Safe" by an independent panel of the US Food & Drug Administration.
The GRAS designation marks the safety of a product to be added to food. The status is therefore required for the use of these substances in foods.
"GRAS assessment involves submitting an extensive technical dossier for evaluation by an independent panel of experts. They confirm if the ingredient is safe, under what conditions it can be used, and for which applications," OptiBiotix explained.
The panel determined that LPLDL is safe for use in food and beverage up to 10 billion colony forming units per serving, more than double the dose found to "significantly reduce cholesterol and blood pressure" in a 2017 trial.
"We are pleased to announce that the independent expert panel has ruled in favour of LPLDL's GRAS status. 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 US," Chief Executive Officer Stephen O'Hara said.
OptiBiotix Health shares were trading up 1.0% at 87.40 pence. Earlier on Thursday the stock rose as high as to 91.70p.
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