28th October|Blogs

LPLDL® achieves GRAS status

OptiBiotix Health PLC (‘OptiBiotix’), a life sciences business developing compounds to tackle obesity, cardiovascular disease and diabetes, has announced that its revolutionary probiotic ingredient LPLDL® has achieved full Generally Recognized As Safe (‘GRAS’) status.

Next-generation ingredient LPLDL®, supplied by fully owned subsidiary ProBiotix Health Ltd (‘ProBiotix’), improves blood lipid profiles and blood pressure. Discovered using OptiBiotix’ unique screening process and probiotic research to offer a natural, science-backed and non-pharmaceutical approach to physical health. To achieve this, LPLDL® harnesses the microbiome-liver axis to impact positively on the gut microbiome using a naturally occurring strain of the bacterial species Lactobacillus plantarum.

GRAS status is the highest level of safety certification for a food substance or additive in the US and is a significant step in the continual commercialisation of the probiotic in the region and demonstrates the commitment of ProBiotix to developing safe and effective products.

Steve Prescott, CEO at ProBiotix commented: “Achieving GRAS validation is a rewarding step forward for LPLDL® and for ProBiotix. Distinctively, its microbiome-modulating capacity makes it a credible alternative for cardiovascular health, without the associated side effects.

“Fewer than 5% of marketed probiotics, have achieved this level of proven safety and efficacy, which marks LPLDL® out as a science-backed holistic ingredient for health and wellness that is differentiated from the others. Shown to lower LDL cholesterol by up to 13.9% and increase HDL cholesterol by up to 4.5%, it’s a suitable ingredient for a growing array of functional food products and supplements across consumer and pharmaceutical healthcare.”

ProBiotix had obtained a positive opinion from an independent panel of experts earlier this year and has now received confirmation of the probiotic’s status as GRAS. This is the highest level of safety certification for a food ingredient in the US and ends a comprehensive regulatory and scientific process.

Considered as the gold standard for food ingredient safety, GRAS is an FDA designation that indicates a substance added to food is considered safe, further strengthening the marketing attractiveness of LPLDL® and demonstrating the commitment of ProBiotix to developing consistently high quality products.