Kaneka gets no objection GRAS letter from FDA for Cardio Probiotic combination

By Stephen Daniells

- Last updated on GMT

The GRAS notification covers the use of the strains as an ingredient in conventional foods, such as yogurt and many other products. Image © Amguy / Getty Images
The GRAS notification covers the use of the strains as an ingredient in conventional foods, such as yogurt and many other products. Image © Amguy / Getty Images

Related tags Probiotics Gras status Yogurt

Kaneka Probiotics has received a letter of no objection from the US FDA for the GRAS (Generally Recognized as Safe) status of its Cardio Probiotic L. plantarum combination.

The Cardio Probiotic ingredient is comprised of Lactiplantibacillus plantarum ​KABP-011, L. plantarum​ KABP-012, and L. plantarum​ KABP-013*, and is based on a foundation of published clinical trials, phenotypic data, and genotypic analysis.

“The FDA GRAS certification demonstrates our commitment to a higher level of safety and quality for this ingredient.  Brands can be assured to have best in class ingredient when selecting to use the Cardio Probiotic raw material blend in their products for lipid metabolism and cardiovascular benefits,”​ said Mike Kolifrath, VP of sales and marketing of the Probiotics Division at Kaneka.

According to the GRAS notification, the strains are intended for use as an ingredient in conventional foods at a maximum level of 4 billion colony forming units (CFU)/serving, when used individually and at a maximum level of 12 billion CFU/serving, when used in combination.

The L. plantarum​ combination is a clinically tested formulation that specifically supports healthy total cholesterol, LDL and HDL levels already in normal range, said the company in a press release.

The three L. plantarum​ strains used in the Cardio Probiotic formula were initially isolated from the feces of healthy South American infants via a screening process specifically designed to identify strains that have a beneficial effect on lipid metabolism.

* T​he Colección Española de Cultivos Tipo (CECT) designations for the strains, as listed in the GRAS dossier, are: Lactiplantibacillus plantarum ​CECT 7527, L. plantarum strain ​CECT 7528 and L. plantarum strain ​CECT 7529

The GRAS notification can be found HERE​. 

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