High Potency Turmeric Extract Granted GRAS Status for Medical Food
13 Sep 2016 --- BCM-95, the turmeric extract from DolCas Biotec LLC, has received GRAS (Generally Recognized as Safe) status for use in foods, dietary supplements and medical foods. The status comes after more than 24 clinical trials as well as ongoing clinical research programs on its safety and application for health-related conditions.
The food ingredient safety evaluation was undertaken in accordance with US Food and Drug Administration (FDA) safety criteria whereby “reasonable certainty of no harm under the intended conditions of use” must be established.
The GRAS evaluation was based on scientific procedures and substantial corroborative evidence derived from history-of-use considerations for related substances.
"GRAS status will allow us to expand our reach beyond our current presence in the dietary supplement market into use in the medical foods and food space," Dr. Shavon Jackson-Michel, ND Medical and Scientific Affairs Advisor at DolCas Biotech told NutritionInsight, "This more expansive presence, as confirmed by a third party expert panel gives the end-user an enhanced level of confidence in the safety our ingredient for its intended use."
As curcumin is not absorbed well by the body, an enhanced delivery system is needed to increase its bioavailability. With BCM-95, the extracted curcumin is highly bioavailable due to the synergism between the curcumin itself and the compound ar-turmerone, an essential oil component of turmeric extract.
“The superior quality and analytical testing of the turmeric used for BCM-95 confirms the lack of contamination and ensures the finished product’s purity,” says Nipen Lavingia, VP of Business Development of DolCas Biotech.
Lavingia continued, “The company utilizes the highest measure of quality control procedures, guaranteeing BCM-95 curcumin is safe to use, and completely free of any contamination. In this way, DolCas Biotech has an established consumer and customer trust of its curcumin brand, internationally.”
DolCas has marketed BCM-95 in the US since 2006, enjoying a steady increase in demand, thanks to dedicated consumers. KG Rao, CEO of Dolcas, said, “Attaining GRAS status as a medical food is a strategic move that will position BCM-95 as a leading curcumin brand in the US market.”
The panel convened by GRAS Associates concluded that BCM-95, when being used in accordance with the designated food uses and use levels, is GRAS when consumed as proposed at a maximum of 180 mg per person per day in conventional foods, and at 1000 mg per person per day in medical foods.
The company now hope to move more aggressively into the medical food sector.
“We intend to promote BCM-95 for use in medical foods for various conditions, at a dose level of 500 mg per serving,” explains Lavingia, “If two servings of the subject medical food were consumed daily, the daily dietary exposure level of curcumin would be 1,000 mg per person.”
Jackson-Michel added, "As we continue to expand our clinical and scientific research portfolio and through clinical trial actualize the vast health benefits afforded by BCM-95, our future impact will be greatest in the medical and functional food space, now that GRAS status has been obtained."
by Hannah Gardiner
