A panel of qualified experts reviewed data from animal studies, metabolism studies, estimated human exposure, in vitro studies, and refined chemical characterization to assess the safety of BCM-95.
The expert panel convened by GRAS Associates, LLC, 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.
“DolCas has marketed BCM-95 in the US since 2006, enjoying a steady increase in demand, thanks to dedicated consumers,” notes KG Rao, CEO of Dolcas. “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.”
“We intend to promote BCM-95 for use in medical foods for various conditions, at a dose level of 500 mg per serving,” said Nipen Lavingia, VP of Business Development of DolCas. “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.”
A spokesperson for Dolcas confirmed that the company plans to submit with FDA before end of the year.