DolCas Biotech Receives FDA “No Objection” Letter following GRAS Review for BCM-95 Curcumin Ingredient


The company also secured self-affirmed GRAS status for its ingredient back in 2016.

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Botanical extracts supplier DolCas Biotech LLC (Landing, NJ) recently announced it received a FDA “no objection” letter following the agency’s Generally Recognized as Safe (GRAS) review of the company’s proprietary curcumin (Curcuma longa) ingredient BCM-95. DolCas says that its BCM-95 ingredient has been deemed safe at a dose of 500 mg/day twice daily for medical foods, and 40-60 mg/day for conventional foods.

According to the company, BCM-95 has undergone more than 25 studies on its efficacy and safety. It cites one study in particular, published in Scientific Reports, which found that the “specific combination of curcuminoids and essential oils found in BCM-95 more significantly modulated various attributes of disease activity in a murine model of colitis than did a standalone curcumin ingredient or placebo.”

BCM-95 had previously achieved self-affirmed GRAS status for BCM-95 for medical foods purposes. The GRAS panel, which was convened by GRAS Associates LLC (Bonita Springs, FL), found that BCM-95 is safe at levels of 1,000 mg/day in medical foods. DolCas has since been promoting the ingredient for use at 500 mg/day, twice daily, for medical foods.

Shavon Jackson Michel, ND, medical & scientific affairs advisor, commented on the significance of the safety review in a press release: “Not all curcumin products are the same or have gone through the most rigorous safety reviews,” she said. “The additional level of review that led to the FDA’s recent response reflects our commitment to ensuring the safety of our products go above and beyond what is commonplace in the industry.”<

She added: “The FDA’s response adds further credence to our expert panel’s confirmation of GRAS status. This is a rare accomplishment and distinguishes BCM-95 as a product our customers can trust.”

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