Mike Montemarano, Associate Editor 03.16.21
Curcugen, DolCas Biotech’s bioavailability-enhanced, water-dispersible curcuminoid complex, has received self-affirmed GRAS (Generally Recognized As Safe) status. The designation was unanimously accorded by an independent panel of scientific experts and based on scientific procedures, who concluded that Curcugen meets FDA’s definition of safety when used as an ingredient in yogurt, nutrition bars, smoothies, and other food and beverage products at levels of 40-60 mg per serving.
The panel concurrently determined an acceptable daily intake (ADI) of Curcugen at 210 mg/person/day, using both JECFA standards which falls in line with the 2010 EFSA scientific opinion on the “conservative estimate” for assessing exposure to curcumin. The committee also determined an upper limit up to 1400 mg/person/day in the same food formats which it considered safe, and met the requirements of GRAS, as defined by the FDA. This conclusion was drawn directly from a battery of toxicological studies performed using Curcugen.
DolCas’ new curcumin formula is a 100% natural, water-dispersible curcumin ingredient. It is a proprietary 98.5% turmeric-based preparation of turmeric oleoresin extract and fresh turmeric rhizome extract derived from Curcuma longa L. The company applies a Self D platform technology to optimize the oleoresin base so that its benefits can be fully realized. At the same time, it eliminates the need to complement the curcuminoids with other, non-turmeric ingredients, or reconstitute it with displaced turmeric ingredients.
The independent GRAS conclusion included an appraisal of the manufacturing process, product specifications, and consideration of opinions by other regulatory bodies around the globe that verified its Current Good Manufacturing Practices (cGMP) status.
“In contrast to certain generic curcumin products currently on the market, our formulation preserves the original complex of curcuminoids, essential oils, and polar resins within the optimized oleoresin matrix,” Dr. Shavon Jackson-Michel, Medical and Scientific Affairs director for DolCas Biotech, said. “This supports its superior bioactive and holistic qualities – Curcugen is time-tested and its efficacy has been scientifically explored for its positive role in gut health and mood, as well as mitigating inflammation.”
Curcugen’s 98.5% turmeric formulation provides a high concentration of curcuminoids at a 50% standard, without omitting other, well-characterized and functional turmeric actives, including turmeric essential oils and polysaccharides. The synergy between these compounds is what elicits the clinical benefits associated with the ingredient at doses as low as 500 mg/day, and is pivotal in the brand’s novel dispersion mechanism, Jackson-Michel said. “Curcugen’s fidelity to the rhizome, its low effective dose, and diverse delivery potential combined with therapeutic application and the new high-limit independent safety affirmation opens the brand to be among the most trusted in the industry.”
DolCas will take Curcugen to the highest level of safety appraisal with the FDA in a comprehensive GRAS submission within the next few months. “With the new self-GRAS status in place, we can continue studying the brand and broaden its integration into beverages, food, and confectionary, and expand its application to additional categories, including sports nutrition and general wellbeing,” KG Rao, CEO and president of DolCas Biotech, said.
Mike Montemarano has been the Associate Editor of Nutraceuticals World since February 2020. He can be reached at mmontemarano@rodmanmedia.com.
The panel concurrently determined an acceptable daily intake (ADI) of Curcugen at 210 mg/person/day, using both JECFA standards which falls in line with the 2010 EFSA scientific opinion on the “conservative estimate” for assessing exposure to curcumin. The committee also determined an upper limit up to 1400 mg/person/day in the same food formats which it considered safe, and met the requirements of GRAS, as defined by the FDA. This conclusion was drawn directly from a battery of toxicological studies performed using Curcugen.
DolCas’ new curcumin formula is a 100% natural, water-dispersible curcumin ingredient. It is a proprietary 98.5% turmeric-based preparation of turmeric oleoresin extract and fresh turmeric rhizome extract derived from Curcuma longa L. The company applies a Self D platform technology to optimize the oleoresin base so that its benefits can be fully realized. At the same time, it eliminates the need to complement the curcuminoids with other, non-turmeric ingredients, or reconstitute it with displaced turmeric ingredients.
The independent GRAS conclusion included an appraisal of the manufacturing process, product specifications, and consideration of opinions by other regulatory bodies around the globe that verified its Current Good Manufacturing Practices (cGMP) status.
“In contrast to certain generic curcumin products currently on the market, our formulation preserves the original complex of curcuminoids, essential oils, and polar resins within the optimized oleoresin matrix,” Dr. Shavon Jackson-Michel, Medical and Scientific Affairs director for DolCas Biotech, said. “This supports its superior bioactive and holistic qualities – Curcugen is time-tested and its efficacy has been scientifically explored for its positive role in gut health and mood, as well as mitigating inflammation.”
Curcugen’s 98.5% turmeric formulation provides a high concentration of curcuminoids at a 50% standard, without omitting other, well-characterized and functional turmeric actives, including turmeric essential oils and polysaccharides. The synergy between these compounds is what elicits the clinical benefits associated with the ingredient at doses as low as 500 mg/day, and is pivotal in the brand’s novel dispersion mechanism, Jackson-Michel said. “Curcugen’s fidelity to the rhizome, its low effective dose, and diverse delivery potential combined with therapeutic application and the new high-limit independent safety affirmation opens the brand to be among the most trusted in the industry.”
DolCas will take Curcugen to the highest level of safety appraisal with the FDA in a comprehensive GRAS submission within the next few months. “With the new self-GRAS status in place, we can continue studying the brand and broaden its integration into beverages, food, and confectionary, and expand its application to additional categories, including sports nutrition and general wellbeing,” KG Rao, CEO and president of DolCas Biotech, said.
Mike Montemarano has been the Associate Editor of Nutraceuticals World since February 2020. He can be reached at mmontemarano@rodmanmedia.com.
