DolCas Biotech’s Curcugen curcuminoid complex earns GRAS safety approval

16 Mar 2021 --- Curcugen, a natural water-dispersible curcuminoid formula produced by DolCas Biotech, has been recognized as safe for consumption in the US market. 

The bioavailability-enhanced ingredient has been greenlighted as safe to include F&B products including yogurt, nutrition bars and smoothies at levels of 40 to 60 mg per serving. 

The Self-Affirmed Generally Recognized As Safe (GRAS) of the turmeric ingredient was unanimously agreed on by an independent panel of scientific experts, concluding that Curcugen meets Food and Drug Administration’s (FDA) definition of safety.

“The highest demand for curcumin brands in general has been the US and some Asian countries, like Japan, Korea and Taiwan. However, we are seeing a growing market and interest in Europe, developing Asian countries and even South America,” Dr. Shavon Jackson-Michel, director of medical and scientific affairs for DolCas Biotech, tells NutritionInsight.

“Curcugen is a newer curcumin brand to the market, but we are seeing the interest for this ingredient following this same pattern. We believe that with the addition of self-GRAS designation we will be seeing this flourish even more in the near future.”

Curcugen was found in previous research to have a positive role in improving gut health and boosting mood, as well as mitigating inflammation. Next-gen qualities
Among its bioactive and holistic qualities, Curcugen was found in previous research to have a positive role in improving gut health and boosting mood, as well as mitigating inflammation. 

DolCas’ new curcumin formula is a proprietary 98.5 percent turmeric-based preparation of turmeric oleoresin extract and fresh turmeric rhizome extract derived from Curcuma longa L. 

This synergism is what elicits the clinical benefits associated with Curcugen at doses as low as 500 mg/day, and is pivotal in the brand’s novel dispersion mechanism.

The high concentration of curcuminoids at a 50 percent standard does not omit other functional turmeric actives, including turmeric essential oils and polysaccharides. 

“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,” explains Dr. Jackson-Michel.

Last August, IFF Health and DolCas Biotech partnered for the sale and marketing of Curcugen.

SELF D platform technology
The company applies a SELF D platform technology to optimize the oleoresin base, so that benefits can be fully realized.

“The SELF D platform technology helps to concentrate curcuminoids, while availing other natural constituents of the rhizome that complement curcuminoids,” details Dr. Jackson-Michel.

“Furthermore, the SELF D platform reserves resins within the extract that display more polar properties and facilitate curcuminoids dispersion in solution,” she continues.

“This surfactant-like effect is believed to be at least one of the mechanisms for Curcugen’s enhanced bioavailability, when compared to C-95, or 95 percent curcuminoids extract.”

At the same time, Curcugen eliminates the need to complement the curcuminoids with other, non-turmeric ingredients, or reconstitute it with displaced turmeric ingredients.

The nutrition industry continues to innovate curcumin to reach superior bioavailability and anti-inflammatory benefits as a “spiceutical.”Aligning with scientific guidance
The scientific panel concurrently determined an Acceptable Daily Intake (ADI) of Curcugen at 210 mg/person/day, according to Joint FAO/WHO Expert Committee on Food Additives (JECFA) standards.

This ADI conclusion falls in line with the 2010 European Food Safety Authority (EFSA) scientific opinion on the “conservative estimate” for assessing exposure to curcumin. 

The committee also determined an upper limit up to 1400 mg per person per day in the same food formats, which it considered was 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.

The independent GRAS conclusion included an appraisal of the manufacturing process, product specifications, as well as consideration of opinions by other regulatory bodies around the globe that verified its Current Good Manufacturing Practice (CGMP) status.

DolCas will take the brand 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,” concludes KG Rao, CEO and president of DolCas Biotech.

This latest development follows DolCas Biotech’s partnership with Olene unveil a “formidable” ginger root extract targeting gut health

An in-demand “spiceutical”
The nutrition industry continues to innovate curcumin to reach superior bioavailability and anti-inflammatory benefits as a “spiceutical.” 

Last January, Akay Group’s curcuminoid-fenugreek complex, CurQfen, was shown to improve memory and concentration compared to unformulated curcumin (UC) or a placebo. 

Also in the space, Robertet launched curcuRouge last November, a “groundbreaking” curcumin that has shown 93 times greater absorption than traditional extracts, according to research.

By Benjamin Ferrer