Arjuna turmeric extract granted a “no questions” letter from US FDA
03 Aug 2017 --- Arjuna Naturals Extracts Ltd.’s BCM-95, a high-potency turmeric extract, has been granted a “No Questions” response letter from the US Food and Drug Administration (FDA). This letter confirms the complete safety of BCM-95 and helps position the ingredient as an all-natural and clean curcumin antioxidant brand.
“The FDA’s latest positive response is a testimony to our unwavering commitment to ensuring maximum safety and quality products,” says Benny Antony, Ph.D., Joint Managing Director for Arjuna. “BCM-95 is one of only a few supplements in the nutraceutical industry to receive an FDA ‘No Questions’ response letter, after previously undergoing safety and quality evaluations.”
“The growing demand for our turmeric extracts drives us to develop new formulations not just for dietary supplements but also for food and beverages since some consumers prefer to get curcumin via food or drink and not to swallow pills. We developed a new formulation for beverages that contain water dispersible curcumin without any effect on taste. We also intend to develop new applications for nutrition bars and gummies,” Antony tells NutritionInsight.
BCM-95 is a proprietary combination of curcuminoids and essential oil of turmeric-ar-turmerone, ensuring a high level of bioavailability of curcumin. The formulation holds 13 international patents and has been extensively researched in 33 clinical studies by universities throughout the US, Japan, Australia and India.
In 2016, BCM-95 was granted self-affirmed GRAS status (Generally Recognized as Safe) by an expert panel of scientists for use in medical foods at a dose of 500 mg, twice a day. BCM-95 is composed of pure curcuminoids and essential oils from turmeric with a specific content of turmerones. The synergism of its components has been confirmed in a study published April 2017, in the journal, Scientific Reports, by Shusuke Toden, Ph.D., et alia, of Baylor University, Dallas, Texas.
“It certainly sets a high bar in the marketplace, and our customers can leverage their curcumin supplements to gain more market share,” says P.J. Kunjachan, Chairman and Managing Director for Arjuna. “Consumers deserve clean and safe curcumin, wholly from turmeric root, and should not have to compromise with less effective alternatives.”
“We recently opened a new, state-of-the-art plant in Coimbatore, India, for producing BCM-95 turmeric extract,” adds Antony. “This will triple the curcumin capacity and will help us meet the growing demand for safe, natural curcumin.”
The growing demand for clean label solutions offers a unique opportunity for botanical ingredients of Indian origin. These can be relayed to Western markets and for many offer a more natural preventative alternative to pharmaceutical solutions. Several studies have shown that curcumin taken in capsule form is efficacious for pain relief and functions in preventing osteoarthritis. Innova Market Insights has noted turmeric as a key trending ingredient. In fact, a +46% growth has been reported for new products with a “turmeric content” claim (Global, 2016 vs. 2015).
“Consumers are looking for healthy ingredients backed by clinical research to prove its efficacy. Turmeric extract is one of the most researched ingredients for a wide range of specific health related applications and has substantial clinical evidence supporting its therapeutic benefits. I believe that our patented turmeric has many advantages since it is a clean-label, trusted brand and backed by research,” Antony tells NutritionInsight.
