New Clinical & Safety Data, NDI Notification and GRAS Affirmation Make Patented Zembrin® a Solid Ingredient for Nutritional Supplements to Provide “Experiential” Support for Stress-Related Mood, Cognition and Anxiety Issues
MORRISTOWN, N.J., Oct. 22, 2012 /PRNewswire/ — P.L. Thomas & Co. Inc. (Morristown, NJ) and HG&H Pharmaceuticals (Pty) Ltd. (Bryanston, South Africa) announced today that they will conduct a full-scale launch of Zembrin® Sceletium tortuosum extract at Supply Side West, 3-5 November in Las Vegas. Over the last two years, the companies have been engaged in a series of successful clinical and safety studies, have completed the NDI notification process, and will now make the ingredient available throughout North America for the first time. Zembrin is the world’s first patented, standardized and clinically studied extract of an elite selection of Sceletium tortuosum. Sceletium, known by the San people of South Africa as “Kanna,” has been used for millennia for its stress-relieving and mood-enhancing effects. Zembrin has been awarded the first ever Export and Bioprospecting permit to be issued by the South African Government. HG&H Pharmaceuticals and its USA partner P.L. Thomas are introducing Zembrin to nutraceutical and functional food and beverage producers who are interested in incorporating this innovative, evidence-based ingredient in products that experientially support reduced anxiety, enhanced mood, and improved cognitive function.
According to Dr. Nigel Gericke , founding Director of HG&H Pharmaceuticals, Zembrin represents the application of cutting edge neuro-scientific research and agricultural technology to a traditional plant in order to address the unmet need for a rapidly acting, safe, effective and experiential stress relieving ingredient. “Zembrin is truly remarkable, because in addition to relieving symptoms of stress, it enhances cognitive function and elevates mood. In the United States today, more than 75 million people experience stress with negative consequences for their physical and mental health quality of life and economic activity.” Gericke went on to point out that HG&H has to date invested over $4 million in R&D, getting Zembrin ready for sale into the North American market. As a socially responsible company, HG&H has formally recognized the primary indigenous knowledge holders of Sceletium, and successfully concluded Africa’s first prior-informed consent benefit-sharing agreement with the South African San Council.
New clinical study points to enhanced cognition and improved mood
Recently, Zembrin was studied in a randomized, double-blind, placebo controlled cross-over study in 20 healthy adult subjects. The overall aim of the study was to examine whether 25mg of Zembrin taken once a day enhances cognition in normal subjects. Statistically significant improvement for the Zembrin group was seen in two cognitive domains: cognitive set flexibility and executive function including processing speed. Despite conducting the study on a healthy non-depressed population, a positive effect of Zembrin on mood was noted. The results of this study were presented at the Natural Bioactives International Conference from July 9th-11th 2012, London Convention Centre, London, Ontario, and at the World Psychiatric Association International Congress form 17th-21st October 2012, Prague, Hungary.
Promising ingredient for burgeoning market need
According to Seth Flowerman , Director of Business Development at P.L. Thomas, the work conducted in preparation for the full-scale launch of Zembrin in the United States creates an excellent opportunity for manufacturers and product marketers looking for innovative ingredients. “The strong convergence of historical, anecdotal, in-vitro, in-vivo and clinical information provides compelling evidence that supports Zembrin’s experiential stress benefits. PLT has been in the natural ingredients supply business for more than 60 years, and Zembrin is among the most unique ingredients we have come across. This is a special product because of the care with which it was developed, its fully sustainable and traceable supply, and the multidimensional benefits that can support a number of product claims,” he said. “When you look at what the market has been in the past for mood products like St. John’s Wort, 5-HTP, Valerian, and others, Zembrin represents both an economic and social opportunity for our industry to provide a safe, effective and high quality product that can tangibly improve the quality of people’s lives,” he added. For more information, visit www.plthomas.com
P.L. Thomas & Co. Inc.
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SOURCE P.L. Thomas & Co. Inc.