MORRISTOWN, N.J.—PLT Health Solutions received a license from the Natural Health Products (NHP) Directorate of Health Canada to market its Zembrin® Sceletium tortuosum to support cognitive functioning in healthy adults.
Zembrin is the first patented, standardized and clinically studied extract of a unique selection of the South African plant Sceletium tortuosum. In the United States, Zembrin has been marketed to nutraceutical and functional food and beverage producers interested in incorporating the evidence-based ingredient in products that experientially support stress relief, enhanced mood and improved cognitive function.
In Canada, the approved claim is: “Helps support cognitive function in adults." PLT Health Solutions worked with Dicentra Regulatory & Scientific Solutions in the development of documentation for the Canadian license.
According to Barbara Davis, director, medical and scientific affairs at PLT Health Solutions, the granting of an NHP license by Health Canada is a significant milestone for Zembrin as an ingredient because it opens up the Canadian market.
“We’re very pleased that Health Canada has recognized the years of scientific study and support behind Zembrin as an ingredient," Davis said. “Providing rigorous scientific data that can support label claims and attract consumers is the standard that we at PLT set for ourselves and the ingredients we market."
The NHP product license received by PLT states that a 25-mg dose of Zembrin Sceletium tortuosum, taken for a minimum of three weeks “helps support cognitive functioning in adults." Known by the San people of South Africa as “Kanna," Sceletium has been used for millennia for its stress-relieving and mood-enhancing effects.
Backed by extensive safety testing, Zembrin has been clinically demonstrated to improve cognitive function, specifically, cognitive flexibility and executive function. One of the most intriguing aspects of Zembrin is that it is experiential – users “feel" its benefits.
A recently published study that used functional Magnetic Resonance Imaging (fMRI) technology to examine the effects of acute (short term) supplementation with Zembrin on the “threat circuitry" of the human brain showed reduced anxiety-related activity of the amygdala and its associated anxiety circuitry within two hours of administration.