South African anti-anxiety extract set for 2011 US roll-out

03-Oct-2010 - Last updated on 12-Mar-2014 at 16:58 GMT

The US launch of the proprietary plant ingredient Zembrin is on-course for the first half of 2011, after South Africa’s HGH Pharmaceuticals received the first ever bioprospecting permit for the anxiety-alleviating extract.

The ingredient – to be exclusively distributed in North America by PL Thomas – is a proprietary extract from the South African plant Sceletium tortuosum. HGH’s large-scale sustainable cultivation of a select variety of the plant has led to it being awarded the country’s first ever Integrated Export and Bioprospecting Permit by the Ministry of Water and Environmental Affairs.

The National Environmental Management: Biodiversity Act of 2004 requires the permit for a continuation of pharmacological and clinical research on the plant, and for HGH to export its cultivated raw plant material and the extract Zembrin.

Dr Nigel Gericke, director of research at HGH Pharmaceuticals, explained to NutraIngredients-USA that every single person who uses South African biological material must have a permit. And since HGH has been the awarded the first bioprospecting permit all other operations selling Sceletium are therefore illegal.

“We are honoured to be the first company to be awarded this permit by the Minister, which allows us to research, commercialise and export a valuable indigenous biological resource,” said Dr Gericke. “It is the culmination of eight years of hard work, and a testament to our commitment to working in a socially responsible and environmentally sustainable way.”

Indigenous use

Sceletium is a groundcover plant native to Southern Africa. Also known as kanna and kauwgoed, it is said to be used as a mood enhancer and relaxant.

The compound’s mood-enhancing activity are said to be related to a number of alkaloids including mesembrine, mesembrenol and tortuosamine, which interact with the brain's dopamine and serotonin receptors. HGH’s unique selection of Sceletium tortuosum is reportedly low in mesembrine, but rich in other desirable alkaloids.

The plant has a long history of use by indigenous people, and the South African San Council, representing the first indigenous peoples of Africa, will receive royalties from the sale of Zembrin.

Anxiety and stress management

The most recent study published, according to PubMed, was an in vivo animal study conducted by Dr Carine Smith from the Department of Physiological Sciences at Stellenbosch University, South Africa (Journal of Ethnopharmacology, doi: 10.1016/j.jep.2010.08.058). The study found that Sceletium did have positive effects on psychological stress, but side effects such as an inflammatory or intolerance response. The Sceletium used in this study was not the same as Zembrin, said Dr Gericke.

“We knew that Sceletium was likely to have central nervous system activity,” said Dr Gericke, “but our research has shown that only certain plant selections are rapidly effective for the specific health and wellness applications of interest to us, are non-addictive, and have a low side-effect profile. The carefully controlled conditions under which the selected plants are grown, harvested, dried and extracted, play a vital role in determining Zembrin’s efficacy.”

Commenting on supply capacity, Dr Gericke said that the company currently has enough stock to supply the US market for three years.

Learning from the ‘Hoodia distaster’

One of the most high profile exports from Southern Africa has been hoodia gordoonii, a succulent plant found in the South African desert, that, it is claimed, fires satiety-stimulators in the brain when ingested, leaving people with the sensation of fullness.

But safety concerns and fake hoodia supplements flooding the market over the years have tarnished the plant’s image. In November 2008 Unilever dropped its interest citing “safety and efficacy” concerns over the product – which was rumoured to cause digestive problems in a shake formulation because it was metabolised too quickly.

Dr Gericke said that the “hoodia disaster informed us straight from the outset to pursue best practice from scratch”. “There is nowhere in the literature to indicate that hoodia should be taken every day,” he said, before adding that documented evidence shows that people in South Africa have been chewing Sceletium daily for 40-50 years without problem.

“Hoodia still doesn’t have an Integrated Export and Bioprospecting Permit,” he added.

Ministerial welcome

The permit was handed over by Buyelwa Sonjica, South African Minister of Water and Environmental Affairs at a ceremony on October 1, 2010, who called it an “auspicious day in the history of [South Africa]”.

“We live in a country that is rich in biodiversity- ranked third after Brazil and Indonesia,” said Sonjica. “We are home to approximately 24,000 plants species and contain an entire floral kingdom within our borders. These natural and cultural resources underpin a large proportion of the economy and many urban and rural people are directly dependent on them for employment, food, shelter, medicine and spiritual well being.

“The beneficiaries of the bioprospecting project include the South African San Council (San), Paulshoek and Nourivier or Nama communities,” she added.

“HGH Pharmaceuticals will pay the South African San Council an annual royalty of the net proceeds they receive. During the first three years the royalty will only be payable in respect of net proceeds received during each year in excess of R 5-million.”