Moving beyond hoodia

Do exotic plants from Africa offer the alluring promise of improved health for consumers in the developed world? You betcha. With long histories of usage by indigenous peoples, many of these plants have documented and attractive me­dicinal properties that marry well to the pre­vailing health conditions reaching epidemic proportions in Western society. But the days of simply finding a new plant, wild harvesting it, and then exporting the raw material to in­ternational markets are long gone. Between newly developed standards for plant identi­fication, sustainable cultivation and protec­tions of indigenous plant knowledge to vary­ing regulatory hurdles around the world, the commercialization of African herbs can be a long and daunting process.

A few companies, however, are rising to the challenge. New ingredients, such as sceletium (Sceletium tortuosum) and devil’s claw (Harpagophytum procumbens) are generating strong interest, have compel­ling safety and efficacy documentation, and burgeoning consumer health applications. Although expert opinions are divided on whether such products can truly find suc­cess in global markets, some believe they have the potential to herald a new era for bo­tanical ingredients of African origin.

Medicinal and aromatic plants from Af­rican have a long history of contribution to the world’s drug, food, herbal and dietary supplement markets, according to Mark Blumenthal, founder and executive director of the American Botanical Council. Many plants of African origin are household words, including peanuts, yams and watermelon, he says. Think of the beverage category, where an extract from the seeds of the West African kola tree became the basis for Coca Cola. Think of coffee (Coffea arabica L.) and its East African origin. More recently, plants for application in dietary supplements—such as rooibos (Aspalathus linearis) and pelargonium (Pelargonium sidoides)—have established a solid market presence thanks to commercialize efforts by such names as Nature’s Way.

The potential for medicinal ingredients from Africa is enormous, according to botanist Nigel Gericke, director of medical and scientific research for HG&H Phar­maceuticals in Cape Town, South Africa. “There is a beautiful saying about Africa in Latin, which in English means, ‘Out of Africa, always something new.’ The biodi­versity in Africa is breathtaking. There is a high degree of endemism, and we also have unbelievable cultural diversity and a long history of people who have been ex­posed to these botanicals and depend on them for food and their very survival.”

Beyond sceletium, which has been re­cently commercialized as a proprietary in­gredient for cognitive function and stress relief called Zembrin, and devil’s claw for inflammation and pain relief, there is a growing list of plants that have interesting potential, such as African mango extract (Irvingia gabonensis), a plant with weight loss properties, and Pygeum africanum, a prostate health remedy.

Lessons learned from hoodia

When discussing the potential for devel­opment of any African plant, however, the conversation always turns to hoodia (Hoodia gordonii), an appetite suppres­sant that saw phenomenal market suc­cess only to flame out as a poster child for potential abuses in the marketplace. According to Blumenthal, hoodia’s reputa­tion as an appetite suppressant was based on the fact that the San people of South Africa used it not as a staple, but as a sur­vival food in emergencies when food was not plentiful. Furthermore, there was no documentation on safety and the clinical trials were proprietary.

Simultaneously, demand was expand­ing with more hoodia being sold in inter­national markets than could possibly be harvested from the slow-growing desert succulent. “As a result, a lot of the raw material that was put in products was adulterated with prickly pear and other things that were not hoodia,” Blumen­thal says.

“The U.S. market burnt a finger with the over-promise and under-delivery of hoodia as an appetite suppressant,” Ger­icke says. “There was so much hype, and the demand led to catastrophic over-har­vesting and destruction of the wild plant.”

The hoodia experience underscores sev­eral important lessons on both the African and international side. Though there was growing interest in many plants, there was little quality control which lead to many ingredient buyers hesitant to source raw materials from Africa, according to Thomas Brendler of Plantaphile, a natural product and regulatory consultancy, and co-founder of the African Association of Medicinal Plants Standards (AAMPS). This lack of standardization prompted AAMPS to establish the African Herbal Pharmacopoeia project to create mono­graphs for plants and to stimulate their trade out of Africa.

Plant standardization

The monographs should address a key is­sue for African herbs in general, according to Dierdre Allen of CanAm Resources, a regulatory consultant for foods, food ad­ditives and dietary supplements. Many of these plants have been used traditionally, and their identification has been informal among hunter gatherers. “So you have peo­ple selling sceletium products and no one knows what’s in them,” says Allen. “There is so much variation even within the same species of plants growing in the same area. Within one species of sceletium, you can have a chemotype that produces a calming effect for colic or send you on a psyche­delic trip.”

The publication of the pharmacopoeia in 2009 represents the culmination of six years of effort from scientists—like Brendler, a chief editor—who initially looked at thousands of plants from a cross-section of regions and applications. The project initially published 52 plant monographs in book form and will present a draft of another 10 at a general meeting of the AAMPS in July.

South Africa also is taking a leading role in developing new standards and pro­cesses in the wake of hoodia. “We learned that there is enormous demand in the U.S. for botanicals with activity,” Gericke says. As a result, the South African government established new standards for the devel­opment and commercialization of native plants, including demonstration of a sus­tainable supply chain.

Per the Biodiversity Act of 2004, any bo­tanical exported from South Africa must have a signed permit by the Minister of Environmental Affairs. HG&H Pharma­ceuticals received the first such permit to commercialize its proprietary sceletium extract Zembrin. “The permit recognizes that we are not ripping up a wild resource, and we are recognizing the indigenous contribution to the product,” Gericke says. The company also established the first benefit-sharing agreement with an indig­enous community, the South African San Council.

The Zembrin product is now widely tout­ed as a strong example of the new model for sourcing and commercializing African raw materials. In addition to the landmark permits, the company studied the plant for more than a decade to identify an elite che­motype of sceletium with a unique experi­ential signature that reduces anxiety while enhancing cognitive function. Zembrin has self-affirmed GRAS status in the U.S.

Paul Flowerman, president of PL Thomas, the U.S. partner for Zembrin, acknowledges that the process is both long and ongoing. “HG&H spent 12 years getting the product prepared and ready for the world. We’ve been at it two years, dotting the I’s and crossing the T’s. We will continue to build on this work and do more research, because we’re in it for the long term.”

The quality of work on ingredients like Zembrin surpasses just about anything Allen has seen before. Companies like HG&H in South Africa are doing HPLC before harvesting, after harvesting and in storage to ensure consistency along the way, she explains. “They can answer questions we have about the species identification, and some we don’t even ask. They have spent millions doing it right.”

“Zembrin is a very promising ingredient, and they have taken the right approach in developing clinical documentation,” says Blumenthal. “The question is whether oth­er companies will be as responsible and have the financial resources to invest in this kind of safety and efficacy work.”

The reality is that current international regulatory hurdles make that a charged question. Although African plants are now getting some traction in the US, it’s much more difficult to develop herbal medicinal products in other markets like the EU. The current data for many of these plants is too weak to meet regulatory requirements for European herbal drugs, according to Brendler. In the U.S., products can enter as dietary supplements (as an old or new di­etary ingredient) but are left with struc­ture function claims that may not ade­quately communicate a plant’s function or benefit. “There are many great candidates, but no one is looking at them, so they are left half way between something you’ve never heard of and something patentable,” says Brendler.