Commercialization of medicinal herbs: What's good for the goose is not good for the gander

Botanical products including Traditional Chinese Medicinal (TCM) herbs are increasingly popular globally although their legal classification can vary from country to country. While they are, for example, often marketed as dietary supplements in many western countries, Asian countries have preserved their traditional usage and continue to classify local botanicals as herbal medicines, TCMs or Kampo medicine. Cultural knowledge is, therefore, an important heritage of many botanical products and has a significant impact on the heterogeneity of global regulatory guidelines.

Notwithstanding, a research-based strategy that clarifies the putative health benefits of botanicals adds considerable value, not least in the area of safety and efficacy of such products. Transforming medicinal herbs into viable products in the West requires evidence-based substantiation but obtaining such data has to take into account global regulatory differences.

For global companies a single R&D strategy to meet global objectives is difficult to achieve. The complexity of herbal extracts or blends also adds constraints. Taking such factors into account, we describe a scheme that could at least generate credible scientific data to support structure/function claims as allowed by the US dietary supplement health and education act while preserving the ability to use such data to support an herbal product on a global scale. This scheme, while it shares certain elements of the drug approval process, is not intended to duplicate a pharmaceutical approach; instead, this strategy is specifically designed with an eye toward establishing a unique template for a dietary supplement company. We believe such an approach allows dietary supplements to be supported by scientific evidence, resulting in higher quality products for consumers.