Successful Nutraceutical Products-Need for Regulatory and Marketing Strategies

The Dietary Supplement Health and Education Act (DSHEA) passed by U. S. Congress in 1994 is accelerating the penetration of herbal products into mainstream markets. Under this Act, herbal dietary supplements are categorized as food products, and do not require approval by the FDA prior to marketing. In today's aggressive sales arena, growing and standardization for the bioactive constituents is often a source of competitive advantage. Thus one of the biggest challenges in the world of botanical extracts is the raw material and its standardization. Producers are allowed to make limited claims for structure or function as long as a significant body of historical and scientific data supports them. The regulatory environment in the United States for nutraceuticals is becoming similar to the European model, in which herbal supplements are regulated in the same manner as other OTC and prescription drugs. This will lead to demands for carefully formulated and standardized products which contain specified levels of active ingredients, and which are labelled with explicit statements of therapeutic indications and adverse effects. Consumers will pay premium prices for standardized nutraceutical products of the highest possible purity and quality. Today, the herbal/nutritional supplement market is valued over $100 billion worldwide with an annual increase of 20%. Market potential for nutraceuticals is estimated based on prevalence forecasts based on different market reports and statistical data. These products are not meant as a replacement for meals, but as an enhancement to the normal dietary intake of nutrients or as a preventative measure in reducing the risk of a particular disease. As one would expect, the production processes vary greatly both between and within product types.