The nutraceutical revolution: Emerging vision or broken dream? Understanding scientific and regulatory concerns

Abstract ‘Nutraceuticals’ are a category of substances without a legal definition, often sold as dietary supplements or components of conventional foods. Nutraceuticals are considered to impart health benefits beyond ordinary nutrition; many nutraceuticals do improve health, but for others evidence is often equivocal or based on animal and/or in vitro data. Moreover, evidence that a component of a substance in a food has a beneficial effect often does not translate into benefits of a substance that has been isolated and consumed in greater quantities. Increasing regulatory requirements from multiple government agencies complicate the design, testing, and marketing of these substances. Dietary advice also is contradictory to much of the marketing of nutraceuticals as it emphasizes using whole foods and ensuring that the overall diet is adequate, rather than focusing on individual components. How the nutraceutical industry responds to these changing conditions will determine the health and growth of the industry over the coming decade(s).