Nutraceuticals: a pharmaceutical viewpoint: I

To review pharmaceutical aspects of selected amino acids, antioxidants and related nutraceuticals, deemed to be important for clinical nutrition.

New clinical applications of nutraceuticals are increasingly being reported, but there are fundamental differences between formulation, production and the evidence supporting clinical use. Nutraceuticals generally fall within the novel foods and ingredients regulations but their purity, dosage requirements and clinical consequences exceed those of most 'healthfoods'. Replacement of one nutrient or antioxidant is unlikely to correct the cascade of interconnected metabolic abnormalities associated with many diseases. However, it is difficult to ascertain whether the reported benefits of complex mixtures, with little published stability data, are due to one or more individual substrates or some in-vitro interaction between them. Many clinical studies have suffered from inconsistencies of dose, formulation discrepancies and unproven outcome. These contradictory results weaken any firm evidence base to substantiate their effectiveness.

Nutraceuticals are destined to play an important role in future therapeutic developments but their success will be governed by control of purity, safety and efficacy without inhibiting innovation. The straightforward application of pharmaceutical standards, especially across national borders, is likely to be a difficult challenge and could effectively paralyse the industry. Nevertheless more standardized formulations, dosage forms and production controls are called for. A place for nutraceuticals in clinical practice is emerging, but important pharmaceutical and clinical issues need to be addressed by further research.