Clear definition and regulations needed to tap into nutraceuticals’ potential: review


13 Feb 2018 --- Nutraceuticals with health benefits substantiated by clinical data can be powerful tools to prevent and treat medical conditions, especially in individuals who may not yet be eligible for conventional pharmaceutical drugs. However, there is a clear need for clear regulations to ensure their safety. This is according to a review published in the British Journal of Clinical Pharmacology, which further proposes a clear definition for this type of product.

There is a growing demand for nutraceuticals, which currently reside in the grey area between pharmaceuticals and food and are thought to provide medical or health benefits “beyond the diet, but before the drugs.” Currently, nutraceuticals do not have a specific definition distinct from those of other food-derived categories, e.g., food supplements, herbal products, pre- and probiotics, functional foods and fortified foods.

However, the review by a team led by Ettore Novellino, Ph.D., and Antonello Santini, Ph.D., of the University of Napoli Federico II in Italy, finds that it is of utmost importance to have an unequivocal definition of nutraceuticals, to conduct clinical studies on their safety and efficacy, and to have standardized regulations for their use. 

The authors propose the following definition for nutraceuticals: the phytocomplex of a vegetable or the pool of secondary metabolites from an animal. Both are concentrated and administered in a pharmaceutical form and are capable of providing beneficial health effects, including the prevention and/or treatment of a disease.

“Nutraceuticals, in the collective imagination of the consumer, tend to be confused and wrongly identified with many other products available on the market on the basis of potential health benefits,” says Dr. Novellino. “An evaluation of the safety, the mechanism of action, and the effectiveness of nutraceuticals – and substantiating this with clinical data – is the central point that differentiates nutraceuticals from food supplements.”

Dr. Santini adds that the growing demand and interest in nutraceuticals justifies the need for a restructuring of the entire regulatory framework that differentiates nutraceuticals from food supplements. 

“We propose a regulatory system that is similar to the one used for drugs, which is more rigorous and more complex than the one commonly accepted for food supplements,” he says. “It is important for consumer protection that national authorities and regulatory agencies require manufacturers to provide data to support any claim in the labels of products when the term nutraceutical is used.”

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