Writing in the British Journal of Clinical Pharmacology, the team behind the review noted that while there is a growing demand for nutraceutical products and dietary supplements, it is of great importance that a ‘proper and unequivocal’ definition of the term nutraceuticals is developed and that standardised regulations for their use – including a separate classification from food supplements and pharmaceutical products are put in place.
"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," said lead researcher Dr Ettore Novellino, from the University of Napoli Federico II in Italy.
"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."
Co-author Dr Antonello Santini added 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 said. "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."
Definitions and regulations
The Italian team noted that currently nutraceuticals do not have a specific definition distinct from those of other food-derived categories, such as food supplements, herbal products, pre- and probiotics, functional foods, and fortified foods.
“Many studies have led to an understanding of the potential mechanisms of action of pharmaceutically active components contained in food that may improve health and reduce the risk of pathological conditions while enhancing overall well-being,” wrote the team. “Nevertheless, there is a lack of clear information and, often, the claimed health benefits may not be properly substantiated by safety and efficacy information.”
They suggested that an officially shared and accepted definition of nutraceuticals is still missing – which seem to operate in a ‘grey area’ between pharmaceuticals and food.
“As nutraceuticals are mostly referred to as pharma-foods, a powerful toolbox to be used beyond the diet but before the drugs to prevent and treat pathological conditions, such as in subjects who may not yet be eligible for conventional pharmaceutical therapy,” they said.
Novellino and colleagues commented that it is ‘obvious’ that the current situation regarding nutraceuticals “is far from satisfactory.”
“Our aim is to stimulate a fruitful debate on this subject. We hope that our proposals generate comments and useful objections from other experts in this field,” they noted.
“Based on the above discussion, in our personal opinion, a restructuring of the entire regulatory framework of dietary supplements in view of the role of nutraceuticals is deemed necessary to first give credit to their different purposes and definition, and second, to assess their specific role in the prevention and treatment of pathological conditions, supporting their potential medical use in prevention and therapy only when proven by sound scientific and clinical data.”
Source: British Journal of Clinical Pharmacology
Published Online ahead of print, doi: 10.1111/bcp.13496
“Nutraceuticals: opening the debate for a regulatory framework"
Authors: Antonello Santini, et al