Clear definition and new regulatory framework: The way forward for nutraceuticals?
A clear definition of nutraceuticals and shared regulation is essential, proposed the review authors, led by the University of Napoli Federico II. To achieve this, they suggested a new category should be established which distinguishes nutraceuticals from food supplements and pharmaceuticals.
“It is of utmost importance to have a proper and unequivocal definition of nutraceuticals and shared regulations,” wrote review co-leader Dr. Ettore Novellino.
“It would hence be advisable that the European Commission or authorities in charge explore the possibility of including nutraceuticals in their Directives or Regulations by defining a new category that differentiates them from food supplements and pharmaceuticals,” he added.
The review also proposed the need for restructuring 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,” said review co-leader Dr. Antonello Santini. “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.”
Overlap and confusion
There is a growing demand for nutraceuticals, which could become a powerful toolbox to prevent and treat medical conditions, advocate the authors. However, the overlap between foods, food supplements, functional foods and nutraceuticals is confusing for the consumer.
“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 co-lead researcher Dr. Ettore Novellino.
“What could be considered a functional food under a given set of circumstances may be named a dietary supplement, medical food, food for special dietary use, or nutraceutical under different circumstances, depending on its ingredients (active components) and the claims reported on its label,” he explained.
Proposed new definition
The authors proposed that nutraceuticals be redefined as:
“1) For food of vegetal origin, a nutraceutical is the phytocomplex; and 2) for food of animal origin, a nutraceutical is the pool of secondary metabolites. Both are concentrated and administered in the proper pharmaceutical form. They are capable of providing beneficial health effects, including the prevention and/or the treatment of a disease.”
The new framework would incorporate the necessity for in vivo clinical trials to assess safety and efficacy as well as identifying how the nutraceutical exerted its effect.
“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.”
While the authors are realistic that it is unlikely that the EU would adopt a new definition and framework in the near future, the aim of the review was to stimulate a productive debate on the subject.
Source: British Journal of Clinical Pharmacology
Published online 13th Feb 2018, doi: 10.1111/bcp.13496
Nutraceuticals: opening the debate for a regulatory framework
Authors: Antonello Santini, Ettore Novellino, et al
