Define, defend and direct: researchers give three proposals for the nutraceutical world

Nutraceuticals, a category that includes things like vitamins, minerals, herbal supplements and more, occupy a gray space between pharmaceuticals and food. Their somewhat nebulous state has been a damper on the industry’s ability to flourish, and now a group of researchers from Italy have published a paper declaring three areas where development is needed in order to tap into these products’ potential.

The three areas outlined are as follows: establishing a clear definition of what types of products are considered nutraceuticals, conducting clinical studies on their safety and efficacy, and standardizing the regulations governing these products.

“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 Ettore Novellino, one of the paper’s authors. “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.”

Define “nutraceuticals.” Can you use it in a sentence?

When it comes to defining the category of nutraceuticals, the paper’s authors have a suggestion: chemical components of plants and animals concentrated and administered in a pharmaceutical form that provides beneficial health effects, including the prevention and/or treatment of a disease.

Specifically, the authors suggest including in the definition that nutraceuticals come from the phytocomplex of plants or the secondary metabolites from animals. The phytocomplex is a chemical compound produced by plants, and secondary metabolites are organic compounds in an animal that aren’t directly involved in its growth, development and reproduction.

A clear definition makes it easier for agencies to regulate the products that fall under its umbrella.

Clinical studies

According to the researchers, nutraceutical products have powerful, untapped potential for the world market — as long as each product has its health benefits backed by clinical data. The researchers note that nutraceuticals could be used to treat people with medical conditions, especially those who might not be eligible for traditional pharmaceuticals, but that science will need to back this up for the sake of a healthy industry.

Regulatory affairs

In a regulatory sense, nutraceuticals tend to have their own categorization between food and drug.

The U.S. Food and Drug Administration currently covers nutraceuticals under a different set of rules than traditional sources of nutrition. Under the European Union’s European Food and Safety Authority, specific legislation covers what it calls “food supplements.” In Canada and Australia, nutraceuticals are treated more like pharmaceuticals. Many other countries are still working on how to address this unique category, though most of them already regard them more closely with food products.

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