Nutraceuticals: opening the debate for a regulatory framework

Abstract

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. Nevertheless, there is a lack of clear information and, often, the claimed health benefits may not be properly substantiated by safety and efficacy information or in vitro and in vivo data, which can induce false expectations and miss the target for a product to be effective, as claimed. An officially shared and accepted definition of nutraceuticals is still missing, 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. Hence, it is of utmost importance to have a proper and unequivocal definition of nutraceuticals and shared regulations. It also seems wise to assess the safety, mechanism of action and efficacy of nutraceuticals with clinical data. A growing demand exists for nutraceuticals, which seem to reside in the grey area between pharmaceuticals and food. Nonetheless, given specific legislation from different countries, nutraceuticals are experiencing challenges with safety and health claim substantiation.

International Perspectives on Substantiating the Efficacy of Herbal Dietary Supplements and Herbal Medicines Through Evidence on Traditional Use

“…In the United States, EU, New Zealand, and India, dietary supplements should be marketed in dose form (European Parliament and the Council of the European Union, ; Ministry of Health, ; Ministry of Health and Family Welfare, ; National Institute of Health, ). In the Indian regulation, dietary supplements are referred to as nutraceuticals (Ministry of Health and Family Welfare, ; Santini et al., ). These nutraceuticals can, however, not claim to treat, cure, or prevent disease.…”

“…In Santini et al, 2018). These nutraceuticals can, however, not claim to treat, cure, or prevent disease.…”

“…These nutraceuticals can, however, not claim to treat, cure, or prevent disease. Dietary supplements may be named nutraceuticals for marketing purposes in the United States, but are legally considered to be food products (National Institute of Health, 1994;Santini et al, 2018). In China and Japan, there is no separate legislation dealing with dietary supplements and therefore no specificities on the dose form are given (Low, Wong, Yap, De Haan, & Rietjens, 2017;O'Brien, 2015;Tanaka, Kaneda, Suguro, & Baba, 2001).…”

Polyphenols: A concise overview on the chemistry, occurrence, and human health

“…Within nutraceuticals (Andrew & Izzo, ; Daliu, Santini, & Novellino, ; Durazzo & Lucarini, ; Santini et al, ; Santini & Novellino, ; Santini & Novellino, ; Santini, Tenore, & Novellino, ), more than 8,000 different phenolics are identified in the plant kingdom and represent one of most numerous and widely distributed class of plant secondary metabolites (Cheynier, Comte, Davies, Lattanzio, & Martens, ; Kabera, Semana, Mussa, & He, ; Santini, Novellino, Armini, & Ritieni, ). Several outstanding reviews on polyphenols have been recently published (Amiot, Riva, & Vinet, ; Bernatoniene & Kopustinskiene, ; Białecka‐Florjańczyk, Fabiszewska, & Zieniuk, ; Clifford, Jaganath, Ludwig, & Crozier, ; Costa et al, ; Durazzo et al, ; Pervaiz, Songtao, Faghihi, Haider, & Fang, ; Roche et al, ; Xiao, Zhang, Tong, & Shi, ; H. Zhang & Tsao, ; Zhao et al, ), and the reader is referred to them for a more in‐depth information.…”

Nutraceuticals as modulators of gut microbiota: Role in therapy

“…Interestingly, the term nutraceutical does not appear to have been defined by either regulatory body. Santini and colleagues, who have written extensively on the subject (Daliu, Santini, & Novellino, ; Santini et al, ; Santini & Novellino, 2018 Santini et al, ), stress the need for a universal definition of a nutraceutical which they envision as occupying the middle ground between food and drug. They suggest the following steps towards definition of a nutraceutical: appropriate target identification, safety assessment, a clear understanding of the mechanism of action, efficacy assessment substantiated by clinical studies, an evaluation of possible unwanted side effects, and an evaluation of possible interactions with other products (e.g.…”