OPIS for Nutraceutics
Current Pharmaceutical Biotechnology 2020 presents a review on current prospective of nutraceuticals.
Nutraceuticals are dietary supplements, dietary fibers utilized to ameliorate health, delay senescence, prevent diseases, and support the proper functioning of the human body.
Currently nutraceuticals are getting substantial attention due to nutritional and therapeutic potentials. On the basis of their source, they are categorized into different terms such as nutrients, dietary supplements, herbals, dietary fibers, etc.
The global market nutraceutical is huge, i.e. approximately USD 117 billion. Herbal nutraceutical is a powerful tool in maintaining health and acting against nutritionally induced diseases, thus promoting optimal health, longevity and quality of life.
Studies have shown promising outcomes from the intervention of nutraceuticals in treating several diseases such as cancer, neurodegenerative disorders, cardiovascular illnesses, etc.
As reported by the British Journal of Clinical Pharmacology in 2018 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-related 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 for is still missing. 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.
In this scenario, over its long experience in the field of clinical trials, OPIS has acquired the necessary tools to successfully manage clinical trials related to food supplements and Foods for Special Medical Purposes (FSMP). As they are clearly different from drug trials, food trials are currently regulated under the Food Supplements Directive (FSD) 2002/46/EC.
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