The Need For Evidence-based Nutraceuticals

The Need For Evidence-based Nutraceuticals

Nutraceuticalsare dietary supplements that help in the prevention and treatment of diseases such as neurological disorders, cardiovascular diseases, obesity, cell damage, immunodeficiency, diabetes, osteoarthritis, osteoporosis, bone and joint disorders, anemia, common cold, allergy, etc.

The demand and growth rate for nutraceuticals is increasing all over the world due toan increase in awareness of health issues and well-being, increase in social media awareness, increase in usage of vitamins, adoption of fitness (need of multivitamins and proteins), usage as a preventive option for improving health, increasing incidence of chronic and degenerative diseases.

The Food and Safety Standard Act (FSSA), 2006 has established the Food Safety Standard Authority of India (FSSAI) for regulating scientific standards of quality, regulations, labeling and packagingand to supervise the food and nutraceutical industry as the pharmaceutical industry in maintenance required quality standards for efficacy, safety, toxicity, stability and amount of bioactive constituent.

Since long, word of mouth testimonials and traditional use was enough for physicians to prescribe nutraceuticals using herbal extracts without documented active ingredient and proof of efficacy resulting in lack of funding for evidence-based clinical trials for nutraceuticals in India which is the need of the day. Marketing is the most reliable way to create awareness among the general public about Nutraceuticals but without sufficient evidence and supporting clinical data it becomes a challenge for marketing the nutraceutical among the population.

Good quality clinical trials evaluating the efficacy and safety of nutraceuticals in different therapy areas are needed to be conducted in large numbers to generate appropriate clinical data. The safety and tolerability of the product are well known when trials are done on a large scale. To gain trust among the general public and medical community, the effectiveness and efficacy of the drug have to be well established. Nutraceutical trials are often harder to recruit for and have higher drop-out rates than pharmaceutical drugs. Increasing awareness and gathering more data would help in improving recruitment rates.

There is widespread interest in supplements among many stakeholders that include consumers, industry members, and scientists. Consumer motivations for use of supplements are broad, and usually relate to the perceived belief of efficacy, and can include general well-being, aesthetic pursuits, prevention or management of chronic disease, longevity, fitness, sports performance, and/or any combination of such factors.To substantiate these claims requires a varying degree of relevant & credible scientific evidence additionally using regulatory pathways which can be engaged to make a claim on your product depending on its composition.

The Need For Evidence-based Nutraceuticals

Nutraceuticals trials need to be with a strong experimental design to help discern between evidence-based findings and those that have not been substantiated. This trend will go a long way in establishing the credibility of nutraceuticals in the minds of the medical fraternity and consumers.

The nutraceutical industry is gradually emerging and growing in India. Improved awareness over the years has led to higher consumption of nutraceutical products. Regulations have evolved and are now stricter than ever in terms of quality, claims, efficacy, and safety. Various challenges need to be resolved to stabilize the growth of the nutraceuticalindustry including their innovation, conducting randomized clinical trials and real-world evidence studies must be encouraged.

References :

  • Banerjee S. Dietary supplements market in India is rapidly growing-An Overview. IMS Management Journal. 2018;10(1):1-6.
  • Santini A, Novellino E. To Nutraceuticals and Back: Rethinking a Concept. Foods (Basel, Switzerland). 2018 Sep;6(9). DOI: 10.3390/foods6090074
  • https://nutraceuticalbusinessreview.com/news
  • Mukherjee, P. K. (2019). Phyto-Pharmaceuticals, Nutraceuticals and Their Evaluation. Quality Control and Evaluation of Herbal Drugs, 707–722.
  • Lachance, Paul A., and Raymond G. Saba. "Quality Management of Nutraceuticals: Intelligent Product-Delivery Systems and Safety through Traceability." 2002. 2-9.