Study of Nutraceutical regulations around the Globe

  • Akanksha Rani M.pharm (Drug Regulatory affairs)
  • Vikesh Kumar Shukla


Nutraceutical is a food or fortified meals product that supposedly offer medicinal or health benefits such as the prevention and remedy of disorder. Nutraceuticals have appeared as a requisite for consumers in developed as well as developing countries with diseases due to changing lifestyles. As nutraceuticals blur the border between food, medicine and health supplements, it is difficult, with the aid of legal definition, to differentiate between nutrients, meals components, drug and pharmaceuticals. Globally, regulatory authorities are converging on the product safety and quality as such products are destined for human intake. When food product reaches from one country to another, it becomes important to maintain safety and quality standards in compliance with the different regulatory guideline set by the respective government; which can be a real driver for the growth of the industry. This article focuses mainly on the review of the regulatory framework for nutraceuticals in India, USA, Canada, Europe, and Australia with harmonized regulation for nutraceutical product registration in this market.

Keywords: Nutraceutical, Fortified Meal, Nutrient, DSHEA


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How to Cite
Rani, A., and V. K. Shukla. “Study of Nutraceutical Regulations Around the Globe”. International Journal of Drug Regulatory Affairs, Vol. 8, no. 1, Mar. 2020, pp. 15-24, doi:10.22270/ijdra.v8i1.378.