Applied Clinical Research, Clinical Trials and Regulatory Affairs

Author(s): Shikha Girdhar, Deepti Pandita, Amit Girdhar and Viney Lather

DOI: 10.2174/2213476X03666160801150607

Safety, Quality and Regulatory Aspects of Nutraceuticals

Page: [36 - 42] Pages: 7

  • * (Excluding Mailing and Handling)

Abstract

Background: Nutraceuticals are the concentrated nutrients that are isolated from food or food products and have therapeutic and preventive qualities. They are gaining wide popularity because beyond providing basic nutrition, they have several health benefits. The global nutraceutical market is forecasted to reach $ 241.1 billion by 2019. However, the safety and quality of nutraceuticals are the major issues that need attention.

Objectives: The aim of this mini-review is to discuss the safety, quality and regulatory aspects of nutraceuticals. A little attempt has been made to provide information about global nutraceutical market, recent patents and marketed products.

Discussion and Conclusion: Currently, nutraceutical industry is operating as a blend of regional regulations of different countries. The existing regulatory framework for nutraceuticals is disorganized with no global standards for compliance. Therefore harmonization of regulations is necessary to remove the regulatory flaws across the countries and to ensure the product quality.

Keywords: Nutraceuticals, dietary supplements, regulation, functional foods, marketed products, safety and quality.

Graphical Abstract