Study of Nutraceutical regulations around the Globe
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.
2. Keservani RK, Sharma AK, Kesharwani RK. An Overview and Therapeutic Applications of Nutraceutical and Functional Foods [Internet]. 2017 [Cited 2020 Jan 03]. Available from:
3. Brower V. Nutraceuticals: poised for a healthy slice of the healthcare market? Nat. Biotechnol [Internet]. 1998 Aug [cited 2019 Nov 10]; 16(8), 728–731. Available from:
4. Kotilainen L., Rajalahti R., Ragasa C, Pehu E, et al. Health Enhancing Foods: Opportuni¬ties for Strengthening the Sector in Developing Countries. International Bank for Reconstruction and Development [Internet]. Washington, DC: 2006 [cited 2019 Nov 11]. Available from:
5. Zawistowski J, Kitts D.D, Stoynov N, Du K, et al. Thermal oxidation behavior of a phytosterol mixture in different oil systems. 94th American Oil Chemists’ Society Annual Meeting [Internet]. Kansas City: MI. 2003 May 4-7 [cited 2019 Nov11]. Available from:
6. De Figueiredo MC, Lajolo FM. Supplements and functional foods legislation in Brazil. In: Bagchi, D. (Ed.), Nutraceutical and Functional Food Regulations in the United States and Around the World. New York: Academic Press. p. 349-364.
7. Bhowmik D, Gopinath H, Kumar BP, Duraivel S, Sampath KP,et al.Nutraceutical - a bright scope and opportunity of Indian healthcare market. Pharma Innovation Journal [Internet] 2013 Jan [cited 2019 Nov 10]; 1(11):29-41. Available from:
8. Rajasekaran A, Sivagnanam G, Xavier R. Nutraceuticals as therapeutic agents: a review. Research Journal of Pharmacy Technology [Internet]. 2008 Dec [cited 2019 Nov 2019]; 1(4):328-340. Available from:
9. Andlauer W, Furs, P. Nutraceuticals: a piece of history, present status and outlook. Food Research International [Internet]. 2002 [cited 2019 Nov]; 35:171-176. Available from:
10. FSSAI. The Food Safety and Standards Regulations [Internet]. 2011 [cited 2018 Jan 23]. Available from: http://www.fssai.gov.in
11. FSSAI. Health claims in India [Internet]. 2014 Mar [cited 2020 Jan 03]. Available from: http://www.fssai.gov.in
12. Health Canada. Drug health products regulations [Internet]. 2020 Jan [cited 2020 Jan 03]. Available from: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/regulation.html#a2
13. U.S Food and Drug Administration. To regulate the safety of dietary supplements [Internet]. 2003 [cited 2018 Jan 24]. Available from:
http://www.crnusa.org/pdfs/CRN-Hutt_WhitePaper_ FDA RegulatesDS_090711.pdf
14. Taylor CV. Regulatory Frameworks for Functional Foods and Dietary Supplements. Nutrition Review [Internet]. 2004 [cited 2019 Oct 30]; 62(2):55-59. Available from:
15. Ratnaparkhi PK, Karode NP, Patil KB, Gohel SN, Prajapati VD and Jani GK, et al. Nutraceuticals-It’s current scenario and challenges in dietary supplements. World Journal of Pharmacy and Pharmaceutical Sciences [Internet] 2015 [cited 2019 Oct]; 4(7): 460-474. Available from:
16. Coppens P, Pettman S. European regulations on food supplements, fortified foods, dietetic foods, and health claims. In: Bagchi D, editor. 2015. Second edition Nutraceutical and functional food regulation in the United States and around the world; 2014. p. 201-17.
17. Agarwal S, Hordvik S, Morar S. Nutrition and health-related labelling claims for functional foods and dietary supplements in the United States. Second edition. In: Bagchi D, editor. Nutraceutical and functional food regulation in the United States and around the world; 2015. p. 141-50.
18. Yamada K, Sato-Mito N, Nagata J, Umegaki K,et al,. Health Claim Evidence Requirements in Japan. Japan Journal of Nutrition [Internet]. 2008 Jun [cited 2019 Oct 30]; 138:1192-98. Available from:
19. Department of Health and Ageing. Therapeutic Goods Administration, Australia [Internet]. 2020 Jan [cited 2020 Jan 03]. Available from:
20. Health Canada. Natural Health Products Directorate [Internet]. 2020 Jan [cited 2020 Jan 03]. Available from: www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#a2
21. FSSAI. Regulations in India [Internet]. 2008 Jan [cited 2020 Jan 03]. Available from:
22. Degnan FHE. Federal regulation of dietary supplements: Eight years after the enactment of DSHEA, where are we? [Internet]. 2003 [cited 2010 Dec 30]; 6:11-22. Available from:
23. Taylor CV. Regulatory Frameworks for Functional Foods and Dietary Supplements. Nutrition Review. [Internet]. 2004 [cited 2019 Oct 30]; 62(2):55-59.Available from:
24. Health Canada. Natural Health Products Directorate [Internet]. 2020 Jan [cited 2020 Jan 03]. Available from:
25. Department of Health and Ageing, Therapeutic Goods Administration, Australia [Internet]. January 2020 [cited 2020 Jan 03]. Available from:
26. Baker JT, Borris RP, Carte B, Cordell GA, Soejarto DD, Cragg GM, Gupta MP, Iwu MM, Madulid DR, Tyler VE. Natural products drug discovery and development: new perspectives on international collaboration. J. Nat. Prod. 1995; 58:1325-57.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM