Current Regulatory requirements for Registration of Nutraceuticals in India and USA

  • Pooja Nemichand Jain no
  • Meera H. Rathod
  • Vineet C. Jain
  • Vijayendraswamy S. M.

Abstract

There is growing recognition of the potential role for nutraceuticals and dietary supplements in helping to reduce health risks and improve health quality. Pharmaceutical and nutritional companies are aware of the monetary success taking advantage of the nutraceuticals and dietary supplements. Nutraceuticals has proven health benefits and their Consumption will keep disease at bay and allow humans to maintain an overall good health. Functional foods and internationally products represent a value added growth opportunity both domestically and internationally. Development of better characterized and research proven products will help enhance consumer confidence in nutraceutical and functional food products in the world. Regulatory aspects of such products were in a state of confusion in 20th century. Till date the regulations are not harmonized for the globe and change from country to country. But now it is clearly understood that the regulations for clinical evidence and safety of such products cannot be less stringent than rules for modern medicines and thus the science of nutraceutical is progressing. The global nutraceutical market will reach $285.0 billion by 2021 from $198.7 billion in 2016 at CAGR of 7.5% from 2016-2021. The present research has been devoted towards better understanding of the nutraceuticals and its regulation in India and USA.

Keywords: Nutraceuticals, dietary supplements, Regulations, Market scenario

Downloads

Download data is not yet available.

References

1. Bland JS. Phytonutrition, phytotherapy and phytopharmacology. Altern Ther HealthMed. 1996; (2):73-6.
2. Berger MM, Shenkin A. Vitamins and trace elements: Practical aspects of Supplementation. Nutrition. 2006; 22:952-5.
3. Bagchi D.“Nutraceuticals and functional foods regulations in the United States and around the world.” Toxicol 2006; 221:1-3.
4. Ramaa CS, Shirode AR, Mundada AS, Kadam VJ. Nutraceuticals-an emerging era in the treatment and prevention
of cardiovascular diseases. Current Pharm Biotech. 2006;7:15-23.
5. Biesalski HK. “Nutraceuticals: the link between nutrition and medicine” New York:Marcel Dekker Inc; 2001:1-26.
6. Allen LV. Nutritional Products, In: Covington TR, Berardi RR, Young LL, et al. Editors Handbook of Non-prescription Drugs.
Washington DC: American Pharmaceutical Association; 1997.
7. Tyler VE, Foster F. Herbs and phytochemicals, In: Covington TR, Berardi RR, Young LL et al. editors. Handbook
of Non-prescription Drugs. Washington DC: American Pharmaceutical Association; 1996.
8. National Institutes of Health National Center for Complementary and Alternative Medicine. National Center for Complementary
and Integrative Health (NCCIH) [Internet]. Rockville: 2017 Sept [cited 2013 Jan 23]. Available from:
https://nccih.nih.gov/
9. Brower V. Nutraceuticals: poised for a healthy slice of the healthcare market? Nat Biotechnol. 1999; 16:728-31.
10. Eskin NAM and Tamir S. Dictionary of Nutraceuticals and Functional Foods. USA:CRC Press, Boca Raton; 2006.
11. Benkouider C “Functional Foods and Nutraceuticals.” 2005; 44:8-11.
12. “The Food Safety and Standards Regulations.” [Internet]. FSSAI; 2011 [cited 2018 Jan 23]. Available from:
http://www.fssai.gov.in
13. Food Safety and Standards Authority of India (FSSAI) Act 2006
[Internet]. FSSAI; 2018 [cited 2018 Mar 30]. Available from:
http://www.fssai.gov.in
14. Dietary Supplements [Internet]. Drugs control; 2013 Feb [cited 2018 Jan 27]. Available from:
www.drugscontrol.org/diet.htm
15. Dalmia VP. “Law of Nutritional & Supplemental Food Products in India - The Conflict: Food or Drug?” [Internet]. Mondaq;
2013 Feb 12 [cited 2018 Jan 17]. Available from:
http://www.mondaq.com/india/x/221116/food+drugs+law/Law+Of+Nutritional+Supplemental+Food+Products+In+India.
16. U.S Food and Drug Administration. “To Regulate The Safety Of Dietary Supplements” [Internet]. Maryland, United States:
FDA Statutory Authority; 2003 [cited 2018 Jan 24]. Available from:
http://www.crnusa.org/pdfs/CRN-Hutt_WhitePaper_ FDA RegulatesDS_090711.pdf
17. U.S. Food and Drug Administration. Questions and Answers on Dietary Supplements [Internet]. Maryland:
US FDA; 2015 Apr 23 [cited 2018 Jan 24]. Available from:
http://www.fda.gov/Food/DietarySupplements/QADietarySupplements/default.html
18. Kessler RC, Davis RB, Foster DF, et al. Long Term Trends in the Use of Complementary and Alternative
Medical Therapies in the United States. Ann Intern Med. 2001; 135(4):344-51.
19. Food safety and standards authority of India. Food product standards and Food Additives (Amendment) Regulations
[Internet]. New Delhi, India: FSSAI; 2015 [cited 2018 Jan 11]. Available from:
http://www.fssai.gov.in/Portals/0/Pdf/Gazette_Notification_Nutritional.pdf
20. Sharma A, Kumar P, Sharma P, Shrivastav B. A Comparative Study of Regulatory Registration Procedure
of Nutraceuticals in India, Canada and Australia. International Journal of Pharmaceutical Quality Assurance [Internet].
2013 [cited 2013 October 13]; 4(4):61-66. Available from:
http://impactfactor.org/IJPQA/4/IJPQA,Vol4,Issue4,Article2.pdf
21. Functional foods in Japan, Medical Food News, May 1997 No.6 [Internet]. Medicinal food News; 2015 Jul 20
[cited 2018 Jan 10]. Available from:
www.medicinalfoodnews.com/vol01/issue2/japan
22. Ohama H, Ikeda H and Moriyama H. Health foods and Foods with health claims in Japan. Toxicology. 2006;(221):95-111
23. Kumar P. A review on nutraceuticals -critical supplement for building a healthyworld. World journal of pharmacy and
pharmaceutical sciences. 2016; 5(3):579-94.
24. Bowmik D. Nutraceutical –A bright scope and opportunity of Indian healthcare market. The pharma innovation journal. 2013;1(11):29-41.
25. Singh MC. Nutraceutical and regulatory scenario. International journals of pharmacy and pharmaceutical sciences. 2013; 5(3):23-36.
Statistics
154 Views | 1201 Downloads
How to Cite
Jain, P., M. Rathod, V. Jain, and V. S. M. “Current Regulatory Requirements for Registration of Nutraceuticals in India and USA”. International Journal of Drug Regulatory Affairs, Vol. 6, no. 2, June 2018, pp. 22-29, doi:https://doi.org/10.22270/ijdra.v6i2.232.