NUTRACEUTICALS - A REGULATORY REVIEW

  • Ganesh GNK
  • Ramachandran A.
  • Suresh V.
  • Senthil V.
  • Priyadharshini R. Baviya

Abstract

The Nutraceuticals are the emerging sector in the Pharma Industry. As people are more and more concerned about their health and diseases caused by the malnutrition, the growth of the Nutraceuticals worldwide are inevitable. Despite of the growth and the need of the Nutraceuticals by global market there is no apparent regulatory definitions and pathways or procedures for the approval process of Nutraceuticals. The article deals with the regulatory perspective of Nutraceuticals.

Keywords: NDI,ODI,FMCG,21 CFR 190,DSHEA, CFSAN,FSSAI,FSSA.

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References

1. Nutraingredients [Internet] USA : Supplement sales hit $ 11.5 Billion in U.S report says, [ cited 20 sept 2012] Available from:
http://www.nutraingredients-usa.com/Markets/ Suppl ement -sales-hit-11.5-billion-in-U.S.-report-says
2. U.S. Government Publishing office [Internet]. Washington, DC [US] Title 21 - Food and Drugs. chapter i - food and drug administration, department of health and human services (continued). subchapter b - food for human consumption (continued). part 190 - dietary supplements. Subpart B - New Dietary Ingredient Notification. [cited March 26,2008] Available from:
http://www.gpo.gov/fdsys/pkg/CFR-2008-title21-vol3/xml/CFR-2008-title21-vol3-sec190-6.xml
3. World Health Organisation [Internet]. Geneva [Switzerland]. guidelines on food fortification with micronutrients Available from:
http://www.who.int/nutrition/publications/guide_food_fortification_micronutrients.pdf
4. Express Pharma [Internet]. Mumbai (India) Regulatory perspective of Nutraceuticals in India. 2011 [cited 2011 December 31]
Available from:
http://archive.expresspharmaonline.com/20111231/management02.shtml
5. Corporate catalyst India. [Internet] New delhi [India] A Brief Report on Neutraceutical Products in India [cited 2013 August] Available from: http://www.asa.in/pdfs/surveys-reports/ Nutraceutical-Products-in-India.pdf
6. United States. Senate and House of Representatives of the United states of America in Congress. Dietary Supplement Health and Education Act of 1994. Public Law 103 – 417. Available from:
http://ods.od.nih.gov/pdf/About/DSHEA_Wording.aspx.pdf
7. Ministry of health and family [Internet] New Delhi [India] food safety and standards (licensing and registration of food businesses), regulations [cited Aug 2011 01] Available from:
http://www.fssai.gov.in/
8. Ministry of Law and Justice [Internet] New Delhi [India] Food Safety and standards act [cited 2006 August 26] Available from:
http://www.fssai.gov.in/Portals/0/Pdf/FOOD-ACT.pdf
9. Council for Responsible Nutrition. [Internet] Washington DC [USA] Fact Sheet Dietary Supplements: Safe, Regulated and Beneficial [cited 2013] Available from:
http://www.crnusa.org/CRNRegQandA.html
10. U.S. Food and Drug Administration. [Internet] Maryland [United States] FDA Statutory Authority To Regulate The Safety Of Dietary Supplements.2003 [cited 2011] Available from:
http://www.crnusa.org/pdfs/CRN-Hutt_WhitePaper_FDARegulatesDS_090711.pdf
11. U.S. Food and Drug Administration. [Internet] Maryland [United States] Questions and Answers on Dietary Supplements [cited 2015 April 23] Available from:
http://www.fda.gov/Food/DietarySupplements/QADietarySupplements/default.html
12. Wallace TC, MacKay D, Al-Mondhiry R, Nguyen H, Griffiths JC. Dietary Supplement Regulation in the United States [Internet] [cited 2013] Available from:
http://www.springer.com/in/book/9783319015019
13. Vijay Pal Dalmia. Law Of Nutritional & Supplemental Food Products In India - The Conflict: Food Or Drug?, Vaish Associates Advocates [Internet]. 2013 [cited 2013 Feb 12] Available from:
http://www.mondaq.com/india/x/221116/food+drugs+law/Law+Of+Nutritional+Supplemental+Food+Products+In+India
14. Food safety and standards authority of India [Internet] New Delhi [India] Food product standards and Food Additives (Amendment) Regulations, 2015 [cited 2015 Feb 17] Available from:
http://www.fssai.gov.in/Portals/0/Pdf/Gazette_Notification_Nutritional.pdf
15. 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): pg 61-66. Available from:
http://impactfactor.org/IJPQA/4/IJPQA,Vol4,Issue4,Article2.pdf
16. Pasumarthy N V Gopal, Kumar Lakshmi S, P Anusha, D Nagarjuna Reddy, M V Nagabhushanam. Comparison of registration process of Nutraceuticals and herbal supplements in India, US And Europe, an international journal of advances in pharmaceutical sciences[internet]. 2014 July [cited 2014 Aug] 5(4): [about 2271-2280pp] Available from:
http://www.pharmanest.net/comparison-of-registration-process-of-Nutraceuticals-and-herbal-supplements-in-india-us-and-europe-465.html
17. Food safety and standards authority of India [Internet] New Delhi [India] Indian Food Code, Food Categorization System [cited 2006] Available from:
http://www.fssai.gov.in/portals/0/pdf/INDIAN_FOOD_CODE%2825-06-2012%29.pdf
18. Food safety and standards authority of India. [Internet] New Delhi [India] guidelines for preparation of national response or national viewpoint to codex matters and participation in codex meetings & guidelines for codex contact point, national codex committee and national shadow committees [cited 2010] Available from:
http://www.fssai.gov.in/Portals/0/Pdf/Codex_Guidelines.pdf.
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1.
GNK G, A. R, V. S, V. S, Baviya PR. NUTRACEUTICALS - A REGULATORY REVIEW. Int J Drug Reg Affairs [Internet]. 2018Feb.13 [cited 2024Nov.10];3(2):22-9. Available from: https://ijdra.com/index.php/journal/article/view/165