Generic placeholder image

Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)

Editor-in-Chief

ISSN (Print): 2213-476X
ISSN (Online): 2213-4778

Review Article

Safety and Quality of Nutraceuticals: Have FSSAI Guidelines been Able to Blaze the Trail?

Author(s): Payal Dande*, Purva Samant, Yashita Singh and Umang Sheth

Volume 7 , Issue 3 , 2020

Page: [177 - 196] Pages: 20

DOI: 10.2174/2213476X07666200825193259

Price: $65

Abstract

The nutraceutical industry has three main segments, including herbal/- natural products, dietary supplements and functional foods. The dietary supplements market is preliminarily driven by the paradigm shift towards preventive health management practices, amid rising healthcare costs and increasing burden of lifestyle diseases. Rise in healthcare expenditure, increased usage of nutraceuticals product as a substitute to prescription and OTC drugs and augmented demand for the nutritional diet are the major factors driving the global nutraceuticals market. Many individual laws were devised to govern its manufacturing and sale. However, increasing regulatory formalities from multiple agencies and laws, complicate the development, testing and marketing of these substances and hamper the growth of the nutraceutical market. Globally, the regulatory authorities are aware of the changing needs of consumers and proactively protect consumers by amending existing laws to accommodate changes. Market entry requirements of nutraceuticals, functional foods and supplements vary from country to country. The global regulatory guidelines aim at regulating various aspects of the nutraceutical and dietary supplements market, focusing on its manufacture, testing, labeling, sale and registration to assure safety and quality of the product. The major change that was introduced was the ban on marketing Nutraceuticals as medicinal products. This review has been performed to provide a comprehensive understanding of the global regulatory requirements with critical analysis of the Indian regulatory guidelines to explore the lacunae and suggest the need of further amendments in the form of recommendations that can be incorporated into regulatory body guidelines to make it more competitive for national & international trade.

Keywords: Nutraceuticals, FSSAI regulations, food supplements, import, prebiotics, probiotics.

Graphical Abstract
[1]
Keservani RK, Sharma AK, Ahmad F, Baig ME. Nutraceutical and Functional Food Regulations in India. (2nd ed.). Nutraceutical and Functional Food Regulations in the United States and Around the World 2014; pp. 327-42.
[http://dx.doi.org/10.1016/B978-0-12-405870-5.00019-0]
[2]
Report predicts 21% growth for nutraceutical industry by 2025, FSSAI calls for self regulation 2018. Available from: https://www.biovoicenews.com/report-predicts-21-growth-for-nutraceutical-industry-by-2025-fssai-calls-for-self-regulation/
[3]
Austin KG, Farina EK, Lieberman HR. Self-reported side-effects associated with use of dietary supplements in an armed forces population. Drug Test Anal 2016; 8(3-4): 287-95.
[http://dx.doi.org/10.1002/dta.1905] [PMID: 26526399]
[4]
The Gazette of India. Delhi New. Chapter I- definitions, draft of the food safety and standards (food or health supplements, nutraceuticals, foods for special dietary uses, foods for special medical purpose, functional foods, and novel food) regulations In: 2018.
[5]
Das L, Bhaumik E, Raychaudhuri U, Chakraborty R. Role of nutraceuticals in human health. J Food Sci Technol 2012; 49(2): 173-83.
[http://dx.doi.org/10.1007/s13197-011-0269-4] [PMID: 23572839]
[6]
Breemen RB. Van, Pajkovic N. Multitargeted therapy of cancer by lycopene. Cancer Lett 2008; 269(2): 339-51.
[http://dx.doi.org/10.1016/j.canlet.2008.05.016] [PMID: 18585855]
[7]
Goyal A, Sharma V, Upadhyay N, Gill S, Sihag M. Flax and flaxseed oil: an ancient medicine & modern functional food. J Food Sci Technol 2014; 51(9): 1633-53.
[http://dx.doi.org/10.1007/s13197-013-1247-9] [PMID: 25190822]
[8]
Ministry of health and family welfare (Food Safety and Standards Authority of India) Notification New Delhi 2011. Available from: http://fsdaup.gov.in/writereaddata/images/pdf/act-and-rules/fss-regulation/Food-safety-and-standards-Food-product-standards-and-Food-Additives-regulation-2011.pdf
[9]
Food Safety and Standard Authority of India. 2011. Available from: https://archive.fssai.gov.in/home/fss-legislation/fss-regulations.html
[10]
Food Safety and Standard Authority of India. 2019. Available from: https://archive.fssai.gov.in/home/fss-legislation/fss-regulations.html
[11]
Food Safety and Standard Authority of India. Food Safety and Standards (Advertising and Claims). Regulations 2018. Available from: https://archive.fssai.gov-.in/dam/jcr:09bc698a-fa5e-45f6-a244 2699092c11ff/Gazette_Notification_Advertising_Claims_27_11_2018.pdf
[12]
Clinical Research: A Tool to Support Nutraceutical Product Claim Available from: https://www.lambda-cro.com/clinical-research-a-tool-to-support-nutraceutical-product-claim.html
[13]
Food Safety and Standard Authority of India. Food Safety and Standards (Licensing and Registration of Food Businesses). Regulation 2011; 36(i) Available from: https://archive.fssai.gov.in/home/fss-legislation/fss-regulations.html
[14]
Food Safety and Standard Authority of India. Food Safety and Standards (Prohibition and Restriction on Sales). Regulation 2011; (3): 10-6. Available from: https://archive.fssai.gov.in/home/fss-legislation/fss-regulations.html
[15]
Food Safety and Standard Authority of India. 2017. Available from: https://archive.fssai.gov.in/home/fss-legislation/fss-regulations.html
[16]
Tapan J. Ray nutraceuticals: still an oasis amidst well-regulated pharmaceutical 2016. Available from: http://www.tapanray.in/nutraceuticals-still-an-oasis-amidst-well-regulated-pharmaceuticals/
[17]
Ventola CL. Current Issues Regarding Complementary and Alternative Medicine (CAM) in the United States: Part 1: The Widespread Use of CAM and the Need for Better-Informed Health Care Professionals to Provide Patient Counseling. P&T 2010; 35(8): 461-8.
[18]
Dwyer JT, Coates PM, Smith MJ. Dietary Supplements: Regulatory Challenges and Research Resources. Nutrients 2018; 10(1): 1-24.
[http://dx.doi.org/10.3390/nu10010041] [PMID: 29300341]
[19]
Devla MN, Acharya SR, Acharya NS, Kumar V. Dietary supplements : a legal status in india in foreign countries Int J Pharm Pharm Sci 2011; 3(3): 7-12.
[20]
Patel D, Dufour Y, Domigan N. Functional Food and Nutraceutical Registration Process in Japan and China : Similarities and Differences. J Pharm Pharm Sci 2008; 11(4): 1-11.
[http://dx.doi.org/10.18433/J32S3N] [PMID: 19183509]
[21]
Jose Luis Valverde. Regulation of nutritional and health claims made on food in the European Union. Pharmaceuticals Policy and Law 2009; 11: 187-99.
[http://dx.doi.org/10.3233/PPL-2009-0224]
[22]
Tripathi C, Girme A, Champaneri S, Patel RJ, Hingorani L. Nutraceutical regulations: An opportunity in ASEAN countries. Nutrition 2020; 74110729
[http://dx.doi.org/10.1016/j.nut.2020.110729] [PMID: 32203878]
[23]
Profile of definition, terminology and technical requirement of traditional medicines and healh supplements among ASEAN member countries 2016. Available from: http://www.asean.org/storage/images/archive/20258.pdf
[24]
Athalye M, Vaghela S, Bhavsar N. The Study of the Registration Guideline of Nutraceutical Products in ASEAN Countries. Appl Clin Res Clin Trials Regul Aff 2020; 7: 104-16.
[http://dx.doi.org/10.2174/2213476X06666190916121705]

Rights & Permissions Print Export Cite as
© 2022 Bentham Science Publishers | Privacy Policy