Generic placeholder image

Applied Clinical Research, Clinical Trials and Regulatory Affairs

Editor-in-Chief

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

Review Article

Critical Review on Food Safety Standard Regulations: A Real Scrutinizing Authority or a Misleading Player for Probiotic Products

Author(s): Malika Arora *, Navdeep Kaur, Manish Arora and Parveen Bansal

Volume 6, Issue 2, 2019

Page: [71 - 85] Pages: 15

DOI: 10.2174/2213476X05666181011144420

Abstract

Background: Probiotics is a broad term used for friendly bacteria which are increasingly used in present scenario due to their wide range of health benefits accompanied by low cost and negligible side effects. The status of the probiotics as a component of food is not clear in the health industry. The use of probiotic bacteria is exploited over-the-counter as dietary supplements or in food products such as yogurt, as well as in the pharmaceutical preparations too. These products have witnessed tremendous growth in the market around the globe. For acceptance of probiotics based products with uniform quality, greater safety of patients, with established scientific evidences for holistic therapeutic benefits in the treatment of various ailments, appropriate drafting and implementation of comprehensive regulatory guidelines is the need of the hour. So in this context, already prescribed guidelines in India are reviewed critically.

Conclusion: This article has been compiled to highlight the variations of food safety standards since 2002 to till date along with the existing ambiguities. Moreover, suggestive consolidations are compiled to take a lead for framing a comprehensive and harmonized guideline to be accepted universally.

Keywords: Probiotics, FSSAI, ICMR, QPS, dietary supplements, PFA Act.

Graphical Abstract

[1]
Vanderhoof JA, Young R. Probiotics in the United States. J Clin Infect Dis 2008; 46(2): 67-72.
[2]
Report of a Joint FAO/WHO Expert Consultation on Guidelines for the Evaluation of Probiotics in Food, 2002. [Cited: 12 November 2015]. Available from: http://www.who.int/foodsafety/fs_management/en/probiotic
[3]
Draft Food Safety and Standards (Food or Health Supplement, Nutraceuticals, Food for Special Dietary uses, Food for Special Medical Purposes, Functional Foods and Novel Foods) Regulation, 2017. Available from: http://www.fssai.gov.in/home/ fsslegislation/notifications/gazette-notification.html
[4]
FSSAI meeting Summary held on 20 June, 2012. [Cited: 02 November 2014]. Available from: http://old.fssai.gov.in/Portals/0/Pdf/minutes_of_14th_authority_meetingpdf
[5]
Arora M, Sharma S, Baldi A. Comparative insight of regulatory guidelines for probiotics in USA, India and Malaysia: A critical review. Inter J Biotech for Wellness Indust 2013; 2(2): 51-64.
[6]
Nagpal R, Kumar A, Kumar M, Behare PV, Jain S, Yadav H. Probiotics, their health benefits and applications for developing healthier foods: A review. FEMS Microbiol Lett 2012; 334(1): 1-5.
[7]
Sharma S, Arora M, Baldi A. Probiotics in India: Current status and future prospects. Pharm Aspire 2013; 1: 1-2.
[8]
Grajek W, Olejnik A, Sip A. Probiotics, prebiotics and antioxidants as functional foods. Acta Biochim Pol 2005; 52(3): 665.
[9]
Kanmani P, Satish KR, Yuvaraj N, et al. Probiotics and its functionally valuable products- A review. Crit Rev Food Sci Nutr 2013; 53(6): 641-58.
[10]
Parvez S, Malik KA, Ah KS, Kim HY. Probiotics and their fermented food products are beneficial for health. J Appl Microbiol 2006; 100(6): 1171-85.
[11]
Otles S, Cagindi O. Kefir: A probiotic dairy-composition, nutritional and therapeutic aspects. Pak J Nemato 2003; 2(2): 54-9.
[12]
Fuller R. Probiotics in human medicine. Gut 1991; 32(4): 439.
[13]
Arora M, Baldi A. Good manufacturing practice regulations for probiotic based pharmaceuticals: Current scenario and suggestive recommendations. Appl Clin Res Clin Trials and Regul Aff 2015; 2(3): 165-75.
[14]
Hill C, Guarner F, Reid G, et al. Expert consensus document: The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastro Hepat 2014; 11(8): 506-8.
[15]
De Simone C. The Unregulated probiotic market. Clin Gastroenterol Hepatol 2019; 17(5): 809-17.
[16]
Arora M, Baldi A. Selective identification and charcterization of potential probiotic strains: A review on comprehensive polyphasic approach. Appl Clin Res Clin Trials and Regul Aff 2017; 4(1): 60-76.
[17]
Arora M, Baldi A. Comparative account of quality management and regulatory aspects of products with health claims: Existing approaches and future challenges for probiotics and herbal products. Appl Clin Res Clin Trials and Regul Aff 2015; 2(3): 123-32.
[18]
Ganguly NK, Bhattacharya SK, Sesikeran B, et al. ICMR-DBT guidelines for evaluation of probiotics in food. Ind J Med Res 2011; 134(1): 22-4.
[19]
Arora M, Baldi A. Regulatory categories of probiotics across the globe: A review representing existing and recommended categorization. Ind J Med Micro 2015; 33(5): 2-3.
[20]
Gawai KM, Prajapati JB. Safety aspects of fermented and probiotic foods. Inter J Fermented Foods 2017; 6(1): 45-7.
[21]
Degnan FH. The US Food and Drug Administration and probiotics: Regulatory categorization. J Clin Infect Dis 2008; 46(Suppl. 2): S133-6.

© 2024 Bentham Science Publishers | Privacy Policy