DIETARY SUPPLEMENTS: REGULATORY ASPECTS OF THE REGULATORY FRAMEWORK FOR SAFE USE BY THE POPULATION

Introduction:Nutraceuticals although is a widely accepted term and now well understood, there exists several nomenclature and definitions across the countries. The present article discussed the progression of Indian food product regulations over the years, mainly emphasizing on regulations of nutraceuticals and dietary supplements.Regulatory Progression in India:The regulatory structure of nutraceuticals in India has evolved after the establishment of Food Safety and Standard act in 2006, which brought together preexisting eight laws to one single law regulated by Food Safety and Standard Authority of India (FSSAI). After the introduction of this act, the regulatory framework of food products progressed year by year with continuous amendments to this Act. The major milestone in the field of nutraceuticals was in 2016 with the introduction of regulations of functional food and nutraceuticals. Under these regulations, various guidelines were laid down for nutraceuticals in terms of their safety standards, health claims along with permissible limits of active ingredients and excipients for the safe and effective use.Conclusion:India has progressed in the development of a strong regulatory framework for nutraceuticals; however, to effectively implement these guidelines and for ensuring the safe and nutritious food, a robust system and a better-coordinated actions are required.

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Regulatory framework for dietary supplements and the public health challenge

Revista de Saúde Pública ◽

10.11606/s1518-8787.2019053001263 ◽

2019 ◽

Vol 53 ◽

pp. 90 ◽

Cited By ~ 1

Author(s):

Thaís Ramos Dal Molin ◽

Gabriela Camera Leal ◽

Diana Tomazzi Muratt ◽

Gabriela Zanella Marcon ◽

Leandro Machado de Carvalho ◽

...

Keyword(s):

Dietary Supplements ◽

Scientific Evidence ◽

Legal Framework ◽

Regulatory Framework ◽

The Public ◽

Wide Range ◽

Search Tool ◽

Public Health Challenge ◽

Online Stores ◽

New Guidelines

OBJECTIVE: The new regulatory framework for dietary supplements in Brazil prompted this analysis of the current outlook of these products and the challenges posed by the new guidelines. METHODS: We conducted a qualitative, observational and descriptive study of dietary supplements commercialized in Brazilian online stores with the help of the Google® search tool. We considered the ingredients on the labels, the effects attributed to these products and the commercial claims used as a means of promoting them to assess the necessary changes for the legal framework in the new guidelines. Finally, with the help of a database, we compared the effects declared by the manufacturers and attributed to certain ingredients with the scientific evidence described in literature. RESULTS: In total, we purchased 44 dietary supplements from Brazilian online stores (n = 7). Of the samples studied, 34.2% could not be classified in the category Dietary Supplements, as recommended by the new regulation of the Brazilian Health Regulatory Agency due to the presence of prohibited substances; 16% of products should be commercialized as medicines. Regarding the commercial appeals, 97.7% had banned expressions. Numerous claims of effects attributed to certain products were characterized as consumer fraud because they have no scientific evidence. CONCLUSIONS: The necessary changes represent a major regulatory and production challenge due to the wide range of dietary supplements and markets, an effort that aims to protect the consumers’ health. Some previous gaps in the regulatory framework were not fully solved.

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Cell transplantation: regulatory aspects, prospects and trends in the clinical use

Cell and Organ Transplantology ◽

10.22494/cot.v1i1.50 ◽

2013 ◽

Vol 1 (1) ◽

pp. 44-46 ◽

Cited By ~ 1

Author(s):

Yu. Polyachenko ◽

O. Nikonenko ◽

R. Salyutin ◽

M. Komarov ◽

S. Palyanitsya ◽

...

Keyword(s):

Cell Transplantation ◽

Clinical Application ◽

Regulatory Framework ◽

Clinical Use ◽

Regulatory Aspects ◽

Current State ◽

Cell Technologies

This is review of the current state of cell and tissue technologies in Ukraine and in other countries. The advances and problems of domestic and foreign regulatory framework of this field are discussed in a framework of the legislations governing research and clinical application of cell technologies in Ukraine.

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The Quest for a Better Legal and Regulatory Framework for Islamic Banking

Ecclesiastical Law Journal ◽

10.1017/s0956618x14000878 ◽

2014 ◽

Vol 17 (1) ◽

pp. 15-35 ◽

Cited By ~ 2

Author(s):

Abdul Karim Aldohni

Keyword(s):

Business Model ◽

Islamic Law ◽

Regulatory Framework ◽

Islamic Banking ◽

Regulatory Aspects ◽

Regulatory Authorities ◽

Compatibility Analysis ◽

Banking Business ◽

Regulatory Complexity ◽

Regulatory Challenge

The legal and regulatory aspects of Islamic banking present a challenge to most financial and regulatory authorities. To many observers, legal and regulatory complexity in this respect stems from the link between the banking business and Islamic law. Compliance with some Islamic rulings forces the sector to operate an unusual business model, which is different from that of their conventional counterparts. After expounding the ideological foundation of Islamic banking and the sector's evolution, this article examines the genesis of the legal and regulatory challenge by conducting a compatibility analysis between Islam and banking. It will be argued that the conceptions of Islam and banking ought not to conflict, which means that achieving regulatory equilibrium in relation to Islamic banking is possible.

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Regulatory Aspects of Omega Polyunsaturated Fatty Acids in Dietary Supplements

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2017/35627 ◽

2017 ◽

Vol 18 (2) ◽

pp. 1-7 ◽

Cited By ~ 2

Author(s):

Valentina Petkova ◽

Danka Obreshkova ◽

Bozhidarka Hadzhieva ◽

Stefka Ivanova

Keyword(s):

Fatty Acids ◽

Polyunsaturated Fatty Acids ◽

Dietary Supplements ◽

Regulatory Aspects

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Field Survey of Dietary Supplements and Foods with Probiotics Added – Annotation of USA Label Compliance

TEXILA INTERNATIONAL JOURNAL OF ACADEMIC RESEARCH ◽

10.21522/tijar.2014.08.04.art004 ◽

2021 ◽

Vol 8 (4) ◽

pp. 35-41

Author(s):

Tsukasa Jonathan Tanaka

Keyword(s):

Los Angeles ◽

Dietary Supplements ◽

Dietary Supplement ◽

Regulatory Compliance ◽

Regulatory Framework ◽

Educational Outreach ◽

Clinical Effects ◽

The Us ◽

Probiotic Strains ◽

Living Organisms

As US regulatory framework lays the foundation of safety aspects and the efficacy of clinical effects of food products, specifically dietary supplement products, the reality of regulatory compliance is not well understood. Especially, live microorganisms as dietary supplements have many challenges in label compliance due to the unclear regulatory framework, but also due to the complexity of such living organisms. Field surveys were conducted in Southern California, USA (specifically in the Orange County and Los Angeles County regions) at local retailers or online from January 2019 to April 2021. Dietary supplements and food categories that included probiotics specifically into formula were assessed for label compliance and ingredient safety through manual annotations and curation of information. The data were observed and documented statistically. Eighty (80) unique products were collected where the number of probiotic strains ranged from 34 to 1 strain. Thirty-three (33) unique statement of identity were recorded, range of violations were maximum 9 to minimum 0. Violations were checked against the US label compliance per Chapter 21 of the Code of Federal Regulations (CFR) in food and dietary supplement label compliance regulations. Eighty-one (81) unique probiotics were observed where 33 were not confirmed of GRAS (generally recognized as safe) status, and 6 had no NDI (new dietary ingredient) status. Most labels were not in compliance with all the regulatory nuances that were found. Although most probiotics were only listed on the species level, it is still a topic worthwhile the discussion of increasing regulatory awareness to the industry. Non-compliance with labels could be mitigated by such educational outreach.

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Assessment of the Regulatory Aspects of Supply Chain Management of Hazardous Materials HAZMAT with Respect to the Indian Chemical Industry

Journal of Resources Energy and Development ◽

10.3233/red-170102 ◽

2021 ◽

Vol 17 (1) ◽

pp. 17-26

Author(s):

Parag Dadeech

Keyword(s):

Supply Chain ◽

Supply Chain Management ◽

Chemical Industry ◽

Hazardous Materials ◽

Regulatory Framework ◽

Raw Material ◽

Chain Management ◽

Critical Part ◽

Regulatory Aspects ◽

Proper Management

HAZMAT, defined as materials which can harm people, organisms, and the environment, are a critical part of the industry supply chain as raw material, intermediates, or finished products. A strong and effective regulatory framework for dealing with HAZMAT and its proper management is of utmost importance for ensuring adequate safety and minimizing the risks during different stages of supply chain (manufacturing, storage, transportation). In view of this, the objective of research was to study the prevailing regulatory framework for supply chain management of HAZMAT in the context of Indian chemical industry.

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