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

2020 ◽  
Vol 7 (3) ◽  
pp. 177-196
Author(s):  
Payal Dande ◽  
Purva Samant ◽  
Yashita Singh ◽  
Umang Sheth
Keyword(s):  
Dietary Supplements ◽  
Functional Foods ◽  
Management Practices ◽  
Health Management ◽  
Major Change ◽  
Regulatory Body ◽  
Regulatory Guidelines ◽  
Entry Requirements ◽  
Major Factors

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.

The Study of the Registration Guideline of Nutraceutical Products in ASEAN Countries

2020 ◽  
Vol 7 (2) ◽  
pp. 104-116
Author(s):  
Mansi Athalye ◽  
Sneha Vaghela ◽  
Nehal Bhavsar
Keyword(s):  
Dietary Supplements ◽  
Health Research ◽  
Functional Foods ◽  
Health Management ◽  
Health Benefits ◽  
Safety Evaluation ◽  
Prevention And Treatment ◽  
Medical Health ◽  
Asean Countries ◽  
Nutraceutical Products

Over the years, a number of dietary supplements and health foods are being utilized and are available at pharmacy stores. These medicinally or nutritionally functional foods are considered as ‘Nutraceuticals’. The term was defined in 1989 by Stephen De Felice, founder and chairman of the Foundation for Innovation in Medicine, an American organization which encourages medical health research. He defined a nutraceutical as a “food, or parts of a food, that provide medical or health benefits, including the prevention and treatment of disease”. As these substances are neither be considered as drug or as food, the risk of toxicity and safety should be considered for better health management which requires the research and safety evaluation of Nutraceuticals as per the regulations. Therefore, the aim of the present work is to review regulatory prospects of these Nutraceutical products in ASEAN countries.

scholarly journals A Comprehensive Review on Nutraceuticals

2021 ◽  
Vol 68 (2) ◽  
Author(s):  
Dr.S. Ruby ◽  
S. Prakash ◽  
V.Pradeep Kumar ◽  
T.Praveen Kumar ◽  
S. Prathab
Keyword(s):  
Dietary Supplements ◽  
Functional Foods ◽  
Health Benefits ◽  
Indian Government ◽  
Herbal Products ◽  
Major Health ◽  
Optimal Health ◽  
Recent Developments ◽  
Key Terms

Nutraceuticals have received considerable interest because of their presumed safety. Nutraceuticals are food or part of food that provides medical or health benefits including the prevention and/or treatment of a disease. These nutraceuticals help in combating some of the major health problems of the century such as obesity, cardiovascular diseases, cancer, osteoporosis, arthritis, diabetes, cholesterol etc. Nutraceutical has advantage over the medicine because they avoid side effect, have naturally dietary supplement, etc. Nutraceutical on the basis of their natural source, chemical grouping, categories into three key terms –nutrients, herbals, dietary supplements, etc. The most rapidly growing segments of the industry were dietary supplements (19.5 percent per year) and natural/herbal products (11.6 percent per year). Global nutraceutical market is estimated as USD 404.8billion by 2025. FDA regulated dietary supplements as foods to ensure that they were safe. In 2006, the Indian government passed Food Safety and Standard Act to regulate the nutraceutical industry. Herbal nutraceutical is used as a powerful instrument in maintaining health and to act against nutritionally induced acute and chronic diseases, thereby promoting optimal health, longevity, and quality of life. The Present article focuses on the need for adhere to the known healthy eating models, development of new nutraceuticals/functional foods/food supplements with novel health benefits, elucidation mechanisms of action of these products, to define the comprehensive aspects of nutraceutical. This article may act as a tool to abreast with the recent developments in nutraceutical research.

scholarly journals Spotlight on the Compositional Quality of Probiotic Formulations Marketed Worldwide

2021 ◽  
Vol 12 ◽  
Author(s):  
Diletta Mazzantini ◽  
Marco Calvigioni ◽  
Francesco Celandroni ◽  
Antonella Lupetti ◽  
Emilia Ghelardi
Keyword(s):  
Dietary Supplements ◽  
Functional Foods ◽  
Microbiological Quality ◽  
Microbial Identification ◽  
Quality Controls ◽  
Beneficial Effects ◽  
Compositional Quality ◽  
Living Organisms ◽  
Stringent Quality

On the worldwide market, a great number of probiotic formulations are available to consumers as drugs, dietary supplements, and functional foods. For exerting their beneficial effects on host health, these preparations should contain a sufficient amount of the indicated living microbes and be pathogen-free to be safe. Therefore, the contained microbial species and their amount until product expiry are required to be accurately reported on the labels. While commercial formulations licensed as drugs are subjected to rigorous quality controls, less stringent regulations are generally applied to preparations categorized as dietary supplements and functional foods. Many reports indicated that the content of several probiotic formulations does not always correspond to the label claims in terms of microbial identification, number of living organisms, and purity, highlighting the requirement for more stringent quality controls by manufacturers. The main focus of this review is to provide an in-depth overview of the microbiological quality of probiotic formulations commercialized worldwide. Many incongruences in the compositional quality of some probiotic formulations available on the worldwide market were highlighted. Even if manufacturers carry at least some of the responsibility for these inconsistencies, studies that analyze probiotic products should be conducted following recommended and up-to-date methodologies.

On-farm udder health monitoring

2011 ◽  
Vol 39 (02) ◽  
pp. 95-100
Author(s):  
J. C. van Veersen ◽  
O. Sampimon ◽  
R. G. Olde Riekerink ◽  
T. J. G. Lam
Keyword(s):  
Management Practices ◽  
Health Management ◽  
Action Plan ◽  
Real Life ◽  
Health Data ◽  
Control Points ◽  
Udder Health ◽  
Critical Control Points ◽  
On Farm ◽  
Clinical Problems

SummaryIn this article an on-farm monitoring approach on udder health is presented. Monitoring of udder health consists of regular collection and analysis of data and of the regular evaluation of management practices. The ultimate goal is to manage critical control points in udder health management, such as hygiene, body condition, teat ends and treatments, in such a way that results (udder health parameters) are always optimal. Mastitis, however, is a multifactorial disease, and in real life it is not possible to fully prevent all mastitis problems. Therefore udder health data are also monitored with the goal to pick up deviations before they lead to (clinical) problems. By quantifying udder health data and management, a farm is approached as a business, with much attention for efficiency, thought over processes, clear agreements and goals, and including evaluation of processes and results. The whole approach starts with setting SMART (Specific, Measurable, Acceptable, Realistic, Time-bound) goals, followed by an action plan to realize these goals.

Outcome after complex neurosurgery: the caregiver's burden is forgotten

1999 ◽  
Vol 7 (1) ◽  
pp. E1 ◽  
Author(s):  
Dorothy A. Lang ◽  
Glenn Neil-Dwyer ◽  
John Garfield
Keyword(s):  
Quality Of Life ◽  
Hypoglossal Nerve ◽  
Major Change ◽  
Percutaneous Gastrostomy ◽  
Petroclival Meningioma ◽  
Sf 36 ◽  
Skull Base Approach ◽  
Permanent Neurological Deficit ◽  
The Impact

Object The goals of this study were twofold: 1) to determine outcome, including quality of life, in patients who have undergone surgery for petroclival meningioma in which a standard skull base approach was used; and 2) to assess the impact of the patients' surgical treatment on their caregivers. Methods Seventeen patients (13 women and four men ranging in age from 29 to 63 years) who underwent a transpetrosal approach for a petroclival meningioma during a 5-year period were prospectively included in this study. Pre- and postoperative data including adverse events were noted. The patients were assessed at 3, 6, and 12 months postoperatively, and annually thereafter, and they completed a postoperative SF-36 questionnaire. In addition, each patient's caregiver was interviewed to determine the effect of the patient's illness on the caregiver's life and responsibilities. Twenty-two operations were performed. A new permanent neurological deficit developed in five patients and in eight a temporary deficit or exacerbation of existing deficits occurred. Two patients underwent surgery to create a facial-hypoglossal nerve communication; five required a temporary percutaneous gastrostomy and/or tracheostomy; three required a shunt; and one underwent successful squint surgery. At 1 year postoperatively 13 patients had made a good or moderate recovery, three were severely disabled, and one had died--outcomes in keeping with other studies. By contrast, responses to the SF-36 questionnaire showed that, in all eight of its categories, between 43% and 75% of surviving patients were functioning below accepted norms. Fifty-six percent of caregivers experienced a major change in lifestyle and 38% experienced a major change with respect to their work. Conclusions After transpetrosal excision of a petroclival meningioma, the quality of life for the patient is worse than that indicated in surgeons' reported results. The impact on the patient's caregiver is profound--a burden perhaps not fully appreciated by the surgeon.

Monitoring Effects of Catchment Management Practices on Phosphorus Loads into the Eutrophic Peel-Harvey Estuary, Western Australia

1986 ◽  
Vol 18 (4-5) ◽  
pp. 53-61 ◽  
Author(s):  
P. B. Birch ◽  
G. G. Forbes ◽  
N. J. Schofield
Keyword(s):  
Management Practices ◽  
Major Change ◽  
High Flow ◽  
Catchment Management ◽  
Flow Rates ◽  
Early Results ◽  
Phosphorus Loads ◽  
Time Of Year ◽  
High Runoff

Early results from monitoring runoff suggest that the programme to reduce application of superphosphate to farmlands in surrounding catchments has been successful in reducing input of phosphorus to the eutrophic Peel-Harvey estuary. In the estuary this phosphorus fertilizes algae which grow in abundance and accumulate and pollute once clean beaches. The success of the programme has been judged from application of an empirical statistical model, which was derived from 6 years of data from the Harvey Estuary catchment prior to a major change in fertilizer practices in 1984. The model relates concentration of phosphorus with rate of flow and time of year. High phosphorus concentrations were associated with high flow rates and with flows early in the high runoff season (May-July). The model predicted that the distribution of flows in 1984 should have resulted in a flow-weighted concentration of phosphorus near the long-term average; the observed concentration was 25% below the long-term average. This means that the amount of phosphorus discharged into the Harvey Estuary could have been about 2 5% less than expected from the volume of runoff which occurred. However several more years of data are required to confirm this trend.

DRUG REGULATORY PROCEDURES IN TANZANIA: A GLIMPSE

2015 ◽  
Vol 3 (2) ◽  
pp. 1-7 ◽  
Author(s):  
Achin Jain ◽  
M P Venkatesh M P ◽  
Pramod T.M. Kumar
Keyword(s):  
Quality Control ◽  
Medical Devices ◽  
Emerging Market ◽  
Well Being ◽  
New Drugs ◽  
Regulatory Body ◽  
Herbal Drugs ◽  
Drug Products ◽  
Set Up

In Tanzania, Tanzania Food and Drugs Authority (TFDA), is a regulatory body responsible for controlling the quality,safety and effectiveness of food, drugs, herbal drugs, cosmetics and medical devices. The Authority has been ensuringsafety, efficacy and quality of medicines by quality control tests; in addition to other quality assessment mechanisms.The guidelines laid by TFDA have also emanated from commitment to democracy and gives strong emphasis to thefulfilment of the needs of the less privileged rural population.Tanzania is an emerging market; the pharmaceutical market is valued at over US$250 million, and is growing at anannual rate of around 16.5% and is expected to reach approximately US$550 billion in 2020. Currently, the market ishighly dependent on imports, which account for around 75% of the total pharmaceutical market.The procedures and approval requirements of new drugs, variations, import, export and disposal have been set up bythe TFDA, which help in maintaining quality of the drug products that are imported as well being produced locally 

scholarly journals Processes, Challenges and Optimisation of Rum Production from Molasses—A Contemporary Review

Fermentation ◽  
2021 ◽  
Vol 7 (1) ◽  
pp. 21
Author(s):  
Tinashe Mangwanda ◽  
Joel B. Johnson ◽  
Janice S. Mani ◽  
Steve Jackson ◽  
Shaneel Chandra ◽  
...  
Keyword(s):  
Management Practices ◽  
Scientific Literature ◽  
Asia Pacific ◽  
Yeast Strains ◽  
Challenges And Opportunities ◽  
The Caribbean ◽  
The Impact ◽  
Production Industry ◽  
Stringent Quality

The rum industry is currently worth USD 16 billion, with production concentrated in tropical countries of the Caribbean and Asia-Pacific regions. The primary feedstock for rum production is sugar cane molasses, a by-product of sugar refineries. The main variables known to affect rum quality include the composition of the molasses, the length of fermentation, and the type of barrels and length of time used for aging the rum. The goal of this review is to provide an overview of the impact of these variables on rum quality, and to highlight current challenges and opportunities in the production of rum from molasses. In order to achieve this, we review the relevant contemporary scientific literature on these topics. The major contemporary challenges in the rum production industry include minimising the effects of variability in feedstock quality, ensuring the fermentation process runs to completion, preventing microbial contamination, and the selection and maintenance of yeast strains providing optimum ethanol production. Stringent quality management practices are required to ensure consistency in the quality and organoleptic properties of the rum from batch to batch. Further research is required to fully understand the influences of many of these variables on the final quality of the rum produced.

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