scholarly journals Regulatory framework for dietary supplements and the public health challenge

2019 ◽  
Vol 53 ◽  
pp. 90 ◽  
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.

Нормативно-правовое поле в сфере водоснабжения и водоотведения

2019 ◽  
pp. 70-72
Author(s):  
I. Pavlinova
Keyword(s):  
Water Supply ◽  
Systems Design ◽  
Careful Analysis ◽  
Legal Framework ◽  
Regulatory Framework ◽  
Codes Of Practice ◽  
Wide Range ◽  
Construction Operation ◽  
Sanitation Systems ◽  
Water Supply And Sanitation

В настоящее время в России принципиально изменился подход к процессу создания новой нормативной базы и контролю качества продукции. АО МосводоканалНИИпроект уже 80 лет занимается проектированием систем водоснабжения и водоотведения с использованием нормативноправовой базы РФ. Институт не только проектирует, но и имеет большой опыт по созданию нормативных документов (санитарных норм и правил, сводов правил и др.). Проведенный анализ нормативноправовой базы в сфере проектирования, строительства и эксплуатации систем водоснабжения и водоотведения показал, что на федеральном уровне этот вопрос решен, однако на региональном уровне требуется его дальнейшая глубокая проработка. Нередко требуется доработка, а в некоторых случаях и переработка утвержденных ключевых документов. Избежать недоработок в нормативной базе возможно лишь при тщательном анализе технических и технологических решений с привлечением широкого круга специалистов и при корректном внесении изменений в действующие нормативноправовые акты.At present the approach to the process of developing a new regulatory framework and product quality control has been essentially changed. MosvodokanalNIIproject JSC already 80 years has been designing water supply and sanitation systems with the use of the RF regulatory and legal framework. Aside from designing the Institute has been well experienced in developing regulatory documents (sanitary norms and rules, codes of practice etc.). The analysis of the regulatory and legal framework conducted in the field of designing, constructing and operating water supply and sanitation systems shows that this matter has been settled at the federal level however, at the regional level its indepth analysis is needed. Every so often improvement and, in some cases, revision of the approved key documents is required. Avoiding shortfalls in the regulatory framework is possible only with the careful analysis of the technical and technological solutions involving a wide range of experts and with the correct amendments to the effective regulatory and legal acts. Key words: regulatory and legal framework, water supply and sanitation systems, design, construction, operation.

LEGAL AND REGULATORY FRAMEWORK FOR STRATEGIC MANAGEMENT OF STATE JOINT-STOCK COMPANIES IN UKRAINE

2019 ◽  
Vol 5 (1) ◽  
pp. 225-237
Author(s):  
Iryna Ratynska
Keyword(s):  
Public Sector ◽  
Strategic Management ◽  
State Level ◽  
Legal Framework ◽  
Regulatory Framework ◽  
Decentralized System ◽  
National Legislation ◽  
The Public ◽  
The One

The article analyzes the features of the existing legal framework of strategic management of state joint-stock companies in Ukraine. It was established that Ukraine has formed a regulatory framework for the management of state-owned companies, which is typical for a decentralized system of management of state-owned objects. It was covered that the for-mation of the modern regulatory framework of this activity took place in 3 stages. For all stages, it is characteristic that at each of them long-term planning of development of the public sector of the economy had declarative, exclusively formal character. It was found that on the one hand, in the current national legislation, at the state level of management of joint-stock companies of the public sector of the economy, an unlimited number of too detailed program and forecast documents are recorded. On the other hand, the priority and coordination of such documents have not been established. In addition, the attention is focused on the fact that in the national legislation there was a consolidation of the contradiction between the strategic and operational management of state joint-stock companies.

Comparative Study of the Legal Framework of Securities Disclosure Requirements in Kuwait and the U.S.

2007 ◽  
Vol 21 (3) ◽  
pp. 230-250
Author(s):  
Fahad Al-Zumai
Keyword(s):  
Regulatory Reform ◽  
The United States ◽  
Legal Framework ◽  
Regulatory Framework ◽  
Securities Regulation ◽  
Sensitive Information ◽  
The Public ◽  
Disclosure Requirements ◽  
Regulatory Analysis ◽  
The U.S

This paper examines the regulatory framework of disclosure in Kuwait in comparison with the situation in the United States of America. It covers the theoretical arguments for and against mandatory disclosure and then engages in a regulatory analysis of the rules governing disclosure in Kuwait and the U.S. The main areas that are explored in this paper include, inter alia , the disclosure of interest; periodic and real time disclosures; and rumours and duties to disclose in both jurisdictions. Afterward, anti-fraud provisions and their role in enhancing the disclosure framework are discussed and the investigation concludes that the absence of an anti-fraud provision in securities regulation in Kuwait is undermining the efficiency of the regulatory framework of disclosure in the country. Finally, the paper concludes that regulatory reform is needed in Kuwait to fill in the gaps in the current structure and in particular the current available remedies. The scope of disclosure should also be expanded to capture all major sensitive information that needs to be disclosed to the public and the shareholders.

Truth and Consequences: The Perils of Half-Truths and Unsubstantiated Health Claims for Dietary Supplements

2000 ◽  
Vol 19 (1) ◽  
pp. 132-138 ◽  
Author(s):  
David C. Vladeck
Keyword(s):  
Dietary Supplements ◽  
First Amendment ◽  
Scientific Evidence ◽  
Health Claims ◽  
Nutrition Labeling ◽  
The Public ◽  
Commercial Speech ◽  
Court Of Appeals ◽  
Fda Approval ◽  
Education Act

The author examines the recent decision of the U.S. Court of Appeals in Pearson v. Shalala , which struck down on First Amendment grounds the Food and Drug Administration's (FDA's) regulatory scheme for approving health claims for dietary supplements. In its recent ruling, the Pearson court rejected the FDA's view that health claims that cannot be proved as either true or false pose a serious risk to consumers. Although the court recognized that some health claims will mislead consumers, it reasoned that the FDA's regulations are nonetheless impermissibly restrictive because they do not allow manufacturers to make health claims accompanied by clarifying disclosures when significant scientific agreement is lacking. The court suggested that disclaimers referring to the absence of FDA approval, or the inconclusive nature of the scientific evidence, might be sufficient to guard against consumer deception. The author explains why the reasoning of Pearson misconceives basic First Amendment commercial speech principles and places the public at risk. Congress enacted the Nutrition Labeling and Education Act to ensure that consumers would no longer be subjected to unreliable and unverifiable health claims for dietary supplements. Pearson thwarts that purpose. The disclaimers envisioned by the court will simply underscore the uncertainty about the product's utility. Accordingly, Pearson relegates consumers to a marketplace that will be rife with unproven and unreliable health claims and thus poses a real threat to the health of consumers.

Well-Being and Mental Wellness

2020 ◽  
Author(s):  
Gerard Bodeker ◽  
Sergio Pecorelli ◽  
Lawrence Choy ◽  
Ranieri Guerra ◽  
Kishan Kariippanon
Keyword(s):  
Public Health ◽  
Scientific Evidence ◽  
Well Being ◽  
Health Priorities ◽  
Global Public Health ◽  
The Public ◽  
Public Health Challenge ◽  
Mental Wellness ◽  
Individual Self ◽  
Care Development

The scientific landscape of wellbeing and mental wellness has developed significantly through interdisciplinary cross-pollination by researchers in molecular genetics, neuroscience, sociology, economics, including traditional and complementary medicine. The public health challenge lies in using this diverse body of scientific evidence to reframe wellbeing and mental wellness within a 21st-century global public health framework that incorporates evidence-based modalities alongside Western biomedical practice. Evidence on modalities, case studies, policy examples, and emerging directions in societal objectives in wellbeing and mental wellness are discussed in the context of a way forward that focuses on individual self-care, development of resilience, lifespan pathways for wellbeing, and a different economic calculus in framing public health priorities and policies.

scholarly journals Importance of Health literacy in magnesium supplementation - Case study Novi Sad, Serbia

2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
J Gajic ◽  
D Dimovski ◽  
B Vukajlovic ◽  
M Jevtic
Keyword(s):  
Health Literacy ◽  
Dietary Supplements ◽  
Magnesium Oxide ◽  
Health Care Services ◽  
Free Market ◽  
Sources Of Information ◽  
Pharmaceutical Dosage Form ◽  
The Public ◽  
Wide Range ◽  
Novi Sad

Abstract Background Currently the market offers wide range of magnesium dietary supplements that vary either in their pharmaceutical dosage form (capsules, tablets, direct form, effervescences etc.), magnesium compound present (magnesium oxide, - chloride, -citrate,- bisglycinate, -acetyltaurinate etc.) their dosage (ranging from 150 to 400mg) or other vitamins and minerals present (vitamin B complex, vitamin C, zinc, manganese etc). Since the public can now choose to buy dietary supplements not only from pharmacies and specialized stores but from places such as supermarkets, cosmetic shops or even markets it is important to educate the public and help them make healthier choices. Objectives While providing primary health care services in public pharmacy, overall choices and reasons for buying magnesium supplements were noted during the first four months of 2019 (January to April). The goal was to investigate the most important factors patients consider when opting to take magnesium supplements as well as their health literacy regarding the topic. Results The results indicate that the currently most popular choices are mouth dissolving forms of magnesium (more than 50% units sold), and predominantly forms the magnesium oxide form (around 75%). It is suggested that the most important factors when choosing magnesium dietary supplements are its price, media presence, friends advice, general familiarity or even product design as very few the patients asked about the present form of the magnesium. Conclusions Magnesium dietary supplements belong to highly desirable supplements on the free market. It is observed that patients choice mostly doesn’t coincide with health authorities recommendations. Key messages Importance of health literacy and understanding the dietary supplement labels. Higher impact of sources of information other than healthcare authorities.

scholarly journals DEVELOPMENT OF THE LEASING INDUSTRY IN THE ALBANIAN MARKET. AN OVERVIEW OF THE LAST 20 YEARS FROM LEGAL FRAMEWORK TO PERFORMANCE INDICATORS

2018 ◽  
Vol 6 ◽  
pp. 325-332
Author(s):  
Fatjola Lubonja
Keyword(s):  
Developing Countries ◽  
Performance Indicators ◽  
Legal Framework ◽  
Regulatory Framework ◽  
General Description ◽  
Financial Leasing ◽  
The Public ◽  
The Future

Financial leasing, known as well as the financial rent, has been available in the Albanian market since 2005 although most of the leasing operating companies have only been registered since 2009. Even though in developing countries financial leasing is widely available and growing considerably, in the case of Albania this product has faced difficulties in getting recognition in the eyes of the public. Based on the European practices, small and middle enterprises compose 99% of the operating businesses in Albania and these types of enterprises are among the main users of leasing in Europe, about 50%. These elements are exactly what made leasing an alternative to financial borrowing even though financial leasing yet has an unused potential compared to loans and other forms of financing. This article aims to give a general description of the meaning of financial leasing, the legal and the regulatory framework in which this form of financing has been applied in Albania and further provide several conclusions that will focus on the factors that are expected to affect the future of financial leasing in Albania.

scholarly journals Dietary Supplements for Male Infertility: A Critical Evaluation of Their Composition

Nutrients ◽  
2020 ◽  
Vol 12 (5) ◽  
pp. 1472
Author(s):  
Andrea Garolla ◽  
Gabriel Cosmin Petre ◽  
Francesco Francini-Pesenti ◽  
Luca De Toni ◽  
Amerigo Vitagliano ◽  
...  
Keyword(s):  
Male Infertility ◽  
Dietary Supplements ◽  
Scientific Evidence ◽  
Coenzyme Q ◽  
Critical Evaluation ◽  
Lower Class ◽  
Sperm Parameters ◽  
Active Ingredients ◽  
Wide Range ◽  
Daily Dose

Dietary supplements (DS) represent a possible approach to improve sperm parameters and male fertility. A wide range of DS containing different nutrients is now available. Although many authors demonstrated benefits from some nutrients in the improvement of sperm parameters, their real effectiveness is still under debate. The aim of this study was to critically review the composition of DS using the Italian market as a sample. Active ingredients and their minimal effective daily dose (mED) on sperm parameters were identified through a literature search. Thereafter, we created a formula to classify the expected efficacy of each DS. Considering active ingredients, their concentration and the recommended daily dose, DS were scored into three classes of expected efficacy: higher, lower and none. Twenty-one DS were identified. Most of them had a large number of ingredients, frequently at doses below mED or with undemonstrated efficacy. Zinc was the most common ingredient of DS (70% of products), followed by selenium, arginine, coenzyme Q and folic acid. By applying our scoring system, 9.5% of DS fell in a higher class, 71.4% in a lower class and 19.1% in the class with no expected efficacy. DS marketed in Italy for male infertility frequently includes effective ingredients but also a large number of substances at insufficient doses or with no reported efficacy. Manufacturers and physicians should better consider the scientific evidence on effective ingredients and their doses before formulating and prescribing these products.

THE INTERPRETATION OF ISLAM WITHIN THE FRAMEWORK OF THE INDIGENOUS MALAYA

2021 ◽  
Vol 4 (2) ◽  
pp. 1-9
Author(s):  
Datuk Assoc. Prof. Dr. Wan Ahmad Fauzi Wan Husain
Keyword(s):  
Qualitative Study ◽  
Legal History ◽  
Legal Framework ◽  
Public Prosecutor ◽  
The Public ◽  
Accurate Interpretation ◽  
Federal Constitution ◽  
Indigenous Sovereignty

This article attempts to explore the Islamic interpretation within the legal framework of the Malayan indigenous sovereignty. The position of Islam within the country’s legal framework became important when the Court’s decision in Che Omar Che Soh vs the Public Prosecutor, made the sovereignty of the Malay Rulers as a parameter in interpreting Islam within the context of Article 3 of the Federal Constitution. This is a qualitative study applying the legal history design. The findings showed the indigenous sovereignty was sourced from the Islamic teachings which had not been dissolved despite the introduction of the doctrine of advice by the British. Besides, the agreement made between the Malay Rulers and the British retained the indigenous sovereignty despite of various policies introduced by the British throughout their interference in Malaya which was subjected to the old Malayan Constitution. In conclusion, the accurate interpretation of Islam should be based on the al-Qur'an and al-Sunnah because it is in line with the principle of the indigenous sovereignty inherited from the Malay Sultanate of Malacca.

Our universities away from partisan Altsarat

2019 ◽  
Author(s):  
أ.د.عبد الجبار احمد عبد الله
Keyword(s):  
Political Parties ◽  
Legal Framework ◽  
Public Institutions ◽  
Political Organization ◽  
Moral Duty ◽  
The Political ◽  
Public Office ◽  
State Institutions ◽  
The Public ◽  
The University

In order to codify the political and partisan activity in Iraq, after a difficult labor, the Political Parties Law No. (36) for the year 2015 started and this is positive because it is not normal for the political parties and forces in Iraq to continue without a legal framework. Article (24) / paragraph (5) of the law requires that the party and its members commit themselves to the following: (To preserve the neutrality of the public office and public institutions and not to exploit it for the gains of a party or political organization). This is considered because it is illegal to exploit State institutions for partisan purposes . It is a moral duty before the politician not to exploit the political parties or some of its members or those who try to speak on their behalf directly or indirectly to achieve partisan gains. Or personality against other personalities and parties at the expense of the university entity.

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