scholarly journals One is okay, more is better? Pharmacological aspects and safe limits of nutritional supplements

2007 ◽  
Vol 66 (4) ◽  
pp. 493-507 ◽  
Author(s):  
Pamela Mason
Keyword(s):  
Food Supplements ◽  
Health Food ◽  
Nutrition Survey ◽  
Safety Issues ◽  
Upper Limits ◽  
Wide Availability ◽  
Potential Benefits ◽  
Safe Limits ◽  
The Uk ◽  
The Eu

The use of vitamins, minerals and other supplements has increased considerably during recent years. In the National Diet and Nutrition Survey of British adults aged 19–64 years 40% of those surveyed were taking supplements. In 2005 sales of dietary supplements in the UK were approximately £325·7×106in ‘bricks and mortar’ shops (excluding health food shops). The physiological effects of vitamins and minerals in amounts approximating to the UK reference nutrient intake or the EU RDA are well understood in terms of reducing the risk of micronutrient deficiency. However, the effects of vitamins, minerals and other supplements in larger amounts have attracted much attention in recent decades, and these effects, some of which may be pharmacological, are not as well categorised. Some of these effects are beneficial, some are not. Although vitamins and minerals and other supplements are generally safe at higher doses, there are some safety issues that are relevant in the context of the wide availability of supplements without a doctor's prescription. Thus, several authorities throughout the world have established upper limits (UL) for the intake of vitamins and minerals, and the EU is in the process of setting maximum permitted levels (MPL) for vitamins and minerals in food supplements. The present paper discusses the potential benefits and safety issues relating to the use of supplements at doses higher than the RDA. The rationale for the establishment of UL is also discussed, explaining the differences between the values set by different authorities and the expected guidance and legislation from the European Commission on MPL for vitamins and minerals in food supplements.

scholarly journals Risk Assessment of RYR Food Supplements: Perception vs. Reality

2021 ◽  
Vol 8 ◽  
Author(s):  
Laura Righetti ◽  
Chiara Dall'Asta ◽  
Renato Bruni
Keyword(s):  
Risk Assessment ◽  
Food Supplements ◽  
Red Yeast Rice ◽  
The European Union ◽  
Health Claim ◽  
Active Constituent ◽  
Safety Issues ◽  
Good Manufacturing Practices ◽  
Daily Dose ◽  
The Eu

Thirty-seven red yeast rice (RYR) food supplements were screened for their mycotoxin and natural statin content. Products included pure RYR capsules and multi-ingredient formulations with standardized amounts of monacolin K (MK), marketed both online and retail in the European Union. In terms of mycotoxins, citrinin (CIT) was found in all the monitored products. As CIT content ranged from 100 to 25100 μg/kg, only four products were compliant with maximum EU levels in force until April 2020, while a single product was compliant with the limit of 100 μg/kg introduced after that date. Four contaminated products were labeled as “citrinin free”. In terms of natural statins, nine products had a lower content vs. label statements (from −30 to −83%), while for 24 a larger MK amount (from 10 to 266%) was noticed. Three products had a negligible MK content and only 19 offered a daily dosage exceeding 10 mg as dictated by the health claim granted by EFSA in the EU. No sample had label values compliant with pharmaceutical Good Manufacturing Practices requirements (95–105% content of active constituent). Variable, but small amounts of simvastatin (0.1–7.5 μg per daily dose) were found in 30 samples. These results suggest that limited efficacy and reported safety issues may stem from an under-regulated and undercontrolled market, weakening both effectiveness and risk assessment evaluations.

DECISION-MAKING ON BIOTECHNOLOGY: DEVELOPING NEW PRINCIPLES FOR REGULATION

1999 ◽  
Vol 01 (01) ◽  
pp. 61-79 ◽  
Author(s):  
JULIE HILL
Keyword(s):  
Decision Making ◽  
Ethical Concerns ◽  
The United Kingdom ◽  
Agricultural Applications ◽  
Decision Making Processes ◽  
Potential Benefits ◽  
Social Environmental ◽  
The Uk ◽  
Risk Assessment Methodology ◽  
The Eu

Biotechnology, specifically genetic modification, offers potential benefits to mankind, but also raises major social, environmental, health and ethical concerns. This paper deals with the agricultural applications of genetic technology, in particular, the potential environmental impacts of those applications. It considers the current underpinning principles of regulation in the United Kingdom (UK) and European Union (EU) and examines the problems for present decision-making processes, including disputes over risk assessment methodology, the handling of uncertainty, and lack of trust in official processes. The paper proposes a new set of underpinning principles for the decision-making process in the UK, and concludes that the UK should exercise leadership within the EU to ensure that these new principles are adopted across Europe.

scholarly journals Nutritional supplements and the EU: is anyone happy?

2007 ◽  
Vol 66 (4) ◽  
pp. 508-511 ◽  
Author(s):  
Christine Eberhardie
Keyword(s):  
Food Supplement ◽  
Poor Quality ◽  
Food Supplements ◽  
Patient Choice ◽  
Herbal Remedies ◽  
Medical Community ◽  
Positive List ◽  
The Uk ◽  
The Eu

In 2000 an estimated £335×106 was spent on food supplements and herbal remedies in the UK. Until recently, The Trades Description Act 1968, the Food Safety Act 1990 and The Food Labelling Regulations 1996 (amended 2004) were the only form of regulation available to protect the public. The medical community has been concerned about the risk to patients of inaccurate dosages and poor-quality products as well as drug–nutrient and nutrient–nutrient interactions. Following growing concern about the type and quality of food supplements and herbal remedies available in the EU, the European Commission has published directives regulating food supplements (2002/46/EC) and herbal remedies (2004/24/EC and 2004/27/EC) available within the EU. The directives came into force in 2005 and limit the number and quality of permitted food supplements through the creation of a ‘positive list’ of approved supplements. In the present paper the new regulatory frameworks and the implications for the food supplement manufacturers, traditional and complementary therapists, the healthcare professions and patients will be examined. It would appear that there is considerable dissatisfaction with the regulations in their present form. Several questions remain: is regulation the answer; who decides which nutrients go on the positive list; what effect has the regulation had on patient safety and patient choice?

An exploratory study of intangibles risk disclosure in annual reports of banking companies from the UK, US, Germany and Italy - Some descriptive insights

2013 ◽  
pp. 81-120 ◽  
Author(s):  
Susanne Durst
Keyword(s):  
Intellectual Capital ◽  
Exploratory Study ◽  
The United States ◽  
Annual Reports ◽  
Risk Disclosure ◽  
Related Risk ◽  
Potential Benefits ◽  
Report Data ◽  
Key Drivers ◽  
The Uk

Intangibles are viewed as the key drivers in most industries, and current research shows that firms voluntarily disclose information about their investments in intangibles and their potential benefits. Yet little is known of the risks relating to such resources and the disclosures firms make about such risks. In order to obtain a more balanced and complete picture of firms' activities, information about the risky side of their intangibles is also needed. This exploratory study provides some descriptive insights into intangibles-related risk disclosure in a sample of 16 large banks from the United States (US), United Kingdom (UK), Germany and Italy. Annual report data is analyzed using the three Intellectual Capital dimensions. Study findings illustrate the variety of intangibles-related risk disclosure as demonstrated by the banks involved.

Brexit and the EU Area of Freedom, Security, and Justice

2017 ◽  
Author(s):  
Deirdre Curtin
Keyword(s):  
Member State ◽  
Data Retention ◽  
Free Zone ◽  
The Uk ◽  
The Eu

UK involvement in the EU Area of Freedom, Security, and Justice (AFSJ) has been patchy. It never joined the Schengen border-free zone, and when in 2014 it exercised a block exit from all AFSJ measures, it selectively rejoined a substantial number. Even if partially outside, the UK has been a leader inside. Advanced intelligence capabilities meant it provided important support to the functioning of agencies such as Europol and UK laws inspired EU laws, for example, on data retention. The need to preserve some pragmatic forms of cooperation between the UK and the EU is obvious and shared by the UK security establishment. There is a partial institutional precedent . When Denmark rejected participation in Europol in a popular referendum, the Danish government obtained a deal from the EU institutions which allows it to remain associated to Europol as a ‘third country’ (and a Member State). The bespoke Brexit reality may prove even more complex.

The Law & Politics of Brexit: Volume II

2020 ◽  
Keyword(s):  
Decision Making ◽  
European Union ◽  
Legal Framework ◽  
Comprehensive Analysis ◽  
The European Union ◽  
Trade Relations ◽  
The United Kingdom ◽  
The Uk ◽  
Financial Settlement ◽  
The Eu

This book provides the first comprehensive analysis of the withdrawal agreement concluded between the United Kingdom and the European Union to create the legal framework for Brexit. Building on a prior volume, it overviews the process of Brexit negotiations that took place between the UK and the EU from 2017 to 2019. It also examines the key provisions of the Brexit deal, including the protection of citizens’ rights, the Irish border, and the financial settlement. Moreover, the book assesses the governance provisions on transition, decision-making and adjudication, and the prospects for future EU–UK trade relations. Finally, it reflects on the longer-term challenges that the implementation of the 2016 Brexit referendum poses for the UK territorial system, for British–Irish relations, as well as for the future of the EU beyond Brexit.

Medical Device Regulation: Requirements for Dental Professionals Who Prescribe and Manufacture Custom-Made Devices

2021 ◽  
Vol 10 (1) ◽  
pp. 64-88
Author(s):  
James I. J. Green
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Transition Period ◽  
Eu Directive ◽  
Custom Made ◽  
Dental Setting ◽  
The Uk ◽  
Dental Professionals ◽  
The Eu ◽  
Medical Device Regulation

A custom-made device (CMD) is a medical device intended for the sole use of a particular patient. In a dental setting, CMDs include prosthodontic devices, orthodontic appliances, bruxism splints, speech prostheses and devices for the treatment of obstructive sleep apnoea, trauma prevention and orthognathic surgery facilitation (arch bars and interocclusal wafers). Since 1993, the production and provision of CMDs have been subject to European Union (EU) Directive 93/42/EEC (Medical Device Directive, MDD) given effect in the UK by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618), and its subsequent amendments. Regulation (EU) 2017/745 (Medical Device Regulation, EU MDR) replaces the MDD and the other EU Directive pertaining to Medical Devices, Council Directive 90/385/EEC (Active Implantable Medical Device Directive, AIMDD). The EU MDR was published on 5 April 2017, came into force on 25 May 2017 and, following a three-year transition period was due to be fully implemented and repeal the MDD on 26 May 2020, but was deferred until 26 May 2021 due to the coronavirus disease 2019 (COVID-19) pandemic. In the UK, in preparation for the country’s planned departure from the EU, the EU MDR, with necessary amendments, was transposed into UK law (Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, UK MDR). The UK left the Union on 31 January 2020 and entered a transition period that ended on 31 December 2020, meaning that, from 1 January 2021, dental professionals in Great Britain who prescribe and manufacture CMDs are mandated to do so in accordance with the new legislation while Northern Ireland remains in line with the EU legislation and implementation date. This paper sets out the requirements that relate to the production and provision of CMDs in a UK dental setting.

scholarly journals Our Evolving Understanding of ME/CFS

Medicina ◽  
2021 ◽  
Vol 57 (3) ◽  
pp. 200 ◽  
Author(s):  
Kenneth J. Friedman ◽  
Modra Murovska ◽  
Derek F. H. Pheby ◽  
Paweł Zalewski
Keyword(s):  
Active Phase ◽  
Case Definitions ◽  
Diagnostic Laboratory ◽  
Biochemical Pathways ◽  
Patient Organizations ◽  
Clinical Consequences ◽  
Potential Benefits ◽  
Multiple Case ◽  
Use Of The Internet ◽  
The Uk

The potential benefits of the scientific insights gleaned from years of treating ME/CFS for the emerging symptoms of COVID-19, and in particular Longhaul- or Longhauler-COVID-19 are discussed in this opinion article. Longhaul COVID-19 is the current name being given to the long-term sequelae (symptoms lasting beyond 6 weeks) of SARS-CoV-2 infection. Multiple case definitions for ME/CFS exist, but post-exertional malaise (PEM) is currently emerging as the ‘hallmark’ symptom. The inability to identify a unique trigger of ME/CFS, as well as the inability to identify a specific, diagnostic laboratory test, led many physicians to conclude that the illness was psychosomatic or non-existent. However, recent research in the US and the UK, championed by patient organizations and their use of the internet and social media, suggest underlying pathophysiologies, e.g., oxidative stress and mitochondrial dysfunction. The similarity and overlap of ME/CFS and Longhaul COVID-19 symptoms suggest to us similar pathological processes. We put forward a unifying hypothesis that explains the precipitating events such as viral triggers and other documented exposures: For their overlap in symptoms, ME/CFS and Longhaul COVID-19 should be described as Post Active Phase of Infection Syndromes (PAPIS). We further propose that the underlying biochemical pathways and pathophysiological processes of similar symptoms are similar regardless of the initiating trigger. Exploration of the biochemical pathways and pathophysiological processes should yield effective therapies for these conditions and others that may exhibit these symptoms. ME/CFS patients have suffered far too long. Longhaul COVD-19 patients should not be subject to a similar fate. We caution that failure to meet the now combined challenges of ME/CFS and Longhaul COVID-19 will impose serious socioeconomic as well as clinical consequences for patients, the families of patients, and society as a whole.

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