The US Food and Drug Administration (FDA) regulates medical devices primarily through the law known as the Federal Food, Drug, and Cosmetic Act, as Amended (“the FD&C Act,” or “the Act”). Regulations promulgated by FDA in Title 21 of the Code of Federal Regulations (CFR) spell out the broad provisions contained in the Act.

United States food and drug administration

The last decade has witnessed the continued growth and evolution of medical ethics into a mainstream medical discipline, and paralleling this maturation is an increasing array of textbooks. Clinical Ethics , now in its third edition, has successfully spanned that decade to become one of the most popular, concise texts in the field. The well-known authors, an ethicist, clinician, and legal scholar, have considerable overlapping expertise, which, fortunately, results in a consistent literary style more typical of a single-authored work. The espoused purpose of the book is twofold: to serve as a reference work of reflective opinion about typical ethical problems that occur in medical practice and to develop a method for analyzing such problems as they occur. The structure of the text is unique with five main topics and chapters covering indications for medical intervention, preferences of patients, quality of life, contextual factors (such as social, economic, and legal issues),

Clinical Ethics: A Practical Approach to Ethical Decisions in Clinical Medicine

https://onlinelibrary.wiley.com/doi/pdf/10.1002/erv.2738

COVID-19 and implications for eating disorders.

Anorexia nervosa is a debilitating psychiatric disorder with profound biological, psychological, and social consequences. After an initial evaluation of the most widely used diagnostic criteria for anorexia nervosa, this paper reviews genetic and environmental risk factors for the development of anorexia with special emphasis on gene environment interplay and the impact of adverse perinatal events.

Anorexia nervosa : Definition, epidemiology, and cycle of risk. Commentary

INTRODUCTION Folic acid (FA) deficiency is associated with neural tube defects (NTD). In a non-risk pregnancy, The Danish National Board of Health recommends FA supplementation from planned pregnancy until three months after conception. We explored pregnant women's knowledge about and actual supplementation with FA and related this to education, number of pregnancies and age. MATERIAL AND METHODS Eighty-four consecutive pregnant women with a midwife consultation were included in the period 25-28 August 2008. All filled in a unified questionnaire. RESULTS 82% had knowledge of FA supplementation and 89% received FA supplementation. 51% followed national recommendations. We found a statistically significant correlation between higher educational level and knowledge about FA supplementation, actual supplementation of FA and FA supplementation in accordance with national recommendations. No statistical associations were found between number of pregnancies or age and any FA-related parameters. Family, friends, general practitioner (GP) and the internet were the main information sources. CONCLUSION Correct FA supplementation is quite low; conversely, knowledge about and actual FA supplementation are fairly high. Further intervention is necessary to increase the level of correct FA supplementation. Women with a low educational level--which may herald low socio-economic status--seem to form a suitable target group for information campaigns. Multiple pregnancies or higher age should not be perceived as indicators of a higher information level. Dissemination of information to the pregnant women including family, friends, GPs or the internet is recommended.

Folic acid supplementation in pregnant women

The link between the gut microbiome and obesity is not well defined. Understanding of the role of the gut microbiome in weight and health management may lead to future revolutionary changes for treating obesity. This review examined the relationship between obesity and the gut microbiome, and the role of probiotics, prebiotics, and synbiotics for preventing and treating obesity. We used PubMed and Google Scholar to collect appropriate articles for the review. We showed that the gut microbiome has an impact on nutrient metabolism and energy expenditure. Moreover, different modalities of obesity treatment have been shown to change the diversity and composition of the gut microbiome; this raises questions about the role these changes may play in weight loss. In addition, studies have shown that supplementation with probiotics, prebiotics, and synbiotics may alter the secretion of hormones, neurotransmitters, and inflammatory factors, thus preventing food intake triggers that lead to weight gain. Further clinical studies are needed to better understand how different species of bacteria in the gut microbiome may affect weight gain, and to determine the most appropriate doses, compositions, and regimens of probiotics, prebiotics, and synbiotics supplementation for long-term weight control.

The Influence of the Gut Microbiome on Obesity in Adults and the Role of Probiotics, Prebiotics, and Synbiotics for Weight Loss

Fluoride is one of the most abundant elements found in nature. Water is the major dietary source of fluoride. The only known association with low fluoride intake is the risk of dental caries. Initially, fluoride was considered beneficial when given systemically during tooth development, but later research has shown the importance and the advantages of its topical effects in the prevention or treatment of dental caries and tooth decay. Water fluoridation was once heralded as one of the best public health achievements in the twentieth century. Since this practice is not feasible or cost effective in many regions, especially rural areas, researchers and policy makers have explored other methods of introducing fluoride to the general population such as adding fluoride to milk and table salt. Lately, major concerns about excessive fluoride intake and related toxicity were raised worldwide, leading several countries to ban fluoridation. Health-care professionals and the public need guidance regarding the debate around fluoridation. This paper reviews the different aspects of fluoridation, their effectiveness in dental caries prevention and their risks. It was performed in the PubMed and the Google Scholar databases in January 2018 without limitation as to the publication period.

/pdf/the-fluoride-debate-the-pros-and-cons-of-fluoridation-31njbk3gr5.pdf

The Fluoride Debate: The Pros and Cons of Fluoridation.

The objective of this cross-sectional study was to examine the prevalence and correlates of a positive screen for eating disorders (EDs) in a sample of Syrian refugees living in North Lebanon. The study was conducted on a convenience sample of 450 (84.67% women and 15.33% men) refugees, aged between 18 and 45 years. The prevalence of a positive screen for ED was 5.79%. Bivariate analyses revealed that female gender (p = 0.02), presence of medical conditions (p = 0.01), old occurrence of major stressful life event (p < 0.01), and positive primary care post-traumatic stress disorder screen (p < 0.01) were associated with the positive sick, control, one stone, fat, food tool. Multiple logistic regression analyses showed that subjects screened with post-traumatic stress disorder had a three times higher risk of having a positive screen for ED (odds ratio = 3.2; 95% confidence interval [1.32, 7.78]). Early detection of ED and related factors may help identify refugees who would benefit from interventions to improve mental health.

Prevalence and correlates of a positive screen for eating disorders among Syrian refugees.

Vitamin D deficiency is considered a major public health concern Inadequate sun exposure, limited oral intake, and impaired intestinal absorption are common risk factors for vitamin D deficiency An increasing amount of research is aimed at answering questions regarding the most convenient test that can assess vitamin D status, the indications for screening, and finally the utility of treatments for vitamin D deficiency Our review outlines practical strategies to diagnose and treat vitamin D deficiency in adults This study was undertaken in the PubMed and the Google Scholar databases in April 2018 without limitation as to the publication period Vitamin D status is determined by measuring the 25-hydroxyvitamin D serum concentration However, this technique has several limitations Determining the accurate thresholds for vitamin D deficiency is still a matter of debate Only individuals at risk for vitamin D deficiency should be screened The symptoms of vitamin D deficiency are unspecific and very common Therefore, physicians may easily suspect vitamin D deficiency, measure 25-hydroxyvitamin D levels, and sometimes overprescribe supplementation Hypovitaminosis D could rarely be treated by increasing consumption of foods naturally containing and fortified with vitamin D Special attention should be given to vitamin D supplementation to prevent adverse effects No safe and well-defined threshold of ultraviolet exposure allows adequate vitamin D synthesis without increasing the risk of skin cancer Unanimous and decisive guidelines are urgently needed to improve knowledge and practices related to vitamin D deficiency

When and How to Diagnose and Treat Vitamin D Deficiency in Adults: A Practical and Clinical Update.

Infertility is defined as the inability to conceive after 12 months of unprotected intercourse or six months for women aged 35 years or older. The physical, emotional, psychological, and financial statuses of infertile couples are tremendously affected especially after undergoing diagnostic and/or curative treatments. Human fertility is influenced by multiple factors including female or male, and modifiable or non-modifiable factors. There is growing evidence that nutri-tion may play an important role in adjusting fertility-related outcomes in both men and women. The objective of our study was to summarize the latest data on nutritional factors (specific food groups, nutrients, and nutritional supplements) that have an impact on female or male sexual and reproductive function. PubMed and Google Scholar platforms were used to collect appropriate articles for the review using several combinations of keywords (infertility, diet, dietary supplements, antioxidants, and beverages). Adherence to a healthy dietary pattern favoring fish, poultry, whole grains, fruits, vegetables, and healthy fats, was related to better fertility in both genders. Despite the multifactorial etiology of sexual infertility, nutrition may affect the sexual/reproductive function in both women and men.

A. Aoun

Papers

The Influence of the Gut Microbiome on Obesity in Adults and the Role of Probiotics, Prebiotics, and Synbiotics for Weight Loss

The Fluoride Debate: The Pros and Cons of Fluoridation.

Prevalence and correlates of a positive screen for eating disorders among Syrian refugees.

When and How to Diagnose and Treat Vitamin D Deficiency in Adults: A Practical and Clinical Update.

Can Nutrition Help in the Treatment of Infertility