Download or read book Dietary Supplements and FDA Use of Adverse Event Reports written by William M. Forsberg and published by Nova Science Publishers. This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Manufacturers, packers, and distributors of dietary supplements in the United States are required to report information about serious adverse effects associated with the use of these supplements to the Food and Drug Administration (FDA). The FDA carefully considers all the available safety information submitted to the agency before a product is approved. However, unexpected and sometimes serious safety problems can emerge once a product goes to market and is used by millions of people. As a result, post-market safety monitoring, that is, analysing information on products once they go to market, is a critical part of the FDA's responsibilities. The public provides an important source of such safety information. Health care facilities, practitioners, and patients submit reports to the FDA and to manufacturers on advise events, medical errors, and product quality problems observed during the use of a product. This book examines the number of adverse event reports the FDA has received since 2008; their source and types of products identified, and the actions the FDA has taken to ensure that firms are complying with adverse event report requirements.
Download or read book Use of Dietary Supplements by Military Personnel written by Institute of Medicine and published by National Academies Press. This book was released on 2008-10-31 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dietary supplements are widely available through a rapidly expanding market of products commonly advertised as beneficial for health, performance enhancement, and disease prevention. Given the importance and frequent evaluation of physical performance and health as a criteria to join and remain in the military, the use of these products by military personnel has raised concern regarding over-all and long-term efficacy and safety. This evaluation is especially difficult, as many of these supplements contain multiple ingredients, have a changing composition over time, or are used intermittently at doses difficult to measure. This book analyzes the patterns of dietary supplement use among military personnel, examines published reviews of the scientific evidence, and identifies those dietary supplements that are beneficial and/or warrant concern due to risks to health or performance. The book also recommends a system to monitor adverse health effects and a framework to identify the need for active management of dietary supplements by military personnel. Military policy makers, personnel, and recruits will find this book useful, as will nutritionists, athletes, and others working in strenuous environments.
Download or read book Dietary Supplements written by Lisa Shames and published by DIANE Publishing. This book was released on 2009-09 with total page 77 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dietary supplements (DS) and foods with added dietary ingred., such as vitamins and herbs, are multibillion dollar industries. Past reports on the FDA¿s reg¿n. of these products raised concerns about product safety and the availability of reliable info. Since then, FDA published draft guidance on requirements for reporting adverse events -- which are harmful effects or illnesses -- and Current Good Mfg. Practice reg¿s. for DS. This report examines FDA's: (1) actions to respond to the new serious adverse event reporting require.;(2) ability to identify and act on concerns about the safety of DS, and the safety of foods with added dietary ingred.; and (3) actions to ensure that consumers have useful info. about the safety and efficacy of DS. Illustrations.
Download or read book Dietary Supplements written by National Research Council and published by National Academies Press. This book was released on 2005-01-03 with total page 527 pages. Available in PDF, EPUB and Kindle. Book excerpt: The growing consumer interest in health and fitness has expanded the market for a wide range of products, from yoga mats to the multiple dietary supplements now on the market. Supplements are popular, but are they safe? Many dietary supplements are probably safe when used as recommended. However, since 1994 when Congress decided that they should be regulated as if they were foods, they are assumed to be safe unless the Food and Drug Administration can demonstrate that they pose a significant risk to the consumer. But there are many types of products that qualify as dietary supplements, and the distinctions can become muddled and vague. Manufacturers are not legally required to provide specific information about safety before marketing their products. And the sales of supplements have been steadily increasingâ€"all together, the various types now bring in almost $16 billion per year. Given these confounding factors, what kind of information can the Food and Drug Administration use to effectively regulate dietary supplements? This book provides a framework for evaluating dietary supplement safety and protecting the health of consumers.
Download or read book DIETARY SUPPLEMENT AND NONPRESCRIPTION DRUG CONSUMER PROTECTION ACT SEPTEMBER 5 2006 109 2 SENATE REPORT 109 324 written by and published by . This book was released on 2006* with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Recommendations for Adverse Event Monitoring Programs for Dietary Supplements written by and published by . This book was released on 2004 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Dietary Supplement Regulation in the United States written by Taylor C. Wallace and published by Springer Science & Business Media. This book was released on 2013-10-01 with total page 51 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contrary to the common belief that dietary supplements are “unregulated” in the United States, nutrients and other dietary ingredient-containing products have been regulated in this country for a little over a century at least in some capacity, initially through the Pure Food and Drug Act (PFDA) of 1906 and culminating with the many anticipated regulations to be implemented following the recent enactment of the Food Safety Modernization Act of 2010 (FSMA). The goal of this brief is to review and discuss the current statutes and regulations surrounding the ingredients, manufacturing standards, safety, and labeling of dietary supplements for the purpose of protecting consumers.
Download or read book Dietary Supplements written by J. Alfredo Gomez and published by . This book was released on 2013-04-19 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dietary supplements, such as vitamins and botanical products, are a multibillion dollar industry in the U.S. The Food and Drug Admin. (FDA) regulates dietary supplements and generally relies on postmarket surveillance, such as monitoring adverse event reports (AERs), to identify potential concerns. Since December 2007, firms receiving a serious AER have had to report on it to FDA within 15 days. This report examines the (1) number of AERs FDA has received since 2008, their source, and types of products identified; (2) actions FDA has taken to ensure that firms are complying with AER requirements; (3) extent to which FDA is using AERs to initiate and support its consumer protection efforts; and (4) extent to which FDA has implemented GAO’s 2009 recommendations to help FDA identify and act on safety concerns for dietary supplements. Tables and figures. This is a print on demand report.
Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Dietary Supplements written by Timothy H. Riley and published by Nova Science Publishers. This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDA has taken some steps to identify and act upon safety concerns related to dietary supplements; however, several factors limit the agency's ability to detect concerns and remove products from the market. For example, FDA has limited information on the number and location of dietary supplement firms, the types of products currently available in the marketplace, and information about moderate and mild adverse events reported to industry. Additionally, FDA dedicates relatively few resources to oversight activities, such as providing guidance to industry regarding notification requirements for products containing new dietary ingredients. This book highlights the limited steps taken by the FDA to educate consumers about dietary supplements and their risks. This book consists of public documents which have been located, gathered, combined, reformatted, and enhanced with a subject index, selectively edited and bound to provide easy access.
Download or read book Dietary Supplement Safety Act written by United States. Congress. Senate. Committee on Governmental Affairs. Subcommittee on Oversight of Government Management, the Federal Workforce, and the District of Columbia and published by . This book was released on 2004 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Dietary supplements uncertainties in analyses underlying FDA s proposed rule on ephedrine alkaloids report to the chairman and ranking minority member Committee on Science House of Representatives written by and published by DIANE Publishing. This book was released on with total page 83 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book An Overview of FDA Regulated Products written by Eunjoo Pacifici and published by Academic Press. This book was released on 2018-06-13 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today’s challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations
Download or read book Complementary and Alternative Medicine in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2005-04-13 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: Integration of complementary and alternative medicine therapies (CAM) with conventional medicine is occurring in hospitals and physicians offices, health maintenance organizations (HMOs) are covering CAM therapies, insurance coverage for CAM is increasing, and integrative medicine centers and clinics are being established, many with close ties to medical schools and teaching hospitals. In determining what care to provide, the goal should be comprehensive care that uses the best scientific evidence available regarding benefits and harm, encourages a focus on healing, recognizes the importance of compassion and caring, emphasizes the centrality of relationship-based care, encourages patients to share in decision making about therapeutic options, and promotes choices in care that can include complementary therapies where appropriate. Numerous approaches to delivering integrative medicine have evolved. Complementary and Alternative Medicine in the United States identifies an urgent need for health systems research that focuses on identifying the elements of these models, the outcomes of care delivered in these models, and whether these models are cost-effective when compared to conventional practice settings. It outlines areas of research in convention and CAM therapies, ways of integrating these therapies, development of curriculum that provides further education to health professionals, and an amendment of the Dietary Supplement Health and Education Act to improve quality, accurate labeling, research into use of supplements, incentives for privately funded research into their efficacy, and consumer protection against all potential hazards.
Download or read book Dietary Supplements written by United States. General Accounting Office and published by . This book was released on 1999 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Regulatory procedures manual written by and published by . This book was released on 2004 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease written by Institute of Medicine and published by National Academies Press. This book was released on 2010-06-25 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.
