Author: Publisher:
ISBN:
Category : Dietary supplements
Languages : en
Pages : 154
Book Description
Recommendations for Adverse Event Monitoring Programs for Dietary Supplements
Author: Dietary Supplements and FDA Use of Adverse Event Reports
Author: William M. ForsbergPublisher: Nova Science Publishers
ISBN: 9781628080230
Category : Health & Fitness
Languages : en
Pages : 0
Book Description
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.
Adverse Event Reporting for Dietary Supplements
Author: Michael F. ManganoPublisher:
ISBN: 9780756712365
Category : Medical
Languages : en
Pages : 100
Book Description
Assesses the effectiveness of the FDA's AER system for DS in protecting the Amer. consumer. 60% of Amer. take some form of DS every day without any problems. They include vit., minerals, botanicals, and amino acids. FDA does not have the authority to require DS to undergo pre-market approval for safety and efficacy. Instead, it relies mostly on its AER system to identify safety problems. However, FDA lacks key med., product, mfr., trend, and clinical info. to generate signals of public health concerns from the AER system. Offers actions that FDA can take to strengthen its ability to detect adverse events, appropriately assess reported events, and disclose more useful info. to the public.
Dietary Supplements
Author: National Research CouncilPublisher: National Academies Press
ISBN: 0309091101
Category : Medical
Languages : en
Pages : 527
Book Description
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.
Adverse Event Reporting System for Dietary Supplements
Author: United States. Department of Health and Human Services. Office of Inspector GeneralPublisher:
ISBN:
Category : Consumer protection
Languages : en
Pages : 100
Book Description
Dietary Supplement Regulation in the United States
Author: Taylor C. WallacePublisher: Springer Science & Business Media
ISBN: 3319015028
Category : Science
Languages : en
Pages : 51
Book Description
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.
Adverse Event Reporting for Dietary Supplements
Author: Adverse Event Reporting System for Dietary Supplements
Author: Office of Inspector (Oig)Publisher:
ISBN: 9781296044718
Category :
Languages : en
Pages : 114
Book Description
This work has been selected by scholars as being culturally important, and is part of the knowledge base of civilization as we know it. This work was reproduced from the original artifact, and remains as true to the original work as possible. Therefore, you will see the original copyright references, library stamps (as most of these works have been housed in our most important libraries around the world), and other notations in the work. This work is in the public domain in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity (individual or corporate) has a copyright on the body of the work.As a reproduction of a historical artifact, this work may contain missing or blurred pages, poor pictures, errant marks, etc. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant.
Use of Dietary Supplements by Military Personnel
Author: Institute of MedicinePublisher: National Academies Press
ISBN: 0309116171
Category : Technology & Engineering
Languages : en
Pages : 474
Book Description
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.
Adverse Event Reporting System for Dietary Supplements :.
Author: United States. Department of Health and Human Services. Office of Inspector GeneralPublisher:
ISBN:
Category :
Languages : en
Pages :
Book Description