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.

Twenty-nine new dietary supplements have been added to this edition. This guide comprehensively explores the media claims, drug-supplement interactions, dosage information and relevant research for more than 100 of today's most popular dietary supplements. Completely revised, updated and indexed information is provided for dietetics professionals and their clients. Written by industry experts, this guide's recommendations are reliable and backed by credible clinical research.

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.

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

Caffeine in Food and Dietary Supplements is the summary of a workshop convened by the Institute of Medicine in August 2013 to review the available science on safe levels of caffeine consumption in foods, beverages, and dietary supplements and to identify data gaps. Scientists with expertise in food safety, nutrition, pharmacology, psychology, toxicology, and related disciplines; medical professionals with pediatric and adult patient experience in cardiology, neurology, and psychiatry; public health professionals; food industry representatives; regulatory experts; and consumer advocates discussed the safety of caffeine in food and dietary supplements, including, but not limited to, caffeinated beverage products, and identified data gaps. Caffeine, a central nervous stimulant, is arguably the most frequently ingested pharmacologically active substance in the world. Occurring naturally in more than 60 plants, including coffee beans, tea leaves, cola nuts and cocoa pods, caffeine has been part of innumerable cultures for centuries. But the caffeine-in-food landscape is changing. There are an array of new caffeine-containing energy products, from waffles to sunflower seeds, jelly beans to syrup, even bottled water, entering the marketplace. Years of scientific research have shown that moderate consumption by healthy adults of products containing naturally-occurring caffeine is not associated with adverse health effects. The changing caffeine landscape raises concerns about safety and whether any of these new products might be targeting populations not normally associated with caffeine consumption, namely children and adolescents, and whether caffeine poses a greater health risk to those populations than it does for healthy adults. This report delineates vulnerable populations who may be at risk from caffeine exposure; describes caffeine exposure and risk of cardiovascular and other health effects on vulnerable populations, including additive effects with other ingredients and effects related to pre-existing conditions; explores safe caffeine exposure levels for general and vulnerable populations; and identifies data gaps on caffeine stimulant effects.

The physiological or psychological stresses that employees bring to their workplace affect not only their own performance but that of their co-workers and others. These stresses are often compounded by those of the job itself. Medical personnel, firefighters, police, and military personnel in combat settingsâ€"among othersâ€"experience highly unpredictable timing and types of stressors. This book reviews and comments on the performance-enhancing potential of specific food components. It reflects the views of military and non-military scientists from such fields as neuroscience, nutrition, physiology, various medical specialties, and performance psychology on the most up-to-date research available on physical and mental performance enhancement in stressful conditions. Although placed within the context of military tasks, the volume will have wide-reaching implications for individuals in any job setting.

The Institute of Medicine's (IOM's) Food Forum was established in 1993 to allow science and technology leaders in the food industry, top administrators in the federal government, representatives from consumer interest groups, and academicians to discuss and debate food and food safety issues openly and in a neutral setting. The Forum provides a mechanism for these diverse groups to identify possible approaches for addressing food and food safety problems and issues surrounding the often complex interactions among industry, academia, regulatory agencies, and consumers. On May 6-7, 1997, the Forum convened a workshop titled Enhancing the Regulatory Decision-Making Process for Direct Food Ingredient Technologies. Workshop speakers and participants discussed legal aspects of the direct food additive approval process, changes in science and technology, and opportunities for reform. Two background papers, which can be found in Appendix A and B, were shared with the participants prior to the workshop. The first paper provided a description and history of the legal framework of the food ingredient approval process and the second paper focused on changes in science and technology practices with emphasis placed on lessons learned from case studies. This document presents a summary of the workshop.