Dietary Supplements
Dietary Supplements

Author: National Research Council

Publisher: National Academies Press

Published: 2005-01-03

Total Pages: 527

ISBN-13: 0309091101

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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.

The Regulation of Dietary Supplements
The Regulation of Dietary Supplements

Author: Stephen J. Pintauro

Publisher: CRC Press

Published: 2018-12-07

Total Pages: 222

ISBN-13: 0429808623

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This book documents the long, still ongoing battle between the US Food and Drug Administration and the dietary supplement industry. It presents the complex, often subtle, and sometimes overlooked series of events that had a major impact on how dietary supplements are manufactured, marketed, sold, and used today. While the first few chapters focus on some background topics, the remaining chapters walk the reader through timeline of events, legislative actions, FDA proposed and final rules, and judicial decisions that led to our current dietary supplement regulatory framework. Interwoven in narrative are examples of the roles of science, social and public policy, politics, and popular media.

Dietary Supplements
Dietary Supplements

Author: Katja Berginc

Publisher: Elsevier

Published: 2014-11-24

Total Pages: 263

ISBN-13: 1782420819

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Dietary supplements made from foods, herbs and their constituents are a rapidly growing market sector. Consumers often view food supplements as ‘natural’ and therefore safe; however, supplements are regulated as foods rather than as pharmaceuticals and so are not as closely monitored as may be necessary. With the commercial market in these products growing, this book provides essential research into their safety, efficacy and potential risk of interaction with pharmaceuticals. Following an introductory chapter, part one covers the chemical composition, manufacture and regulation of dietary supplements. Part two looks at the effectiveness of different types of dietary supplement and methods of evaluation. Finally, part three focuses on supplement safety. Reviews the design, production and regulation of dietary supplements. Analyses the potential for pharmacokinetic and pharmacodynamics interactions between dietary supplements and pharmaceuticals. Offers reviews of important clinical studies on the efficacy of dietary supplements for range of conditions.

Dietary Supplement Regulation in the United States
Dietary Supplement Regulation in the United States

Author: Taylor C. Wallace

Publisher: Springer Science & Business Media

Published: 2013-10-01

Total Pages: 51

ISBN-13: 3319015028

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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. ​

Complementary and Alternative Medicine in the United States
Complementary and Alternative Medicine in the United States

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2005-04-13

Total Pages: 360

ISBN-13: 0309133424

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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.

Food Law and Regulation for Non-Lawyers
Food Law and Regulation for Non-Lawyers

Author: Marc C. Sanchez

Publisher: Springer

Published: 2018-02-22

Total Pages: 287

ISBN-13: 3319717030

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Designed and modeled after a six-week introductory food law course taught at Northeastern University, Food Law and Regulation for Non-Lawyers offers a succinct overview of key topics and core concepts for food scientists, quality managers, and others who need to understand the regulation of food in the U.S. This second edition includes critical updates on the Food Safety Modernization Act-- the first change to the food safety laws in over 70 years. The seven foundational rules, finalized in 2015, are discussed in detail. The new edition also includes other regulatory updates such as the new Nutrition Fact Panel, changes to the definition of fiber, and the FDA’s attempt to regulate the widely used “healthy” claim. These timely updates, along with the core concepts of the first edition, make the volume an essential and practical tool for regulatory professionals.

Regulation of Functional Foods and Nutraceuticals
Regulation of Functional Foods and Nutraceuticals

Author: Clare M. Hasler

Publisher: John Wiley & Sons

Published: 2008-02-28

Total Pages: 428

ISBN-13: 047027641X

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Regulation of Functional Foods and Nutraceuticals: A Global Perspective offers a comprehensive resource for information on regulatory aspects of the growing and economically important functional food industry. Regulatory systems and definitions of key terms-food, supplement, drug, etc-vary from country to country. A thorough understanding of laws and regulation within and among key countries with regard to functional foods, herbal extracts or drugs, and nutritional supplements is critical to the direction of food companies that are developing products for these markets. International experts with legal and/or scientific expertise address relevant topics from quality issues, to organic foods to labeling. Innovative product development within the framework of existing regulations will be addressed in individual chapters. Overview chapters will discuss global principles, inter-country trading issues, and present a comparison of the laws and regulations within different countries graphically. A "must-have" handbook for research professionals, management, and marketing strategists in the worldwide functional foods/nutritional supplements business. Food technicians and engineers responsible for manufacturing quality in this industry should add it to their library to ensure that they have a thorough knowledge of the applicable legal requirements. The book will also serve as an indispensable shelf reference for lawyers in the food industry and government health professionals with regulatory responsibilities.

Foods and Dietary Supplements in the Prevention and Treatment of Disease in Older Adults
Foods and Dietary Supplements in the Prevention and Treatment of Disease in Older Adults

Author: Ronald Ross Watson

Publisher: Academic Press

Published: 2015-01-27

Total Pages: 400

ISBN-13: 0124186866

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Foods and Dietary Supplements in the Prevention and Treatment of Disease in Older Adults focuses on the ways in which food and dietary supplements affect the major health problems of aging adults. Researchers in nutrition, diet, epidemiology, and aging studies, as well as healthcare providers who work with elderly patients will use this comprehensive resource as a tool in their long-term goal of preventing and treating chronic disease within the elderly. This book brings together a broad range of experts working on the different aspects of foods and dietary supplements (vitamins, herbs, plant extracts, etc.) in health promotion and disease prevention. They have contributed chapters which define a range of ways in which foods, nutriceuticals, and dietary supplements prevent disease and promote health in older adults. They begin by reviewing the medicinal role of foods, herbal, and dietary supplements in health promotion in older adults, as well as some of the most commonly used supplements in elder "self-medication." They review the most recent studies of how foods, herbal, and dietary supplements are effective in the prevention and treatment of cancer, cardiovascular disease, diabetes, and other obesity associated diseases in older adults. Then they consider alcohol, other drugs, and plant based drugs of abuse which can adversely affect the health of older adults. Lastly, they consider foods and dietary supplements in gene regulation in older adults. Investigates the important nutritional requirements of the aging population in health and in relation to various acute and chronic diseases Explores the nutritional effects of botanical extracts and components that can have important health promotion benefits, and risks, to ensure safe consumption Reviews studies of common diseases within the aging population including cancer, cardiovascular, metabolic, and infectious diseases that can alter the intake of foods, supplements, and/or requirements for various nutrients Investigates the mechanisms of action of components of foods and dietary supplements, in particular gene activation and epigenetics