Committee on the Framework for Evaluating the Safety of the Dietary Supplements's Books

Dietary Supplements

A Framework for Evaluating Safety

By: National Research Council,Institute of Medicine,Board on Life Sciences,Food and Nutrition Board,Committee on the Framework for Evaluating the Safety of the Dietary Supplements

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Dietary Supplements

A Framework for Evaluating Safety

By: National Research Council,Institute of Medicine,Board on Life Sciences,Food and Nutrition Board,Committee on the Framework for Evaluating the Safety of the Dietary Supplements

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.

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527

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National Academies Press

Published Date

ISBN 10

0309091101

ISBN 13

9780309091107

Complementary and Alternative Medicine in the United States

By: Institute of Medicine,Board on Health Promotion and Disease Prevention,Committee on the Use of Complementary and Alternative Medicine by the American Public

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Complementary and Alternative Medicine in the United States

By: Institute of Medicine,Board on Health Promotion and Disease Prevention,Committee on the Use of Complementary and Alternative Medicine by the American Public

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.

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361

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National Academies Press

Published Date

ISBN 10

0309092701

ISBN 13

9780309092708

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease

By: Institute of Medicine,Food and Nutrition Board,Board on Health Sciences Policy,Board on Health Care Services,Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease

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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease

By: Institute of Medicine,Food and Nutrition Board,Board on Health Sciences Policy,Board on Health Care Services,Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease

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.

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334

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National Academies Press

Published Date

ISBN 10

0309151295

ISBN 13

9780309151290

Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment

By: National Research Council,Division on Earth and Life Studies,Board on Life Sciences,Board on Environmental Studies and Toxicology,Committee on Applications of Toxicogenomic Technologies to Predictive Toxicology

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Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment

The new field of toxicogenomics presents a potentially powerful set of tools to better understand the health effects of exposures to toxicants in the environment. At the request of the National Institute of Environmental Health Sciences, the National Research Council assembled a committee to identify the benefits of toxicogenomics, the challenges to achieving them, and potential approaches to overcoming such challenges. The report concludes that realizing the potential of toxicogenomics to improve public health decisions will require a concerted effort to generate data, make use of existing data, and study data in new waysâ€"an effort requiring funding, interagency coordination, and data management strategies.

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300

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National Academies Press

Published Date

ISBN 10

0309178894

ISBN 13

9780309178891

Safety of Dietary Supplements for Horses, Dogs, and Cats

By: National Research Council,Division on Earth and Life Studies,Board on Agriculture and Natural Resources,Committee on Examining the Safety of Dietary Supplements for Horses, Dogs, and Cats

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Safety of Dietary Supplements for Horses, Dogs, and Cats

By: National Research Council,Division on Earth and Life Studies,Board on Agriculture and Natural Resources,Committee on Examining the Safety of Dietary Supplements for Horses, Dogs, and Cats

Growing numbers of pet owners are giving their pets dietary supplements in hopes of supporting their health. Many people presume that supplements are safer than drugs, but the reality is that there are very limited safety data on dietary supplements for pets. Many challenges stand in the way of determining whether animal dietary supplements are safe and at what dosage. Supplements considered safe in humans and other species are not always safe in horses, dogs, and cats. An improved adverse event reporting system is badly needed. Also, the absence of laws and regulations that specifically address animal dietary supplements causes considerable confusion to the industry and to the public. Clear and precise regulations are needed to allow only safe dietary supplements on the market. This book examines issues in determining safety of animal dietary supplements in general, and the safety of three animal dietary supplements; lutein, evening primrose oil, and garlic, in particular.

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National Academies Press

Published Date

ISBN 10

0309125707

ISBN 13

9780309125703

Preventing Childhood Obesity

Health in the Balance

By: Institute of Medicine,Board on Health Promotion and Disease Prevention,Food and Nutrition Board,Committee on Prevention of Obesity in Children and Youth

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Preventing Childhood Obesity

Health in the Balance

By: Institute of Medicine,Board on Health Promotion and Disease Prevention,Food and Nutrition Board,Committee on Prevention of Obesity in Children and Youth

Children's health has made tremendous strides over the past century. In general, life expectancy has increased by more than thirty years since 1900 and much of this improvement is due to the reduction of infant and early childhood mortality. Given this trajectory toward a healthier childhood, we begin the 21st-century with a shocking developmentâ€"an epidemic of obesity in children and youth. The increased number of obese children throughout the U.S. during the past 25 years has led policymakers to rank it as one of the most critical public health threats of the 21st-century. Preventing Childhood Obesity provides a broad-based examination of the nature, extent, and consequences of obesity in U.S. children and youth, including the social, environmental, medical, and dietary factors responsible for its increased prevalence. The book also offers a prevention-oriented action plan that identifies the most promising array of short-term and longer-term interventions, as well as recommendations for the roles and responsibilities of numerous stakeholders in various sectors of society to reduce its future occurrence. Preventing Childhood Obesity explores the underlying causes of this serious health problem and the actions needed to initiate, support, and sustain the societal and lifestyle changes that can reverse the trend among our children and youth.

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435

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National Academies Press

Published Date

ISBN 10

0309133408

ISBN 13

9780309133401

Use of Dietary Supplements by Military Personnel

By: Institute of Medicine,Food and Nutrition Board,Committee on Dietary Supplement Use by Military Personnel

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Use of Dietary Supplements by Military Personnel

By: Institute of Medicine,Food and Nutrition Board,Committee on Dietary Supplement Use by Military Personnel

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.

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474

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National Academies Press

Published Date

ISBN 10

0309116171

ISBN 13

9780309116176

Framework for Dietary Risk Assessment in the WIC Program

Interim Report

By: Institute of Medicine,Food and Nutrition Board,Committee on Dietary Risk Assessment in the WIC Program

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Framework for Dietary Risk Assessment in the WIC Program

Interim Report

By: Institute of Medicine,Food and Nutrition Board,Committee on Dietary Risk Assessment in the WIC Program

The Food and Nutrition Board of the Institute of Medicine (IOM), part of the National Academies, was asked to evaluate the use of various dietary assessment tools and to make recommendations for the assessment of inadequate or inappropriate dietary patterns. These assessments should accurately identify dietary risk of individuals and thus eligibility for participation in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). The Committee on Dietary Risk Assessment in the WIC Program was appointed for the 2-year study and directed to develop an interim report which was to include (1) a framework for assessing inadequate diet or inappropriate dietary patterns, (2) a summary of a workshop on methods to assess dietary risk, and (3) the results of literature searches conducted to date. This interim report includes these three components. Building on the approach used in the 1996 IOM report, WIC Nutrition Risk Criteria, the framework proposed by the committee identifies characteristics of dietary assessment tools that can identify dietary patterns or behaviors for which there is scientific evidence of increased nutrition or health risk in either the short or long-term. The proposed framework consists of eight characteristics that a food intake and/or behavior-based tool should have when used to determine eligibility to participate in WIC programs. This interim report also includes authored summaries of the presentations at the workshop, along with the results of literature searches conducted in the initial phase of the study.

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112

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National Academies Press

Published Date

ISBN 10

0309072638

ISBN 13

9780309072632

Perspectives on Biomarker and Surrogate Endpoint Evaluation

Discussion Forum Summary

By: Institute of Medicine,Food and Nutrition Board,Board on Health Sciences Policy,Board on Health Care Services,Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease

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Perspectives on Biomarker and Surrogate Endpoint Evaluation

Discussion Forum Summary

By: Institute of Medicine,Food and Nutrition Board,Board on Health Sciences Policy,Board on Health Care Services,Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease

In 2010 the Institute of Medicine (IOM) recommended a framework for the evaluation of biomarkers in the chronic disease setting. Published in the book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, the framework is intended to bring consistency and transparency to the previously disparate process of biomarker evaluation. Following the book's release, the IOM convened a 2-day discussion forum in Washington, DC, in order to provide an opportunity for stakeholders to learn about, react to, and discuss the book. Presentations reviewed the authoring committee's work process, recommendations, and provided perspectives on the book from the point of view of participants. Thomas Fleming, professor of biostatistics and statistics at the University of Washington, gave a keynote presentation on the critical issues in the validation of surrogate endpoints, a specific use of a biomarker. The present volume recounts the discussion forum proceedings, focusing in turn on each represented sector. A summary of Dr. Fleming's presentation then sets the committee's recommendations within the context of biomarker utilization. Lastly, this summary examines the main themes raised by stakeholders, and the challenges and opportunities presented to stakeholders by the book's recommendations.

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140

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National Academies Press

Published Date

ISBN 10

0309163242

ISBN 13

9780309163248

Reference Manual on Scientific Evidence

Third Edition

By: National Research Council,Federal Judicial Center,Policy and Global Affairs,Committee on Science, Technology, and Law,Committee on the Development of the Third Edition of the Reference Manual on Scientific Evidence

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Reference Manual on Scientific Evidence

Third Edition

The Reference Manual on Scientific Evidence, Third Edition, assists judges in managing cases involving complex scientific and technical evidence by describing the basic tenets of key scientific fields from which legal evidence is typically derived and by providing examples of cases in which that evidence has been used. First published in 1994 by the Federal Judicial Center, the Reference Manual on Scientific Evidence has been relied upon in the legal and academic communities and is often cited by various courts and others. Judges faced with disputes over the admissibility of scientific and technical evidence refer to the manual to help them better understand and evaluate the relevance, reliability and usefulness of the evidence being proffered. The manual is not intended to tell judges what is good science and what is not. Instead, it serves to help judges identify issues on which experts are likely to differ and to guide the inquiry of the court in seeking an informed resolution of the conflict. The core of the manual consists of a series of chapters (reference guides) on various scientific topics, each authored by an expert in that field. The topics have been chosen by an oversight committee because of their complexity and frequency in litigation. Each chapter is intended to provide a general overview of the topic in lay terms, identifying issues that will be useful to judges and others in the legal profession. They are written for a non-technical audience and are not intended as exhaustive presentations of the topic. Rather, the chapters seek to provide judges with the basic information in an area of science, to allow them to have an informed conversation with the experts and attorneys.

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1034

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National Academies Press

Published Date

ISBN 10

0309214211

ISBN 13

9780309214216

Preparing for Future Products of Biotechnology

By: National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Chemical Sciences and Technology,Board on Agriculture and Natural Resources,Board on Life Sciences,Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System

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Preparing for Future Products of Biotechnology

Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.

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231

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National Academies Press

Published Date

ISBN 10

0309452082

ISBN 13

9780309452083

Ensuring Safe Food

From Production to Consumption

By: Committee to Ensure Safe Food from Production to Consumption,Institute of Medicine,Board on Agriculture,Institute of Medicine and National Research Council

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Ensuring Safe Food

From Production to Consumption

By: Committee to Ensure Safe Food from Production to Consumption,Institute of Medicine,Board on Agriculture,Institute of Medicine and National Research Council

How safe is our food supply? Each year the media report what appears to be growing concern related to illness caused by the food consumed by Americans. These food borne illnesses are caused by pathogenic microorganisms, pesticide residues, and food additives. Recent actions taken at the federal, state, and local levels in response to the increase in reported incidences of food borne illnesses point to the need to evaluate the food safety system in the United States. This book assesses the effectiveness of the current food safety system and provides recommendations on changes needed to ensure an effective science-based food safety system. Ensuring Safe Food discusses such important issues as: What are the primary hazards associated with the food supply? What gaps exist in the current system for ensuring a safe food supply? What effects do trends in food consumption have on food safety? What is the impact of food preparation and handling practices in the home, in food services, or in production operations on the risk of food borne illnesses? What organizational changes in responsibility or oversight could be made to increase the effectiveness of the food safety system in the United States? Current concerns associated with microbiological, chemical, and physical hazards in the food supply are discussed. The book also considers how changes in technology and food processing might introduce new risks. Recommendations are made on steps for developing a coordinated, unified system for food safety. The book also highlights areas that need additional study. Ensuring Safe Food will be important for policymakers, food trade professionals, food producers, food processors, food researchers, public health professionals, and consumers.

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209

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National Academies Press

Published Date

ISBN 10

0309593409

ISBN 13

9780309593403

Enhancing Food Safety

The Role of the Food and Drug Administration

By: National Research Council,Institute of Medicine,Board on Agriculture and Natural Resources,Food and Nutrition Board,Committee on the Review of the Food and Drug Administration's Role in Ensuring Safe Food

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Enhancing Food Safety

The Role of the Food and Drug Administration

Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.

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588

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National Academies Press

Published Date

ISBN 10

0309152739

ISBN 13

9780309152730

A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration

By: Institute of Medicine,National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II

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A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration

With the responsibility to ensure the safety of food, drugs, and other products, the U.S. Food and Drug Administration (FDA) faces decisions that may have public-health consequences every day. Often the decisions must be made quickly and on the basis of incomplete information. FDA recognized that collecting and evaluating information on the risks posed by the regulated products in a systematic manner would aid in its decision-making process. Consequently, FDA and the Department of Health and Human Services (DHHS) asked the National Research Council (NRC) to develop a conceptual model that could evaluate products or product categories that FDA regulates and provide information on the potential health consequences associated with them. A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration describes the proposed risk-characterization framework that can be used to evaluate, compare, and communicate the public-health consequences of decisions concerning a wide variety of products. The framework presented in this report is intended to complement other risk-based approaches that are in use and under development at FDA, not replace them. It provides a common language for describing potential public-health consequences of decisions, is designed to have wide applicability among all FDA centers, and draws extensively on the well-vetted risk literature to define the relevant health dimensions for decision-making at the FDA. The report illustrates the use of that framework with several case studies, and provides conclusions and recommendations.

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206

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National Academies Press

Published Date

ISBN 10

0309212804

ISBN 13

9780309212809

Nanotechnologies and Food

1st Report of Session 2009-10. Evidence

By: Great Britain. Parliament. House of Lords. Science and Technology Committee

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Nanotechnologies and Food

1st Report of Session 2009-10. Evidence

By: Great Britain. Parliament. House of Lords. Science and Technology Committee

Nanotechnologies and Food : 1st report of session 2009-10, Vol. 2: Evidence

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380

Publisher

The Stationery Office

Published Date

ISBN 10

0108459233

ISBN 13

9780108459238

The Clinical Utility of Compounded Bioidentical Hormone Therapy

A Review of Safety, Effectiveness, and Use

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy

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The Clinical Utility of Compounded Bioidentical Hormone Therapy

A Review of Safety, Effectiveness, and Use

The U.S. Food and Drug Administration (FDA) has approved dozens of hormone therapy products for men and women, including estrogen, progesterone, testosterone, and related compounds. These products have been reviewed for safety and efficacy and are indicated for treatment of symptoms resulting from hormonal changes associated with menopause or other endocrine-based disorders. In recent decades, an increasing number of health care providers and patients have turned to custom-formulated, or compounded, drug preparations as an alternative to FDA-approved drug products for hormone-related health concerns. These compounded hormone preparations are often marketed as "bioidentical" or "natural" and are commonly referred to as compounded bioidentical hormone therapy (cBHT). In light of the fast-growing popularity of cBHT preparations, the clinical utility of these compounded preparations is a substantial public health concern for various stakeholders, including medical practitioners, patients, health advocacy organizations, and federal and state public health agencies. This report examines the clinical utility and uses of cBHT drug preparations and reviews the available evidence that would support marketing claims of the safety and effectiveness of cBHT preparations. It also assesses whether the available evidence suggests that these preparations have clinical utility and safety profiles warranting their clinical use and identifies patient populations that might benefit from cBHT preparations in lieu of FDA-approved BHT.

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337

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National Academies Press

Published Date

ISBN 10

0309677157

ISBN 13

9780309677158

Book's by Committee on the Framework for Evaluating the Safety of the Dietary Supplements

Dietary Supplements

Dietary Supplements

Complementary and Alternative Medicine in the United States

Complementary and Alternative Medicine in the United States

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease

Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment

Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment

Safety of Dietary Supplements for Horses, Dogs, and Cats

Safety of Dietary Supplements for Horses, Dogs, and Cats

Preventing Childhood Obesity

Preventing Childhood Obesity

Use of Dietary Supplements by Military Personnel

Use of Dietary Supplements by Military Personnel

Framework for Dietary Risk Assessment in the WIC Program

Framework for Dietary Risk Assessment in the WIC Program

Perspectives on Biomarker and Surrogate Endpoint Evaluation

Perspectives on Biomarker and Surrogate Endpoint Evaluation

Reference Manual on Scientific Evidence

Reference Manual on Scientific Evidence

Preparing for Future Products of Biotechnology

Preparing for Future Products of Biotechnology

Ensuring Safe Food

Ensuring Safe Food

Enhancing Food Safety

Enhancing Food Safety

A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration

A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration

Nanotechnologies and Food

Nanotechnologies and Food

The Clinical Utility of Compounded Bioidentical Hormone Therapy

The Clinical Utility of Compounded Bioidentical Hormone Therapy

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