Often thought of as a subdialect of American "governmentese," FDA-Speak is a language unique to healthcare regulators and those regulated. If you have any involvement with the US Food and Drug Administration, or if they have involvement with you, you need to speak the language. This revised and updated edition of FDA-Speak retains the original easy

During the past decade, tremendous growth has occurred in the use of nutrition symbols and rating systems designed to summarize key nutritional aspects and characteristics of food products. These symbols and the systems that underlie them have become known as front-of-package (FOP) nutrition rating systems and symbols, even though the symbols themselves can be found anywhere on the front of a food package or on a retail shelf tag. Though not regulated and inconsistent in format, content, and criteria, FOP systems and symbols have the potential to provide useful guidance to consumers as well as maximize effectiveness. As a result, Congress directed the Centers for Disease Control and Prevention (CDC) to undertake a study with the Institute of Medicine (IOM) to examine and provide recommendations regarding FOP nutrition rating systems and symbols. The study was completed in two phases. Phase I focused primarily on the nutrition criteria underlying FOP systems. Phase II builds on the results of Phase I while focusing on aspects related to consumer understanding and behavior related to the development of a standardized FOP system. Front-of-Package Nutrition Rating Systems and Symbols focuses on Phase II of the study. The report addresses the potential benefits of a single, standardized front-label food guidance system regulated by the Food and Drug Administration, assesses which icons are most effective with consumer audiences, and considers the systems/icons that best promote health and how to maximize their use.

FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.

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.

A New York Times Notable Book The inspiration for PBS's AMERICAN EXPERIENCE film The Poison Squad. From Pulitzer Prize winner and New York Times-bestselling author Deborah Blum, the dramatic true story of how food was made safe in the United States and the heroes, led by the inimitable Dr. Harvey Washington Wiley, who fought for change By the end of nineteenth century, food was dangerous. Lethal, even. "Milk" might contain formaldehyde, most often used to embalm corpses. Decaying meat was preserved with both salicylic acid, a pharmaceutical chemical, and borax, a compound first identified as a cleaning product. This was not by accident; food manufacturers had rushed to embrace the rise of industrial chemistry, and were knowingly selling harmful products. Unchecked by government regulation, basic safety, or even labelling requirements, they put profit before the health of their customers. By some estimates, in New York City alone, thousands of children were killed by "embalmed milk" every year. Citizens--activists, journalists, scientists, and women's groups--began agitating for change. But even as protective measures were enacted in Europe, American corporations blocked even modest regulations. Then, in 1883, Dr. Harvey Washington Wiley, a chemistry professor from Purdue University, was named chief chemist of the agriculture department, and the agency began methodically investigating food and drink fraud, even conducting shocking human tests on groups of young men who came to be known as, "The Poison Squad." Over the next thirty years, a titanic struggle took place, with the courageous and fascinating Dr. Wiley campaigning indefatigably for food safety and consumer protection. Together with a gallant cast, including the muckraking reporter Upton Sinclair, whose fiction revealed the horrific truth about the Chicago stockyards; Fannie Farmer, then the most famous cookbook author in the country; and Henry J. Heinz, one of the few food producers who actively advocated for pure food, Dr. Wiley changed history. When the landmark 1906 Food and Drug Act was finally passed, it was known across the land, as "Dr. Wiley's Law." Blum brings to life this timeless and hugely satisfying "David and Goliath" tale with righteous verve and style, driving home the moral imperative of confronting corporate greed and government corruption with a bracing clarity, which speaks resoundingly to the enormous social and political challenges we face today.

The Bad Bug was created from the materials assembled at the FDA website of the same name. This handbook provides basic facts regarding foodborne pathogenic microorganisms and natural toxins. It brings together in one place information from the Food & Drug Administration, the Centers for Disease Control & Prevention, the USDA Food Safety Inspection Service, and the National Institutes of Health.

Each year, Americans consume hundreds of food products that contain truly dangerous compounds, including heavy metals, pesticides, and other harmful additives—with the blessing of the FDA. Why is this happening and why haven’t you heard about it? In Unsafe at Any Meal, Dr. Renee Dufault, former food investigator for the Food and Drug Administration, provides the startling answers. While at the FDA, Dr. Dufault discovered that mercury—a highly toxic metal—was contaminating the plumbing systems of many food manufacturing plants. Upon further examination, she discovered that the same mercury was also evident in a number of processed foods commonly sold in supermarkets. When Dr. Dufault revealed these disturbing findings to her superiors, she was told to stop her investigation. Her continued efforts to raise the issue always met with a dead end, so she chose to take an early retirement from the FDA. Dr. Dufault then devoted her energy to making the public aware of the insidious dangers that contaminate our food. In 2010, she founded an organization of scientists to study the scope of this problem and has published numerous research articles on the topic with little fanfare. To expose what still seems to be a well-kept secret by the FDA, she has written Unsafe at Any Meal to provide consumers with the information they need to know. The book begins with the author’s story leading up to the creation of this work. It then describes the various toxic substances that are most commonly found in our food supply, and explains how they affect your genes, health, and the surrounding environment. After examining the Standard American Diet, which is sorely lacking in disease-preventing nutrients, it discusses the country’s trend toward consuming a skyrocketing amount of ingredients that can contain heavy metals. It further shows how exposure to these heavy metals can contribute to conditions such as ADHD or autism. Also included is a helpful guide to reading food labels, recognizing misleading marketing tactics, and knowing what to look for—and what to look out for—in the aisles of your grocery store. Over fifty years ago, Rachel Carson’s book Silent Spring exposed the dangers of DDT in our food supply. Unfortunately, it seems that the problem of food contamination has actually become worse. Backed by research and first-hand experience, Dr. Dufault reveals how the FDA has failed us, and outlines how you can protect yourself and your family by knowing what to avoid and by filling your kitchen with food that is clear of toxins.