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.

"The goal of this practical guide to food law is to offer attorneys of all stripes an introduction to how different areas of law and legal practice intersect with food"--

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.

estation, habitat destruction and zoonoses; food naming and labelling; and food risk management. Throughout there is reference to an abundance of legislation, treaties, conventions, and case law at domestic, regional, and international levels, with particular attention to European, US, and World Trade Organization law and the work of the FAO. The book clearly demonstrates the necessity for reform of the global system of food production in the direction of a more sustainable and environment-friendly model. In its authoritative discussion of the relations among fields of law that are rarely discussed together – food law and the environment, food law and human rights, food law and animal welfare – this collection of chapters will prove a valuable resource both for officials working in food governance and security and for lawyers and scholars concerned with environmental management, sustainable development, and human rights around the world.

For both student food scientists and experienced professionals, a knowledge of U.S. food law is the foundation that supports an understanding of all industry regulation. Based on a popular internet course, Guide to Food Laws and Regulations, 2nd Edition informs students on the significance, range, and background of food laws and gives tools for finding current regulations. This compact resource outlines major U.S. food laws, factors that led to their passage, and explains the role of key agencies like the FDA and FSIS in regulation and enforcement. Students are directed to internet sites as well as to indexes and resources available from the Federal government. Other topics include religious dietary law, Occupational Safety and Health Administration regulations, environmental regulations, HACCP and GMPs, laws governing health claims, and the regulation of biotechnology. New to this edition are six chapters on subjects that have risen to prominence during the last few years: Poultry Processing Regulations Federal Trade Commission Animal Welfare Regulations and Food Production Egg Laws and Regulations Catfish Regulations Locating Laws and Regulations Guide to Food Laws and Regulations, 2nd Edition is an ideal sourcebook for students and professionals in food science and technology, chemistry, biosystems engineering, food animal production and medicine, agribusiness, and other closely related fields.