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.

Food additives have been used since the beginning of time to enhance the quality and quantity of food products. We know from historical research that alcohol, vinegar, oils, and spices were used more than 10,000 years ago to preserve foods. The incorporation of various additives to human food has never ceased. Additives have been used and continue to be used to perform various functions from enhancing the flavor to increasing the shelf-life of the food. Until the time of the Industrial Revolution, the above-mentioned ingredients and a limited number of other ingredients were the major food additives used. However, the Industrial Revolution brought about advances in machinery development and changes in technology. Food production, especially grain, increased at a hectic pace and new food additives were developed. Fast forward to current times; knowledge regarding food additives, how they are prepared, their composition, and how they work has become very important to those in the food industry and health conscious consumers. Regulating Food Additives: The Good, Bad, and the Ugly addresses both the importance and the dangers of food additives. It discusses how food additives are prepared, what they are composed of, and why we need to be concerned about them. In addition, this book provides a timeline of laws regulating food in U.S. history such as the Federal Food, Drug and Cosmetic Act (FFDCA) passed in 1938 and the Food Additives Amendment to that Act passed in 1958.

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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.

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.

In the U.S., before any additive is added to a food product the manufacturer must submit it to the FDA for approval and prove that its use has a reasonable certainty of not causing harm. The Priority-Based Assessment of Food Additives (PAFA) Database, compiled and maintained by the U.S. FDA/CFSAN (Center for Food Safety and Applied Nutrition), is a team resource for evaluating the status of all food additives. Food Additives: Toxicology, Regulation, and Properties contains a wealth of facts regarding the chemical and toxicological effects of direct food additives. It consists of identifying/administrative information for nearly 2,000 compounds that are, could be, or have been added to the U.S. food supply. Limited information is also provided for an additional 1,000 compounds. Part 1, Administrative and Chemical Information, includes data such as the CAS registry number, name of the compound, other identifying numbers, exposure to the population, and much more. The toxicological data fields are divided into three main sections: Genetic Toxicity and Cytotoxicity Information, Acute Toxicology Information, and Oral Toxicology Information. These sections contain data from toxicological studies.

Featuring case studies and discussion questions, this textbook – with revisions addressing significant changes to US food law – offers accessible coverage appropriate to a wide audience of students and professionals. Overviews the federal statutes, regulations, and regulatory agencies concerned with food regulation and introduces students to the case law and statutory scheme of food regulation Focuses updated content on the 2011 FDA Food Safety Modernization Act (FSMA), the biggest change to US food law since the 1930s Contains over 20% new material, particularly a rewritten import law chapter and revisions related to food safety regulation, health claims, and food defense Features case studies and discussion questions about application of law, policy questions, and emerging issues