Roseann B. Termini, B.S., Ed. M., J.D. has over thirty years of extensive experience in food and drug law. This volume is contained in the new print eighth edition and emanates from her comprehensive sixth edition food and drug regulatory law book, “Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Cosmetics, Veterinary and Tobacco Products Regulation,” available at www.fortipublications.com. Ms. Termini presents and publishes in a broad array of specialized food and drug law topics, such as corporate accountability, enforcement, health claims, supplements, safety, duty to warn, preemption, regulation, promotion, tobacco, stem cells, risk assessment and globalization. She was the first recipient of the Plain English Award by the Pennsylvania Bar Association. Her expertise includes an appellate clerkship, position as sole corporate counsel, regulatory attorney and senior deputy attorney general at the Pennsylvania Office of Attorney General. Ms. Termini designed and developed the inaugural online food and drug law courses at Widener University School of Law, Johns Hopkins University, the University of Georgia, Drexel University and a direct to consumer promotion course at St. Joseph’s University’s Executive Program. Ms. Termini has also taught food and drug law courses at Temple University’s Quality and Regulatory Affairs Graduate Program and Penn State-Dickinson School of Law. Ms. Termini has been active on the committees of several professional associations for many years, including her service as Chair of a Food and Drug Law Institute Committee. She has also served on the President’s Council at Immaculata University and is a member of the Central Atlantic Association of Food and Drug Law Officials.
The "Why" of the United States Food and Drug Administration, Landmark Legislation and Court Decisionsby Roseann B. Termini, Esq.
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Volume I focuses on the "Why" of the United States Food and Drug Administration (FDA). The evolution of food and drug law legislation and milestone legal cases in Food and Drug Law is included. Volume I contains United States Supreme Court legal decisions that have impacted on the practice of food and drug law. Chapter 1 details the "Why" of the FDA. Chapter 2 details key legislation enactments originating from the early English influence. Chapter 3 details landmark legislation and court decisions starting with 2000. For example, the decision of Washington Legal Foundation (WLF) v. Henney, decided in 2000, and Thompson v. Western States decided in 2002, invalidated portions of the Food and Drug Administration Modernization Act based on First Amendment principles. The products that FDA regulates in interstate commerce account for about 25 percent of every consumer dollar spent. The United States Food and Drug Administration’s (FDA) mission, in accordance with the Federal Food, Drug and Cosmetic Act (FDCA), is to protect the public health and safety. Public protection, a vital factor in food and drug law legislation, has remained steadfast over the years. Chapter 4 details the federal agencies that regulate food and drug related products. Each chapter contains critical analysis issues to explore.
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