This volume focuses on food safety, recalls, health claims, and other important topics related to the regulation of the United States food supply. The United States Department of Agriculture (USDA) and the United States Food and Drug Administration (FDA) play a significant role. Accomplishments of the (USDA’s) Food Safety and Inspection Service and FDA’s Center for Food Safety and Applied Nutrition are noted in this volume as well as specific legislation. Enacted in response to...
This volume focuses on food safety, recalls, health claims, and other important topics related to the regulation of the United States food supply. The United States Department of Agriculture (USDA) and the United States Food and Drug Administration (FDA) play a significant role. Accomplishments of the (USDA’s) Food Safety and Inspection Service and FDA’s Center for Food Safety and Applied Nutrition are noted in this volume as well as specific legislation.
Enacted in response to the events of September 11, 2001, Title III of the 2002 Bioterrorism Act applies to protecting the safety and security of the food and drug supply. The 2007 Food and Drug Administration Amendments Act (FDAAA) mandated an electronic reportable food registry system. Specific measures include registration of food facilities with FDA and prior notice of imported food.
Hailed as the most significant overhaul of food safety regulation, the Food Safety Modernization Act (FSMA) became law in early 2011. Significant aspects of the FSMA and other pertinent food safety legislation are detailed. Threats of bioterrorism continue and the safety of the United States food supply including food imports is crucial. Finally, the United States food system was revamped with enactment of the FSMA which grants FDA the legal authority to order food recalls, increase inspections of domestic and foreign processing plants and the authority to establish standards for how fruits and vegetables are grown abroad.
Additionally, this volume details the collaborative approach to food safety initiatives by governmental agencies and the continued debate about a single food safety agency. Yet, despite legislative measures, fooborne illness remains problematic. Specific foodborne pathogens such as Listeria monocytogenes, E. coli O157:H7 and Salmonella are discussed with illustrative firm initiated recalls. The significance of the Hazard Analysis and Critical Control Points (HACCP) system is explained. The landmark decision of Supreme Beef, Inc. where the court ruled against USDA enforcement concerning Salmonella is incorporated. Other court decisions represent excellent examples of FDA enforcement for HACCP noncompliance, misbranding and sanitation problems.
Health claims on food labeling and the impact of the Nutrition Labeling and Education Act (NLEA) of 1990 are detailed along with trans fat disclosure requirements. Claims continue to proliferate. Qualified health claims on foods remains controversial and in response, FDA initiated advanced notice of proposed rulemaking. FDA continues to both approve and deny qualified claims.
Misbranding, terminology and caloric disclosure are discussed in the legal cases of Farinella, Manischewitz Diet Thins and Gerber. Following the example of local and state regulatory efforts such as the New York City regulation, the Patient Protection and Affordable Care Act of 2010 mandates caloric disclosure
Tolerance levels are explained and special topics such as obesity, arsenic, bovine spongiform encephalopathy (BSE), hydrogenated and trans fatty acids and biotechnology are reviewed. This volume concludes with a case discussion of the specific duties of a food manufacturer.
Roseann B. Termini, B.S., Ed. M., J.D. has over twenty-five years of extensive experience in food and drug law. This volume, contained in the new print sixth edition, emanates from her comprehensive food and drug regulatory law books. Ms. Termini has frequently presented food and drug law topics as a featured speaker. Further, she has published a broad array of specialized food and drug law issues such as corporate accountability, criminal liability, 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 (OAG). While at the OAG, she prosecuted cases at the trial and appellate levels and was in charge of implementation procedures for the Pennsylvania Plain Language Act. 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 Uni-versity 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 com-mittees 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.