Food Law RegulationFood Safety, Pathogens, Recalls, Claims, Additives, Allergens, Biotechnology and HACCP: Food and Drug Law Book 9 of 12

Food Law RegulationFood Safety, Pathogens, Recalls, Claims, Additives, Allergens, Biotechnology and HACCP: Food and Drug Law Book 9 of 12

by Roseann B. Termini, Esq.
Food Law RegulationFood Safety, Pathogens, Recalls, Claims, Additives, Allergens, Biotechnology and HACCP: Food and Drug Law Book 9 of 12

Food Law RegulationFood Safety, Pathogens, Recalls, Claims, Additives, Allergens, Biotechnology and HACCP: Food and Drug Law Book 9 of 12

by Roseann B. Termini, Esq.



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The United States Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) perform a significant role in the regulation of the United States food supply. Accomplishments of the (USDA's) Food Safety and Inspection Service and FDA's Center for Food Safety and Applied Nutrition are noted in this Book as well as specific legislation. This Book focuses on food safety, recalls, health claims, and other significant topics.
This Book details the collaborative approach to food safety initiatives by governmental agencies and the continued debate about a single food safety agency. Hailed as the most significant overhaul of food safety regulation, the Food Safety Modernization Act (FSMA) became law in early 2011. The United States food safety 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. Significant aspects of the FSMA and other pertinent food safety legislation are detailed. Yet, despite legislative measures, foodborne illness remains problematic. Specific foodborne pathogens such as Listeria monocytogenes, E. coli O157:H7 and Salmonella are discussed with illustrative firm-initiated recalls such as the recall of 206 million shell eggs in 2018.
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 and the declaratory order concerning the phase out of hydrogenated trans fats supported by the World Health Organization An updated nutrition label was released in 2016 and implementation several years later. Front-of-Package labeling by industry remains in the forefront as FDA considers how to best address this issue for consumer comprehension and protection. Health claims continue to proliferate. Qualified health claims on food labeling remains controversial. 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. Besides NLEA, allegations of deceptive business practices under the Unfair Trade Practices Act were permitted to proceed in Pom LLC v. Coke-Cola, Inc. In response to the obesity crisis, the Patient Protection and Affordable Care Act of 2010 mandated caloric disclosure and towards the end of 2014, FDA issued the long-awaited rules on calorie disclosure for foods sold in vending machines and in some restaurants effective January 1, 2020 for manufacturers with $10 million or more in annual food sale; however, manufacturers with less than $10 million in annual food sales have until January 1, 2021 to comply.
Threats of bioterrorism continue and the safety of the United States food supply including food imports is crucial. Enacted in response to the events of September 11, 2001, the 2002 Bioterrorism Act, specifically Title III, 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.
Congress enacted the Bioengineered Food Disclosure legislation in 2016 perhaps in response to state legislative enactments. A case discussion of specific duties of a food manufacturer is included. Trade issues are addressed by review of the country-of-origin labelling. Special topics such as obesity, arsenic, bovine spongiform encephalopathy (BSE), hydrogenated and trans fatty acids and biotechnology are reviewed. Finally, FDA is reviewing the terms "healthy" and "natural". Finally, enforcement in food safety has been increased with case examples.

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Product Details

BN ID: 2940160997872
Publisher: Forti Publications
Publication date: 01/09/2022
Series: Food and Drug Law , #9
Sold by: Barnes & Noble
Format: eBook
File size: 574 KB

About the Author

Roseann B. Termini, B.S., Ed. M., J.D. has over thirty years of extensive experience in food and drug law. This volume, contained in the new print eighth 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. Ms. Termini was admitted in 2018 to the bar of the United States Supreme Court.

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