This volume focuses on key issues and legal cases in Food and Drug Law pertaining to en-forcement. The United States Food and Drug Administration (FDA), the Federal Trade Commis-sion (FTC) and United States Department of Agriculture (USDA) enforcement mechanisms are for compliance purposes by the regulated industry that is in keeping with public protection and public trust. The FDCA enumerates prohibited acts under 21 U.S.C. section 331 that includes criminal misdemeanor and felony provisions. The Office of ...
This volume focuses on key issues and legal cases in Food and Drug Law pertaining to en-forcement. The United States Food and Drug Administration (FDA), the Federal Trade Commis-sion (FTC) and United States Department of Agriculture (USDA) enforcement mechanisms are for compliance purposes by the regulated industry that is in keeping with public protection and public trust. The FDCA enumerates prohibited acts under 21 U.S.C. section 331 that includes criminal misdemeanor and felony provisions. The Office of Criminal Investigations focuses on the submission of false information and criminal activity related to product safety. The Office of General Counsel assumes a major role in enforcement activities by advising FDA employees and reviewing materials related to enforcement activities such as product withdrawals, inspections and search warrants.
Did you know that the FDCA contains criminal sanctions and over the years, FDA has pur-sued what is termed a Park prosecution? A Park prosecution stems from a case back in 1975 concerning individual criminal liability; that is, prosecution of a corporate official. The Park United States Supreme Court decision changed the landscape in terms of individual corporate accountability and is still followed today as this volume details in several decisions.
This volume contains enforcement terminology, FDA enforcement mechanisms and strategies such as seizure, warning letters, detention and debarment as well as criminal sanctions and strict criminal liability. FDA utilizes other enforcement tools not detailed in the FDCA. For example, FDA utilizes advisory letters, known as “Titled” and “Untitled” warning letters as an enforce-ment tool although not enumerated under the FDCA. Economic harm is discussed as well. “Off Label” enforcement is included and is also discussed in Volume V Human Drugs. Each chapter contains critical analysis issues to explore.
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.