Criminal and Civil Enforcement StrategiesFood and Drug Administration: Food and Drug Law Book 3 of 12

by Roseann B. Termini, Esq.

Overview

This Book focuses on regulatory issues and legal court cases in Food and Drug Law pertaining to enforcement. The United States Food and Drug Administration (FDA), the Federal Trade Commission (FTC) and the United States Department of Agriculture (USDA) are charged with the responsibility of enforcement in accordance with the particular statute that each agency or Commission regulates. Public protection and public trust remain paramount.
This Book 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 enforcement tool. Warning letters serve as a "caveat" for the potential of legal action. Economic harm is covered. "Off-label" enforcement is included in this Book and in Book V Human Drugs.
The Food Drug and Cosmetic Act 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.
The FDCA contains criminal sanctions and over the years, FDA has pursued 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. Park v. United States, a Supreme Court decision, changed the landscape in terms of individual corporate accountability and is still followed today as this Book details in several decisions. United States v. Dotterweich was the precursor to the Park decision. Fast forward to today and the "Park" doctrine remains viable as illustrated in this Book. Prosecution of corporate executives remains a constant deterrent as illustrated in the misdemeanor Jensen Farms and Quality Egg convictions of corporate officials and the felony conviction of the Peanut Corporation of America executives.
Warning letters, import refusals, seizures, recalls and injunctions remain important regulatory enforcement tools. The FDA, FTC and USDA continue to use enforcement mechanisms to protect the public in adherence with the underlying statutes. Yet the issue remains, whether more should be done in terms of violative products that enter the marketplace.

Product Details

BN ID:	2940160968278
Publisher:	FORTI Publications
Publication date:	01/07/2022
Series:	Food and Drug Law , #3
Sold by:	Barnes & Noble
Format:	eBook
File size:	197 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 in2018 to the bar of the United States Supreme Court.