Criminal and Civil Enforcement Strategiess

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.