Criminal and Civil Enforcement StrategiesFood and Drug Administration: Food and Drug Law Book 3 of 12
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.
"1140853270"
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.
Criminal and Civil Enforcement StrategiesFood and Drug Administration: Food and Drug Law Book 3 of 12
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.
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.
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Criminal and Civil Enforcement StrategiesFood and Drug Administration: Food and Drug Law Book 3 of 12
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Product Details
BN ID: | 2940160968278 |
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Publisher: | FORTI Publications |
Publication date: | 01/07/2022 |
Series: | Food and Drug Law , #3 |
Sold by: | Barnes & Noble |
Format: | eBook |
File size: | 197 KB |
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