An Examination of Strict Criminal Liability Under the Food, Drug and Cosmetic Act of 1938:

LEDA at Harvard Law School

An Examination of Strict Criminal Liability Under the Food, Drug and Cosmetic Act of 1938:

Is It Time For Change?

Breena L. Holt

October 18, 1999

Table of Contents

`Part I:`	`Introduction`	`1`
`Part II:`	`Evolution of Strict Criminal Liability in the Food and Drug Industry`	`2`
`Part III:`	`Case History`	`12`
	`A. The “Responsible Relation” Standard`	`12`
	`B. The “Foresight and Vigilance” Standard and the “Objective Impossibility” Defense`	`18`
`Part IV:`	`Defenses to Criminal Charges for Violations of the Act`	`29`
`Part V:`	`Pros and Cons of Strict Criminal Liability for Violations of the Act`	`32`
`Part VI:`	`Criminal Prosecutions Under the Act`	`36`
`Part VII:`	`Is Strict Personal Criminal Liability Necessary to Achieve its Desired Goals?`	`38`
	`A. Corporate Compliance Program Defense`	`42`
	`B. Civil Penalties Rather than Criminal Sanctions`	`47`
	`C. Negligence Standard`	`51`
`Part VIII:`	`Conclusion`	`59`