An Examination of Strict Criminal Liability Under the Food, Drug and Cosmetic Act of 1938: Is It Time For Change?

Abstract

Food and drug violations have been largely governed by a strict liability standard since the nineteenth century. Use of this standard in connection with criminal sanctions has generally been defended on the grounds that the health and welfare of the public are of such importance that it is necessary to provide members of the food and drug industry with an extra impetus to abide by the applicable food and drug regulations. Nonetheless, strict criminal liability has not been wholly successful in averting violations of food and drug regulations, as evidenced by the presence of a number of criminal cases involving food and drug industry participants. It, therefore, might be time to question the goals of the Food, Drug and Cosmetic Act of 1938, enforcement policy, and whether the use of strict criminal liability is a necessary method of achieving those goals in the current setting. This paper attempts to analyze these questions by tracing the history of strict liability in the area of food and drug law violations, discussing the common arguments in favor and against the imposition of strict liability in that context, and exploring alternative regimes given the current state of affairs.