Federal Food and Drug Act Violations

Article excerpt

    A. Statutory Elements
       1. Food, Drug, Cosmetic, or Device
       2. Adulterated or Misbranded
       3. Delivery or Transportation in Interstate Commerce
    B. Misdemeanor Violations and the "Responsible Relation"
    C. Felony Prosecutions
    A. Constitutional Defenses
       1. Fourth Amendment
       2. Fifth Amendment
       3. First Amendment
    B. Impossibility Defense
    A. Inspections
    B. Sanctions and Sentencing
   A. Bio-terrorism
   B. Prevention


This Article describes the elements of criminal violations of the Food, Drug, and Cosmetic Act ("FDCA" or the "Act"). (1) In 1938, Congress enacted the FDCA pursuant to its constitutional authority to regulate interstate commerce. (2) The primary purpose of the law is to protect the health and safety of the public (3) by preventing deleterious, adulterated, or misbranded articles from entering interstate commerce. (4) Violators are subject to criminal penalties, injunctions, and seizure of the adulterated or misbranded goods. (5) Alleged violators may be charged with either a misdemeanor or a felony. (6)

Section II of this Article outlines the statutory and common law elements of misdemeanor and felony offenses. Section III discusses constitutional challenges to FDCA prosecutions, including Fourth, Fifth, and First Amendment claims and the use of the affirmative defense of impossibility to avoid criminal liability. Section IV considers issues related to enforcement of the FDCA, such as inspections, sanctions, and sentencing. Section V highlights recent developments at the FDA, including the Agency's response to bio-terrorism threats and its implementation of new preventative measures to protect the public health and welfare.


Convictions under the FDCA require proof of several elements. First, the object of the violation must be a "food," "drug," "device," or "cosmetic." (7) Second, the item must be "adulterated" or "misbranded." (8) Third, the item must have been introduced into interstate commerce. (9) Generally, establishing these three statutory elements is sufficient to obtain a misdemeanor conviction, although courts have required a fourth element to find a corporate officer liable: the officer must bear a "responsible relation" to the offense. (10) Additionally, introducing "new drugs" into interstate commerce that are not safe or effective for their intended use is subject to prosecution under the FDCA. (11) Felony violations must include all the statutory elements required for a misdemeanor violation and either evidence of intent or a past violation of the FDCA. (12)

A. Statutory Elements

The FDCA outlines three essential elements of an offense. Part One of this section reviews the definitions of the terms "food," "drug" (including "new drug"), "cosmetic," and "device." Part Two discusses the meanings of the terms "adulterated" and "misbranded" under the Act. Part Three considers the interstate commerce requirement.

1. Food, Drug, Cosmetic, or Device

According to FDCA definitions, "food" includes "(i) articles used for food or drink for man or other animals, (ii) chewing gum, and (iii) articles used for components of any such article." (13) "Drug[s]" are defined as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals." (14) Under the Act, a "new drug" is "any drug ... the composition of which is such that [it] is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof." (15)

According to the Act, "cosmetics" are "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance. …


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