Federal food and drug act violations.

AuthorHuang, Jeffrey S.
PositionAnnual white collar crime survey

    In 1938, Congress enacted the federal Food, Drug, and Cosmetic Act ("FDCA" or "Act"),(1) pursuant to its constitutional authority to regulate interstate commerce.(2) The primary purpose of this legislation is to protect the health and safety of the public(3) by preventing deleterious, adulterated, or misbranded articles from entering interstate commerce.(4) Those who violate its provisions 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)

    This Article describes the prosecution of criminal violations of the FDCA. Section II outlines both the statutory and common law elements of misdemeanor and felony offenses. Section III discusses constitutional challenges to FDCA prosecutions, including Fourth and Fifth 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 current developments in FDCA prosecution, including recent tobacco litigation.


    Convictions under the FDCA require proof of various elements. Part A of this Section discusses the three fundamental statutory elements of a FDCA violation. 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 be introduced into interstate commerce.(9) Additionally, the introduction into interstate commerce of so-called "new drugs" that are not safe or effective for their intended use are subject to prosecution under the FDCA.(10) Generally, establishing the above three statutory elements is sufficient to obtain a misdemeanor conviction.

    In addition, to find a corporate officer liable, courts have required a fourth element: the officer must bear a "responsible relation" to the offense.(11) Part B discusses this element.

    Felony violations, addressed in Part C, require all the statutory elements necessary for a misdemeanor violation, and either evidence of intent or a past violation of the FDCA.

    1. Statutory Elements

      The FDCA outlines three essential elements of an offense. Part One of this section reviews the definitions of "food," "drug," "cosmetic," and "device". Part Two discusses the meaning of "adulterated" or "misbranded" under the Act. Finally, Part Three considers the interstate commerce element.

      1. Food, Drug, Cosmetic, or Device

        According to FDCA definitions, "food" includes: "(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article."(12) "Drug[s]" are defined as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals."(13) "New drugs" subject to the Act are defined as "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 condition prescribed, recommended, or suggested in the labeling thereof."(14)

        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."(15)

        "Devices" are defined as any:

        instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (1) recognized in the official National Formulary ..., (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease ... or (3) intended to affect the structure or any function of the body of man or other animals.(16) The federal Food and Drug Administration ("FDA") may also regulate products that are a "combination of" the items listed above.(17) In determining the intended use for any food, drug, cosmetic, or device, "the FDA is not bound by the manufacturer's subjective claims of intent but can find actual therapeutic intent on the basis of objective evidence."(18)

      2. Adulterated or Misbranded

        An article is "adulterated" if its ingredients are poisonous, filthy, putrid, or otherwise unsanitary, or if it has come into contact with unsanitary substances.(19) Drugs are also considered "adulterated" if strength, quality, or purity differs from official standards.(20) Courts have found that food may be considered "adulterated" within the scope of the Act when there exists a "reasonable possibility" that unsanitary conditions under which the food is stored or processed may result in filth contamination.(21) Further, a device is considered "adulterated" if it should receive pre-market approval ("PMA") from the FDA but moves in commerce without such approval.(22)

        "Misbranding" includes using false or misleading labels, packaging, or containers.(23) The crimes of adulteration and misbranding are separate and distinct; an individual may be prosecuted for either or both, depending upon his or her actions.(24)

      3. Delivery or Transportation into Interstate Commerce

        The requirement that the article be introduced into interstate commerce is the final statutory element that must be satisfied for a successful misdemeanor prosecution.(25) Interstate commerce is defined as "commerce between any State or Territory and any place outside thereof."(26) It "is not confined in meaning to the actual transportation of articles across state lines, but includes the whole transaction of which such transportation is a part."(27) In prosecutions concerning violations with respect to a device, courts have held that the statute presumes a connection with interstate commerce.(28)

    2. Misdemeanor Violations and the "Responsible Relation "Element

      Courts also require a finding of responsible relation to impose criminal liability on a corporate officer. In United States v. Dotterweich,(29) the Supreme Court established a standard of strict liability for violations of the FDCA by holding that proof of the defendant's intent to commit a violation was not required to obtain a misdemeanor conviction.(30) In Dotterweich, although the president and general manager of a pharmaceutical supply company took no actual part in the interstate shipment of misbranded and adulterated drugs, the Supreme Court upheld their convictions for violation of the FDCA because of their positions within the company.(31) In an attempt to define the limits of this type of liability, the Court held that a finding of corporate guilt would extend only to those individuals who had a "responsible share in the furtherance of the transaction which the statute outlaws."(32)

      Courts encountered difficulties in defining what has become known as the Dotterweich "responsible relation" test, as applied to the scope of criminal liability under the FDCA.(33) The Supreme Court attempted to resolve this confusion in United States v. Park.(34) The Park Court refined the Dotterweich "responsible relation" standard, holding that the government must establish a prima facie case by showing that the defendant failed to act on his or her authority, and that such an action could have prevented or corrected the violation.(35) Thus, where an individual is in a position of power or authority that would allow him to prevent, detect, or correct violations of the Act, the individual will be held strictly liable for failing to act on that authority.(36) The Supreme Court found Park, the president of a national retail food chain, subject to strict criminal liability under [sections] 301(k) of the FDCA because Park failed to use his authority and responsibility in operating the company to prevent the storage of food in an area where it could be contaminated by rodents.(37)

      The Park standards have been widely applied.(38) Some circuits have also applied Park's rationale to non-FDCA cases where the statute at issue was meant to protect the public welfare.(39)

      Despite the Park clarification, lower courts and commentators continue to struggle to determine the appropriate scope of strict liability with respect to corporate officers. The confusion results from the Park Court's statement that although strict liability requires the higher standard of foresight and vigilance, the criminal aspect of the FDCA does not require that which is objectively impossible.(40) Based upon this statement, several corporate agents tried for violations of the FDCA have used the "objective impossibility" defense which requires proof that the defendant was powerless to prevent or remedy the violations.(41) Where such a claim is made, the defendant must come forward with evidence, but the government still bears the ultimate burden of proving beyond a reasonable doubt the defendant's guilt, including his or her power to prevent or correct the violation.(42)

    3. Felony Prosecutions

      Felony prosecutions involve the same statutory elements as a misdemeanor prosecution: involvement of a food, drug, cosmetic or device; adulteration or misbranding; and introduction into interstate commerce.(43) Furthermore, in felony prosecutions, the government either must prove intent on the part of the defendant(44) or must prosecute an individual subsequent to a prior misdemeanor conviction.(45) In instances where a corporate entity is being prosecuted for defrauding the FDA, the defendant corporation will often plead guilty.(46) Sometimes, a defendant corporation will plead guilty as part of a larger settlement with the government.(47)


    There are two categories of defenses for alleged violations of FDCA provisions. Part A of this Section reviews constitutional challenges to an FDCA...

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