Federal Food and Drug Act violations.

AuthorNiezgoda, Erica L.
PositionThirteenth Survey of White Collar Crime

    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 court-mated elements of the possible 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.


    A conviction under the FDCA requires proof of various elements. Part A of this Section discusses the three statutory elements of an FDCA violation. First, the object of the violation must be a "food," "drug," "cosmetic," or "device."(7) Second, the item must be "adulterated" or "misbranded."(8) Third, the item must be introduced into interstate commerce.(9) Generally, establishing the three statutory elements is sufficient to obtain a misdemeanor conviction. Yet, courts have read a fourth element into the Act which they have held to be essential for a misdemeanor conviction of a corporate officer under the FDCA: in order for individuals to be liable under the Act, they must bear a "responsible relation" to the offense;(10) this is addressed in Part B. Felony convictions, 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 elements of an offense. This Part first reviews the definitions of food, drug, cosmetic, and device, then discusses the meaning of adulterated or misbranded under the Act, and finally 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."(11) "Drugs" are defined as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals."(12) 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."(13) "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 ...(14)

        The federal Food and Drug Administration ("FDA") may also regulate products which are a combination of the items listed above.(15) 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."(16)

      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.(17) "Misbranding" includes using false or misleading labels, packaging, or containers.(18) The crimes of adulteration and misbranding are separate and distinct; an individual may be prosecuted for either or both, depending upon his actions.(19)

      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.(20) Interstate commerce is defined as "commerce between any State or Territory and any place outside thereof."(21) It is not confined "to the actual transportation of articles across state lines, but includes the whole transaction of which such transportation is a part."(22) In prosecutions concerning violations with respect to a device, the connection with interstate commerce is presumed by statute.(23)

    2. Misdemeanor Violations and the "Responsible Relation" Element

      FDA and the courts impose broad standards of criminal liability for violations of the FDCA. In United States v. Dotterweich,(24) the Supreme Court established a standard of strict liability for violations of the FDCA's provisions by holding that proof of the defendant's intent to commit a violation was not required to obtain a misdemeanor conviction.(25) 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.(26) 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."(27)

      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.(28) The Supreme Court attempted to resolve this confusion in United States v. Park.(29) The Park Court refined the Dotterweich "responsible relation" standard by requiring that the government establish a prima facie case showing that the defendant failed to act on authority which could have prevented or corrected the violation.(30) Thus, where an individual is in a position of power or authority which 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.(31)

      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.(32) 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.(33) Where such a claim is made, the defendant has the burden of coming forward with evidence, but the Government still bears the ultimate burden of proving beyond a reasonable doubt the defendant's guilt, including his power to prevent or correct the violation.(34)

    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.(35) Further, in felony prosecutions, the government either must prove intent on the part of the defendant(36) or must be prosecuting the individual subsequent to a prior misdemeanor(37) conviction. In instances where a corporate entity is being prosecuted for defrauding the FDA, settlement often occurs.(38)


    There are two categories of defenses for alleged violations of the provisions of the Food, Drug and Cosmetic Act. Part A reviews constitutional challenges to an FDCA prosecution. Part B discusses the impossibility defense in light of the Supreme Court's Park decision. Although the seminal cases discussing to these defenses arose in the 1970's and 80's, courts often refer to these cases today.

    1. Constitutional Defenses

      Alleged violators have attacked the Act's constitutionality under both the Fourth and Fifth Amendments. This part first discusses Fourth Amendment challenges which focus on the legality of the administrative searches conducted by FDA officials, and then describes defenses based on the Fifth Amendment, including assertions that the FDCA prosecution violates a defendant's right to due process and his right against self-incrimination.

      1. Fourth Amendment

        Fourth Amendment(39) challenges to the FDCA have been numerous and controversial. The general rule holds that the Fourth Amendment's prohibition against unreasonable searches applies to administrative inspections of commercial property.(40) However, legislative schemes which authorize warrantless administrative searches of commercial property do not necessarily violate the Fourth Amendment,(41) particularly where the warrantless inspection involves a "closely regulated" industry.(42) Such warrantless inspections are reasonable if (1) a "`substantial' government interest ... informs the regulatory scheme pursuant to which the inspection is made," (2) the inspection is "necessary to further [the] regulatory scheme," and (3) "the statute's inspection program both in terms of certainty and regularity of its application provides a constitutionally adequate substitute for a warrant."(43)

        It is a criminal offense for corporate officials or employees to deny entry for inspection when FDA officials arrive...

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