Federal Food and Drug Act violations.

AuthorBachman, Brenda A.
PositionEleventh Survey of White Collar Crime

    1. Statutory Elements

      1. Food, Drug, Cosmetic or Device

      2. Adulterated or Misbranded

      3. Delivery or Transportation into Interstate Commerce

    2. "Responsible Relation" Element III. DEFENSES

    3. Constitutional Defenses

      1. First Amendment

      2. Fourth Amendment

      3. Fifth Amendment

    4. Impossibility Defense IV. ENFORCEMENT

    5. Inspections

    6. Sanctions




    In 1938, pursuant to its constitutional authority to regulate interstate commerce,(1) Congress enacted the Federal Food, Drug and Cosmetic Act ("FDCA" or "Act").(2) The primary goal 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 adulterated or misbranded goods.(5)


    There are four essential elements to a FDCA violation. First, the object of the violation must be a "food," "drug," "cosmetic," or "device." Second, the item must be "adulterated" or "misbranded." Third, the item must be introduced into interstate commerce. Finally, for individuals to be liable under the act, they must bear a "responsible relation" to the offense.

    1. Statutory Elements

      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."(6) Drugs are defined as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals."(7) 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."(8) 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 ...."(9) In determining the intended use for any 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."(10)

      2. Adulterated or Misbranded

        An article is said to be adulterated if its ingredients are poisonous, filthy, putrid, or otherwise unsanitary, or if it has come into contact with unsanitary substances.(11) Misbranding includes false or misleading labels, packaging, and containers.(12)

      3. Delivery or Transportation into Interstate Commerce

        The requirement that the article be introduced into interstate commerce is the final element of the statute that must be satisfied.(13) Interstate commerce is defined as "commerce between any State or Territory and any place outside thereof." 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."(14) In prosecutions concerning violations with respect to a device, the connection with interstate commerce is presumed to exist.(15)

    2. "Responsible Relation" Element

      The Food and Drug Administration ("FDA") and the courts impose broad standards of criminal liability for violations of the FDCA. In United States v. Dotterweich,(16) the Supreme Court established a standard of strict liability for violations of the Act's provisions by holding that proof of the defendant's intent to commit a violation was not required to obtain a conviction.(17)

      In an attempt to define the limits of this 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."(18) However, a number of courts encountered difficulties in defining what has become known as the Dotterweich "responsible relation" test as it applied to the scope of criminal liability under the FDCA.(19) The Supreme Court attempted resolve this confusion in United States v. Park.(20) In Park, the Court limited 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.(21) 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.(22)

      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 impossibility defense as established by the Park court's statement that although strict liability requires the highest standard of foresight and vigilance, the criminal aspect of the Act does not require that which is objectively impossible.(23)


    The provisions of the Food, Drug and Cosmetic ACt have been challenged on a number of constitutional grounds. In addition, defendants faced with prosecution have raised affirmative defences to the FDCA. Much of the litigation in these areas occurred in the 1970s and 80S, and courts still refer to these seminal cases today.

    1. Constitutional Defenses

      1. First Amendment

        Challenges to the ACt based on the First Amendment(24) grounds of free speech have been mounted, but such challenges have met with defeat.(25)

      2. Fourth Amendment

        Fourth Amendment(26) challenges to the FDCA have been both numerous and controversial. The general rule iS that the Fourth Amendment's prohibition against unreasonable searches applies to administrative inspections of commercial property.(27) However, legislative schemes which authorize warrantless administrative searches of commercial property are not necessarily violative of the Fourth Amendment,(28) particularly where the warrantless inspection involves a "closely regulated" industry.(29) Such warrantless inspections are deemed reasonable if a (1) "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 provides a constitutionally adequate substitute for a warrant, "both in terms of certainty and regularity of its application."(30)

        It is a criminal offense for corporate officials or employees to deny entry or inspection when FDA officials arrive with written notice and present appropriate credentials.(31) However, authorities are divided as to whether valid consent is necessary to legitimize a warrantless search. The United States Supreme Court and a few United States District Courts have held that the lawfulness of a warrantless search is solely dependent upon the search being conducted pursuant to a valid, statutory authority, irrespective of consent.(32) The Ninth and Fifth Circuits added a consent requirement, finding that a warrantless search is not legitimate without valid consent.(33) If consent is withheld, the FDA is required to obtain an administrative search warrant before it may re-enter the premises.(34) Such a warrant requires a more relaxed demonstration of evidence than that required by. traditional Fourth Amendment standards.(35) Thus, while it is permissible for a corporate agent to refuse consent, refusal may not be in the agent's best interests, since the FDA will most likely obtain a search warrant. Furthermore, denying entry to FDA officials may ultimately result in punishment under the criminal provisions of the FDCA.(36)

        Some courts have also addressed the issue of whether FDA agents may seize items without a search warrant under the FDCA. While a few district court decisions have authorized the in rem arrest procedure of [sections] 304,(37) the Ninth Circuit concluded that agents seeking to enter homes and offices in order to seize items alleged to violate the FDCA must comply with the Fourth Amendment by obtaining a warrant based upon probable cause and authorized by a detached judicial officer.(38)

      3. Fifth Amendment

        Fifth Amendment(39) due process challenges based on the vagueness of various provisions,(40) or on the lack of notice,(41) have also been unsuccessful. One may have the right to invoke the Fifth Amendment privilege against self-incrimination in order to avoid providing the government with information under certain circumstances in FDCA litigation,(42) though the traditional warnings outlined in Miranda v. Arizona(43) need not be given to corporate officials prior to interviews with FDA inspectors. The courts have consistently found that company representatives on their own premises are neither in custody nor deprived of their freedom since they are not prohibited from moving about the premises, and they are not prohibited from consulting with their attorneys during the FDA inspections.(44)

    2. Impossibility Defense

      One potential affirmative defense to FDCA liability is the "impossibility defense."(45) In United States v. New England Grocers Supply Co.,(46) the court discussed the alternative interpretations of the impossibility defense and decided on an interpretation which requires a corporate officer to prove that although extraordinary care was used, he was nevertheless powerless to correct or prevent the violation.(47) Upon such a showing, the burden of proof shifts to the government to prove that the officer was not, in...

To continue reading

Request your trial

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT