Sssmokinnn': the Supreme Court Burns the Fda's Authority to Regulate Tobacco in Fda v. Brown & Williamson Tobacco Corp

• Publication year: 2022
• Citation: Vol. 34

34 Creighton L. Rev. 1111. SSSMOKINNN': THE SUPREME COURT BURNS THE FDA'S AUTHORITY TO REGULATE TOBACCO IN FDA V. BROWN & WILLIAMSON TOBACCO CORP

Creighton Law Review

Vol. 34

Rodney A. Morris- '02

The purpose of the Constitution was not only to grant power, but to keep it from getting out of hand.(fn1)

INTRODUCTION

In 1938, Congress adopted the Federal Food, Drug, and Cosmetic Act ("FDCA")(fn2) which formed the Food and Drug Administration ("FDA").(fn3) The FDCA's purpose is to protect the public from dangerous products.(fn4) To protect the public from dangerous products, the FDCA prohibits the movement of misbranded and adulterated devices and drugs in interstate commerce.(fn5) The FDCA also prohibits the introduction of any adulterated or misbranded drug into commerce, the misbranding or adulterating of a drug in commerce, the receipt of an adulterated or misbranded drug in commerce, the delivery of an adulterated or misbranded drug, and the delivery or introduction of any item violating the provision which requires approval of new drugs.(fn6) After years of the FDA denying its authority to regulate tobacco, the FDA asserted its authority to regulate tobacco productsunder the FDCA in 1996.(fn7) The FDA based its authority to regulate tobacco products on its finding that, within the context of the FDCA, nicotine is a drug and the tobacco product manufacturers intended tobacco products to affect the function or structure of the body.(fn8) Based upon the FDA's findings, it concluded that tobacco products are devices that deliver drugs within the context of the FDCA.(fn9) Finding that the best way to reduce nicotine addiction was to reduce the number of adolescents who use tobacco, the FDA promulgated regulations regarding the promotion and labeling of tobacco products as well as regulations regarding child's access to tobacco products.(fn10) Subsequently, tobacco manufacturers, retailers, and advertisers challenged the FDA's authority to regulate tobacco products.(fn11)

In FDA v. Brown & Williamson Tobacco Corp.,(fn12) the United States Supreme Court reasoned that the FDA's regulation of tobacco products exceeded its authority under the FDCA.(fn13) The Court used the framework established in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc.(fn14) to determine whether the FDA had authority to regulate tobacco products.(fn15) In order to determine the scope of authority granted the FDA, the Court surveyed the tobacco-specific legislation enacted by Congress in the last thirty-five years.(fn16) Embracing the rule that "a later federal statute should control [the] construction of an earlier statute, even though it has not been expressly amended," the Court found that Congress had preempted the FDA's authority to regulate tobacco products.(fn17) The Court observed that Congress, with knowledge of tobacco's health consequences and pharmacological effects, adopted six pieces of legislation concerning tobacco.(fn18) The Court concluded that Congress' enactment of tobaccospecific legislation, and the failure to grant the FDA explicit authority to regulate tobacco, precluded the FDA from regulating tobacco products.(fn19)

This Note will first review the facts and holding of Brown & Williamson.(fn20) This Note will then examine the statutes and cases applicable to the Court's holding and this Note's analysis.(fn21) Finally, this Note will scrutinize the Court's decision and will criticize the Court for using the Chevron framework to determine the scope of the FDA's authority to regulate tobacco products under the FDCA.(fn22) Finally, this Note will then apply the framework propounded by Justice Jackson in his concurrence in Youngstown Sheet & Tube Co. v. Sawyer(fn23) to analyze the FDA's authority to regulate tobacco products.(fn24)

FACTS AND HOLDING

In FDA v. Brown & Williamson Tobacco Corp.,(fn25) the Court observed that the Food and Drug Administration ("FDA") asserted its authority under the Federal Food, Drug, and Cosmetic Act ("FDCA")(fn26) to regulate tobacco products in 1996.(fn27) The Court remarked that the FDA determined that nicotine was a "drug" within the context of the FDCA.(fn28) As noted by the Court, the FDA further found that smokeless tobacco and cigarettes "are 'combination products' that deliver nicotine to the body."(fn29) The Court commented that the FDA ascertained that nicotine and cigarettes are a drug and device, respectively, within the meaning of the FDCA.(fn30) The Court found that the FDA established that "tobacco products 'affect the structure or function of the body.'"(fn31) The Court noted that the FDA's determination was based on nicotine's "significant pharmacological effects."(fn32) The Court observed that the FDA found that nicotine has a tranquilizing and stimulating effect on the human body.(fn33) Furthermore, the Court remarked that the FDA determined that nicotine acts as a weight control device.(fn34) The court observed that the FDA reasoned these effects were intended because the effects of nicotine are widely known and foreseeable.(fn35) Moreover, the Court found that the FDA discovered that the manufacturer's statements, actions, and research indicated that cigarettes were designed to "provide pharmacologically active doses" of nicotine to the body.(fn36)

Finding that the best way to reduce nicotine addiction was to reduce the number of adolescents who use tobacco, the Court observed that the FDA promulgated regulations regarding the promotion and labeling of tobacco products, as well as regulations regarding a child's access to tobacco products.(fn37) The Court commented that the tobaccospecific regulations ranged from prohibiting the sale of tobacco products to persons under the age of eighteen to prohibiting sales through self-service machines.(fn38) The Court further noted that the tobaccospecific regulations controlled the locations and manner of tobacco advertising.(fn39) Furthermore, the Court observed that the FDA adopted labeling requirements for cigarettes and smokeless tobacco.(fn40) The Court found that the FDA based its authority to issue its tobacco products regulations on its power to regulate restricted devices under the FDCA.(fn41)

In Brown & Williamson, a group of tobacco retailers, manufacturers, and advertisers challenged the FDA's tobacco-specific regulations in United States District Court for the Middle District of North Carolina.(fn42) Judge William L. Osteen, writing for the court, opined that the FDA had regulatory power over tobacco products.(fn43) On plaintiff's motion for summary judgment, the court upheld the access and labeling restrictions, but found the FDA lacked the authority to promulgate advertising and promotion restrictions under the FDCA.(fn44)

The district court established that the tobacco products are subject to the provisions of the FDCA.(fn45) Judge Osteen stated a product is regulated by the FDCA if the article fits within the statute's defini-tions of cosmetic, device, drug, or food.(fn46) The district court established that tobacco products fit within the FDCA's definition of device.(fn47) The court observed that the FDCA defines a device as any article which is "intended to affect the structure or any function of the body" without chemical action inside or outside the body.(fn48) The district court noted that the FDA relied on internal manufacturer memoranda, consumer use, and foreseeable use to establish that manufacturers intended to affect the function or structure of the body.(fn49) The district court opined that the FDA is allowed to rely on evidence of foreseeable use and consumer use to determine the manufacturers' intended use for tobacco products.(fn50) Based upon the FDA's interpretation of intended use and the evidence introduced, the district court concluded that the FDA had "adequately and properly supported its finding of intended use with evidence of foreseeability and consumer use."(fn51)

The district court also found that the Federal Cigarette Labeling and Advertising Act ("FCLAA"),(fn52) and the Comprehensive Smokeless Tobacco Health Education Act ("CSTHEA"),(fn53) did not preempt the FDA's regulation of tobacco products.(fn54) The district court noted that, although the Congressional policy and purpose statement appears to preempt any tobacco products regulation not enacted by Congress, the preemption provisions were drafted very narrowly.(fn55) The district court declared that the FCLAA's policy and purpose statement reads "[i]t is the policy of Congress, and the purpose of this chapter, to establish a comprehensive Federal program to deal with cigarette labeling and advertising with respect to any relationship between smoking and health . . . ."(fn56) The court asserted that the FCLAA's preemption provision only states "that '[n]o statement relating to smoking and health, other than the statement required [by the FCLAA], shall be required on any cigarette package.'"(fn57) The district court remarked that the FDA's regulations which would require an intended use statement or the tobacco product's established name on the package are not preempted by the FCLAA or CSTHEA.(fn58)

The district court concluded that the Alcohol, Drug Abuse, and Mental Health Reorganization Act ("ADAMHA Amendments")(fn59) do not preempt the FDA's regulations.(fn60) The court noted that the ADAMHA Amendments deny states federal substance abuse grants if the states fail to...