F.D.A. v Brown & Williamson Tobacco, 981152

CourtUnited States Supreme Court
Writing for the CourtO'Connor
Citation529 U.S. 120,146 L.Ed.2d 121,120 S.Ct. 1291
Docket Number981152
Decision Date21 March 2000
Parties FOOD AND DRUG ADMINISTRATION et al., Petitioners v. BROWN & WILLIAMSON TOBACCO CORP. et al.SUPREME COURT OF THE UNITED STATES

529 U.S. 120
120 S.Ct. 1291
146 L.Ed.2d 121

NOTICE: This opinion is subject to formal revision before publication in the preliminary print of the United States Reports. Readers are requested to notify the Reporter of Decisions, Supreme Court of the United States, Washington, D. C. 20543, of any typographical or other formal errors, in order that corrections may be made before the preliminary print goes to press.

FOOD AND DRUG ADMINISTRATION et al., Petitioners
v.
BROWN & WILLIAMSON TOBACCO CORP. et al.

No. 98-1152.

SUPREME COURT OF THE UNITED STATES

Argued December 1, 1999

Decided March 21, 2000

CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

Syllabus

The Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., grants the Food and Drug Administration (FDA), as the designee of the Secretary of Health and Human Services (HHS), the authority to regulate, among other items, "drugs" and "devices," §§321(g)-(h), 393. In 1996, the FDA asserted jurisdiction to regulate tobacco products, concluding that, under the FDCA, nicotine is a "drug" and cigarettes and smokeless tobacco are "devices" that deliver nicotine to the body. Pursuant to this authority, the FDA promulgated regulations governing tobacco products' promotion, labeling, and accessibility to children and adolescents. The FDA found that tobacco use is the Nation's leading cause of premature death, resulting in more than 400,000 deaths annually, and that most adult smokers begin when they are minors. The regulations therefore aim to reduce tobacco use by minors so as to substantially reduce the prevalence of addiction in future generations, and thus the incidence of tobacco-related death and disease. Respondents, a group of tobacco manufacturers, retailers, and advertisers, filed this suit challenging the FDA's regulations. They moved for summary judgment on the ground, inter alia, that the FDA lacked jurisdiction to regulate tobacco products as customarily marketed, that is, without manufacturer claims of therapeutic benefit. The District Court upheld the FDA's authority, but the Fourth Circuit reversed, holding that Congress has not granted the FDA jurisdiction to regulate tobacco products. The court concluded that construing the FDCA to include tobacco products would lead to several internal inconsistencies in the Act. It also found that evidence external to the FDCA-that the FDA consistently stated before 1995 that it lacked jurisdiction over tobacco, that Congress has enacted several tobacco-specific statutes fully cognizant of the FDA's position, and that Congress has considered and rejected many bills that would have given the agency such authority-confirms this conclusion.

Held: Reading the FDCA as a whole, as well as in conjunction with Congress' subsequent tobacco-specific legislation, it is plain that Congress has not given the FDA the authority to regulate tobacco products as customarily marketed. Pp. 8-40.

(a) Because this case involves an agency's construction of a statute it administers, the Court's analysis is governed by Chevron U.S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, under which a reviewing court must first ask whether Congress has directly spoken to the precise question at issue, id., at 842. If so, the court must give effect to Congress' unambiguously expressed intent. E.g., id., at 843. If not, the court must defer to the agency's construction of the statute so long as it is permissible. See, e.g., INS v. Aguirre-Aguirre, 526 U.S. 415, 424. In determining whether Congress has specifically addressed the question at issue, the court should not confine itself to examining a particular statutory provision in isolation. Rather, it must place the provision in context, interpreting the statute to create a symmetrical and coherent regulatory scheme. Gustafson v. Alloyd Co., 513 U.S. 561, 569. In addition, the meaning of one statute may be affected by other Acts, particularly where Congress has spoken subsequently and more specifically to the topic at hand. See, e.g., United States v. Estate of Romani, 523 U.S. 517, 530-531. Finally, the court must be guided to a degree by common sense as to the manner in which Congress is likely to delegate a policy decision of such economic and political magnitude to an administrative agency. Cf. MCI Telecommunications Corp. v. American Telephone & Telegraph Co., 512 U.S. 218, 231. Pp. 8-10.

(b) Considering the FDCA as a whole, it is clear that Congress intended to exclude tobacco products from the FDA's jurisdiction. A fundamental precept of the FDCA is that any product regulated by the FDA that remains on the market must be safe and effective for its intended use. See, e.g., §393(b)(2). That is, the potential for inflicting death or physical injury must be offset by the possibility of therapeutic benefit. United States v. Rutherford, 442 U.S. 544, 556. In its rulemaking proceeding, the FDA quite exhaustively documented that tobacco products are unsafe, dangerous, and cause great pain and suffering from illness. These findings logically imply that, if tobacco products were "devices" under the FDCA, the FDA would be required to remove them from the market under the FDCA's misbranding, see, e.g., §331(a), and device classification, see, e.g., §360e(d)(2)(A), provisions. In fact, based on such provisions, the FDA itself has previously asserted that if tobacco products were within its jurisdiction, they would have to be removed from the market because it would be impossible to prove they were safe for their intended use. Congress, however, has foreclosed a ban of such products, choosing instead to create a distinct regulatory scheme focusing on the labeling and advertising of cigarettes and smokeless tobacco. Its express policy is to protect commerce and the national economy while informing consumers about any adverse health effects. See 15 U.S.C. § 1331. Thus, an FDA ban would plainly contradict congressional intent. Apparently recognizing this dilemma, the FDA has concluded that tobacco products are actually "safe" under the FDCA because banning them would cause a greater harm to public health than leaving them on the market. But this safety determination-focusing on the relative harms caused by alternative remedial measures-is not a substitute for those required by the FDCA. Various provisions in the Act require the agency to determine that, at least for some consumers, the product's therapeutic benefits outweigh the risks of illness or serious injury. This the FDA cannot do, because tobacco products are unsafe for obtaining any therapeutic benefit. The inescapable conclusion is that there is no room for tobacco products within the FDCA's regulatory scheme. If they cannot be used safely for any therapeutic purpose, and yet they cannot be banned, they simply do not fit. Pp. 10-20.

(c) The history of tobacco-specific legislation also demonstrates that Congress has spoken directly to the FDA's authority to regulate tobacco products. Since 1965, Congress has enacted six separate statutes addressing the problem of tobacco use and human health. Those statutes, among other things, require that health warnings appear on all packaging and in all print and outdoor advertisements, see 15 U.S.C. § 1331 1333, 4402; prohibit the advertisement of tobacco products through any electronic communication medium regulated by the Federal Communications Commission, see §§1335, 4402(f); require the Secretary of HHS to report every three years to Congress on research findings concerning tobacco's addictive property, 42 U.S.C. § 290aa-2(b)(2); and make States' receipt of certain federal block grants contingent on their prohibiting any tobacco product manufacturer, retailer, or distributor from selling or distributing any such product to individuals under age 18, §300x-26(a)(1). This tobacco-specific legislation has created a specific regulatory scheme for addressing the problem of tobacco and health. And it was adopted against the backdrop of the FDA consistently and resolutely stating that it was without authority under the FDCA to regulate tobacco products as customarily marketed. In fact, Congress several times considered and rejected bills that would have given the FDA such authority. Indeed, Congress' actions in this area have evidenced a clear intent to preclude a meaningful policymaking role for any administrative agency. Further, Congress' tobacco legislation prohibits any additional regulation of tobacco product labeling with respect to tobacco's health consequences, a central aspect of regulation under the FDCA. Under these circumstances, it is evident that Congress has ratified the FDA's previous, long-held position that it lacks jurisdiction to regulate tobacco products as customarily marketed. Congress has created a distinct scheme for addressing the subject, and that scheme excludes any role for FDA regulation. Pp. 20-37.

(d) Finally, the Court's inquiry is shaped, at least in some measure, by the nature of the question presented. Chevron deference is premised on the theory that a statute's ambiguity constitutes an implicit delegation from Congress to the agency to fill in the statutory gaps. See 467 U.S., at 844. In extraordinary cases, however, there may be reason to hesitate before concluding that Congress has intended such an implicit delegation. This is hardly an ordinary case. Contrary to the agency's position from its inception until 1995, the FDA has now asserted jurisdiction to regulate an industry constituting a significant portion of the American economy. In fact, the FDA contends that, were it to determine that tobacco products provide no "reasonable assurance of safety," it would have the authority to ban cigarettes and smokeless tobacco entirely. It is highly unlikely that Congress would leave the determination as to whether the sale of tobacco products would be regulated, or even banned, to the FDA's discretion...

To continue reading

Request your trial
1627 practice notes
  • Railroad consolidations, mergers, and acquisitions of control: Safety integration plans,
    • United States
    • Federal Register March 15, 2002
    • March 15, 2002
    ...Pennsylvania v. Lynn, 501 F.2d 848, 857 (D.C. Cir. 1974); see also Food and Drug Administration v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 134 (2000) (a reviewing court should ``examin[e] a particular statutory provision * * * (in) context and with a view to [its] place in the o......
  • Part II
    • United States
    • Federal Register May 22, 2008
    • May 22, 2008
    ...(1969). Section 5904 is applicable only to VA and was amended in 2006. See Food and Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133 (2000). (``The meaning of one statute may be affected by other acts, particularly where Congress has spoken subsequently and more specif......
  • Part II
    • United States
    • Federal Register November 07, 2008
    • November 7, 2008
    ...this term in a reasonable fashion (``Chevron step two''). Chevron, 467 U.S. at 842-843; FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 132 We have determined that in enacting section 801(m) of the act, Congress did not clearly manifest its intention with respect to the meaning o......
  • Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Food facilities registration,
    • United States
    • Federal Register October 10, 2003
    • October 10, 2003
    ...be read in their context and with a view to their place in the overall statutory scheme.''' FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 121 (2000). Other parts of the registration provisions in section 415 of the FD&C Act indicate that Congress only intended businesses to......
  • Request a trial to view additional results
1576 cases
  • GRAHAM COUNTY SOIL, WATER v. US ex rel. Wilson, No. 08-304.
    • United States
    • United States Supreme Court
    • November 30, 2009
    ...must be read in their context and with a view to their place in the overall statutory scheme.'" FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133, 120 S.Ct. 1291, 146 L.Ed.2d 121 (2000) (quoting Davis v. Michigan Dept. of Treasury, 489 U.S. 803, 809, 109 S.Ct. 1500, 103 L.Ed.2d 891......
  • Shalom Pentecostal Church v. Acting Sec'y U.S. Dep't of Homeland Sec., No. 13–4434.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (3rd Circuit)
    • April 7, 2015
    ...and coherent regulatory scheme, and fit, if possible, all parts into an harmonious whole,” FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133, 120 S.Ct. 1291, 146 L.Ed.2d 121 (2000) (internal citation and quotation marks 783 F.3d 165omitted), we also may consider the broader statuto......
  • Inst. for Fisheries Res. v. Hahn, Case No. 16-cv-01574-VC
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Northern District of California
    • December 19, 2019
    ...of our laws rather than the principal concerns of our legislators by which we are governed." FDA v. Brown & Williamson Tobacco Corp. , 529 U.S. 120, 147, 120 S.Ct. 1291, 146 L.Ed.2d 121 (2000) (internal quotation marks omitted).Relying on a legal treatise, the plaintiffs suggest that a lite......
  • Golden Northwest Alum. v. Bonneville Power Admin., No. 03-73426.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (9th Circuit)
    • May 3, 2007
    ...a manner that is inconsistent with the administrative structure that Congress enacted into law.'" FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 125, 120 S.Ct. 1291, 146 L.Ed.2d 121 (2000) (quoting ETSI Pipeline Project v. Missouri, 484 U.S. 495, 517, 108 S.Ct. 805, 98 L.Ed.2d 898 (......
  • Request a trial to view additional results
13 firm's commentaries
  • Supreme Court Expands States' Ability To Recoup Future Medicaid Costs From Tort Recoveries
    • United States
    • Mondaq United States
    • June 17, 2022
    ...of the majority: Arkansas Dept. of Health and Human Servs. v. Ahlborn, 547 U. S. 268 (2006); FDA v. Brown & Williamson Tobacco Corp., 529 U. S. 120 (2000); National Assn. of Mfrs. v. Department of Defense, 583 U. S. ___, ___ (2018); Russello v. United States, 464 U. S. 16, 23 (1983); United......
  • Guest Post − No One Should Ever Rely on What Lohr Says about FDA Device Clearance
    • United States
    • LexBlog United States
    • September 9, 2022
    ...(B), (C). That is what the statute says, and what the Supreme Court has affirmed, in FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 134 (2000): “Regardless of which category FDA chooses, there must be a ‘reasonable assurance of the safety and effectiveness of the device’” Id. The cl......
  • Guest Post − No One Should Ever Rely on What Lohr Says about FDA Device Clearance
    • United States
    • LexBlog United States
    • September 9, 2022
    ...(B), (C). That is what the statute says, and what the Supreme Court has affirmed, in FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 134 (2000): “Regardless of which category FDA chooses, there must be a ‘reasonable assurance of the safety and effectiveness of the device’” Id. The cl......
  • West Virginia v. EPA: The Major Questions Doctrine Arrives to Rein in Administrative Power
    • United States
    • JD Supra United States
    • July 5, 2022
    ...a clear congressiona l directive. The cases included the FDA’s attempt to regu latetobacco (F DA v. Brown & Williamson Tobacco Co rp., 529 U.S. 120 (20 00), the CDC’s effo rt to issue aneviction moratorium dur ing the COVID-19 pandemic (Alabama Assn. of Rea ltors v. Dept. of Health &Human S......
  • Request a trial to view additional results
13 books & journal articles
  • Administering the National Environmental Policy Act
    • United States
    • Environmental Law Reporter Nbr. 45-4, April 2015
    • April 1, 2015
    ...weight” to an agency’s interpretation of its own regulation interpreting its statutes); FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 132-33 (2000) ( Chevron deference was denied to the Food & Drug Administration’s interpretation inferring jurisdictional authority from one statute ......
  • In Re L-a-c-: a Pragmatic Approach to the Burden of Proof and Corroborating Evidence in Asylum Proceedings
    • United States
    • Georgetown Immigration Law Journal Nbr. 35-1, October 2020
    • October 1, 2020
    ...government has no discretion 204. Wei Sun v. Sessions, 883 F.3d 23, 30 (2d Cir. 2018). 205. See FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133 (2000) (noting that courts must read the text of a statutory provision “in [its] context and with a view to [its] place in the overall s......
  • The Future of Administrative Law
    • United States
    • Environmental Law Reporter Nbr. 47-3, March 2017
    • March 1, 2017
    ...their place in the overall statutory scheme.’” King , 135 S. Ct. at 2483, quoting Food & Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133 (2000). 7. United States v. Texas , 136 S. Ct. 2271, 2272, reh’g denied , 137 S. Ct. 285, 196 L. Ed. 2d 206 (2016), concerned the const......
  • The Legal and Administrative Risks of Climate Regulation
    • United States
    • Environmental Law Reporter Nbr. 51-6, June 2021
    • June 1, 2021
    ...in ways that avoid the “absurd results” that would (2014) ( UARG )); see also Food & Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000). 23. UARG , 573 U.S. at 324 (quoting Brown & Williamson Tobacco , 529 U.S. at 159). 24. 549 U.S. 497, 37 ELR 20075 (2007). For a detailed......
  • Request a trial to view additional results

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