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

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120 OCTOBER TERM, 1999
Syllabus
FOOD AND DRUG ADMINISTRATION et al. v. BROWN
& WILLIAMSON TOBACCO CORP. et al.
certiorari to the united states court of appeals for
the fourth circuit
No. 98–1152. Argued December 1, 1999—Decided March 21, 2000
The Food, Drug, and Cosmetic Act (FDCA or Act), 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 regu-
late, among other items, “drugs” and “devices,” §§ 321(g)–(h), 393. In
1996, the FDA asserted jurisdiction to regulate tobacco products, con-
cluding that, under the FDCA, nicotine is a “drug” and cigarettes and
smokeless tobacco are “devices” that deliver nicotine to the body. Pur-
suant 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 annu-
ally, and that most adult smokers begin when they are minors. The
regulations therefore aim to reduce tobacco use by minors so as to sub-
stantially 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 Con-
gress has not granted the FDA jurisdiction to regulate tobacco prod-
ucts. The court concluded that construing the FDCA to include to-
bacco products would lead to several internal inconsistencies in the Act.
It also found that evidence external to the FDCA—that the FDA con-
sistently 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 Con-
gress’ subsequent tobacco-specific legislation, it is plain that Congress
has not given the FDA the authority to regulate tobacco products as
customarily marketed. Pp. 131–161.

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121 Cite as: 529 U. S. 120 (2000)
Syllabus
(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 Telecommunica-
tions Corp. v. American Telephone & Telegraph Co., 512 U. S. 218, 231.
Pp. 131–133.
(b) Considering the FDCA as a whole, it is clear that Congress in-
tended to exclude tobacco products from the FDA’s jurisdiction. A fun-
damental precept of the FDCA is that any product regulated by the
FDA that remains on the market must be safe and effective for its in-
tended 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 rule-
making proceeding, the FDA quite exhaustively documented that to-
bacco products are unsafe, dangerous, and cause great pain and suffer-
ing 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 smoke-
less tobacco. Its express policy is to protect commerce and the national
economy while informing consumers about any adverse health effects.

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122 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
Syllabus
See 15 U. S. C. § 1331. Thus, an FDA ban would plainly contradict con-
gressional 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 consum-
ers, 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 conclu-
sion is that there is no room for tobacco products within the FDCA’s
regulatory scheme. If they cannot be used safely for any therapeu-
tic purpose, and yet they cannot be banned, they simply do not fit.
Pp. 133–143.
(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 ad-
dressing the problem of tobacco use and human health. Those statutes,
among other things, require that health warnings appear on all packag-
ing 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 Communica-
tions Commission, see §§ 1335, 4402(f); require the Secretary of HHS
to report every three years to Congress on research findings concern-
ing tobacco’s addictive property, 42 U. S. C. § 290aa–2(b)(2); and make
States’ receipt of certain federal block grants contingent on their prohib-
iting 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 evi-
denced 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 rat-
ified the FDA’s previous, long-held position that it lacks jurisdiction to
regulate tobacco products as customarily marketed. Congress has

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123 Cite as: 529 U. S. 120 (2000)
Syllabus
created a distinct scheme for addressing the subject, and that scheme
excludes any role for FDA regulation. Pp. 143–159.
(d) Finally, the Court’s inquiry is shaped, at least in some measure,
by the nature of the question presented. Chevron deference is prem-
ised on the theory that a statute’s ambiguity constitutes an implicit dele-
gation 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 im-
plicit delegation. This is hardly an ordinary case. Contrary to the
agency’s position from its inception until 1995, the FDA has now as-
serted jurisdiction to regulate an industry constituting a significant por-
tion 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 regu-
lated, or even banned, to the FDA’s discretion in so cryptic a fashion.
See MCI Telecommunications, supra, at 231. Given tobacco’s unique
political history, as well as the breadth of the authority that the FDA
has asserted, the Court is obliged to defer not to the agency’s expansive
construction of the statute, but to Congress’ consistent judgment to
deny the FDA this power. Pp. 159–161.
(e) No matter how important, conspicuous, and controversial the
issue, and regardless of how likely the public is to hold the Executive
Branch politically accountable, an administrative agency’s power to reg-
ulate in the public interest must always be grounded in a valid grant of
authority from Congress. Courts must take care not to extend a stat-
ute’s scope beyond the point where Congress indicated it would stop.
E. g., United States v. Article of Drug . . . Bacto-Unidisk, 394 U. S. 784,
800. P. 161.
153 F. 3d 155, affirmed.
O’Connor, J., delivered the opinion of the Court, in which Rehnquist,
C. J., and Scalia, Kennedy, and Thomas, JJ., joined. Breyer, J., filed
a dissenting opinion, in which Stevens, Souter, and Ginsburg, JJ.,
joined, post, p. 161.
Solicitor General Waxman argued the cause for petition-
ers. With him on the briefs were Acting Assistant Attor-
ney General Ogden, Deputy Solicitor General Kneedler,
Deputy Assistant Attorney General Schultz, Irving L. Gorn-
stein, Eugene Thirolf, Douglas Letter, Gerald C. Kell, Chris-

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124 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
Counsel
tine N. Kohl, Margaret Jane Porter, Karen E. Schifter, and
Patricia J. Kaeding.
Richard M. Cooper argued the cause for respondents.
With him on the brief for respondent R. J. Reynolds Tobacco
Co. was Steven M. Umin. Andrew S. Krulwich, Bert W.
Rein, Thomas W. Kirby, and Michael L. Robinson filed a
brief for respondent Brown & Williamson Tobacco Corp.
Larry B. Sitton filed a brief for respondents United States
Tobacco Co. et al. William C. MacLeod filed a brief for re-
spondents National Association of Convenience Stores et al.
Peter T. Grossi, Jr., Arthur N. Levine, Jeff Richman, Rich-
ard A. Merrill, and Herbert Dym filed a brief for respond-
ents Philip Morris Inc. et al.*
*Briefs of amici curiae urging reversal were filed for the State of Min-
nesota et al. by Mike Hatch, Attorney General of Minnesota, James S.
Alexander, Assistant Attorney General, Louise H. Renne, and by the At-
torneys General for their respective States as follows: Bruce M. Botelho
of Alaska, Janet Napolitano of Arizona, Mark Pryor of Arkansas, Bill
Lockyer of California, Ken Salazar of Colorado, Richard Blumenthal of
Connecticut, Robert A. Butterworth of Florida, Earl I. Anzai of Hawaii,
Alan G. Lance of Idaho, James E. Ryan of Illinois, Jeffrey A. Modisett of
Indiana, Thomas J. Miller of Iowa, Carla J. Stovall of Kansas, Andrew
Ketterer of Maine, J. Joseph Curran, Jr., of Maryland, Thomas F. Reilly
of Massachusetts, Jennifer M. Granholm of Michigan, Mike Moore of Mis-
sissippi, Jeremiah W. Nixon of Missouri, Joseph P. Mazurek of Montana,
Frankie Sue Del Papa of Nevada, Philip T. McLaughlin of New Hamp-
shire, John J. Farmer, Jr., of New Jersey, Patricia A. Madrid of New
Mexico, Eliot Spitzer of New York, Heidi Heitkamp of North Dakota,
Betty D. Montgomery of Ohio, W. A. Drew Edmondson of Oklahoma,
Hardy Myers of Oregon, D. Michael Fisher of Pennsylvania, Sheldon
Whitehouse of Rhode Island, Mark Barnett of South Dakota, John Cornyn
of Texas, Jan Graham of Utah, William H. Sorrell of Vermont, Christine
O. Gregoire of Washington, Darrell V. McGraw, Jr., of West Virginia,
James E. Doyle of Wisconsin, and Gay Woodhouse of Wyoming; for Action
on Smoking and Health by John F. Banzhaf III and Kathleen E. Scheg;
for the American Cancer Society, Inc., by Russell E. Brooks, David R.
Gelfand, Charles W. Westland, and William J. Dalton; for the American

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125 Cite as: 529 U. S. 120 (2000)
Opinion of the Court
Justice O’Connor delivered the opinion of the Court.
This case involves one of the most troubling public health
problems facing our Nation today: the thousands of prema-
ture deaths that occur each year because of tobacco use. In
1996, the Food and Drug Administration (FDA), after having
expressly disavowed any such authority since its inception,
asserted jurisdiction to regulate tobacco products. See 61
Fed. Reg. 44619–45318. The FDA concluded that nicotine is
a “drug” within the meaning of the Food, Drug, and Cos-
metic Act (FDCA or Act), 52 Stat. 1040, as amended, 21
U. S. C. § 301 et seq., and that cigarettes and smokeless to-
bacco are “combination products” that deliver nicotine to the
body. 61 Fed. Reg. 44397 (1996). Pursuant to this author-
ity, it promulgated regulations intended to reduce tobacco
consumption among children and adolescents. Id., at 44615–
44618. The agency believed that, because most tobacco
consumers begin their use before reaching the age of 18,
curbing tobacco use by minors could substantially reduce
the prevalence of addiction in future generations and thus
the incidence of tobacco-related death and disease. Id., at
44398–44399.
Regardless of how serious the problem an administrative
agency seeks to address, however, it may not exercise its
authority “in a manner that is inconsistent with the adminis-
trative structure that Congress enacted into law.” ETSI
Pipeline Project v. Missouri, 484 U. S. 495, 517 (1988). And
although agencies are generally entitled to deference in the
interpretation of statutes that they administer, a reviewing
“court, as well as the agency, must give effect to the unam-
College of Chest Physicians by Raymond D. Cotton; and for Public Citizen,
Inc., et al. by Allison M. Zieve, Alan B. Morrison, and David C. Vladeck.
Briefs of amici curiae urging affirmance were filed for the Pacific Legal
Foundation by Anne M. Hayes and M. Reed Hopper; for the Product Lia-
bility Advisory Council, Inc., by Kenneth S. Geller; and for the Washington
Legal Foundation et al. by Daniel J. Popeo and Richard A. Samp.

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126 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
Opinion of the Court
biguously expressed intent of Congress.” Chevron U. S. A.
Inc. v. Natural Resources Defense Council, Inc., 467 U. S.
837, 842–843 (1984). In this case, we believe that Congress
has clearly precluded the FDA from asserting jurisdiction
to regulate tobacco products. Such authority is inconsistent
with the intent that Congress has expressed in the FDCA’s
overall regulatory scheme and in the tobacco-specific legisla-
tion that it has enacted subsequent to the FDCA. In light
of this clear intent, the FDA’s assertion of jurisdiction is
impermissible.
I
The FDCA grants the FDA, as the designee of the Secre-
tary of Health and Human Services (HHS), the authority to
regulate, among other items, “drugs” and “devices.” See 21
U. S. C. §§ 321(g)–(h), 393 (1994 ed. and Supp. III). The Act
defines “drug” to include “articles (other than food) intended
to affect the structure or any function of the body.” 21
U. S. C. § 321(g)(1)(C). It defines “device,” in part, as “an
instrument, apparatus, implement, machine, contrivance, . . .
or other similar or related article, including any component,
part, or accessory, which is . . . intended to affect the struc-
ture or any function of the body.” § 321(h). The Act also
grants the FDA the authority to regulate so-called “combi-
nation products,” which “constitute a combination of a drug,
device, or biological product.” § 353(g)(1). The FDA has
construed this provision as giving it the discretion to regu-
late combination products as drugs, as devices, or as both.
See 61 Fed. Reg. 44400 (1996).
On August 11, 1995, the FDA published a proposed rule
concerning the sale of cigarettes and smokeless tobacco to
children and adolescents. 60 Fed. Reg. 41314–41787. The
rule, which included several restrictions on the sale, distribu-
tion, and advertisement of tobacco products, was designed to
reduce the availability and attractiveness of tobacco products
to young people. Id., at 41314. A public comment period
followed, during which the FDA received over 700,000 sub-

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127 Cite as: 529 U. S. 120 (2000)
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missions, more than “at any other time in its history on any
other subject.” 61 Fed. Reg. 44418 (1996).
On August 28, 1996, the FDA issued a final rule entitled
“Regulations Restricting the Sale and Distribution of Ciga-
rettes and Smokeless Tobacco to Protect Children and Ado-
lescents.” Id., at 44396. The FDA determined that nico-
tine is a “drug” and that cigarettes and smokeless tobacco
are “drug delivery devices,” and therefore it had jurisdiction
under the FDCA to regulate tobacco products as customarily
marketed—that is, without manufacturer claims of therapeu-
tic benefit. Id., at 44397, 44402. First, the FDA found that
tobacco products “ ‘affect the structure or any function of
the body’ ” because nicotine “has significant pharmacological
effects.” Id., at 44631. Specifically, nicotine “exerts psy-
choactive, or mood-altering, effects on the brain” that cause
and sustain addiction, have both tranquilizing and stimulat-
ing effects, and control weight. Id., at 44631–44632. Sec-
ond, the FDA determined that these effects were “intended”
under the FDCA because they “are so widely known and
foreseeable that [they] may be deemed to have been intended
by the manufacturers,” id., at 44687; consumers use tobacco
products “predominantly or nearly exclusively” to obtain
these effects, id., at 44807; and the statements, research, and
actions of manufacturers revealed that they “have ‘designed’
cigarettes to provide pharmacologically active doses of nico-
tine to consumers,” id., at 44849. Finally, the agency con-
cluded that cigarettes and smokeless tobacco are “combina-
tion products” because, in addition to containing nicotine,
they include device components that deliver a controlled
amount of nicotine to the body, id., at 45208–45216.
Having resolved the jurisdictional question, the FDA next
explained the policy justifications for its regulations, detail-
ing the deleterious health effects associated with tobacco
use. It found that tobacco consumption was “the single
leading cause of preventable death in the United States.”
Id., at 44398. According to the FDA, “[m]ore than 400,000

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128 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
Opinion of the Court
people die each year from tobacco-related illnesses, such
as cancer, respiratory illnesses, and heart disease.” Ibid.
The agency also determined that the only way to reduce the
amount of tobacco-related illness and mortality was to re-
duce the level of addiction, a goal that could be accomplished
only by preventing children and adolescents from starting to
use tobacco. Id., at 44398–44399. The FDA found that 82%
of adult smokers had their first cigarette before the age of
18, and more than half had already become regular smokers
by that age. Id., at 44398. It also found that children were
beginning to smoke at a younger age, that the prevalence
of youth smoking had recently increased, and that similar
problems existed with respect to smokeless tobacco. Id., at
44398–44399. The FDA accordingly concluded that if “the
number of children and adolescents who begin tobacco use
can be substantially diminished, tobacco-related illness can
be correspondingly reduced because data suggest that any-
one who does not begin smoking in childhood or adolescence
is unlikely ever to begin.” Id., at 44399.
Based on these findings, the FDA promulgated regulations
concerning tobacco products’ promotion, labeling, and acces-
sibility to children and adolescents. See id., at 44615–44618.
The access regulations prohibit the sale of cigarettes or
smokeless tobacco to persons younger than 18; require retail-
ers to verify through photo identification the age of all pur-
chasers younger than 27; prohibit the sale of cigarettes in
quantities smaller than 20; prohibit the distribution of free
samples; and prohibit sales through self-service displays and
vending machines except in adult-only locations. Id., at
44616–44617. The promotion regulations require that any
print advertising appear in a black-and-white, text-only for-
mat unless the publication in which it appears is read almost
exclusively by adults; prohibit outdoor advertising within
1,000 feet of any public playground or school; prohibit the
distribution of any promotional items, such as T-shirts or
hats, bearing the manufacturer’s brand name; and prohibit a

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manufacturer from sponsoring any athletic, musical, artistic,
or other social or cultural event using its brand name. Id.,
at 44617–44618. The labeling regulation requires that the
statement, “A Nicotine-Delivery Device for Persons 18 or
Older,” appear on all tobacco product packages. Id., at
44617.
The FDA promulgated these regulations pursuant to its
authority to regulate “restricted devices.” See 21 U. S. C.
§ 360j(e). The FDA construed § 353(g)(1) as giving it the
discretion to regulate “combination products” using the Act’s
drug authorities, device authorities, or both, depending on
“how the public health goals of the act can be best accom-
plished.” 61 Fed. Reg. 44403 (1996). Given the greater
flexibility in the FDCA for the regulation of devices, the
FDA determined that “the device authorities provide the
most appropriate basis for regulating cigarettes and smoke-
less tobacco.” Id., at 44404. Under 21 U. S. C. § 360j(e), the
agency may “require that a device be restricted to sale, dis-
tribution, or use . . . upon such other conditions as [the FDA]
may prescribe in such regulation, if, because of its potential-
ity for harmful effect or the collateral measures necessary to
its use, [the FDA] determines that there cannot otherwise
be reasonable assurance of its safety and effectiveness.”
The FDA reasoned that its regulations fell within the au-
thority granted by § 360j(e) because they related to the sale
or distribution of tobacco products and were necessary for
providing a reasonable assurance of safety. 61 Fed. Reg.
44405–44407 (1996).
Respondents, a group of tobacco manufacturers, retailers,
and advertisers, filed suit in United States District Court for
the Middle District of North Carolina challenging the regula-
tions. See Coyne Beahm, Inc. v. FDA, 966 F. Supp. 1374
(1997). They moved for summary judgment on the grounds
that the FDA lacked jurisdiction to regulate tobacco prod-
ucts as customarily marketed, the regulations exceeded the
FDA’s authority under 21 U. S. C. § 360j(e), and the advertis-

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130 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
Opinion of the Court
ing restrictions violated the First Amendment. Second
Brief in Support of Plaintiffs’ Motion for Summary Judgment
in No. 2:95CV00591 (MDNC), in 3 Rec. in No. 97–1604 (CA4),
Tab No. 40; Third Brief in Support of Plaintiffs’ Motion
for Summary Judgment in No. 2:95CV00591 (MDNC), in 3
Rec. in No. 97–1604 (CA4), Tab No. 42. The District Court
granted respondents’ motion in part and denied it in part.
966 F. Supp., at 1400. The court held that the FDCA au-
thorizes the FDA to regulate tobacco products as custom-
arily marketed and that the FDA’s access and labeling regu-
lations are permissible, but it also found that the agency’s
advertising and promotion restrictions exceed its author-
ity under § 360j(e). Id., at 1380–1400. The court stayed im-
plementation of the regulations it found valid (except the
prohibition on the sale of tobacco products to minors) and
certified its order for immediate interlocutory appeal. Id.,
at 1400–1401.
The Court of Appeals for the Fourth Circuit reversed,
holding that Congress has not granted the FDA jurisdiction
to regulate tobacco products. See 153 F. 3d 155 (1998). Ex-
amining the FDCA as a whole, the court concluded that the
FDA’s regulation of tobacco products would create a number
of internal inconsistencies. Id., at 162–167. Various provi-
sions of the Act require the agency to determine that any
regulated product is “safe” before it can be sold or allowed to
remain on the market, yet the FDA found in its rulemaking
proceeding that tobacco products are “dangerous” and “un-
safe.” Id., at 164–167. Thus, the FDA would apparently
have to ban tobacco products, a result the court found clearly
contrary to congressional intent. Ibid. This apparent
anomaly, the Court of Appeals concluded, demonstrates that
Congress did not intend to give the FDA authority to regu-
late tobacco. Id., at 167. The court also found that evi-
dence external to the FDCA confirms this conclusion. Im-
portantly, the FDA consistently stated before 1995 that it
lacked jurisdiction over tobacco, and Congress has enacted

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131 Cite as: 529 U. S. 120 (2000)
Opinion of the Court
several tobacco-specific statutes fully cognizant of the FDA’s
position. See id., at 168–176. In fact, the court reasoned,
Congress has considered and rejected many bills that would
have given the agency such authority. See id., at 170–171.
This, along with the absence of any intent by the enacting
Congress in 1938 to subject tobacco products to regulation
under the FDCA, demonstrates that Congress intended to
withhold such authority from the FDA. Id., at 167–176.
Having resolved the jurisdictional question against the
agency, the Court of Appeals did not address whether the
regulations exceed the FDA’s authority under 21 U. S. C.
§ 360j(e) or violate the First Amendment. See 153 F. 3d, at
176, n. 29.
We granted the federal parties’ petition for certiorari, 526
U. S. 1086 (1999), to determine whether the FDA has author-
ity under the FDCA to regulate tobacco products as custom-
arily marketed.
II
The FDA’s assertion of jurisdiction to regulate tobacco
products is founded on its conclusions that nicotine is a
“drug” and that cigarettes and smokeless tobacco are “drug
delivery devices.” Again, the FDA found that tobacco prod-
ucts are “intended” to deliver the pharmacological effects
of satisfying addiction, stimulation and tranquilization, and
weight control because those effects are foreseeable to any
reasonable manufacturer, consumers use tobacco products
to obtain those effects, and tobacco manufacturers have de-
signed their products to produce those effects. 61 Fed. Reg.
44632–44633 (1996). As an initial matter, respondents take
issue with the FDA’s reading of “intended,” arguing that it
is a term of art that refers exclusively to claims made by the
manufacturer or vendor about the product. See Brief for
Respondent Brown & Williamson Tobacco Corp. 6. That is,
a product is not a drug or device under the FDCA unless the
manufacturer or vendor makes some express claim concern-
ing the product’s therapeutic benefits. See id., at 6–7. We

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132 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
Opinion of the Court
need not resolve this question, however, because assuming,
arguendo, that a product can be “intended to affect the struc-
ture or any function of the body” absent claims of therapeutic
or medical benefit, the FDA’s claim to jurisdiction contra-
venes the clear intent of Congress.
A threshold issue is the appropriate framework for ana-
lyzing the FDA’s assertion of authority to regulate tobacco
products. Because this case involves an administrative
agency’s construction of a statute that it administers, our
analysis is governed by Chevron U. S. A. Inc. v. Natural Re-
sources Defense Council, Inc., 467 U. S. 837 (1984). Under
Chevron, a reviewing court must first ask “whether Con-
gress has directly spoken to the precise question at issue.”
Id., at 842. If Congress has done so, the inquiry is at an
end; the court “must give effect to the unambiguously ex-
pressed intent of Congress.” Id., at 843; see also United
States v. Haggar Apparel Co., 526 U. S. 380, 392 (1999); Holly
Farms Corp. v. NLRB, 517 U. S. 392, 398 (1996). But if Con-
gress has not specifically addressed the question, a reviewing
court must respect the agency’s construction of the statute
so long as it is permissible. See INS v. Aguirre-Aguirre,
526 U. S. 415, 424 (1999); Auer v. Robbins, 519 U. S. 452, 457
(1997). Such deference is justified because “[t]he responsi-
bilities for assessing the wisdom of such policy choices and
resolving the struggle between competing views of the pub-
lic interest are not judicial ones,” Chevron, supra, at 866, and
because of the agency’s greater familiarity with the ever-
changing facts and circumstances surrounding the subjects
regulated, see Rust v. Sullivan, 500 U. S. 173, 187 (1991).
In determining whether Congress has specifically ad-
dressed the question at issue, a reviewing court should not
confine itself to examining a particular statutory provision
in isolation. The meaning—or ambiguity—of certain words
or phrases may only become evident when placed in context.
See Brown v. Gardner, 513 U. S. 115, 118 (1994) (“Ambiguity
is a creature not of definitional possibilities but of statutory

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context”). It is a “fundamental canon of statutory construc-
tion that the words of a statute must be read in their context
and with a view to their place in the overall statutory
scheme.” Davis v. Michigan Dept. of Treasury, 489 U. S.
803, 809 (1989). A court must therefore interpret the stat-
ute “as a symmetrical and coherent regulatory scheme,”
Gustafson v. Alloyd Co., 513 U. S. 561, 569 (1995), and “fit, if
possible, all parts into an harmonious whole,” FTC v. Mandel
Brothers, Inc., 359 U. S. 385, 389 (1959). Similarly, the
meaning of one statute may be affected by other Acts, partic-
ularly where Congress has spoken subsequently and more
specifically to the topic at hand. See United States v. Estate
of Romani, 523 U. S. 517, 530–531 (1998); United States v.
Fausto, 484 U. S. 439, 453 (1988). In addition, we 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 (1994).
With these principles in mind, we find that Congress has
directly spoken to the issue here and precluded the FDA’s
jurisdiction to regulate tobacco products.
A
Viewing the FDCA as a whole, it is evident that one of the
Act’s core objectives is to ensure that any product regulated
by the FDA is “safe” and “effective” for its intended use.
See 21 U. S. C. § 393(b)(2) (1994 ed., Supp. III) (defining the
FDA’s mission); More Information for Better Patient Care:
Hearing before the Senate Committee on Labor and Human
Resources, 104th Cong., 2d Sess., 83 (1996) (statement of
FDA Deputy Comm’r Schultz) (“A fundamental precept of
drug and device regulation in this country is that these prod-
ucts must be proven safe and effective before they can be
sold”). This essential purpose pervades the FDCA. For
instance, 21 U. S. C. § 393(b)(2) (1994 ed., Supp. III) defines

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134 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
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the FDA’s “[m]ission” to include “protect[ing] the public
health by ensuring that . . . drugs are safe and effective”
and that “there is reasonable assurance of the safety and
effectiveness of devices intended for human use.” The
FDCA requires premarket approval of any new drug, with
some limited exceptions, and states that the FDA “shall
issue an order refusing to approve the application” of a new
drug if it is not safe and effective for its intended purpose.
§§ 355(d)(1)–(2), (4)–(5). If the FDA discovers after approval
that a drug is unsafe or ineffective, it “shall, after due notice
and opportunity for hearing to the applicant, withdraw ap-
proval” of the drug. 21 U. S. C. §§ 355(e)(1)–(3). The Act
also requires the FDA to classify all devices into one of three
categories. § 360c(b)(1). Regardless of which category the
FDA chooses, there must be a “reasonable assurance of
the safety and effectiveness of the device.” 21 U. S. C.
§§ 360c(a)(1)(A)(i), (B), (C) (1994 ed. and Supp. III); 61 Fed.
Reg. 44412 (1996). Even the “restricted device” provision
pursuant to which the FDA promulgated the regulations at
issue here authorizes the agency to place conditions on the
sale or distribution of a device specifically when “there can-
not otherwise be reasonable assurance of its safety and effec-
tiveness.” 21 U. S. C. § 360j(e). Thus, the Act generally re-
quires the FDA to prevent the marketing of any drug or
device where the “potential for inflicting death or physical
injury is not offset by the possibility of therapeutic benefit.”
United States v. Rutherford, 442 U. S. 544, 556 (1979).
In its rulemaking proceeding, the FDA quite exhaustively
documented that “tobacco products are unsafe,” “danger-
ous,” and “cause great pain and suffering from illness.” 61
Fed. Reg. 44412 (1996). It found that the consumption of
tobacco products presents “extraordinary health risks,” and
that “tobacco use is the single leading cause of preventable
death in the United States.” Id., at 44398. It stated that
“[m]ore than 400,000 people die each year from tobacco-
related illnesses, such as cancer, respiratory illnesses, and

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heart disease, often suffering long and painful deaths,” and
that “[t]obacco alone kills more people each year in the
United States than acquired immunodeficiency syndrome
(AIDS), car accidents, alcohol, homicides, illegal drugs, sui-
cides, and fires, combined.” Ibid. Indeed, the FDA charac-
terized smoking as “a pediatric disease,” id., at 44421, be-
cause “one out of every three young people who become
regular smokers . . . will die prematurely as a result,” id.,
at 44399.
These findings logically imply that, if tobacco products
were “devices” under the FDCA, the FDA would be required
to remove them from the market. Consider, first, the
FDCA’s provisions concerning the misbranding of drugs or
devices. The Act prohibits “[t]he introduction or delivery
for introduction into interstate commerce of any food, drug,
device, or cosmetic that is adulterated or misbranded.” 21
U. S. C. § 331(a). In light of the FDA’s findings, two distinct
FDCA provisions would render cigarettes and smokeless to-
bacco misbranded devices. First, § 352( j) deems a drug or
device misbranded “[i]f it is dangerous to health when used
in the dosage or manner, or with the frequency or duration
prescribed, recommended, or suggested in the labeling
thereof.” The FDA’s findings make clear that tobacco prod-
ucts are “dangerous to health” when used in the manner pre-
scribed. Second, a drug or device is misbranded under the
Act “[u]nless its labeling bears . . . adequate directions for
use . . . in such manner and form, as are necessary for
the protection of users,” except where such directions are
“not necessary for the protection of the public health.”
§ 352(f)(1). Given the FDA’s conclusions concerning the
health consequences of tobacco use, there are no directions
that could adequately protect consumers. That is, there are
no directions that could make tobacco products safe for ob-
taining their intended effects. Thus, were tobacco products
within the FDA’s jurisdiction, the Act would deem them mis-
branded devices that could not be introduced into interstate

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136 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
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commerce. Contrary to the dissent’s contention, the Act ad-
mits no remedial discretion once it is evident that the device
is misbranded.
Second, the FDCA requires the FDA to place all devices
that it regulates into one of three classifications. See
§ 360c(b)(1). The agency relies on a device’s classification in
determining the degree of control and regulation necessary
to ensure that there is “a reasonable assurance of safety and
effectiveness.” 61 Fed. Reg. 44412 (1996). The FDA has
yet to classify tobacco products. Instead, the regulations at
issue here represent so-called “general controls,” which the
Act entitles the agency to impose in advance of classification.
See id., at 44404–44405. Although the FDCA prescribes no
deadline for device classification, the FDA has stated that it
will classify tobacco products “in a future rulemaking” as
required by the Act. Id., at 44412. Given the FDA’s find-
ings regarding the health consequences of tobacco use, the
agency would have to place cigarettes and smokeless tobacco
in Class III because, even after the application of the Act’s
available controls, they would “presen[t] a potential unrea-
sonable risk of illness or injury.” 21 U. S. C. § 360c(a)(1)(C).
As Class III devices, tobacco products would be subject to
the FDCA’s premarket approval process. See 21 U. S. C.
§ 360c(a)(1)(C) (1994 ed., Supp. III); 21 U. S. C. § 360e; 61
Fed. Reg. 44412 (1996). Under these provisions, the FDA
would be prohibited from approving an application for pre-
market approval without “a showing of reasonable assurance
that such device is safe under the conditions of use pre-
scribed, recommended, or suggested in the proposed labeling
thereof.” 21 U. S. C. § 360e(d)(2)(A). In view of the FDA’s
conclusions regarding the health effects of tobacco use, the
agency would have no basis for finding any such reasonable
assurance of safety. Thus, once the FDA fulfilled its statu-
tory obligation to classify tobacco products, it could not allow
them to be marketed.

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The FDCA’s misbranding and device classification provi-
sions therefore make evident that were the FDA to regulate
cigarettes and smokeless tobacco, the Act would require the
agency to ban them. In fact, based on these provisions, the
FDA itself has previously taken the position that if tobacco
products were within its jurisdiction, “they would have to
be removed from the market because it would be impossi-
ble to prove they were safe for their intended us[e].” Pub-
lic Health Cigarette Amendments of 1971: Hearings before
the Commerce Subcommittee on S. 1454, 92d Cong., 2d Sess.,
239 (1972) (hereinafter 1972 Hearings) (statement of FDA
Comm’r Charles Edwards). See also Cigarette Labeling
and Advertising: Hearings before the House Committee on
Interstate and Foreign Commerce, 88th Cong., 2d Sess., 18
(1964) (hereinafter 1964 Hearings) (statement of Dept. of
Health, Education, and Welfare (HEW) Secretary Anthony
Celebrezze that proposed amendments to the FDCA that
would have given the FDA jurisdiction over “smoking prod-
uct[s]” “might well completely outlaw at least cigarettes”).
Congress, however, has foreclosed the removal of tobacco
products from the market. A provision of the United States
Code currently in force states that “[t]he marketing of to-
bacco constitutes one of the greatest basic industries of the
United States with ramifying activities which directly affect
interstate and foreign commerce at every point, and stable
conditions therein are necessary to the general welfare.” 7
U. S. C. § 1311(a). More importantly, Congress has directly
addressed the problem of tobacco and health through legisla-
tion on six occasions since 1965. See Federal Cigarette La-
beling and Advertising Act (FCLAA), Pub. L. 89–92, 79 Stat.
282; Public Health Cigarette Smoking Act of 1969, Pub. L.
91–222, 84 Stat. 87; Alcohol and Drug Abuse Amendments of
1983, Pub. L. 98–24, 97 Stat. 175; Comprehensive Smoking
Education Act, Pub. L. 98–474, 98 Stat. 2200; Comprehensive
Smokeless Tobacco Health Education Act of 1986, Pub. L.
99–252, 100 Stat. 30; Alcohol, Drug Abuse, and Mental

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138 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
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Health Administration Reorganization Act, Pub. L. 102–321,
§ 202, 106 Stat. 394. When Congress enacted these statutes,
the adverse health consequences of tobacco use were well
known, as were nicotine’s pharmacological effects. See, e. g.,
U. S. Dept. of Health, Education, and Welfare, U. S. Surgeon
General’s Advisory Committee, Smoking and Health 25–40,
69–75 (1964) (hereinafter 1964 Surgeon General’s Report)
(concluding that cigarette smoking causes lung cancer, coro-
nary artery disease, and chronic bronchitis and emphysema,
and that nicotine has various pharmacological effects, includ-
ing stimulation, tranquilization, and appetite suppression);
U. S. Dept. of Health and Human Services, Public Health
Service, Health Consequences of Smoking for Women 7–12
(1980) (finding that mortality rates for lung cancer, chronic
lung disease, and coronary heart disease are increased for
both women and men smokers, and that smoking during
pregnancy is associated with significant adverse health ef-
fects on the unborn fetus and newborn child); U. S. Dept.
of Health and Human Services, Public Health Service, Why
People Smoke Cigarettes (1983), in Smoking Prevention Ed-
ucation Act, Hearings on H. R. 1824 before the Subcommittee
on Health and the Environment of the House Committee on
Energy and Commerce, 98th Cong., 1st Sess., 32–37 (1983)
(hereinafter 1983 House Hearings) (stating that smoking is
“the most widespread example of drug dependence in our
country,” and that cigarettes “affect the chemistry of the
brain and nervous system”); U. S. Dept. of Health and Human
Services, Public Health Service, The Health Consequences of
Smoking: Nicotine Addiction 6–9, 145–239 (1988) (herein-
after 1988 Surgeon General’s Report) (concluding that to-
bacco products are addicting in much the same way as heroin
and cocaine, and that nicotine is the drug that causes addic-
tion). Nonetheless, Congress stopped well short of ordering
a ban. Instead, it has generally regulated the labeling and
advertisement of tobacco products, expressly providing that
it is the policy of Congress that “commerce and the national

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economy may be . . . protected to the maximum extent con-
sistent with” consumers “be[ing] adequately informed about
any adverse health effects.” 15 U. S. C. § 1331. Congress’
decisions to regulate labeling and advertising and to adopt
the express policy of protecting “commerce and the national
economy . . . to the maximum extent” reveal its intent that
tobacco products remain on the market. Indeed, the collec-
tive premise of these statutes is that cigarettes and smoke-
less tobacco will continue to be sold in the United States. A
ban of tobacco products by the FDA would therefore plainly
contradict congressional policy.
The FDA apparently recognized this dilemma and con-
cluded, somewhat ironically, that tobacco products are ac-
tually “safe” within the meaning of the FDCA. In promul-
gating its regulations, the agency conceded that “tobacco
products are unsafe, as that term is conventionally under-
stood.” 61 Fed. Reg. 44412 (1996). Nonetheless, the FDA
reasoned that, in determining whether a device is safe under
the Act, it must consider “not only the risks presented by a
product but also any of the countervailing effects of use of
that product, including the consequences of not permitting
the product to be marketed.” Id., at 44412–44413. Apply-
ing this standard, the FDA found that, because of the high
level of addiction among tobacco users, a ban would likely be
“dangerous.” Id., at 44413. In particular, current tobacco
users could suffer from extreme withdrawal, the health care
system and available pharmaceuticals might not be able to
meet the treatment demands of those suffering from with-
drawal, and a black market offering cigarettes even more
dangerous than those currently sold legally would likely de-
velop. Ibid. The FDA therefore concluded that, “while
taking cigarettes and smokeless tobacco off the market could
prevent some people from becoming addicted and reduce
death and disease for others, the record does not establish
that such a ban is the appropriate public health response
under the act.” Id., at 44398.

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140 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
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It may well be, as the FDA asserts, that “these factors
must be considered when developing a regulatory scheme
that achieves the best public health result for these prod-
ucts.” Id., at 44413. But the FDA’s judgment that leaving
tobacco products on the market “is more effective in achiev-
ing public health goals than a ban,” ibid., is no substitute for
the specific safety determinations required by the FDCA’s
various operative provisions. Several provisions in the Act
require the FDA to determine that the product itself is safe
as used by consumers. That is, the product’s probable ther-
apeutic benefits must outweigh its risk of harm. See United
States v. Rutherford, 442 U. S., at 555 (“[T]he Commissioner
generally considers a drug safe when the expected therapeu-
tic gain justifies the risk entailed by its use”). In contrast,
the FDA’s conception of safety would allow the agency, with
respect to each provision of the FDCA that requires the
agency to determine a product’s “safety” or “dangerousness,”
to compare the aggregate health effects of alternative admin-
istrative actions. This is a qualitatively different inquiry.
Thus, although the FDA has concluded that a ban would be
“dangerous,” it has not concluded that tobacco products are
“safe” as that term is used throughout the Act.
Consider 21 U. S. C. § 360c(a)(2), which specifies those fac-
tors that the FDA may consider in determining the safety
and effectiveness of a device for purposes of classification,
performance standards, and premarket approval. For all
devices regulated by the FDA, there must at least be a “rea-
sonable assurance of the safety and effectiveness of the de-
vice.” See 21 U. S. C. §§ 360c(a)(1)(A)(i), (B), (C) (1994 ed.
and Supp. III); 61 Fed. Reg. 44412 (1996). Title 21 U. S. C.
§ 360c(a)(2) provides that
“the safety and effectiveness of a device are to be
determined—
“(A) with respect to the persons for whose use the
device is represented or intended,

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“(B) with respect to the conditions of use prescribed,
recommended, or suggested in the labeling of the de-
vice, and
“(C) weighing any probable benefit to health from the
use of the device against any probable risk of injury or
illness from such use.”
A straightforward reading of this provision dictates that the
FDA must weigh the probable therapeutic benefits of the
device to the consumer against the probable risk of injury.
Applied to tobacco products, the inquiry is whether their
purported benefits—satisfying addiction, stimulation and
sedation, and weight control—outweigh the risks to health
from their use. To accommodate the FDA’s conception of
safety, however, one must read “any probable benefit to
health” to include the benefit to public health stemming from
adult consumers’ continued use of tobacco products, even
though the reduction of tobacco use is the raison d’eˆtre of
the regulations. In other words, the FDA is forced to con-
tend that the very evil it seeks to combat is a “benefit to
health.” This is implausible.
The FDA’s conception of safety is also incompatible with
the FDCA’s misbranding provision. Again, § 352( j) pro-
vides that a product is “misbranded” if “it is dangerous to
health when used in the dosage or manner, or with the fre-
quency or duration prescribed, recommended, or suggested
in the labeling thereof.” According to the FDA’s under-
standing, a product would be “dangerous to health,” and
therefore misbranded under § 352( j), when, in comparison to
leaving the product on the market, a ban would not produce
“adverse health consequences” in aggregate. Quite simply,
these are different inquiries. Although banning a particular
product might be detrimental to public health in aggregate,
the product could still be “dangerous to health” when used
as directed. Section 352( j) focuses on dangers to the con-
sumer from use of the product, not those stemming from the
agency’s remedial measures.

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Consequently, the analogy made by the FDA and the dis-
sent to highly toxic drugs used in the treatment of various
cancers is unpersuasive. See 61 Fed. Reg. 44413 (1996);
post, at 177 (opinion of Breyer, J.). Although “dangerous”
in some sense, these drugs are safe within the meaning of
the Act because, for certain patients, the therapeutic benefits
outweigh the risk of harm. Accordingly, such drugs cannot
properly be described as “dangerous to health” under 21
U. S. C. § 352( j). The same is not true for tobacco products.
As the FDA has documented in great detail, cigarettes and
smokeless tobacco are an unsafe means to obtaining any
pharmacological effect.
The dissent contends that our conclusion means that “the
FDCA requires the FDA to ban outright ‘dangerous’ drugs
or devices,” post, at 174, and that this is a “perverse” reading
of the statute, post, at 174, 180. This misunderstands our
holding. The FDA, consistent with the FDCA, may clearly
regulate many “dangerous” products without banning them.
Indeed, virtually every drug or device poses dangers under
certain conditions. What the FDA may not do is conclude
that a drug or device cannot be used safely for any therapeu-
tic purpose and yet, at the same time, allow that product to
remain on the market. Such regulation is incompatible with
the FDCA’s core objective of ensuring that every drug or
device is safe and effective.
Considering the FDCA as a whole, it is clear that Con-
gress intended to exclude tobacco products from the FDA’s
jurisdiction. A fundamental precept of the FDCA is that
any product regulated by the FDA—but not banned—must
be safe for its intended use. Various provisions of the Act
make clear that this refers to the safety of using the product
to obtain its intended effects, not the public health ramifica-
tions of alternative administrative actions by the FDA.
That is, the FDA must determine that there is a reasonable
assurance that the product’s therapeutic benefits outweigh
the risk of harm to the consumer. According to this stand-

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ard, the FDA has concluded that, although tobacco products
might be effective in delivering certain pharmacological ef-
fects, they are “unsafe” and “dangerous” when used for these
purposes. Consequently, if tobacco products were within
the FDA’s jurisdiction, the Act would require the FDA to
remove them from the market entirely. But a ban would
contradict Congress’ clear intent as expressed in its more
recent, tobacco-specific legislation. The inescapable conclu-
sion 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.
B
In determining whether Congress has spoken directly to
the FDA’s authority to regulate tobacco, we must also con-
sider in greater detail the tobacco-specific legislation that
Congress has enacted over the past 35 years. At the time a
statute is enacted, it may have a range of plausible meanings.
Over time, however, subsequent acts can shape or focus
those meanings. The “classic judicial task of reconciling
many laws enacted over time, and getting them to ‘make
sense’ in combination, necessarily assumes that the implica-
tions of a statute may be altered by the implications of a
later statute.” United States v. Fausto, 484 U. S., at 453.
This is particularly so where the scope of the earlier statute
is broad but the subsequent statutes more specifically ad-
dress the topic at hand. As we recognized recently in
United States v. Estate of Romani, “a specific policy embod-
ied in a later federal statute should control our construction
of the [earlier] statute, even though it ha[s] not been ex-
pressly amended.” 523 U. S., at 530–531.
Congress has enacted six separate pieces of legislation
since 1965 addressing the problem of tobacco use and human
health. See supra, at 137–138. Those statutes, among
other things, require that health warnings appear on all
packaging and in all print and outdoor advertisements, see

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15 U. S. C. §§ 1331, 1333, 4402; prohibit the advertisement of
tobacco products through “any medium of electronic commu-
nication” subject to regulation by the Federal Communica-
tions Commission (FCC), see §§ 1335, 4402(f); require the
Secretary of HHS to report every three years to Congress
on research findings concerning “the addictive property of
tobacco,” 42 U. S. C. § 290aa–2(b)(2); and make States’ receipt
of certain federal block grants contingent on their making
it unlawful “for any manufacturer, retailer, or distributor of
tobacco products to sell or distribute any such product to any
individual under the age of 18,” § 300x–26(a)(1).
In adopting each statute, Congress has acted against the
backdrop of the FDA’s consistent and repeated statements
that it lacked authority under the FDCA to regulate tobacco
absent claims of therapeutic benefit by the manufacturer.
In fact, on several occasions over this period, and after the
health consequences of tobacco use and nicotine’s pharmaco-
logical effects had become well known, Congress considered
and rejected bills that would have granted the FDA such
jurisdiction. Under these circumstances, it is evident that
Congress’ tobacco-specific statutes have effectively ratified
the FDA’s long-held position that it lacks jurisdiction under
the FDCA to regulate tobacco products. Congress has
created a distinct regulatory scheme to address the problem
of tobacco and health, and that scheme, as presently con-
structed, precludes any role for the FDA.
On January 11, 1964, the Surgeon General released the
report of the Advisory Committee on Smoking and Health.
That report documented the deleterious health effects of
smoking in great detail, concluding, in relevant part, “that
cigarette smoking contributes substantially to mortality
from certain specific diseases and to the overall death rate.”
1964 Surgeon General’s Report 31. It also identified the
pharmacological effects of nicotine, including “stimulation,”
“tranquilization,” and “suppression of appetite.” Id., at 74–
75. Seven days after the report’s release, the Federal Trade

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Commission (FTC) issued a notice of proposed rulemaking,
see 29 Fed. Reg. 530–532 (1964), and in June 1964, the FTC
promulgated a final rule requiring cigarette manufacturers
“to disclose, clearly and prominently, in all advertising and
on every pack, box, carton or other container . . . that ciga-
rette smoking is dangerous to health and may cause death
from cancer and other diseases,” id., at 8325. The rule was
to become effective January 1, 1965, but, on a request from
Congress, the FTC postponed enforcement for six months.
See Cipollone v. Liggett Group, Inc., 505 U. S. 504, 513–514
(1992).
In response to the Surgeon General’s report and the FTC’s
proposed rule, Congress convened hearings to consider legis-
lation addressing “the tobacco problem.” 1964 Hearings 1.
During those deliberations, FDA representatives testified
before Congress that the agency lacked jurisdiction under
the FDCA to regulate tobacco products. Surgeon General
Terry was asked during hearings in 1964 whether HEW had
the “authority to brand or label the packages of cigarettes or
to control the advertising there.” Id., at 56. The Surgeon
General stated that “we do not have such authority in exist-
ing laws governing the . . . Food and Drug Administration.”
Ibid. Similarly, FDA Deputy Commissioner Rankin testi-
fied in 1965 that “[t]he Food and Drug Administration has no
jurisdiction under the Food, Drug, and Cosmetic Act over
tobacco, unless it bears drug claims.” Cigarette Labeling
and Advertising—1965: Hearings on H. R. 2248 before the
House Committee on Interstate and Foreign Commerce, 89th
Cong., 1st Sess., 193 (hereinafter 1965 Hearings). See also
Letter to Directors of Bureaus, Divisions and Directors of
Districts from FDA Bureau of Enforcement (May 24, 1963),
in 1972 Hearings 240 (“[T]obacco marketed for chewing or
smoking without accompanying therapeutic claims, does not
meet the definitions in the Food, Drug, and Cosmetic Act for
food, drug, device or cosmetic”). In fact, HEW Secretary
Celebrezze urged Congress not to amend the FDCA to cover

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“smoking products” because, in light of the findings in the
Surgeon General’s report, such a “provision might well com-
pletely outlaw at least cigarettes. This would be contrary
to what, we understand, is intended or what, in the light of
our experience with the 18th amendment, would be accept-
able to the American people.” 1964 Hearings 18.
The FDA’s disavowal of jurisdiction was consistent with
the position that it had taken since the agency’s inception.
As the FDA concedes, it never asserted authority to regulate
tobacco products as customarily marketed until it promul-
gated the regulations at issue here. See Brief for Petition-
ers 37; see also Brief for Appellee (FDA) in Action on Smok-
ing and Health v. Harris, 655 F. 2d 236 (CADC 1980), in 9
Rec. in No. 97–1604 (CA4), Tab No. 4, pp. 14–15 (“In the 73
years since the enactment of the original Food and Drug Act,
and in the 41 years since the promulgation of the modern
Food, Drug, and Cosmetic Act, the FDA has repeatedly in-
formed Congress that cigarettes are beyond the scope of the
statute absent health claims establishing a therapeutic intent
on behalf of the manufacturer or vendor”).
The FDA’s position was also consistent with Congress’
specific intent when it enacted the FDCA. Before the Act’s
adoption in 1938, the FDA’s predecessor agency, the Bureau
of Chemistry, announced that it lacked authority to regulate
tobacco products under the Pure Food and Drug Act of 1906,
ch. 3915, 34 Stat. 768, unless they were marketed with thera-
peutic claims. See U. S. Dept. of Agriculture, Bureau of
Chemistry, 13 Service and Regulatory Announcements 24
(Apr. 1914) (Feb. 1914 Announcements ¶ 13, Opinion of Chief
of Bureau C. L. Alsberg). In 1929, Congress considered and
rejected a bill “[t]o amend the Food and Drugs Act of June
30, 1906, by extending its provisions to tobacco and tobacco
products.” S. 1468, 71st Cong., 1st Sess., 1. See also 71
Cong. Rec. 2589 (1929) (remarks of Sen. Smoot). And, as the
FDA admits, there is no evidence in the text of the FDCA or
its legislative history that Congress in 1938 even considered

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the applicability of the Act to tobacco products. See Brief
for Petitioners 22, n. 4. Given the economic and political
significance of the tobacco industry at the time, it is ex-
tremely unlikely that Congress could have intended to place
tobacco within the ambit of the FDCA absent any discussion
of the matter. Of course, whether the Congress that
enacted the FDCA specifically intended the Act to cover to-
bacco products is not determinative; “it is ultimately the pro-
visions of our laws rather than the principal concerns of our
legislators by which we are governed.” Oncale v. Sun-
downer Offshore Services, Inc., 523 U. S. 75, 79 (1998); see
also TVA v. Hill, 437 U. S. 153, 185 (1978) (“It is not for us
to speculate, much less act, on whether Congress would have
altered its stance had the specific events of this case been
anticipated”). Nonetheless, this intent is certainly relevant
to understanding the basis for the FDA’s representations
to Congress and the background against which Congress
enacted subsequent tobacco-specific legislation.
Moreover, before enacting the FCLAA in 1965, Congress
considered and rejected several proposals to give the FDA
the authority to regulate tobacco. In April 1963, Repre-
sentative Udall introduced a bill “[t]o amend the Federal
Food, Drug, and Cosmetic Act so as to make that Act applica-
ble to smoking products.” H. R. 5973, 88th Cong., 1st Sess.,
1. Two months later, Senator Moss introduced an identical
bill in the Senate. S. 1682, 88th Cong., 1st Sess. (1963). In
discussing his proposal on the Senate floor, Senator Moss
explained that “this amendment simply places smoking prod-
ucts under FDA jurisdiction, along with foods, drugs, and
cosmetics.” 109 Cong. Rec. 10322 (1963). In December
1963, Representative Rhodes introduced another bill that
would have amended the FDCA “by striking out ‘food, drug,
device, or cosmetic, each place where it appears therein and
inserting in lieu thereof ‘food, drug, device, cosmetic, or
smoking product.’ ” H. R. 9512, 88th Cong., 1st Sess., § 3
(1963). And in January 1965, five months before passage of

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148 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
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the FCLAA, Representative Udall again introduced a bill to
amend the FDCA “to make that Act applicable to smoking
products.” H. R. 2248, 89th Cong., 1st Sess., 1. None of
these proposals became law.
Congress ultimately decided in 1965 to subject tobacco
products to the less extensive regulatory scheme of the
FCLAA, which created a “comprehensive Federal program
to deal with cigarette labeling and advertising with respect
to any relationship between smoking and health.” Pub. L.
89–92, § 2, 79 Stat. 282. The FCLAA rejected any regula-
tion of advertising, but it required the warning, “Caution:
Cigarette Smoking May Be Hazardous to Your Health,” to
appear on all cigarette packages. Id., § 4, 79 Stat. 283. In
the FCLAA’s “Declaration of Policy,” Congress stated that
its objective was to balance the goals of ensuring that “the
public may be adequately informed that cigarette smoking
may be hazardous to health” and protecting “commerce and
the national economy . . . to the maximum extent.” Id., § 2,
79 Stat. 282 (codified at 15 U. S. C. § 1331).
Not only did Congress reject the proposals to grant the
FDA jurisdiction, but it explicitly pre-empted any other reg-
ulation of cigarette labeling: “No statement relating to smok-
ing and health, other than the statement required by . . . this
Act, shall be required on any cigarette package.” Pub. L.
89–92, § 5(a), 79 Stat. 283. The regulation of product label-
ing, however, is an integral aspect of the FDCA, both as it
existed in 1965 and today. The labeling requirements cur-
rently imposed by the FDCA, which are essentially identical
to those in force in 1965, require the FDA to regulate the
labeling of drugs and devices to protect the safety of consum-
ers. See 21 U. S. C. § 352; 21 U. S. C. § 352 (1964 ed. and
Supp. IV). As discussed earlier, the Act requires that all
products bear “adequate directions for use . . . as are neces-
sary for the protection of users,” 21 U. S. C. § 352(f)(1); 21
U. S. C. § 352(f)(1) (1964 ed.); requires that all products pro-
vide “adequate warnings against use in those pathological

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conditions or by children where its use may be dangerous to
health,” 21 U. S. C. § 352(f)(2); 21 U. S. C. § 352(f)(2) (1964
ed.); and deems a product misbranded “[i]f it is dangerous to
health when used in the dosage or manner, or with the fre-
quency or duration prescribed, recommended, or suggested
in the labeling thereof,” 21 U. S. C. § 352( j); 21 U. S. C.
§ 352( j) (1964 ed.). In this sense, the FCLAA was—and re-
mains—incompatible with FDA regulation of tobacco prod-
ucts. This is not to say that the FCLAA’s pre-emption pro-
vision by itself necessarily foreclosed FDA jurisdiction. See
Cipollone v. Liggett Group, Inc., 505 U. S., at 518–519. But
it is an important factor in assessing whether Congress
ratified the agency’s position—that is, whether Congress
adopted a regulatory approach to the problem of tobacco and
health that contemplated no role for the FDA.
Further, the FCLAA evidences Congress’ intent to pre-
clude any administrative agency from exercising significant
policymaking authority on the subject of smoking and health.
In addition to prohibiting any additional requirements for
cigarette labeling, the FCLAA provided that “[n]o statement
relating to smoking and health shall be required in the ad-
vertising of any cigarettes the packages of which are labeled
in conformity with the provisions of this Act.” Pub. L. 89–
92, § 5(b), 79 Stat. 283. Thus, in reaction to the FTC’s at-
tempt to regulate cigarette labeling and advertising, Con-
gress enacted a statute reserving exclusive control over both
subjects to itself.
Subsequent tobacco-specific legislation followed a similar
pattern. By the FCLAA’s own terms, the prohibition on
any additional cigarette labeling or advertising regulations
relating to smoking and health was to expire July 1, 1969.
See § 10, 79 Stat. 284. In anticipation of the provision’s expi-
ration, both the FCC and the FTC proposed rules governing
the advertisement of cigarettes. See 34 Fed. Reg. 1959
(1969) (FCC proposed rule to “ban the broadcast of cigarette
commercials by radio and television stations”); id., at 7917

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150 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
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(FTC proposed rule requiring manufacturers to disclose on
all packaging and in all print advertising “ ‘that cigarette
smoking is dangerous to health and may cause death from
cancer, coronary heart disease, chronic bronchitis, pulmonary
emphysema, and other diseases’ ”). After debating the
proper role for administrative agencies in the regulation of
tobacco, see generally Cigarette Labeling and Advertising—
1969: Hearings before the House Committee on Interstate
and Foreign Commerce, 91st Cong., 1st Sess., pt. 2 (1969),
Congress amended the FCLAA by banning cigarette adver-
tisements “on any medium of electronic communication sub-
ject to the jurisdiction of the Federal Communications Com-
mission” and strengthening the warning required to appear
on cigarette packages. Public Health Cigarette Smoking
Act of 1969, Pub. L. 91–222, §§ 4, 6, 84 Stat. 88–89. Impor-
tantly, Congress extended indefinitely the prohibition on any
other regulation of cigarette labeling with respect to smok-
ing and health (again despite the importance of labeling reg-
ulation under the FDCA). § 5(a), 84 Stat. 88 (codified at 15
U. S. C. § 1334(a)). Moreover, it expressly forbade the FTC
from taking any action on its pending rule until July 1, 1971,
and it required the FTC, if it decided to proceed with its rule
thereafter, to notify Congress at least six months in advance
of the rule’s becoming effective. § 7(a), 84 Stat. 89. As the
chairman of the House committee in which the bill originated
stated, “the Congress—the body elected by the people—
must make the policy determinations involved in this legisla-
tion—and not some agency made up of appointed officials.”
116 Cong. Rec. 7920 (1970) (remarks of Rep. Staggers).
Four years later, after Congress had transferred the au-
thority to regulate substances covered by the Hazardous
Substances Act (HSA) from the FDA to the Consumer Prod-
ucts Safety Commission (CPSC), the American Public Health
Association, joined by Senator Moss, petitioned the CPSC to
regulate cigarettes yielding more than 21 milligrams of tar.
See Action on Smoking and Health v. Harris, 655 F. 2d 236,

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241 (CADC 1980); R. Kluger, Ashes to Ashes 375–376 (1996).
After the CPSC determined that it lacked authority under
the HSA to regulate cigarettes, a District Court held that
the HSA did, in fact, grant the CPSC such jurisdiction
and ordered it to reexamine the petition. See American
Public Health Association v. Consumer Product Safety
Commission, [1972–1975 Transfer Binder] CCH Consumer
Prod. Safety Guide ¶ 75,081 (DC 1975), vacated as moot,
No. 75–1863 (CADC 1976). Before the CPSC could take any
action, however, Congress mooted the issue by adopting leg-
islation that eliminated the agency’s authority to regulate
“tobacco and tobacco products.” Consumer Product Safety
Commission Improvements Act of 1976, Pub. L. 94–284,
§ 3(c), 90 Stat. 503 (codified at 15 U. S. C. § 1261(f)(2)). Sena-
tor Moss acknowledged that the “legislation, in effect, re-
verse[d]” the District Court’s decision, 121 Cong. Rec. 23563
(1975), and the FDA later observed that the episode was
“particularly” “indicative of the policy of Congress to limit
the regulatory authority over cigarettes by Federal Agen-
cies,” Letter to Action on Smoking and Health (ASH) Execu-
tive Director Banzhaf from FDA Comm’r Goyan (Nov. 25,
1980), App. 59. A separate statement in the Senate Report
underscored that the legislation’s purpose was to “unmistak-
ably reaffirm the clear mandate of the Congress that the
basic regulation of tobacco and tobacco products is governed
by the legislation dealing with the subject, . . . and that any
further regulation in this sensitive and complex area must
be reserved for specific Congressional action.” S. Rep.
No. 94–251, p. 43 (1975) (additional views of Sens. Hartke,
Hollings, Ford, Stevens, and Beall).
Meanwhile, the FDA continued to maintain that it lacked
jurisdiction under the FDCA to regulate tobacco products as
customarily marketed. In 1972, FDA Commissioner Ed-
wards testified before Congress that “cigarettes recom-
mended for smoking pleasure are beyond the Federal Food,
Drug, and Cosmetic Act.” 1972 Hearings 239, 242. He fur-

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152 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
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ther stated that the FDA believed that the Public Health
Cigarette Smoking Act “demonstrates that the regulation of
cigarettes is to be the domain of Congress,” and that “label-
ing or banning cigarettes is a step that can be take[n] only
by the Congress. Any such move by FDA would be incon-
sistent with the clear congressional intent.” Ibid.
In 1977, ASH filed a citizen petition requesting that the
FDA regulate cigarettes, citing many of the same grounds
that motivated the FDA’s rulemaking here. See Citizen Pe-
tition, No. 77P–0185 (May 26, 1977), 10 Rec. in No. 97–1604
(CA4), Tab No. 22, pp. 1–10. ASH asserted that nicotine
was highly addictive and had strong physiological effects on
the body; that those effects were “intended” because con-
sumers use tobacco products precisely to obtain those ef-
fects; and that tobacco causes thousands of premature deaths
annually. Ibid. In denying ASH’s petition, FDA Commis-
sioner Kennedy stated that “[t]he interpretation of the Act
by FDA consistently has been that cigarettes are not a drug
unless health claims are made by the vendors.” Letter to
ASH Executive Director Banzhaf (Dec. 5, 1977), App. 47.
After the matter proceeded to litigation, the FDA argued in
its brief to the Court of Appeals that “cigarettes are not
comprehended within the statutory definition of the term
‘drug’ absent objective evidence that vendors represent or
intend that their products be used as a drug.” Brief for Ap-
pellee in Action on Smoking and Health v. Harris, 655 F. 2d
236 (CADC 1980), 9 Rec. in No. 97–1604 (CA4), Tab No. 4,
at 27–28. The FDA also contended that Congress had “long
been aware that the FDA does not consider cigarettes to be
within its regulatory authority in the absence of health
claims made on behalf of the manufacturer or vendor,” and
that, because “Congress has never acted to disturb the
agency’s interpretation,” it had “acquiesced in the FDA’s in-
terpretation of the statutory limits on its authority to regu-
late cigarettes.” Id., at 23, 27, n. 23. The Court of Appeals
upheld the FDA’s position, concluding that “[i]f the statute

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requires expansion, that is the job of Congress.” Action on
Smoking and Health v. Harris, 655 F. 2d, at 243. In 1980,
the FDA also denied a request by ASH to commence rule-
making proceedings to establish the agency’s jurisdiction to
regulate cigarettes as devices. See Letter to ASH Execu-
tive Director Banzhaf from FDA Comm’r Goyan (Nov. 25,
1980), App. 50–51. The agency stated that “[i]nsofar as
rulemaking would relate to cigarettes or attached filters as
customarily marketed, we have concluded that FDA has no
jurisdiction under section 201(h) of the Act [21 U. S. C.
§ 321(h)].” Id., at 67.
In 1983, Congress again considered legislation on the
subject of smoking and health. HHS Assistant Secretary
Brandt testified that, in addition to being “a major cause of
cancer,” smoking is a “major cause of heart disease” and
other serious illnesses, and can result in “unfavorable preg-
nancy outcomes.” 1983 House Hearings 19–20. He also
stated that it was “well-established that cigarette smok-
ing is a drug dependence, and that smoking is addictive for
many people.” Id., at 20. Nonetheless, Assistant Secre-
tary Brandt maintained that “the issue of regulation of
tobacco . . . is something that Congress has reserved to itself,
and we do not within the Department have the authority to
regulate nor are we seeking such authority.” Id., at 74. He
also testified before the Senate, stating that, despite the evi-
dence of tobacco’s health effects and addictiveness, the De-
partment’s view was that “Congress has assumed the respon-
sibility of regulating . . . cigarettes.” Smoking Prevention
and Education Act: Hearings on S. 772 before the Senate
Committee on Labor and Human Resources, 98th Cong., 1st
Sess., 56 (1983) (hereinafter 1983 Senate Hearings).
Against this backdrop, Congress enacted three additional
tobacco-specific statutes over the next four years that incre-
mentally expanded its regulatory scheme for tobacco prod-
ucts. In 1983, Congress adopted the Alcohol and Drug
Abuse Amendments, Pub. L. 98–24, 97 Stat. 175 (codified at

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154 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
Opinion of the Court
42 U. S. C. § 290aa et seq.), which require the Secretary of
HHS to report to Congress every three years on the “addic-
tive property of tobacco” and to include recommendations for
action that the Secretary may deem appropriate. A year
later, Congress enacted the Comprehensive Smoking Educa-
tion Act, Pub. L. 98–474, 98 Stat. 2200, which amended the
FCLAA by again modifying the prescribed warning. Nota-
bly, during debate on the Senate floor, Senator Hawkins
argued that the FCLAA was necessary in part because
“[u]nder the Food, Drug and Cosmetic Act, the Congress
exempted tobacco products.” 130 Cong. Rec. 26953 (1984).
And in 1986, Congress enacted the Comprehensive Smoke-
less Tobacco Health Education Act of 1986 (CSTHEA), Pub.
L. 99–252, 100 Stat. 30 (codified at 15 U. S. C. § 4401 et seq.),
which essentially extended the regulatory provisions of the
FCLAA to smokeless tobacco products. Like the FCLAA,
the CSTHEA provided that “[n]o statement relating to the
use of smokeless tobacco products and health, other than the
statements required by [the Act], shall be required by any
Federal agency to appear on any package . . . of a smokeless
tobacco product.” § 7(a), 100 Stat. 34 (codified at 15 U. S. C.
§ 4406(a)). Thus, as with cigarettes, Congress reserved for
itself an aspect of smokeless tobacco regulation that is partic-
ularly important to the FDCA’s regulatory scheme.
In 1988, the Surgeon General released a report summa-
rizing the abundant scientific literature demonstrating that
“[c]igarettes and other forms of tobacco are addicting,” and
that “nicotine is psychoactive” and “causes physical depend-
ence characterized by a withdrawal syndrome that usually
accompanies nicotine abstinence.” 1988 Surgeon General’s
Report 14. The report further concluded that the “pharma-
cologic and behavioral processes that determine tobacco ad-
diction are similar to those that determine addiction to drugs
such as heroin and cocaine.” Id., at 15. In the same year,
FDA Commissioner Young stated before Congress that “it
doesn’t look like it is possible to regulate [tobacco] under the

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Food, Drug and Cosmetic Act even though smoking, I think,
has been widely recognized as being harmful to human
health.” Rural Development, Agriculture, and Related
Agencies Appropriations for 1989: Hearings before a Sub-
committee of the House Committee on Appropriations, 100th
Cong., 2d Sess., 409 (1988). At the same hearing, the FDA’s
General Counsel testified that “what is fairly important in
FDA law is whether a product has a therapeutic purpose,”
and “[c]igarettes themselves are not used for a therapeutic
purpose as that concept is ordinarily understood.” Id., at
410. Between 1987 and 1989, Congress considered three
more bills that would have amended the FDCA to grant the
FDA jurisdiction to regulate tobacco products. See H. R.
3294, 100th Cong., 1st Sess. (1987); H. R. 1494, 101st Cong.,
1st Sess. (1989); S. 769, 101st Cong., 1st Sess. (1989). As
before, Congress rejected the proposals. In 1992, Congress
instead adopted the Alcohol, Drug Abuse, and Mental Health
Administration Reorganization Act, Pub. L. 102–321, § 202,
106 Stat. 394 (codified at 42 U. S. C. § 300x et seq.), which
creates incentives for States to regulate the retail sale of
tobacco products by making States’ receipt of certain block
grants contingent on their prohibiting the sale of tobacco
products to minors.
Taken together, these actions by Congress over the past
35 years preclude an interpretation of the FDCA that grants
the FDA jurisdiction to regulate tobacco products. We do
not rely on Congress’ failure to act—its consideration and
rejection of bills that would have given the FDA this author-
ity—in reaching this conclusion. Indeed, this is not a case
of simple inaction by Congress that purportedly represents
its acquiescence in an agency’s position. To the contrary,
Congress has enacted several statutes addressing the partic-
ular subject of tobacco and health, creating a distinct regula-
tory scheme for cigarettes and smokeless tobacco. In doing
so, Congress has been aware of tobacco’s health hazards and
its pharmacological effects. It has also enacted this legisla-

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156 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
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tion against the background of the FDA repeatedly and con-
sistently asserting that it lacks jurisdiction under the FDCA
to regulate tobacco products as customarily marketed. Fur-
ther, Congress has persistently acted to preclude a meaning-
ful role for any administrative agency in making policy on
the subject of tobacco and health. Moreover, the substance
of Congress’ regulatory scheme is, in an important respect,
incompatible with FDA jurisdiction. Although the super-
vision of product labeling to protect consumer health is a
substantial component of the FDA’s regulation of drugs and
devices, see 21 U. S. C. § 352 (1994 ed. and Supp. III), the
FCLAA and the CSTHEA explicitly prohibit any federal
agency from imposing any health-related labeling require-
ments on cigarettes or smokeless tobacco products, see 15
U. S. C. §§ 1334(a), 4406(a).
Under these circumstances, it is clear that Congress’
tobacco-specific legislation has effectively ratified the FDA’s
previous position that it lacks jurisdiction to regulate to-
bacco. As in Bob Jones Univ. v. United States, 461 U. S. 574
(1983), “[i]t is hardly conceivable that Congress—and in this
setting, any Member of Congress—was not abundantly
aware of what was going on.” Id., at 600–601. Congress
has affirmatively acted to address the issue of tobacco and
health, relying on the representations of the FDA that it had
no authority to regulate tobacco. It has created a distinct
scheme to regulate the sale of tobacco products, focused on
labeling and advertising, and premised on the belief that the
FDA lacks such jurisdiction under the FDCA. As a result,
Congress’ tobacco-specific statutes preclude the FDA from
regulating tobacco products as customarily marketed.
Although the dissent takes issue with our discussion of the
FDA’s change in position, post, at 186–189, our conclusion does
not rely on the fact that the FDA’s assertion of jurisdiction
represents a sharp break with its prior interpretation of the
FDCA. Certainly, an agency’s initial interpretation of a
statute that it is charged with administering is not “carved

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in stone.” Chevron, 467 U. S., at 863; see also Smiley v. Cit-
ibank (South Dakota), N. A., 517 U. S. 735, 742 (1996). As
we recognized in Motor Vehicle Mfrs. Assn. of United States,
Inc. v. State Farm Mut. Automobile Ins. Co., 463 U. S. 29
(1983), agencies “must be given ample latitude to ‘adapt their
rules and policies to the demands of changing circum-
stances.’ ” Id., at 42 (quoting Permian Basin Area Rate
Cases, 390 U. S. 747, 784 (1968)). The consistency of the
FDA’s prior position is significant in this case for a different
reason: It provides important context to Congress’ enact-
ment of its tobacco-specific legislation. When the FDA re-
peatedly informed Congress that the FDCA does not grant
it the authority to regulate tobacco products, its statements
were consistent with the agency’s unwavering position since
its inception, and with the position that its predecessor
agency had first taken in 1914. Although not crucial, the
consistency of the FDA’s prior position bolsters the conclu-
sion that when Congress created a distinct regulatory
scheme addressing the subject of tobacco and health, it un-
derstood that the FDA is without jurisdiction to regulate
tobacco products and ratified that position.
The dissent also argues that the proper inference to be
drawn from Congress’ tobacco-specific legislation is “criti-
cally ambivalent.” Post, at 182. We disagree. In that se-
ries of statutes, Congress crafted a specific legislative re-
sponse to the problem of tobacco and health, and it did so
with the understanding, based on repeated assertions by the
FDA, that the agency has no authority under the FDCA to
regulate tobacco products. Moreover, Congress expressly
pre-empted any other regulation of the labeling of tobacco
products concerning their health consequences, even though
the oversight of labeling is central to the FDCA’s regulatory
scheme. And in addressing the subject, Congress consist-
ently evidenced its intent to preclude any federal agency
from exercising significant policymaking authority in the
area. Under these circumstances, we believe the appro-

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158 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
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priate inference—that Congress intended to ratify the FDA’s
prior position that it lacks jurisdiction—is unmistakable.
The dissent alternatively argues that, even if Congress’
subsequent tobacco-specific legislation did, in fact, ratify the
FDA’s position, that position was merely a contingent dis-
avowal of jurisdiction. Specifically, the dissent contends
that “the FDA’s traditional view was largely premised on
a perceived inability to prove the necessary statutory ‘in-
tent’ requirement.” Post, at 189–190. A fair reading of the
FDA’s representations prior to 1995, however, demonstrates
that the agency’s position was essentially unconditional.
See, e. g., 1972 Hearings 239, 242 (statement of Comm’r Ed-
wards) (“[R]egulation of cigarettes is to be the domain of
Congress,” and “[a]ny such move by FDA would be inconsist-
ent with the clear congressional intent”); 1983 House Hear-
ings 74 (statement of Assistant Secretary Brandt) (“[T]he
issue of regulation of tobacco . . . is something that Congress
has reserved to itself ”); 1983 Senate Hearings 56 (statement
of Assistant Secretary Brandt) (“Congress has assumed the
responsibility of regulating . . . cigarettes”); Brief for Appel-
lee in Action on Smoking and Health v. Harris, 655 F. 2d
236 (CADC 1980), 9 Rec. in No. 97–1604 (CA4), Tab No. 4,
at 27, n. 23 (because “Congress has never acted to disturb
the agency’s interpretation,” it “acquiesced in the FDA’s in-
terpretation”). To the extent the agency’s position could be
characterized as equivocal, it was only with respect to the
well-established exception of when the manufacturer makes
express claims of therapeutic benefit. See, e. g., 1965 Hear-
ings 193 (statement of Deputy Comm’r Rankin) (“The Food
and Drug Administration has no jurisdiction under the Food,
Drug, and Cosmetic Act over tobacco, unless it bears drug
claims”); Letter to ASH Executive Director Banzhaf from
FDA Comm’r Kennedy (Dec. 5, 1977), App. 47 (“The inter-
pretation of the Act by FDA consistently has been that ciga-
rettes are not a drug unless health claims are made by the
vendors”); Letter to ASH Executive Director Banzhaf from

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FDA Comm’r Goyan (Nov. 25, 1980), id., at 67 (“Insofar as
rulemaking would relate to cigarettes or attached filters as
customarily marketed, we have concluded that FDA has no
jurisdiction”). Thus, what Congress ratified was the FDA’s
plain and resolute position that the FDCA gives the agency
no authority to regulate tobacco products as customarily
marketed.
C
Finally, our inquiry into whether Congress has directly
spoken to the precise question at issue is shaped, at least
in some measure, by the nature of the question presented.
Deference under Chevron to an agency’s construction of a
statute that it administers 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
Chevron, supra, at 844. In extraordinary cases, however,
there may be reason to hesitate before concluding that Con-
gress has intended such an implicit delegation. Cf. Breyer,
Judicial Review of Questions of Law and Policy, 38 Admin.
L. Rev. 363, 370 (1986) (“A court may also ask whether the
legal question is an important one. Congress is more likely
to have focused upon, and answered, major questions, while
leaving interstitial matters to answer themselves in the
course of the statute’s daily administration”).
This is hardly an ordinary case. Contrary to its represen-
tations to Congress since 1914, the FDA has now asserted
jurisdiction to regulate an industry constituting a significant
portion of the American economy. In fact, the FDA con-
tends that, were it to determine that tobacco products pro-
vide no “reasonable assurance of safety,” it would have the
authority to ban cigarettes and smokeless tobacco entirely.
See Brief for Petitioners 35–36; Reply Brief for Petitioners
14. Owing to its unique place in American history and soci-
ety, tobacco has its own unique political history. Congress,
for better or for worse, has created a distinct regulatory
scheme for tobacco products, squarely rejected proposals to

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160 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
Opinion of the Court
give the FDA jurisdiction over tobacco, and repeatedly acted
to preclude any agency from exercising significant policy-
making authority in the area. Given this history and the
breadth of the authority that the FDA has asserted, we are
obliged to defer not to the agency’s expansive construction
of the statute, but to Congress’ consistent judgment to deny
the FDA this power.
Our decision in MCI Telecommunications Corp. v. Ameri-
can Telephone & Telegraph Co., 512 U. S. 218 (1994), is in-
structive. That case involved the proper construction of the
term “modify” in § 203(b) of the Communications Act of 1934.
The FCC contended that, because the Act gave it the discre-
tion to “modify any requirement” imposed under the statute,
it therefore possessed the authority to render voluntary the
otherwise mandatory requirement that long distance carri-
ers file their rates. Id., at 225. We rejected the FCC’s con-
struction, finding “not the slightest doubt” that Congress had
directly spoken to the question. Id., at 228. In reasoning
even more apt here, we concluded that “[i]t is highly unlikely
that Congress would leave the determination of whether
an industry will be entirely, or even substantially, rate-
regulated to agency discretion—and even more unlikely that
it would achieve that through such a subtle device as permis-
sion to ‘modify’ rate-filing requirements.” Id., at 231.
As in MCI, we are confident that Congress could not have
intended to delegate a decision of such economic and political
significance to an agency in so cryptic a fashion. To find
that the FDA has the authority to regulate tobacco products,
one must not only adopt an extremely strained understand-
ing of “safety” as it is used throughout the Act—a concept
central to the FDCA’s regulatory scheme—but also ignore
the plain implication of Congress’ subsequent tobacco-
specific legislation. It is therefore clear, based on the
FDCA’s overall regulatory scheme and the subsequent to-
bacco legislation, that Congress has directly spoken to the

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161 Cite as: 529 U. S. 120 (2000)
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question at issue and precluded the FDA from regulating
tobacco products.
* * *
By no means do we question the seriousness of the prob-
lem that the FDA has sought to address. The agency has
amply demonstrated that tobacco use, particularly among
children and adolescents, poses perhaps the single most sig-
nificant threat to public health in the United States. None-
theless, no matter how “important, conspicuous, and contro-
versial” the issue, and regardless of how likely the public is
to hold the Executive Branch politically accountable, post, at
190, an administrative agency’s power to regulate in the pub-
lic interest must always be grounded in a valid grant of au-
thority from Congress. And “ ‘[i]n our anxiety to effectuate
the congressional purpose of protecting the public, we must
take care not to extend the scope of the statute beyond the
point where Congress indicated it would stop.’ ” United
States v. Article of Drug . . . Bacto-Unidisk, 394 U. S. 784,
800 (1969) (quoting 62 Cases of Jam v. United States, 340
U. S. 593, 600 (1951)). 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 that it seeks to exercise here. For
these reasons, the judgment of the Court of Appeals for the
Fourth Circuit is affirmed.
It is so ordered.
Justice Breyer, with whom Justice Stevens, Justice
Souter, and Justice Ginsburg join, dissenting.
The Food and Drug Administration (FDA) has the author-
ity to regulate “articles (other than food) intended to af-
fect the structure or any function of the body . . . .” Fed-
eral Food, Drug, and Cosmetic Act (FDCA), 21 U. S. C.
§ 321(g)(1)(C). Unlike the majority, I believe that tobacco
products fit within this statutory language.

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162 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
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In its own interpretation, the majority nowhere denies the
following two salient points. First, tobacco products (in-
cluding cigarettes) fall within the scope of this statutory
definition, read literally. Cigarettes achieve their mood-
stabilizing effects through the interaction of the chemical
nicotine and the cells of the central nervous system. Both
cigarette manufacturers and smokers alike know of, and de-
sire, that chemically induced result. Hence, cigarettes are
“intended to affect” the body’s “structure” and “function,” in
the literal sense of these words.
Second, the statute’s basic purpose—the protection of
public health—supports the inclusion of cigarettes within
its scope. See United States v. Article of Drug . . . Bacto-
Unidisk, 394 U. S. 784, 798 (1969) (FDCA “is to be given a
liberal construction consistent with [its] overriding pur-
pose to protect the public health” (emphasis added)). Un-
regulated tobacco use causes “[m]ore than 400,000 people [to]
die each year from tobacco-related illnesses, such as cancer,
respiratory illnesses, and heart disease.” 61 Fed. Reg.
44398 (1996). Indeed, tobacco products kill more people in
this country every year “than . . . AIDS . . . , car accidents,
alcohol, homicides, illegal drugs, suicides, and fires, com-
bined.” Ibid. (emphasis added).
Despite the FDCA’s literal language and general purpose
(both of which support the FDA’s finding that cigarettes
come within its statutory authority), the majority nonethe-
less reads the statute as excluding tobacco products for two
basic reasons:
(1) the FDCA does not “fit” the case of tobacco because
the statute requires the FDA to prohibit dangerous
drugs or devices (like cigarettes) outright, and the
agency concedes that simply banning the sale of ciga-
rettes is not a proper remedy, ante, at 139–141; and
(2) Congress has enacted other statutes, which, when
viewed in light of the FDA’s long history of denying

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163 Cite as: 529 U. S. 120 (2000)
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tobacco-related jurisdiction and considered together
with Congress’ failure explicitly to grant the agency
tobacco-specific authority, demonstrate that Congress
did not intend for the FDA to exercise jurisdiction over
tobacco, ante, at 155–156.
In my view, neither of these propositions is valid. Rather,
the FDCA does not significantly limit the FDA’s remedial
alternatives. See infra, at 174–181. And the later statutes
do not tell the FDA it cannot exercise jurisdiction, but sim-
ply leave FDA jurisdictional law where Congress found it.
See infra, at 181–186; cf. Food and Drug Administration
Modernization Act of 1997, 111 Stat. 2380 (codified at note fol-
lowing 21 U. S. C. § 321 (1994 ed., Supp. III)) (statute “shall”
not “be construed to affect the question of whether” the FDA
“has any authority to regulate any tobacco product”).
The bulk of the opinion that follows will explain the basis
for these latter conclusions. In short, I believe that the
most important indicia of statutory meaning—language and
purpose—along with the FDCA’s legislative history (de-
scribed briefly in Part I) are sufficient to establish that the
FDA has authority to regulate tobacco. The statute-specific
arguments against jurisdiction that the tobacco companies
and the majority rely upon (discussed in Part II) are based
on erroneous assumptions and, thus, do not defeat the
jurisdiction-supporting thrust of the FDCA’s language and
purpose. The inferences that the majority draws from later
legislative history are not persuasive, since (as I point out in
Part III) one can just as easily infer from the later laws that
Congress did not intend to affect the FDA’s tobacco-related
authority at all. And the fact that the FDA changed its
mind about the scope of its own jurisdiction is legally insig-
nificant because (as Part IV establishes) the agency’s reasons
for changing course are fully justified. Finally, as I explain
in Part V, the degree of accountability that likely will attach
to the FDA’s action in this case should alleviate any concern

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164 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
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that Congress, rather than an administrative agency, ought
to make this important regulatory decision.
I
Before 1938, the federal Pure Food and Drug Act con-
tained only two jurisdictional definitions of “drug”:
“[1] medicines and preparations recognized in the
United States Pharmacopoeia or National Formulary . . .
and [2] any substance or mixture of substances intended
to be used for the cure, mitigation, or prevention of dis-
ease.” Act of June 30, 1906, ch. 3915, § 6, 34 Stat. 769.
In 1938, Congress added a third definition, relevant here:
“(3) articles (other than food) intended to affect the
structure or any function of the body . . . .” Act of June
25, 1938, ch. 675, § 201(g), 52 Stat. 1041 (codified at 21
U. S. C. § 321(g)(1)(C)).
It also added a similar definition in respect to a “device.”
See § 201(h), 52 Stat. 1041 (codified at 21 U. S. C. § 321(h)).
As I have mentioned, the literal language of the third defini-
tion and the FDCA’s general purpose both strongly support
a projurisdiction reading of the statute. See supra, at
161–162.
The statute’s history offers further support. The FDA
drafted the new language, and it testified before Congress
that the third definition would expand the FDCA’s jurisdic-
tional scope significantly. See Hearings on S. 1944 before a
Subcommittee of the Senate Committee on Commerce, 73d
Cong., 2d Sess., 15–16 (1933), reprinted in 1 FDA, Legislative
History of the Federal Food, Drug, and Cosmetic Act and Its
Amendments 107–108 (1979) (hereinafter Leg. Hist.). In-
deed, “[t]he purpose” of the new definition was to “make pos-
sible the regulation of a great many products that have been
found on the market that cannot be alleged to be treatments
for diseased conditions.” Id., at 108. While the drafters fo-
cused specifically upon the need to give the FDA jurisdiction

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over “slenderizing” products such as “antifat remedies,”
ibid., they were aware that, in doing so, they had created
what was “admittedly an inclusive, a wide definition,” id., at
107. And that broad language was included deliberately, so
that jurisdiction could be had over “all substances and prep-
arations, other than food, and all devices intended to affect
the structure or any function of the body . . . .” Ibid. (em-
phasis added); see also Hearings on S. 2800 before the Senate
Committee on Commerce, 73d Cong., 2d Sess., 516 (1934),
reprinted in 2 Leg. Hist. 519 (statement of then-FDA Chief
Walter Campbell acknowledging that “[t]his definition of
‘drugs’ is all-inclusive”).
After studying the FDCA’s history, experts have written
that the statute “is a purposefully broad delegation of discre-
tionary powers by Congress,” 1 J. O’Reilly, Food and Drug
Administration § 6.01, p. 6–1 (2d ed. 1995) (hereinafter
O’Reilly), and that, in a sense, the FDCA “must be regarded
as a constitution” that “establish[es] general principles” and
“permit[s] implementation within broad parameters” so that
the FDA can “implement these objectives through the most
effective and efficient controls that can be devised.” Hutt,
Philosophy of Regulation Under the Federal Food, Drug and
Cosmetic Act, 28 Food Drug Cosm. L. J. 177, 178–179 (1973)
(emphasis added). This Court, too, has said that the
“historical expansion of the definition of drug, and the
creation of a parallel concept of devices, clearly show . . .
that Congress fully intended that the Act’s coverage be
as broad as its literal language indicates—and equally
clearly, broader than any strict medical definition might
otherwise allow.” Bacto-Unidisk, 394 U. S., at 798.
That Congress would grant the FDA such broad jurisdic-
tional authority should surprise no one. In 1938, the Presi-
dent and much of Congress believed that federal administra-
tive agencies needed broad authority and would exercise that
authority wisely—a view embodied in much Second New

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166 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
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Deal legislation. Cf. Gray v. Powell, 314 U. S. 402, 411–412
(1941) (Congress “could have legislated specifically” but de-
cided “to delegate that function to those whose experience
in a particular field gave promise of a better informed, more
equitable” determination). Thus, at around the same time
that it added the relevant language to the FDCA, Congress
enacted laws granting other administrative agencies even
broader powers to regulate much of the Nation’s transporta-
tion and communication. See, e. g., Civil Aeronautics Act of
1938, ch. 601, § 401(d)(1), 52 Stat. 987 (Civil Aeronautics
Board to regulate airlines within confines of highly general
“public convenience and necessity” standard); Motor Carrier
Act of 1935, ch. 498, § 204(a)(1), 49 Stat. 546 (Interstate Com-
merce Commission to establish “reasonable requirements”
for trucking); Communications Act of 1934, ch. 652, § 201(a),
48 Stat. 1070 (Federal Communications Commission (FCC)
to regulate radio, later television, within confines of even
broader “public interest” standard). Why would the 1938
New Deal Congress suddenly have hesitated to delegate to
so well established an agency as the FDA all of the discre-
tionary authority that a straightforward reading of the rele-
vant statutory language implies?
Nor is it surprising that such a statutory delegation of
power could lead after many years to an assertion of juris-
diction that the 1938 legislators might not have expected.
Such a possibility is inherent in the very nature of a broad
delegation. In 1938, it may well have seemed unlikely that
the FDA would ever bring cigarette manufacturers within
the FDCA’s statutory language by proving that cigarettes
produce chemical changes in the body and that the makers
“intended” their product chemically to affect the body’s
“structure” or “function.” Or, back then, it may have
seemed unlikely that, even assuming such proof, the FDA
actually would exercise its discretion to regulate so popular
a product. See R. Kluger, Ashes to Ashes 105 (1997) (in the
1930’s “Americans were in love with smoking . . .”).

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But it should not have seemed unlikely that, assuming the
FDA decided to regulate and proved the particular juris-
dictional prerequisites, the courts would rule such a juris-
dictional assertion fully authorized. Cf. United States v.
Southwestern Cable Co., 392 U. S. 157, 172 (1968) (reading
Communications Act of 1934 as authorizing FCC jurisdic-
tion to regulate cable systems while noting that “Congress
could not in 1934 have foreseen the development of ” ad-
vanced communications systems). After all, this Court has
read more narrowly phrased statutes to grant what might
have seemed even more unlikely assertions of agency juris-
diction. See, e. g., Permian Basin Area Rate Cases, 390
U. S. 747, 774–777 (1968) (statutory authority to regulate in-
terstate “transportation” of natural gas includes authority to
regulate “prices” charged by field producers); Phillips Petro-
leum Co. v. Wisconsin, 347 U. S. 672, 677–684 (1954) (inde-
pendent gas producer subject to regulation despite Natural
Gas Act’s express exemption of gathering and production
facilities).
I shall not pursue these general matters further, for nei-
ther the companies nor the majority denies that the FDCA’s
literal language, its general purpose, and its particular legis-
lative history favor the FDA’s present jurisdictional view.
Rather, they have made several specific arguments in sup-
port of one basic contention: Even if the statutory delegation
is broad, it is not broad enough to include tobacco. I now
turn to each of those arguments.
II
A
The tobacco companies contend that the FDCA’s words
cannot possibly be read to mean what they literally say.
The statute defines “device,” for example, as “an instrument,
apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article . . . intended
to affect the structure or any function of the body . . . .” 21

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U. S. C. § 321(h). Taken literally, this definition might in-
clude everything from room air conditioners to thermal paja-
mas. The companies argue that, to avoid such a result, the
meaning of “drug” or “device” should be confined to medical
or therapeutic products, narrowly defined. See Brief for
Respondent United States Tobacco Co. 8–9.
The companies may well be right that the statute should
not be read to cover room air conditioners and winter under-
wear. But I do not agree that we must accept their pro-
posed limitation. For one thing, such a cramped reading
contravenes the established purpose of the statutory lan-
guage. See Bacto-Unidisk, 394 U. S., at 798 (third defini-
tion is “clearly, broader than any strict medical definition”);
1 Leg. Hist. 108 (definition covers products “that can-
not be alleged to be treatments for diseased conditions”).
For another, the companies’ restriction would render the
other two “drug” definitions superfluous. See 21 U. S. C.
§§ 321(g)(1)(A), (g)(1)(B) (covering articles in the leading
pharmacology compendia and those “intended for use in
the diagnosis, cure, mitigation, treatment, or prevention of
disease”).
Most importantly, the statute’s language itself supplies a
different, more suitable, limitation: that a “drug” must be a
chemical agent. The FDCA’s “device” definition states that
an article which affects the structure or function of the body
is a “device” only if it “does not achieve its primary intended
purposes through chemical action within . . . the body,” and
“is not dependent upon being metabolized for the achieve-
ment of its primary intended purposes.” § 321(h) (emphasis
added). One can readily infer from this language that at
least an article that does achieve its primary purpose
through chemical action within the body and that is depend-
ent upon being metabolized is a “drug,” provided that it oth-
erwise falls within the scope of the “drug” definition. And
one need not hypothesize about air conditioners or thermal

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pajamas to recognize that the chemical nicotine, an impor-
tant tobacco ingredient, meets this test.
Although I now oversimplify, the FDA has determined
that once nicotine enters the body, the blood carries it almost
immediately to the brain. See 61 Fed. Reg. 44698–44699
(1966). Nicotine then binds to receptors on the surface of
brain cells, setting off a series of chemical reactions that
alter one’s mood and produce feelings of sedation and stimu-
lation. See id., at 44699, 44739. Nicotine also increases the
number of nicotinic receptors on the brain’s surface, and al-
ters its normal electrical activity. See id., at 44739. And
nicotine stimulates the transmission of a natural chemical
that “rewards” the body with pleasurable sensations (dopa-
mine), causing nicotine addiction. See id., at 44700, 44721–
44722. The upshot is that nicotine stabilizes mood, sup-
presses appetite, tranquilizes, and satisfies a physical craving
that nicotine itself has helped to create—all through chemical
action within the body after being metabolized.
This physiology—and not simply smoker psychology—
helps to explain why as many as 75% of adult smokers be-
lieve that smoking “reduce[s] nervous irritation,” 60 Fed.
Reg. 41579 (1995); why 73% of young people (10- to 22-year-
olds) who begin smoking say they do so for “relaxation,” 61
Fed. Reg. 44814 (1996); and why less than 3% of smokers
succeed in quitting each year, although 70% want to quit, id.,
at 44704. That chemistry also helps to explain the Surgeon
General’s findings that smokers believe “smoking [makes
them] feel better” and smoke more “in situations involving
negative mood.” Id., at 44814. And, for present purposes,
that chemistry demonstrates that nicotine affects the “struc-
ture” and “function” of the body in a manner that is quite simi-
lar to the effects of other regulated substances. See id., at
44667 (FDA regulates Valium, NoDoz, weight-loss products).
Indeed, addiction, sedation, stimulation, and weight loss are
precisely the kinds of product effects that the FDA typically
reviews and controls. And, since the nicotine in cigarettes

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plainly is not a “food,” its chemical effects suffice to establish
that it is as a “drug” (and the cigarette that delivers it a
drug-delivery “device”) for the purpose of the FDCA.
B
The tobacco companies’ principal definitional argument fo-
cuses upon the statutory word “intended.” See 21 U. S. C.
§ 321(g)(1)(C). The companies say that “intended” in this
context is a term of art. See Brief for Respondent Brown &
Williamson Tobacco Corp. 2. They assert that the statutory
word “intended” means that the product’s maker has made
an express claim about the effect that its product will have
on the body. Ibid. Indeed, according to the companies, the
FDA’s inability to prove that cigarette manufacturers make
such claims is precisely why that agency historically has said
it lacked the statutory power to regulate tobacco. See id.,
at 19–20.
The FDCA, however, does not use the word “claimed”; it
uses the word “intended.” And the FDA long ago issued
regulations that say the relevant “intent” can be shown not
only by a manufacturer’s “expressions,” but also “by the cir-
cumstances surrounding the distribution of the article.” 41
Fed. Reg. 6896 (1976) (codified at 21 CFR § 801.4 (1999)); see
also 41 Fed. Reg. 6896 (1976) (“objective intent” shown if
“article is, with the knowledge [of its makers], offered and
used” for a particular purpose). Thus, even in the absence
of express claims, the FDA has regulated products that af-
fect the body if the manufacturer wants, and knows, that
consumers so use the product. See, e. g., 60 Fed. Reg.
41527–41531 (1995) (describing agency’s regulation of topical
hormones, sunscreens, fluoride, tanning lamps, thyroid in
food supplements, novelty condoms—all marketed without
express claims); see also 1 O’Reilly § 13.04, at 13–15 (“Some-
times the very nature of the material makes it a drug . . .”).
Courts ordinarily reverse an agency interpretation of this
kind only if Congress has clearly answered the interpretive

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question or if the agency’s interpretation is unreasonable.
Chevron U. S. A. Inc. v. Natural Resources Defense Council,
Inc., 467 U. S. 837, 842–843 (1984). The companies, in an
effort to argue the former, point to language in the legisla-
tive history tying the word “intended” to a technical concept
called “intended use.” But nothing in Congress’ discussion
either of “intended” or “intended use” suggests that an ex-
press claim (which often shows intent) is always necessary.
Indeed, the primary statement to which the companies direct
our attention says only that a manufacturer can determine
what kind of regulation applies—“food” or “drug”—because,
“through his representations in connection with its sale, [the
manufacturer] can determine” whether an article is to be
used as a “food,” as a “drug,” or as “both.” S. Rep. No. 361,
74th Cong., 1st Sess., 4 (1935), reprinted in 3 Leg. Hist. 696.
Nor is the FDA’s “objective intent” interpretation unrea-
sonable. It falls well within the established scope of the
ordinary meaning of the word “intended.” See Agnew v.
United States, 165 U. S. 36, 53 (1897) (intent encompasses the
known consequences of an act). And the companies ac-
knowledge that the FDA can regulate a drug-like substance
in the ordinary circumstance, i. e., where the manufacturer
makes an express claim, so it is not unreasonable to conclude
that the agency retains such power where a product’s effects
on the body are so well known (say, like those of aspirin or
calamine lotion), that there is no need for express represen-
tations because the product speaks for itself.
The companies also cannot deny that the evidence of their
intent is sufficient to satisfy the statutory word “intended”
as the FDA long has interpreted it. In the first place, there
was once a time when they actually did make express ad-
vertising claims regarding tobacco’s mood-stabilizing and
weight-reducing properties—and historical representations
can portend present expectations. In the late 1920’s, for
example, the American Tobacco Company urged weight-
conscious smokers to “ ‘Reach for a Lucky instead of a

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sweet.’ ” Kluger, Ashes to Ashes, at 77–78. The advertise-
ments of R J Reynolds (RJR) emphasized mood stability by
depicting a pilot remarking that “ ‘It Takes Steady Nerves
to Fly the Mail at Night . . . . That’s why I smoke Camels.
And I smoke plenty!’ ” Id., at 86. RJR also advertised the
stimulating quality of cigarettes, stating in one instance that
“ ‘You get a Lift with a Camel,’ ” and, in another, that Camels
are “ ‘A Harmless Restoration of the Flow of Natural Body
Energy.’ ” Id., at 87. And claims of medical proof of mild-
ness (and of other beneficial effects) once were commonplace.
See, e. g., id., at 93 (Brown & Williamson advertised Kool-
brand mentholated cigarettes as “a tonic to hot, tired
throats”); id., at 101, 131 (Philip Morris contended that
“ ‘[r]ecognized laboratory tests have conclusively proven the
advantage of Phillip [sic] Morris’ ”); id., at 88 (RJR pro-
claimed “ ‘For Digestion’s sake, smoke Camels! . . . Camels
make mealtime more pleasant—digestion is stimulated—al-
kalinity increased’ ”). Although in recent decades cigarette
manufacturers have stopped making express health claims in
their advertising, consumers have come to understand what
the companies no longer need to express—that through
chemical action cigarettes stabilize mood, sedate, stimulate,
and help suppress appetite.
Second, even though the companies refused to acknowl-
edge publicly (until only very recently) that the nicotine in
cigarettes has chemically induced, and habit-forming, effects,
see, e. g., Regulation of Tobacco Products (Part 1): Hearings
before the House Subcommittee on Health and the Environ-
ment, 103d Cong., 2d Sess., 628 (1994) (hereinafter 1994
Hearings) (heads of seven major tobacco companies testified
under oath that they believed “nicotine is not addictive” (em-
phasis added)), the FDA recently has gained access to solid,
documentary evidence proving that cigarette manufacturers
have long known tobacco produces these effects within the
body through the metabolizing of chemicals, and that they

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have long wanted their products to produce those effects in
this way.
For example, in 1972, a tobacco-industry scientist ex-
plained that “ ‘[s]moke is beyond question the most optimized
vehicle of nicotine,’ ” and “ ‘the cigarette is the most opti-
mized dispenser of smoke.’ ” 61 Fed. Reg. 44856 (1996)
(emphasis deleted). That same scientist urged company
executives to
“ ‘[t]hink of the cigarette pack as a storage container for
a day’s supply of nicotine. . . . Think of the cigarette as
a dispenser for a dose unit of nicotine [and] [t]hink of a
puff of smoke as the vehicle of nicotine.’ ” Ibid. (Philip
Morris) (emphasis deleted).
That same year, other tobacco industry researchers told
their superiors that
“ ‘in different situations and at different dose levels, nic-
otine appears to act as a stimulant, depressant, tranquil-
izer, psychic energizer, appetite reducer, anti-fatigue
agent, or energizer. . . . Therefore, [tobacco] products
may, in a sense, compete with a variety of other products
with certain types of drug action.’ ” Id., at 44669 (RJR)
(emphasis deleted).
A draft report prepared by authorities at Philip Morris said
that nicotine
“ ‘is a physiologically active, nitrogen containing sub-
stance [similar to] quinine, cocaine, atropine and mor-
phine. [And] [w]hile each of these [other] substances
can be used to affect human physiology, nicotine has
a particularly broad range of influence.’ ” Id., at
44668–44669.
And a 1980 manufacturer’s study stated that
“ ‘the pharmacological response of smokers to nicotine is
believed to be responsible for an individual’s smoking

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174 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
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behaviour, providing the motivation for and the degree
of satisfaction required by the smoker.’ ” Id., at 44936
(Brown & Williamson).
With such evidence, the FDA has more than sufficiently
established that the companies “intend” their products to
“affect” the body within the meaning of the FDCA.
C
The majority nonetheless reaches the “inescapable conclu-
sion” that the language and structure of the FDCA as a
whole “simply do not fit” the kind of public health problem
that tobacco creates. Ante, at 143. That is because, in the
majority’s view, the FDCA requires the FDA to ban outright
“dangerous” drugs or devices (such as cigarettes); yet, the
FDA concedes that an immediate and total cigarette-sale ban
is inappropriate. Ibid.
This argument is curious because it leads with similarly
“inescapable” force to precisely the opposite conclusion,
namely, that the FDA does have jurisdiction but that it must
ban cigarettes. More importantly, the argument fails to
take into account the fact that a statute interpreted as re-
quiring the FDA to pick a more dangerous over a less dan-
gerous remedy would be a perverse statute, causing, rather
than preventing, unnecessary harm whenever a total ban is
likely the more dangerous response. And one can at least
imagine such circumstances.
Suppose, for example, that a commonly used, mildly addic-
tive sleeping pill (or, say, a kind of popular contact lens),
plainly within the FDA’s jurisdiction, turned out to pose seri-
ous health risks for certain consumers. Suppose further
that many of those addicted consumers would ignore an im-
mediate total ban, turning to a potentially more dangerous
black-market substitute, while a less draconian remedy (say,
adequate notice) would wean them gradually away to a safer
product. Would the FDCA still force the FDA to impose

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175 Cite as: 529 U. S. 120 (2000)
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the more dangerous remedy? For the following reasons,
I think not.
First, the statute’s language does not restrict the FDA’s
remedial powers in this way. The FDCA permits the FDA
to regulate a “combination product”—i. e., a “device” (such
as a cigarette) that contains a “drug” (such as nicotine)—
under its “device” provisions. 21 U. S. C. § 353(g)(1). And
the FDCA’s “device” provisions explicitly grant the FDA
wide remedial discretion. For example, where the FDA
cannot “otherwise” obtain “reasonable assurance” of a de-
vice’s “safety and effectiveness,” the agency may restrict by
regulation a product’s “sale, distribution, or use” upon
“such . . . conditions as the Secretary may prescribe.”
§ 360j(e)(1) (emphasis added). And the statutory section
that most clearly addresses the FDA’s power to ban (entitled
“Banned devices”) says that, where a device presents “an
unreasonable and substantial risk of illness or injury,” the
Secretary “may”—not must—“initiate a proceeding . . . to
make such device a banned device.” § 360f(a) (emphasis
added).
The Court points to other statutory subsections which it
believes require the FDA to ban a drug or device entirely,
even where an outright ban risks more harm than other reg-
ulatory responses. See ante, at 135–136. But the cited
provisions do no such thing. It is true, as the majority con-
tends, that “the FDCA requires the FDA to place all de-
vices” in “one of three classifications” and that Class III de-
vices require “premarket approval.” Ante, at 136. But it
is not the case that the FDA must place cigarettes in Class
III because tobacco itself “presents a potential unreasonable
risk of illness or injury.” 21 U. S. C. § 360c(a)(1)(C). In fact,
Class III applies only where regulation cannot otherwise
“provide reasonable assurance of . . . safety.” §§ 360c(a)
(1)(A), (B) (placing a device in Class I or Class II when regu-
lation can provide that assurance). Thus, the statute plainly
allows the FDA to consider the relative, overall “safety” of

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176 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
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a device in light of its regulatory alternatives, and where the
FDA has chosen the least dangerous path, i. e., the safest
path, then it can—and does—provide a “reasonable assur-
ance” of “safety” within the meaning of the statute. A good
football helmet provides a reasonable assurance of safety for
the player even if the sport itself is still dangerous. And the
safest regulatory choice by definition offers a “reasonable”
assurance of safety in a world where the other alternatives
are yet more dangerous.
In any event, it is not entirely clear from the statute’s text
that a Class III categorization would require the FDA af-
firmatively to withdraw from the market dangerous devices,
such as cigarettes, which are already widely distributed.
See, e. g., § 360f(a) (when a device presents an “unreasonable
and substantial risk of illness or injury,” the Secretary “may”
make it “a banned device”); § 360h(a) (when a device “pre-
sents an unreasonable risk of substantial harm to the
public health,” the Secretary “may” require “notification”);
§ 360h(b) (when a defective device creates an “unreasonable
risk” of harm, the Secretary “may” order “[r]epair, replace-
ment, or refund”); cf. 2 O’Reilly § 18.08, at 18–29 (point of
Class III “premarket approval” is to allow “careful scientific
review” of each “truly new” device “before it is exposed” to
users (emphasis added)).
Noting that the FDCA requires banning a “misbranded”
drug, the majority also points to 21 U. S. C. § 352( j), which
deems a drug or device “misbranded” if “it is dangerous to
health when used” as “prescribed, recommended, or sug-
gested in the labeling.” See ante, at 135. In addition, the
majority mentions § 352(f)(1), which calls a drug or device
“misbranded” unless “its labeling bears . . . adequate direc-
tions for use” as “are necessary for the protection of users.”
Ibid. But this “misbranding” language is not determina-
tive, for it permits the FDA to conclude that a drug or device
is not “dangerous to health” and that it does have “adequate”

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177 Cite as: 529 U. S. 120 (2000)
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directions when regulated so as to render it as harmless as
possible. And surely the agency can determine that a sub-
stance is comparatively “safe” (not “dangerous”) whenever it
would be less dangerous to make the product available (sub-
ject to regulatory requirements) than suddenly to withdraw
it from the market. Any other interpretation risks substan-
tial harm of the sort that my sleeping pill example illus-
trates. See supra, at 174–175. And nothing in the statute
prevents the agency from adopting a view of “safety” that
would avoid such harm. Indeed, the FDA already seems to
have taken this position when permitting distribution of
toxic drugs, such as poisons used for chemotherapy, that are
dangerous for the user but are not deemed “dangerous to
health” in the relevant sense. See 61 Fed. Reg. 44413 (1996).
The tobacco companies point to another statutory provi-
sion which says that if a device “would cause serious, adverse
health consequences or death, the Secretary shall issue” a
cease distribution order. 21 U. S. C. § 360h(e)(1) (emphasis
added). But that word “shall” in this context cannot mean
that the Secretary must resort to the recall remedy when-
ever a device would have serious, adverse health effects.
Rather, that language must mean that the Secretary “shall
issue” a cease distribution order in compliance with the sec-
tion’s procedural requirements if the Secretary chooses in
her discretion to use that particular subsection’s recall rem-
edy. Otherwise, the subsection would trump and make
meaningless the same section’s provision of other lesser rem-
edies such as simple “notice” (which the Secretary similarly
can impose if, but only if, she finds that the device “presents
an unreasonable risk of substantial harm to the public”).
§ 360h(a)(1). And reading the statute to compel the FDA to
“recall” every dangerous device likewise would conflict with
that same subsection’s statement that the recall remedy
“shall be in addition to [the other] remedies provided” in the
statute. § 360h(e)(3) (emphasis added).

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178 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
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The statute’s language, then, permits the agency to choose
remedies consistent with its basic purpose—the overall pro-
tection of public health.
The second reason the FDCA does not require the FDA
to select the more dangerous remedy, see supra, at 175, is
that, despite the majority’s assertions to the contrary, the
statute does not distinguish among the kinds of health ef-
fects that the agency may take into account when assessing
safety. The Court insists that the statute only permits the
agency to take into account the health risks and benefits of
the “product itself ” as used by individual consumers, ante,
at 140, and, thus, that the FDA is prohibited from consider-
ing that a ban on smoking would lead many smokers to suffer
severe withdrawal symptoms or to buy possibly stronger,
more dangerous, black market cigarettes—considerations
that the majority calls “the aggregate health effects of al-
ternative administrative actions.” Ibid. But the FDCA
expressly permits the FDA to take account of compara-
tive safety in precisely this manner. See, e. g., 21 U. S. C.
§ 360h(e)(2)(B)(i)(II) (no device recall if “risk of recal[l]” pre-
sents “a greater health risk than” no recall); § 360h(a) (notifi-
cation “unless” notification “would present a greater danger”
than “no such notification”).
Moreover, one cannot distinguish in this context between
a “specific” health risk incurred by an individual and an “ag-
gregate” risk to a group. All relevant risk is, at bottom,
risk to an individual; all relevant risk attaches to “the prod-
uct itself ”; and all relevant risk is “aggregate” in the sense
that the agency aggregates health effects in order to deter-
mine risk to the individual consumer. If unregulated smok-
ing will kill 4 individuals out of a typical group of 1,000 peo-
ple, if regulated smoking will kill 1 out of 1,000, and if a
smoking ban (because of the black market) will kill 2 out of
1,000; then these three possibilities mean that in each group
four, one, and two individuals, on average, will die respec-
tively. And the risk to each individual consumer is 4/1,000,

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1/1,000, and 2/1,000 respectively. A “specific” risk to an indi-
vidual consumer and “aggregate” risks are two sides of the
same coin; each calls attention to the same set of facts.
While there may be a theoretical distinction between the
risk of the product itself and the risk related to the presence
or absence of an intervening voluntary act (e. g., the search
for a replacement on the black market), the majority does
not rely upon any such distinction, and the FDA’s history of
regulating “replacement” drugs such as methadone shows
that it has long taken likely actual alternative consumer be-
havior into account.
I concede that, as a matter of logic, one could consider the
FDA’s “safety” evaluation to be different from its choice of
remedies. But to read the statute to forbid the agency from
taking account of the realities of consumer behavior either
in assessing safety or in choosing a remedy could increase
the risks of harm—doubling the risk of death to each “indi-
vidual user” in my example above. Why would Congress
insist that the FDA ignore such realities, even if the conse-
quent harm would occur only unusually, say, where the FDA
evaluates a product (a sleeping pill; a cigarette; a contact
lens) that is already on the market, potentially habit forming,
or popular? I can find no satisfactory answer to this ques-
tion. And that, I imagine, is why the statute itself says
nothing about any of the distinctions that the Court has tried
to draw. See 21 U. S. C. § 360c(a)(2) (instructing FDA to de-
termine the safety and effectiveness of a “device” in part by
weighing “any probable benefit to health . . . against any
probable risk of injury or illness . . .” (emphasis added)).
Third, experience counsels against an overly rigid inter-
pretation of the FDCA that is divorced from the statute’s
overall health-protecting purposes. A different set of
words, added to the FDCA in 1958 by the Delaney Amend-
ment, provides that “no [food] additive shall be deemed to
be safe if it is found [after appropriate tests] to induce cancer
when ingested by man or animal.” § 348(c)(3). The FDA

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180 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
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once interpreted this language as requiring it to ban any food
additive, no matter how small the amount, that appeared in
any food product if that additive was ever found to induce
cancer in any animal, no matter how large a dose needed to
induce the appearance of a single carcinogenic cell. See
H. R. Rep. No. 95–658, p. 7 (1977) (discussing agency’s view).
The FDA believed that the statute’s ban mandate was abso-
lute and prevented it from establishing a level of “safe use”
or even to judge whether “the benefits of continued use out-
weigh the risks involved.” Id., at 5. This interpretation—
which in principle could have required the ban of everything
from herbal teas to mushrooms—actually led the FDA to
ban saccharine, see 42 Fed. Reg. 19996 (1977), though this
extremely controversial regulatory response never took ef-
fect because Congress enacted, and has continually renewed,
a law postponing the ban. See Saccharin Study and Label-
ing Act, Pub. L. 95–203, § 3, 91 Stat. 1452; e. g., Pub. L. 102–
142, Tit. VI, 105 Stat. 910.
The Court’s interpretation of the statutory language be-
fore us risks Delaney-type consequences with even less lin-
guistic reason. Even worse, the view the Court advances
undermines the FDCA’s overall health-protecting purpose
by placing the FDA in the strange dilemma of either banning
completely a potentially dangerous drug or device or doing
nothing at all. Saying that I have misunderstood its conclu-
sion, the majority maintains that the FDA “may clearly reg-
ulate many ‘dangerous’ products without banning them.”
Ante, at 142. But it then adds that the FDA must ban—
rather than otherwise regulate—a drug or device that “can-
not be used safely for any therapeutic purpose.” Ibid. If I
misunderstand, it is only because this linchpin of the majori-
ty’s conclusion remains unexplained. Why must a widely
used but unsafe device be withdrawn from the market when
that particular remedy threatens the health of many and is
thus more dangerous than another regulatory response? It
is, indeed, a perverse interpretation that reads the FDCA

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181 Cite as: 529 U. S. 120 (2000)
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to require the ban of a device that has no “safe” thera-
peutic purpose where a ban is the most dangerous remedial
alternative.
In my view, where linguistically permissible, we should
interpret the FDCA in light of Congress’ overall desire to
protect health. That purpose requires a flexible interpreta-
tion that both permits the FDA to take into account the real-
ities of human behavior and allows it, in appropriate cases,
to choose from its arsenal of statutory remedies. A statute
so interpreted easily “fit[s]” this, and other, drug- and
device-related health problems.
III
In the majority’s view, laws enacted since 1965 require us
to deny jurisdiction, whatever the FDCA might mean in
their absence. But why? Do those laws contain language
barring FDA jurisdiction? The majority must concede that
they do not. Do they contain provisions that are inconsist-
ent with the FDA’s exercise of jurisdiction? With one
exception, see infra, at 184–185, the majority points to no
such provision. Do they somehow repeal the principles of
law (discussed in Part II, supra) that otherwise would lead
to the conclusion that the FDA has jurisdiction in this area?
The companies themselves deny making any such claim.
See Tr. of Oral Arg. 27 (denying reliance on doctrine of “par-
tial repeal”). Perhaps the later laws “shape” and “focus”
what the 1938 Congress meant a generation earlier. Ante,
at 143. But this Court has warned against using the views
of a later Congress to construe a statute enacted many years
before. See Pension Benefit Guaranty Corporation v. LTV
Corp., 496 U. S. 633, 650 (1990) (later history is a “ ‘hazardous
basis for inferring the intent of an earlier’ Congress” (quot-
ing United States v. Price, 361 U. S. 304, 313 (1960))). And,
while the majority suggests that the subsequent history
“control[s] our construction” of the FDCA, see ante, at 143
(citation and internal quotation marks omitted), this Court

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182 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
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expressly has held that such subsequent views are not “con-
trolling.” Haynes v. United States, 390 U. S. 85, 87–88, n. 4
(1968); accord, Southwestern Cable Co., 392 U. S., at 170 (such
views have “ ‘very little, if any, significance’ ”); see also Sul-
livan v. Finkelstein, 496 U. S. 617, 632 (1990) (Scalia, J.,
concurring) (“Arguments based on subsequent legislative
history . . . should not be taken seriously, not even in a
footnote”).
Regardless, the later statutes do not support the majori-
ty’s conclusion. That is because, whatever individual Mem-
bers of Congress after 1964 may have assumed about the
FDA’s jurisdiction, the laws they enacted did not embody
any such “no jurisdiction” assumption. And one cannot au-
tomatically infer an antijurisdiction intent, as the majority
does, for the later statutes are both (and similarly) consistent
with quite a different congressional desire, namely, the in-
tent to proceed without interfering with whatever authority
the FDA otherwise may have possessed. See, e. g., Ciga-
rette Labeling and Advertising—1965: Hearings on H. R.
2248 et al. before the House Committee on Interstate and
Foreign Commerce, 89th Cong., 1st Sess., 19 (1965) (herein-
after 1965 Hearings) (statement of Rep. Fino that the pro-
posed legislation would not “erode” agency authority). As
I demonstrate below, the subsequent legislative history is
critically ambivalent, for it can be read either as (a) “rati-
f[ying]” a no-jurisdiction assumption, see ante, at 158, or as
(b) leaving the jurisdictional question just where Congress
found it. And the fact that both inferences are “equally ten-
able,” Pension Benefit Guaranty Corp., supra, at 650 (cita-
tion and internal quotation marks omitted); Johnson v.
Transportation Agency, Santa Clara Cty., 480 U. S. 616, 672
(1987) (Scalia, J., dissenting), prevents the majority from
drawing from the later statutes the firm, antijurisdiction im-
plication that it needs.
Consider, for example, Congress’ failure to provide the
FDA with express authority to regulate tobacco—a circum-

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183 Cite as: 529 U. S. 120 (2000)
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stance that the majority finds significant. See ante, at 144,
147–148, 155. But cf. Southwestern Cable Co., supra, at 170
(failed requests do not prove agency “did not already pos-
sess” authority). In fact, Congress both failed to grant ex-
press authority to the FDA when the FDA denied it had
jurisdiction over tobacco and failed to take that authority
expressly away when the agency later asserted jurisdiction.
See, e. g., S. 1262, 104th Cong., 1st Sess., § 906 (1995) (failed
bill seeking to amend FDCA to say that “[n]othing in this
Act or any other Act shall provide the [FDA] with any au-
thority to regulate in any manner tobacco or tobacco prod-
ucts”); see also H. R. 516, 105th Cong., 1st Sess., § 2 (1997)
(similar); H. R. Res. 980, reprinted in 142 Cong. Rec. 5018
(1996) (Georgia legislators unsuccessfully requested that
Congress “rescind any action giving the FDA authority”
over tobacco); H. R. 2283, 104th Cong., 1st Sess. (1995) (failed
bill “[t]o prohibit the [FDA] regulation of the sale or use
of tobacco”); H. R. 2414, 104th Cong., 1st Sess., § 2(a) (1995)
(similar). Consequently, the defeat of various different pro-
posed jurisdictional changes proves nothing. This history
shows only that Congress could not muster the votes neces-
sary either to grant or to deny the FDA the relevant author-
ity. It neither favors nor disfavors the majority’s position.
The majority also mentions the speed with which Con-
gress acted to take jurisdiction away from other agencies
once they tried to assert it. See ante, at 145, 149–151. But
such a congressional response again proves nothing. On the
one hand, the speedy reply might suggest that Congress
somehow resented agency assertions of jurisdiction in an
area it desired to reserve for itself—a consideration that sup-
ports the majority. On the other hand, Congress’ quick re-
action with respect to other agencies’ regulatory efforts con-
trasts dramatically with its failure to enact any responsive
law (at any speed) after the FDA asserted jurisdiction over
tobacco more than three years ago. And that contrast sup-
ports the opposite conclusion.

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184 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
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In addition, at least one post-1938 statute reveals quite a
different congressional intent than the majority infers. See
note following 21 U. S. C. § 321 (1994 ed., Supp. III) (FDA
Modernization Act of 1997) (law “shall [not] be construed to
affect the question of whether the [FDA] has any authority
to regulate any tobacco product,” and “[s]uch authority, if
any, shall be exercised under the [FDCA] as in effect on the
day before the date of [this] enactment”). Consequently, it
appears that the only interpretation that can reconcile all of
the subsequent statutes is the inference that Congress did
not intend, either explicitly or implicitly, for its later laws to
answer the question of the scope of the FDA’s jurisdictional
authority. See 143 Cong. Rec. S8860 (Sept. 5, 1997) (the
Modernization Act will “not interfere or substantially nega-
tively affect any of the FDA tobacco authority”).
The majority’s historical perspective also appears to be
shaped by language in the Federal Cigarette Labeling and
Advertising Act (FCLAA), 79 Stat. 282, 15 U. S. C. § 1331
et seq. See ante, at 148–149. The FCLAA requires manu-
facturers to place on cigarette packages, etc., health warn-
ings such as the following:
“SURGEON GENERAL’S WARNING: Smoking
Causes Lung Cancer, Heart Disease, Emphysema, And
May Complicate Pregnancy.” 15 U. S. C. § 1333(a).
The FCLAA has an express pre-emption provision which
says that “[n]o statement relating to smoking and health,
other than the statement required by [this Act], shall be re-
quired on any cigarette package.” § 1334(a). This pre-
emption clause plainly prohibits the FDA from requiring on
“any cigarette package” any other “statement relating to
smoking and health,” but no one contends that the FDA has
failed to abide by this prohibition. See, e. g., 61 Fed. Reg.
44399 (1996) (describing the other regulatory prescriptions).
Rather, the question is whether the FCLAA’s pre-emption

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185 Cite as: 529 U. S. 120 (2000)
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provision does more. Does it forbid the FDA to regulate
at all?
This Court has already answered that question expressly
and in the negative. See Cipollone v. Liggett Group, Inc.,
505 U. S. 504 (1992). Cipollone held that the FCLAA’s pre-
emption provision does not bar state or federal regulation
outside the provision’s literal scope. Id., at 518. And it de-
scribed the pre-emption provision as “merely prohibit[ing]
state and federal rulemaking bodies from mandating particu-
lar cautionary statements on cigarette labels . . . .” Ibid.
This negative answer is fully consistent with Congress’ in-
tentions in regard to the pre-emption language. When Con-
gress enacted the FCLAA, it focused upon the regulatory
efforts of the Federal Trade Commission (FTC), not the
FDA. See 1965 Hearings 1–2. And the Public Health Cig-
arette Smoking Act of 1969, Pub. L. 91–222, § 7(c), 84 Stat. 89,
expressly amended the FCLAA to provide that “[n]othing in
this Act shall be construed to affirm or deny the [FTC’s]
holding that it has the authority to issue trade regulation
rules” for tobacco. See also H. R. Conf. Rep. No. 91–897,
p. 7 (1970) (statement of House Managers) (we have “no in-
tention to resolve the question as to whether” the FTC could
regulate tobacco in a different way); see also 116 Cong. Rec.
7921 (1970) (statement of Rep. Satterfield) (same). Why
would one read the FCLAA’s pre-emption clause—a provi-
sion that Congress intended to limit even in respect to the
agency directly at issue—so broadly that it would bar a dif-
ferent agency from engaging in any other cigarette regula-
tion at all? The answer is that the Court need not, and
should not, do so. And, inasmuch as the Court already has
declined to view the FCLAA as pre-empting the entire field
of tobacco regulation, I cannot accept that that same law
bars the FDA’s regulatory efforts here.
When the FCLAA’s narrow pre-emption provision is set
aside, the majority’s conclusion that Congress clearly in-
tended for its tobacco-related statutes to be the exclusive

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186 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
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“response” to “the problem of tobacco and health,” ante, at
157, is based on legislative silence. Notwithstanding the
views voiced by various legislators, Congress itself has ad-
dressed expressly the issue of the FDA’s tobacco-related au-
thority only once—and, as I have said, its statement was that
the statute was not to “be construed to affect the question of
whether the [FDA] has any authority to regulate any tobacco
product.” Note following 21 U. S. C. § 321 (1994 ed., Supp.
III). The proper inference to be drawn from all of the
post-1965 statutes, then, is one that interprets Congress’
general legislative silence consistently with this statement.
IV
I now turn to the final historical fact that the majority
views as a factor in its interpretation of the subsequent leg-
islative history: the FDA’s former denials of its tobacco-
related authority.
Until the early 1990’s, the FDA expressly maintained that
the 1938 statute did not give it the power that it now seeks
to assert. It then changed its mind. The majority agrees
with me that the FDA’s change of positions does not make a
significant legal difference. See ante, at 156–157; see also
Chevron, 467 U. S., at 863 (“An initial agency interpretation
is not instantly carved in stone”); accord, Smiley v. Citibank
(South Dakota), N. A., 517 U. S. 735, 742 (1996) (“[C]hange
is not invalidating”). Nevertheless, it labels those denials
“important context” for drawing an inference about Con-
gress’ intent. Ante, at 157. In my view, the FDA’s change
of policy, like the subsequent statutes themselves, does noth-
ing to advance the majority’s position.
When it denied jurisdiction to regulate cigarettes, the
FDA consistently stated why that was so. In 1963, for
example, FDA administrators wrote that cigarettes did not
satisfy the relevant FDCA definitions—in particular, the
“intent” requirement—because cigarette makers did not sell
their product with accompanying “therapeutic claims.”

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Letter to Directors of Bureaus, Divisions and Directors of
Districts from FDA Bureau of Enforcement (May 24, 1963),
in Public Health Cigarette Amendments of 1971: Hearings
on S. 1454 before the Consumer Subcommittee of the Senate
Committee on Commerce, 92d Cong., 2d Sess., 240 (1972)
(hereinafter FDA Enforcement Letter). And subsequent
FDA Commissioners made roughly the same assertion.
One pointed to the fact that the manufacturers only “recom-
mended” cigarettes “for smoking pleasure.” Two others re-
iterated the evidentiary need for “health claims.” Yet an-
other stressed the importance of proving “intent,” adding
that “[w]e have not had sufficient evidence” of “intent with
regard to nicotine.” See, respectively, id., at 239 (Comm’r
Edwards); Letter of Dec. 5, 1977, App. 47 (Comm’r Kennedy);
1965 Hearings 193 (Comm’r Rankin); 1994 Hearings 28
(Comm’r Kessler). Tobacco company counsel also testified
that the FDA lacked jurisdiction because jurisdiction “de-
pends on . . . intended use,” which in turn “depends, in
general, on the claims and representations made by the
manufacturer.” Health Consequences of Smoking: Nicotine
Addiction, Hearing before the Subcommittee on Health and
the Environment of the House Committee on Energy and
Commerce, 100th Cong., 2d Sess., 288 (1988) (testimony of
Richard Cooper) (emphasis added).
Other agency statements occasionally referred to addi-
tional problems. Commissioner Kessler, for example, said
that the “enormous social consequences” flowing from a deci-
sion to regulate tobacco counseled in favor of obtaining spe-
cific congressional “guidance.” 1994 Hearings 69; see also
ante, at 153 (quoting statement of Health and Human Services
Secretary Brandt to the effect that Congress wanted to make
the relevant jurisdictional decision). But a fair reading of
the FDA’s denials suggests that the overwhelming problem
was one of proving the requisite manufacturer intent. See
Action on Smoking and Health v. Harris, 655 F. 2d 236, 238–
239 (CADC 1980) (FDA “comments” reveal its “understand-

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188 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
Breyer, J., dissenting
ing” that “the crux of FDA jurisdiction over drugs lay
in manufacturers’ representations as revelatory of their
intent”).
What changed? For one thing, the FDA obtained evi-
dence sufficient to prove the necessary “intent” despite
the absence of specific “claims.” See supra, at 172–174.
This evidence, which first became available in the early
1990’s, permitted the agency to demonstrate that the tobacco
companies knew nicotine achieved appetite-suppressing,
mood-stabilizing, and habituating effects through chemical
(not psychological) means, even at a time when the compa-
nies were publicly denying such knowledge.
Moreover, scientific evidence of adverse health effects
mounted, until, in the late 1980’s, a consensus on the serious-
ness of the matter became firm. That is not to say that con-
cern about smoking’s adverse health effects is a new phe-
nomenon. See, e. g., Higginson, A New Counterblast, in
Out-door Papers 179, 194 (1863) (characterizing tobacco as
“ ‘a narcotic poison of the most active class’ ”). It is to say,
however, that convincing epidemiological evidence began to
appear mid-20th century; that the first Surgeon General’s
Report documenting the adverse health effects appeared in
1964; and that the Surgeon General’s Report establishing nic-
otine’s addictive effects appeared in 1988. At each stage,
the health conclusions were the subject of controversy, di-
minishing somewhat over time, until recently—and only re-
cently—has it become clear that there is a wide consensus
about the health problem. See 61 Fed. Reg. 44701–44706
(1996).
Finally, administration policy changed. Earlier adminis-
trations may have hesitated to assert jurisdiction for the rea-
sons prior Commissioners expressed. See supra, at 186–187
and this page. Commissioners of the current administration
simply took a different regulatory attitude.
Nothing in the law prevents the FDA from changing its
policy for such reasons. By the mid-1990’s, the evidence

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189 Cite as: 529 U. S. 120 (2000)
Breyer, J., dissenting
needed to prove objective intent—even without an express
claim—had been found. The emerging scientific consensus
about tobacco’s adverse, chemically induced, health effects
may have convinced the agency that it should spend its re-
sources on this important regulatory effort. As for the
change of administrations, I agree with then-Justice Rehn-
quist’s statement in a different case, where he wrote:
“The agency’s changed view . . . seems to be related to
the election of a new President of a different political
party. It is readily apparent that the responsible mem-
bers of one administration may consider public resist-
ance and uncertainties to be more important than do
their counterparts in a previous administration. A
change in administration brought about by the people
casting their votes is a perfectly reasonable basis for an
executive agency’s reappraisal of the costs and benefits
of its programs and regulations. As long as the agency
remains within the bounds established by Congress, it
is entitled to assess administrative records and evaluate
priorities in light of the philosophy of the administra-
tion.” Motor Vehicle Mfrs. Assn. of United States, Inc.
v. State Farm Mut. Automobile Ins. Co., 463 U. S. 29, 59
(1983) (concurring in part and dissenting in part).
V
One might nonetheless claim that, even if my interpreta-
tion of the FDCA and later statutes gets the words right, it
lacks a sense of their “music.” See Helvering v. Gregory, 69
F. 2d 809, 810–811 (CA2 1934) (L. Hand, J.) (“[T]he meaning
of a [statute] may be more than that of the separate words,
as a melody is more than the notes . . .”). Such a claim
might rest on either of two grounds.
First, one might claim that, despite the FDA’s legal right
to change its mind, its original statements played a critical
part in the enactment of the later statutes and now should
play a critical part in their interpretation. But the FDA’s

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190 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
Breyer, J., dissenting
traditional view was largely premised on a perceived inabil-
ity to prove the necessary statutory “intent” requirement.
See, e. g., FDA Enforcement Letter 240 (“The statutory basis
for the exclusion of tobacco products from FDA’s jurisdiction
is the fact that tobacco marketed for chewing or smoking
without accompanying therapeutic claims, does not meet the
definitions . . . for food, drug, device or cosmetic”). The
statement, “we cannot assert jurisdiction over substance X
unless it is treated as a food,” would not bar jurisdiction if
the agency later establishes that substance X is, and is in-
tended to be, eaten. The FDA’s denials of tobacco-related
authority sufficiently resemble this kind of statement that
they should not make the critical interpretive difference.
Second, one might claim that courts, when interpreting
statutes, should assume in close cases that a decision
with “enormous social consequences,” 1994 Hearings 69,
should be made by democratically elected Members of Con-
gress rather than by unelected agency administrators.
Cf. Kent v. Dulles, 357 U. S. 116, 129 (1958) (assuming Con-
gress did not want to delegate the power to make rules inter-
fering with exercise of basic human liberties). If there is
such a background canon of interpretation, however, I do not
believe it controls the outcome here.
Insofar as the decision to regulate tobacco reflects the pol-
icy of an administration, it is a decision for which that admin-
istration, and those politically elected officials who support
it, must (and will) take responsibility. And the very impor-
tance of the decision taken here, as well as its attendant pub-
licity, means that the public is likely to be aware of it and to
hold those officials politically accountable. Presidents, just
like Members of Congress, are elected by the public. In-
deed, the President and Vice President are the only public
officials whom the entire Nation elects. I do not believe that
an administrative agency decision of this magnitude—one
that is important, conspicuous, and controversial—can es-
cape the kind of public scrutiny that is essential in any de-

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191 Cite as: 529 U. S. 120 (2000)
Breyer, J., dissenting
mocracy. And such a review will take place whether it is
the Congress or the Executive Branch that makes the rele-
vant decision.
* * *
According to the FDA, only 2.5% of smokers successfully
stop smoking each year, even though 70% say they want to
quit and 34% actually make an attempt to do so. See 61
Fed. Reg. 44704 (1996) (citing Centers for Disease Control
and Prevention, Cigarette Smoking Among Adults—United
States, 1993; 43 Morbidity and Mortality Weekly Report 929
(Dec. 23, 1994)). The fact that only a handful of those who
try to quit smoking actually succeed illustrates a certain re-
ality—the reality that the nicotine in cigarettes creates a
powerful physiological addiction flowing from chemically in-
duced changes in the brain. The FDA has found that the
makers of cigarettes “intend” these physical effects. Hence,
nicotine is a “drug”; the cigarette that delivers nicotine to
the body is a “device”; and the FDCA’s language, read in
light of its basic purpose, permits the FDA to assert the
disease-preventing jurisdiction that the agency now claims.
The majority finds that cigarettes are so dangerous that
the FDCA would require them to be banned (a result the
majority believes Congress would not have desired); thus, it
concludes that the FDA has no tobacco-related authority. I
disagree that the statute would require a cigarette ban.
But even if I am wrong about the ban, the statute would
restrict only the agency’s choice of remedies, not its
jurisdiction.
The majority also believes that subsequently enacted stat-
utes deprive the FDA of jurisdiction. But the later laws say
next to nothing about the FDA’s tobacco-related authority.
Previous FDA disclaimers of jurisdiction may have helped to
form the legislative atmosphere out of which Congress’ own
tobacco-specific statutes emerged. But a legislative atmos-
phere is not a law, unless it is embodied in a statutory word
or phrase. And the relevant words and phrases here reveal

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192 FDA v. BROWN & WILLIAMSON TOBACCO CORP.
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nothing more than an intent not to change the jurisdictional
status quo.
The upshot is that the Court today holds that a regulatory
statute aimed at unsafe drugs and devices does not authorize
regulation of a drug (nicotine) and a device (a cigarette) that
the Court itself finds unsafe. Far more than most, this par-
ticular drug and device risks the life-threatening harms that
administrative regulation seeks to rectify. The majority’s
conclusion is counterintuitive. And, for the reasons set
forth, I believe that the law does not require it.
Consequently, I dissent.