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 regulate, among other items, "drugs" and
"devices," §§ 321(g)-(h), 393. In 1996, the FDA asserted
jurisdiction to regulate tobacco products, concluding that, under
the FDCA, nicotine is a "drug" and cigarettes and smokeless tobacco
are "devices" that deliver nicotine to the body. Pursuant to this
authority, the FDA promulgated regulations governing tobacco
products' promotion, labeling, and accessibility to children and
adolescents. The FDA found that tobacco use is the Nation's leading
cause of premature death, resulting in more than 400,000 deaths
annually, and that most adult smokers begin when they are minors.
The regulations therefore aim to reduce tobacco use by minors so as
to substantially reduce the prevalence of addiction in future
generations, and thus the incidence of tobacco-related death and
disease. Respondents, a group of tobacco manufacturers, retailers,
and advertisers, filed this suit challenging the FDA's regulations.
They moved for summary judgment on the ground,
inter alia,
that the FDA lacked jurisdiction to regulate tobacco products as
customarily marketed, that is, without manufacturer claims of
therapeutic benefit. The District Court upheld the FDA's authority,
but the Fourth Circuit reversed, holding that Congress has not
granted the FDA jurisdiction to regulate tobacco products. The
court concluded that construing the FDCA to include tobacco
products would lead to several internal inconsistencies in the Act.
It also found that evidence external to the FDCA-that the FDA
consistently stated before 1995 that it lacked jurisdiction over
tobacco, that Congress has enacted several tobacco-specific
statutes fully cognizant of the FDA's position, and that Congress
has considered and rejected many bills that would have given the
agency such authority-confirms this conclusion.
Held: Reading the FDCA as a whole, as well as in
conjunction with Congress' subsequent tobacco-specific legislation,
it is plain that Congress has not given the FDA the authority to
regulate tobacco products as customarily marketed. Pp. 131-161.
121
(a) Because this case involves an agency's construction of a
statute it administers, the Court's analysis is governed by
Chevron U. S.
A. Inc. v.
Natural Resources Defense
Council, Inc., 467 U. S. 837, under
which a reviewing court must first ask whether Congress has
directly spoken to the precise question at issue,
id., at
842. If so, the court must give effect to Congress' unambiguously
expressed intent.
E. g., id., at 843. If not, the court must
defer to the agency's construction of the statute so long as it is
permissible. See,
e. g., INS v.
Aguirre-Aguirre,
526 U. S. 415,
424. In determining whether Congress has specifically addressed the
question at issue, the court should not confine itself to examining
a particular statutory provision in isolation. Rather, it must
place the provision in context, interpreting the statute to create
a symmetrical and coherent regulatory scheme.
Gustafson v.
Alloyd Co., 513 U. S. 561, 569. In
addition, the meaning of one statute may be affected by other Acts,
particularly where Congress has spoken subsequently and more
specifically to the topic at hand. See,
e. g., United States
v.
Estate of Romani, 523 U. S. 517, 530-531.
Finally, the court must be guided to a degree by common sense as to
the manner in which Congress is likely to delegate a policy
decision of such economic and political magnitude to an
administrative agency. Cf.
MCI Telecommunications Corp. v.
American Telephone &
Telegraph Co., 512 U. S. 218, 231. Pp.
131-133.
(b) Considering the FDCA as a whole, it is clear that Congress
intended to exclude tobacco products from the FDA's jurisdiction. A
fundamental precept of the FDCA is that any product regulated by
the FDA that remains on the market must be safe and effective for
its intended use. See,
e. g., § 393(b)(2). That is,
the potential for inflicting death or physical injury must be
offset by the possibility of therapeutic benefit.
United
States v.
Rutherford, 442 U. S. 544, 556. In
its rulemaking proceeding, the FDA quite exhaustively documented
that tobacco products are unsafe, dangerous, and cause great pain
and suffering from illness. These findings logically imply that, if
tobacco products were "devices" under the FDCA, the FDA would be
required to remove them from the market under the FDCA's
misbranding, see,
e. g., § 331(a), and device
classification, see,
e. g., § 360e(d)(2)(A),
provisions. In fact, based on such provisions, the FDA itself has
previously asserted that if tobacco products were within its
jurisdiction, they would have to be removed from the market because
it would be impossible to prove they were safe for their intended
use. Congress, however, has foreclosed a ban of such products,
choosing instead to create a distinct regulatory scheme focusing on
the labeling and advertising of cigarettes and smokeless tobacco.
Its express policy is to protect commerce and the national economy
while informing consumers about any adverse health effects.
122
See 15 U. S. C. § 1331. Thus, an FDA ban would plainly
contradict congressional intent. Apparently recognizing this
dilemma, the FDA has concluded that tobacco products are actually
"safe" under the FDCA because banning them would cause a greater
harm to public health than leaving them on the market. But this
safety determination-focusing on the relative harms caused by
alternative remedial measures-is not a substitute for those
required by the FDCA. Various provisions in the Act require the
agency to determine that, at least for some consumers, the
product's therapeutic benefits outweigh the risks of illness or
serious injury. This the FDA cannot do, because tobacco products
are unsafe for obtaining any therapeutic benefit. The inescapable
conclusion is that there is no room for tobacco products within the
FDCA's regulatory scheme. If they cannot be used safely for any
therapeutic purpose, and yet they cannot be banned, they simply do
not fit. Pp. 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 addressing the problem of tobacco use
and human health. Those statutes, among other things, require that
health warnings appear on all packaging and in all print and
outdoor advertisements, see 15 U. S. C. §§ 1331, 1333, 4402;
prohibit the advertisement of tobacco products through any
electronic communication medium regulated by the Federal
Communications Commission, see §§ 1335, 4402(f); require the
Secretary of HHS to report every three years to Congress on
research findings concerning tobacco's addictive property, 42 U. S.
C. § 290aa-2(b)(2); and make States' receipt of certain federal
block grants contingent on their prohibiting any tobacco product
manufacturer, retailer, or distributor from selling or distributing
any such product to individuals under age 18, § 300x-26(a)(1). This
tobacco-specific legislation has created a specific regulatory
scheme for addressing the problem of tobacco and health. And it was
adopted against the backdrop of the FDA consistently and resolutely
stating that it was without authority under the FDCA to regulate
tobacco products as customarily marketed. In fact, Congress several
times considered and rejected bills that would have given the FDA
such authority. Indeed, Congress' actions in this area have
evidenced a clear intent to preclude a meaningful policymaking role
for any administrative agency. Further, Congress' tobacco
legislation prohibits any additional regulation of tobacco product
labeling with respect to tobacco's health consequences, a central
aspect of regulation under the FDCA. Under these circumstances, it
is evident that Congress has ratified the FDA's previous, long-held
position that it lacks jurisdiction to regulate tobacco products as
customarily marketed. Congress has
123
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 premised on the theory that a statute's ambiguity
constitutes an implicit delegation from Congress to the agency to
fill in the statutory gaps. See 467 U. S., at 844. In extraordinary
cases, however, there may be reason to hesitate before concluding
that Congress has intended such an implicit delegation. This is
hardly an ordinary case. Contrary to the agency's position from its
inception until 1995, the FDA has now asserted jurisdiction to
regulate an industry constituting a significant portion of the
American economy. In fact, the FDA contends that, were it to
determine that tobacco products provide no "reasonable assurance of
safety," it would have the authority to ban cigarettes and
smokeless tobacco entirely. It is highly unlikely that Congress
would leave the determination as to whether the sale of tobacco
products would be regulated, or even banned, to the FDA's
discretion in so cryptic a fashion. See
MC! 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 regulate in the public interest must always be
grounded in a valid grant of authority from Congress. Courts must
take care not to extend a statute'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 petitioners. With
him on the briefs were Acting Assistant Attorney General Ogden,
Deputy Solicitor General Kneedler, Deputy Assistant Attorney
General Schultz, Irving L. Gornstein, Eugene Thirolf, Douglas
Letter, Gerald C. Kell, Chris-
124
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
respondents National Association of Convenience Stores et al.
Peter T. Grossi, Jr., Arthur N.
Levine, Jeff Richman,
Richard A. Merrill, and
Herbert Dym filed a brief for
respondents Philip Morris Inc. et al. *
*Briefs of
amici curiae urging reversal were filed for
the State of Minnesota et al. by
Mike Hatch, Attorney
General of Minnesota,
James S.
Alexander, Assistant
Attorney General,
Louise H. Renne, and by the Attorneys
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 Mississippi,
Jeremiah W Nixon
of Missouri,
Joseph P. Mazurek of Montana,
Frankie Sue
Del Papa of Nevada,
Philip T. McLaughlin of New
Hampshire,
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
125
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 premature 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
Cosmetic Act (FDCA or Act), 52 Stat. 1040, as amended, 21 U. S. C.
§ 301
et seq., and that cigarettes and smokeless tobacco are
"combination products" that deliver nicotine to the body. 61 Fed.
Reg. 44397 (1996). Pursuant to this authority, it promulgated
regulations intended to reduce tobacco consumption among children
and adolescents.
Id., at 4461544618. 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 administrative 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 Liability Advisory Council, Inc., by
Kenneth S.
Geller; and for the Washington Legal
Foundation et al. by
Daniel J. Popeo and
Richard A. Samp.
126
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 legislation 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 Secretary 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 structure or any function of the body." § 321(h). The
Act also grants the FDA the authority to regulate so-called
"combination 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 regulate 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, distribution, 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-
127
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 Cigarettes
and Smokeless Tobacco to Protect Children and Adolescents."
Id., at 44396. The FDA determined that nicotine 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 therapeutic 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 psychoactive, or mood-altering,
effects on the brain" that cause and sustain addiction, have both
tranquilizing and stimulating effects, and control weight.
Id., at 44631-44632. Second, 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 nicotine to
consumers,"
id., at 44849. Finally, the agency concluded
that cigarettes and smokeless tobacco are "combination 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, detailing
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
128
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 reduce 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 anyone 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 accessibility
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 retailers to verify
through photo identification the age of all purchasers 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 format 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
129
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 accomplished." 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 smokeless tobacco."
Id., at 44404. Under 21 U. S. C. § 360j(e), the agency may
"require that a device be restricted to sale, distribution, or use
... upon such other conditions as [the FDA] may prescribe in such
regulation, if, because of its potentiality 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 authority 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 regulations. 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 products as customarily marketed,
the regulations exceeded the FDA's authority under 21 U. S. C. §
360j(e), and the advertis-
130
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 authorizes the FDA to regulate tobacco
products as customarily marketed and that the FDA's access and
labeling regulations are permissible, but it also found that the
agency's advertising and promotion restrictions exceed its
authority under § 360j(e).
Id., at 1380-1400. The court
stayed implementation 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 1400-140l.
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). Examining 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
provisions 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 "unsafe."
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 regulate tobacco.
Id., at 167. The
court also found that evidence external to the FDCA confirms this
conclusion. Importantly, the FDA consistently stated before 1995
that it lacked jurisdiction over tobacco, and Congress has
enacted
131
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 authority under
the FDCA to regulate tobacco products as customarily 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 products 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 designed 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 concerning the
product's therapeutic benefits. See
id., at 6-7. We
132
need not resolve this question, however, because assuming,
arguendo, that a product can be "intended to affect the
structure or any function of the body" absent claims of therapeutic
or medical benefit, the FDA's claim to jurisdiction contravenes the
clear intent of Congress.
A threshold issue is the appropriate framework for analyzing 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 Resources Defense Council,
Inc., 467 U. S.
837 (1984). Under
Chevron, a reviewing court must first
ask "whether Congress 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
expressed 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 Congress 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 responsibilities
for assessing the wisdom of such policy choices and resolving the
struggle between competing views of the public interest are not
judicial ones,"
Chevron, supra, at 866, and because of the
agency's greater familiarity with the everchanging facts and
circumstances surrounding the subjects regulated, see
Rust
v.
Sullivan, 500 U. S. 173, 187
(1991).
In determining whether Congress has specifically addressed 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
133
context"). It is a "fundamental canon of statutory construction
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 statute "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, particularly 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 products 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
134
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 pre market 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 approval" 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
cannot otherwise be reasonable assurance of its safety and
effectiveness." 21 U. S. C. § 360j(e). Thus, the Act generally
requires 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," "dangerous," 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 tobaccorelated illnesses, such as cancer,
respiratory illnesses, and
135
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, suicides, and fires,
combined."
Ibid. Indeed, the FDA characterized smoking as "a
pediatric disease,"
id., at 44421, because "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
tobacco 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 products are "dangerous to health"
when used in the manner prescribed. 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 obtaining their intended effects. Thus, were
tobacco products within the FDA's jurisdiction, the Act would deem
them misbranded devices that could not be introduced into
interstate
136
commerce. Contrary to the dissent's contention, the Act admits
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 findings 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 unreasonable
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 pre
market 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 premarket approval without "a showing of reasonable
assurance that such device is safe under the conditions of use
prescribed, 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 statutory obligation to
classify tobacco products, it could not allow them to be
marketed.
137
The FDCA's misbranding and device classification provisions
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 impossible to prove they were safe for their
intended us[e]." Public 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
product[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 tobacco
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 legislation on six occasions since 1965. See
Federal Cigarette Labeling 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
138
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, coronary artery disease, and
chronic bronchitis and emphysema, and that nicotine has various
pharmacological effects, including 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 effects 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 Education 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) (hereinafter 1988 Surgeon General's Report)
(concluding that tobacco products are addicting in much the same
way as heroin and cocaine, and that nicotine is the drug that
causes addiction). 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
139
economy may be ... protected to the maximum extent consistent
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 collective premise of these statutes is that
cigarettes and smokeless 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 concluded,
somewhat ironically, that tobacco products are actually "safe"
within the meaning of the FDCA. In promulgating its regulations,
the agency conceded that "tobacco products are unsafe, as that term
is conventionally understood." 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.
Applying 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 withdrawal, and a black
market offering cigarettes even more dangerous than those currently
sold legally would likely develop.
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.
140
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 products."
Id., at
44413. But the FDA's judgment that leaving tobacco products on the
market "is more effective in achieving 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 itselfis safe as used by consumers. That is, the
product's probable therapeutic 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 therapeutic 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 administrative 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 factors
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 "reasonable
assurance of the safety and effectiveness of the device." 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,
141
"(B) with respect to the conditions of use prescribed,
recommended, or suggested in the labeling of the device, 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'etre of the regulations. In other words, the FDA is forced to
contend 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) provides that a
product is "misbranded" if "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." According to
the FDA's understanding, 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 consumer from use of the product, not
those stemming from the agency's remedial measures.
142
Consequently, the analogy made by the FDA and the dissent 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 therapeutic 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 Congress
intended to exclude tobacco products from the FDA's jurisdiction. A
fundamental precept of the FDCA is that any product regulated by
the FDA-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 ramifications 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-
143
ard, the FDA has concluded that, although tobacco products might
be effective in delivering certain pharmacological effects, 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 conclusion is that there is no room for tobacco
products within the FDCA's regulatory scheme. If they cannot be
used safely for any therapeutic purpose, and yet they cannot be
banned, they simply do not fit.
B
In determining whether Congress has spoken directly to the FDA's
authority to regulate tobacco, we must also consider 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
implications 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
address the topic at hand. As we recognized recently in
United
States v.
Estate of Romani, "a specific policy embodied
in a later federal statute should control our construction of the
[earlier] statute, even though it ha[s] not been expressly
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
144
15 U. S. C. §§ 1331, 1333, 4402; prohibit the advertisement of
tobacco products through "any medium of electronic communication"
subject to regulation by the Federal Communications 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 pharmacological 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 constructed, 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 7475. Seven days after
the report's release, the Federal Trade
145
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 cigarette 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 legislation
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
existing laws governing the ... Food and Drug Administration."
Ibid. Similarly, FDA Deputy Commissioner Rankin testified 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
146
"smoking products" because, in light of the findings in the
Surgeon General's report, such a "provision might well completely
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 acceptable 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 promulgated the regulations at
issue here. See Brief for Petitioners 37; see also Brief for
Appellee (FDA) in
Action on Smoking 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 informed 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 therapeutic 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 Congo 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
147
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 extremely 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 tobacco products is not determinative; "it is ultimately the
provisions of our laws rather than the principal concerns of our
legislators by which we are governed."
Oncale v.
Sundowner 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, Representative Udall introduced a
bill "[t]o amend the Federal Food, Drug, and Cosmetic Act so as to
make that Act applicable 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 products
under FDA jurisdiction, along with foods, drugs, and cosmetics."
109 Congo 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
148
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 regulation 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 regulation of
cigarette labeling: "No statement relating to smoking 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 labeling, however, is an integral
aspect of the FDCA, both as it existed in 1965 and today. The
labeling requirements currently 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
consumers. 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 necessary 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 provide "adequate
warnings against use in those pathological
149
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 frequency 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 remains-incompatible with FDA
regulation of tobacco products. This is not to say that the FCLAA's
pre-emption provision 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 preclude
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 advertising of any
cigarettes the packages of which are labeled in conformity with the
provisions of this Act." Pub. L. 8992, § 5(b), 79 Stat. 283. Thus,
in reaction to the FTC's attempt to regulate cigarette labeling and
advertising, Congress 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 expiration, 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
150
(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 Advertising1969: Hearings before the House Committee
on Interstate and Foreign Commerce, 91st Cong., 1st Sess., pt. 2
(1969), Congress amended the FCLAA by banning cigarette
advertisements "on any medium of electronic communication subject
to the jurisdiction of the Federal Communications Commission" 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. Importantly, Congress extended indefinitely the
prohibition on any other regulation of cigarette labeling with
respect to smoking and health (again despite the importance of
labeling regulation 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 peoplemust make the policy
determinations involved in this legislation-and not some agency
made up of appointed officials." 116 Congo Rec. 7920 (1970)
(remarks of Rep. Staggers).
Four years later, after Congress had transferred the authority
to regulate substances covered by the Hazardous Substances Act
(HSA) from the FDA to the Consumer Products 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,
151
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 legislation 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)). Senator Moss acknowledged that the "legislation, in
effect, reverse[d]" the District Court's decision, 121 Congo 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 Agencies," Letter
to Action on Smoking and Health (ASH) Executive 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 "unmistakably 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 Edwards testified
before Congress that "cigarettes recommended for smoking pleasure
are beyond the Federal Food, Drug, and Cosmetic Act." 1972 Hearings
239, 242. He fur-
152
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 "labeling or
banning cigarettes is a step that can be take[n] only by the
Congress. Any such move by FDA would be inconsistent 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 Petition, 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 consumers use tobacco products precisely to
obtain those effects; and that tobacco causes thousands of
premature deaths annually.
Ibid. In denying ASH's petition,
FDA Commissioner 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 Appellee 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 interpretation of
the statutory limits on its authority to regulate cigarettes."
Id., at 23, 27, n. 23. The Court of Appeals upheld the FDA's
position, concluding that "[i]f the statute
153
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 rulemaking
proceedings to establish the agency's jurisdiction to regulate
cigarettes as devices. See Letter to ASH Executive 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 pregnancy outcomes." 1983 House Hearings 19-20. He
also stated that it was "well-established that cigarette smoking is
a drug dependence, and that smoking is addictive for many people."
Id., at 20. Nonetheless, Assistant Secretary 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 evidence of tobacco's
health effects and addictiveness, the Department's view was that
"Congress has assumed the responsibility 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
incrementally expanded its regulatory scheme for tobacco products.
In 1983, Congress adopted the Alcohol and Drug Abuse Amendments,
Pub. L. 98-24, 97 Stat. 175 (codified at
154
42 U. S. C. § 290aa
et seq.), which require the Secretary
of HHS to report to Congress every three years on the "addictive
property of tobacco" and to include recommendations for action that
the Secretary may deem appropriate. A year later, Congress enacted
the Comprehensive Smoking Education Act, Pub. L. 98-474, 98 Stat.
2200, which amended the FCLAA by again modifying the prescribed
warning. Notably, 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 Congo Rec. 26953 (1984). And in 1986,
Congress enacted the Comprehensive Smokeless 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
particularly important to the FDCA's regulatory scheme.
In 1988, the Surgeon General released a report summarizing the
abundant scientific literature demonstrating that "[c]igarettes and
other forms of tobacco are addicting," and that "nicotine is
psychoactive" and "causes physical dependence characterized by a
withdrawal syndrome that usually accompanies nicotine abstinence."
1988 Surgeon General's Report 14. The report further concluded that
the "pharmacologic and behavioral processes that determine tobacco
addiction 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
155
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 Subcommittee 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 authority-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 particular subject of tobacco and health,
creating a distinct regulatory 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-
156
tion against the background of the FDA repeatedly and
consistently asserting that it lacks jurisdiction under the FDCA to
regulate tobacco products as customarily marketed. Further,
Congress has persistently acted to preclude a meaningful 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 supervision 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
requirements 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 tobacco.
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
157
in stone."
Chevron, 467 U. S., at 863; see also
Smiley v.
Citibank (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
circumstances.'''
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' enactment of its
tobacco-specific legislation. When the FDA repeatedly 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
conclusion that when Congress created a distinct regulatory scheme
addressing the subject of tobacco and health, it understood 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 "critically
ambivalent."
Post, at 182. We disagree. In that series of
statutes, Congress crafted a specific legislative response 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 consistently evidenced its intent to preclude any
federal agency from exercising significant policymaking authority
in the area. Under these circumstances, we believe the appro-
158
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 disavowal of
jurisdiction. Specifically, the dissent contends that "the FDA's
traditional view was largely premised on a perceived inability to
prove the necessary statutory 'intent' 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 Edwards) ("[R]egulation of cigarettes
is to be the domain of Congress," and "[a]ny such move by FDA would
be inconsistent with the clear congressional intent"); 1983 House
Hearings 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 Appellee
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
interpretation"). 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
Hearings 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 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
from
159
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 Congress 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 representations
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 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. See Brief for Petitioners 35-36; Reply
Brief for Petitioners 14. Owing to its unique place in American
history and society, 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
160
give the FDA jurisdiction over tobacco, and repeatedly acted to
preclude any agency from exercising significant policymaking
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.
American Telephone &
Telegraph Co., 512 U. S. 218 (1994), is
instructive. 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 discretion to "modify
any requirement" imposed under the statute, it therefore possessed
the authority to render voluntary the otherwise mandatory
requirement that long distance carriers file their rates.
Id., at 225. We rejected the FCC's construction, 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, rateregulated to agency discretion-and even more
unlikely that it would achieve that through such a subtle device as
permission 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 understanding 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 tobaccospecific legislation. It is therefore clear,
based on the FDCA's overall regulatory scheme and the subsequent
tobacco legislation, that Congress has directly spoken to the
161
question at issue and precluded the FDA from regulating tobacco
products.
***
By no means do we question the seriousness of the problem 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 significant threat to public health
in the United States. Nonetheless, no matter how "important,
conspicuous, and controversial" 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 public interest must always be grounded in a
valid grant of authority 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 tobaccospecific 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 authority to
regulate "articles (other than food) intended to affect the
structure or any function of the body .... " Federal 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.
162
In its own interpretation, the majority nowhere denies the
following two salient points. First, tobacco products (including
cigarettes) fall within the scope of this statutory definition,
read literally. Cigarettes achieve their moodstabilizing 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 desire, 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 ... BactoUnidisk,
394 U. S. 784,
798 (1969) (FDCA "is to be given
a liberal construction
consistent with [its] overriding purpose to protect the public
health" (emphasis added)). Unregulated 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,
combined." 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 nonetheless 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 cigarettes 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
163
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 simply 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 following 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 (described 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 insignificant 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
164
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 disease." 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 definition 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 jurisdictional 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.). Indeed, "[t]he purpose" of the new definition was to
"make possible 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
focused specifically upon the need to give the FDA jurisdiction
165
over "slenderizing" products such as "anti fat 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
preparations, other than food, and
all devices intended to
affect the structure or any function of the body .... "
Ibid. (emphasis 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 discretionary 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 Co sm. 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 jurisdictional
authority should surprise no one. In 1938, the President and much
of Congress believed that federal administrative agencies needed
broad authority and would exercise that authority wisely-a view
embodied in much Second New
166
Deal legislation. Cf.
Gray v.
Powell, 314 U. S. 402, 411-412
(1941) (Congress "could have legislated specifically" but decided
"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 transportation 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 Commerce 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 discretionary authority that a
straightforward reading of the relevant statutory language
implies?
Nor is it surprising that such a statutory delegation of power
could lead after many years to an assertion of jurisdiction 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 ... ").
167
But it should not have seemed unlikely that, assuming the FDA
decided to regulate and proved the particular jurisdictional
prerequisites, the courts would rule such a jurisdictional
assertion fully authorized. Cf.
United States v.
Southwestern Cable Co., 392 U. S. 157, 172 (1968)
(reading Communications Act of 1934 as authorizing FCC jurisdiction
to regulate cable systems while noting that "Congress could not in
1934 have foreseen the development of" advanced communications
systems). After all, this Court has read more narrowly phrased
statutes to grant what might have seemed even more unlikely
assertions of agency jurisdiction. See,
e. g., Permian Basin
Area Rate Cases, 390 U. S. 747, 774-777 (1968) (statutory
authority to regulate interstate "transportation" of natural gas
includes authority to regulate "prices" charged by field
producers);
Phillips Petroleum Co. v.
Wisconsin,
347 U. S. 672,
677-684 (1954) (independent 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 neither
the companies nor the majority denies that the FDCA's literal
language, its general purpose, and its particular legislative
history favor the FDA's present jurisdictional view. Rather, they
have made several specific arguments in support 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
168
u. S. C. § 321(h). Taken literally, this definition might
include everything from room air conditioners to thermal pajamas.
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 underwear. But I do
not agree that we must accept their proposed limitation. For one
thing, such a cramped reading contravenes the established purpose
of the statutory language. See
Bacto-Unidisk, 394 U. S., at
798 (third definition is "clearly, broader than any strict medical
definition"); 1 Leg. Hist. 108 (definition covers products "that
cannot 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)(l)(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 achievement 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 dependent upon being metabolized
is a "drug," provided that it otherwise falls within the scope of
the "drug" definition. And one need not hypothesize about air
conditioners or thermal
169
pajamas to recognize that the chemical nicotine, an important
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 stimulation. See
id., at 44699,
44739. Nicotine also increases the number of nicotinic receptors on
the brain's surface, and alters its normal electrical activity. See
id., at 44739. And nicotine stimulates the transmission of a
natural chemical that "rewards" the body with pleasurable
sensations (dopamine), causing nicotine addiction. See
id.,
at 44700, 4472144722. The upshot is that nicotine stabilizes mood,
suppresses 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 psychologyhelps to explain
why as many as 75% of adult smokers believe that smoking "reduce[s]
nervous irritation," 60 Fed. Reg. 41579 (1995); why 73% of young
people (10- to 22-yearoIds) 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 "structure" and
"function" of the body in a manner that is quite similar 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
170
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 focuses
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 circumstances 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 affect 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 ("Sometimes 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
171
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 legislative 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
express 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 unreasonable.
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 acknowledge 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
representations 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 advertising 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 weightconscious smokers to "'Reach for a Lucky
instead of a
172
sweet.'" Kluger, Ashes to Ashes, at 77-78. The advertisements 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 mildness (and of other beneficial effects) once were
commonplace. See,
e. g., id., at 93 (Brown &
Williamson advertised Koolbrand 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 proclaimed "'For Digestion's sake, smoke Camels! ...
Camels make mealtime more pleasant-digestion is
stimulated-alkalinity 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 acknowledge
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 Environment, 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" (emphasis 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
173
have long
wanted their products to produce those effects
in this way.
For example, in 1972, a tobacco-industry scientist explained
that" '[s]moke is beyond question the most optimized vehicle of
nicotine,'" and "'the cigarette is the most optimized 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,
nicotine appears to act as a stimulant, depressant, tranquilizer,
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 substance
[similar to] quinine, cocaine, atropine and morphine. [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
174
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 conclusion"
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 requiring the FDA to
pick a more dangerous over a less dangerous 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 addictive
sleeping pill (or, say, a kind of popular contact lens), plainly
within the FDA's jurisdiction, turned out to pose serious health
risks for certain consumers. Suppose further that many of those
addicted consumers would ignore an immediate 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
175
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 device'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 regulatory
responses. See
ante, at 135-136. But the cited provisions do
no such thing. It is true, as the majority contends, that "the FDCA
requires the FDA to place all devices" in "one of three
classifications" and that Class III devices require "pre market
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) (l)(A), (B) (placing a device
in Class I or Class II when regulation can provide that assurance).
Thus, the statute plainly allows the FDA to consider the relative,
overall "safety" of
176
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 assurance" 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 affirmatively
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 "presents 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, replacement, or refund"); cf. 2
O'Reilly § 18.08, at 18-29 (point of Class III "pre market
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 suggested 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 directions for use" as "are necessary
for the protection of users."
Ibid. But this "misbranding"
language is not determinative, for it permits the FDA to conclude
that a drug or device is
not "dangerous to health" and that
it
does have "adequate"
177
directions
when regulated so as to render it as harmless as
possible. And surely the agency can determine that a substance
is comparatively "safe"
(not "dangerous") whenever it would
be
less dangerous to make the product available (subject to
regulatory requirements) than suddenly to withdraw it from the
market. Any other interpretation risks substantial harm of the sort
that my sleeping pill example illustrates. 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 provision 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
whenever 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 section's procedural requirements
if the
Secretary chooses
in her discretion to use that particular
subsection's recall remedy. Otherwise, the subsection would trump
and make meaningless the same section's provision of other lesser
remedies 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).
178
The statute's language, then, permits the agency to choose
remedies consistent with its basic purpose-the overall protection
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 effects 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 considering 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 alternative administrative actions."
Ibid.
But the FDCA expressly
permits the FDA to take account of
comparative 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]" presents "a greater health risk than" no
recall); § 360h(a) (notification "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 "aggregate"
risk to a group.
All relevant risk is, at bottom, risk to an
individual;
all relevant risk attaches to "the product
itself"; and
all relevant risk is "aggregate" in the sense
that the agency aggregates health effects in order to determine
risk to the individual consumer. If unregulated smoking will kill 4
individuals out of a typical group of 1,000 people, if regulated
smoking will kill lout 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 respectively. And the risk to
each individual consumer is 4/1,000,
179
1/1,000, and 2/1,000 respectively. A "specific" risk to an
individual 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 behavior 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 "individual user" in my
example above. Why would Congress insist that the FDA ignore such
realities, even if the consequent 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 question. 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
determine 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
interpretation 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 Amendment, 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
180
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 absolute and prevented it from
establishing a level of "safe use" or even to judge whether "the
benefits of continued use outweigh the risks involved."
Id.,
at 5. This interpretationwhich 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 effect
because Congress enacted, and has continually renewed, a law
postponing the ban. See Saccharin Study and Labeling Act, Pub. L.
95-203, § 3, 91 Stat. 1452;
e. g., Pub. L. 102142,
Tit. VI, 105 Stat. 910.
The Court's interpretation of the statutory language before us
risks Delaney-type consequences with even less linguistic 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 conclusion, the majority maintains that the FDA "may clearly
regulate many 'dangerous' products without banning them."
Ante, at 142. But it then adds that the FDA
must
banrather than otherwise regulate-a drug or device that "cannot be
used safely for any therapeutic purpose."
Ibid. If I
misunderstand, it is only because this linchpin of the majority'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
181
to require the ban of a device that has no "safe" therapeutic
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 interpretation that both
permits the FDA to take into account the realities 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 inconsistent 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 "partial 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" (quoting
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
182
expressly has held that such subsequent views are not
"controlling."
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
Sullivan 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 majority's
conclusion. That is because, whatever individual Members 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 automatically
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 intent to proceed without
interfering with whatever authority the FDA otherwise may have
possessed. See,
e. g., Cigarette 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) (hereinafter 1965 Hearings) (statement of Rep.
Fino that the proposed 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) "ratif[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 tenable,"
Pension Benefit Guaranty Corp., supra, at
650 (citation 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 implication that it
needs.
Consider, for example, Congress' failure to provide the FDA with
express authority to regulate tobacco-a circum-
183
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 possess"
authority). In fact, Congress
both failed to grant express
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 authority to
regulate in any manner tobacco or tobacco products"); see also H.
R. 516, 105th Cong., 1st Sess., § 2 (1997) (similar); H. R. Res.
980, reprinted in 142 Congo 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 proposed jurisdictional changes proves nothing. This
history shows only that Congress could not muster the votes
necessary either to grant or to deny the FDA the relevant
authority. It neither favors nor disfavors the majority's
position.
The majority also mentions the speed with which Congress 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 supports the majority. On the other
hand, Congress' quick reaction with respect to
other
agencies' regulatory efforts contrasts 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 supports the opposite conclusion.
184
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 Congo
Rec. S8860 (Sept. 5, 1997) (the Modernization Act will "not
interfere or substantially negatively 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 manufacturers to place
on cigarette packages, etc., health warnings 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 required on any
cigarette package." § 1334(a). This preemption 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
185
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 preemption provision
does not bar state or federal regulation outside the provision's
literal scope.
Id., at 518. And it described the pre-emption
provision as "merely prohibit[ing] state and federal rulemaking
bodies from mandating particular cautionary statements on cigarette
labels .... "
Ibid.
This negative answer is fully consistent with Congress'
intentions in regard to the pre-emption language. When Congress
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 Cigarette 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
intention to resolve the question as to whether" the FTC could
regulate tobacco in a different way); see also 116 Congo Rec. 7921
(1970) (statement of Rep. Satterfield) (same). Why would one read
the FCLAA's pre-emption clause-a provision that Congress intended
to limit even in respect to the agency directly at issue-so broadly
that it would bar a different agency from engaging in any other
cigarette regulation 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 intended for its
tobacco-related statutes to be the exclusive
186
"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 addressed
expressly the issue of the FDA's tobacco-related authority 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 legislative
history: the FDA's former denials of its tobaccorelated
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
Congress' intent.
Ante, at 157. In my view, the FDA's change
of policy, like the subsequent statutes themselves, does nothing 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."
187
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 "recommended"
cigarettes "for smoking pleasure." Two others reiterated the
evidentiary need for "health claims." Yet another 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 "depends 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 additional
problems. Commissioner Kessler, for example, said that the
"enormous social consequences" flowing from a decision to regulate
tobacco counseled in favor of obtaining specific 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-
188
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 evidence
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 companies were publicly denying such
knowledge.
Moreover, scientific evidence of adverse health effects mounted,
until, in the late 1980's, a consensus on the seriousness of the
matter became firm. That is not to say that concern about smoking's
adverse health effects is a new phenomenon. 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 nicotine's addictive effects appeared in 1988. At each
stage, the health conclusions were the subject of controversy,
diminishing somewhat over time, until recently-and only
recently-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 administrations
may have hesitated to assert jurisdiction for the reasons 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
189
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 resources on this
important regulatory effort. As for the change of administrations,
I agree with then-JusTIcE REHNQUIST'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 members of one administration
may consider public resistance 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
administration." 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 interpretation 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
190
traditional view was largely premised on a perceived inability
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 intended 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 Congress rather than by unelected agency
administrators. Cf.
Kent v.
Dulles, 357 U. S. 116, 129 (1958)
(assuming Congress did not want to delegate the power to make rules
interfering 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 policy
of an administration, it is a decision for which that
administration, and those politically elected officials who support
it, must (and will) take responsibility. And the very importance of
the decision taken here, as well as its attendant publicity, 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. Indeed, 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 escape the kind of public scrutiny that is
essential in any de-
191
mocracy. And such a review will take place whether it is the
Congress or the Executive Branch that makes the relevant
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 reality-the reality that the nicotine in
cigarettes creates a powerful physiological addiction flowing from
chemically induced 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 statutes
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 atmosphere is not a law, unless it is
embodied in a statutory word or phrase. And the relevant words and
phrases here reveal
192
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 particular 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.
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