PUBLISHED UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT
BROWN & WILLIAMSON TOBACCO
CORPORATION; LORILLARD TOBACCO
COMPANY; PHILIP MORRIS,
INCORPORATED; RJ REYNOLDS TOBACCO
COMPANY,
Plaintiffs-Appellants, and COYNE BEAHM, INCORPORATED; LIGGETT
GROUP, INCORPORATED,
Plaintiffs, v. FOOD & DRUG ADMINISTRATION; DAVID
A. KESSLER, M.D., Commissioner of
No. 97-1604
Food and Drugs,
Defendants-Appellees. ATTORNEYS GENERAL OF THE STATE OF
MINNESOTA; STATE OF ALASKA;
STATE OF ARIZONA; STATE OF
ARKANSAS; STATE OF COLORADO;
STATE OF CONNECTICUT; STATE OF
FLORIDA; STATE OF HAWAII; STATE OF
ILLINOIS; STATE OF INDIANA; STATE OF
IOWA; STATE OF LOUISIANA; STATE OF
KANSAS; STATE OF MAINE; STATE OF
MARYLAND; STATE OF MASSACHUSETTS;
STATE OF MICHIGAN; STATE OF
MISSISSIPPI; STATE OF MISSOURI;
STATE OF MONTANA; STATE OF NEVADA;
STATE OF NEW HAMPSHIRE; STATE OF
NEW JERSEY; STATE OF NEW MEXICO;
STATE OF NEW YORK; STATE OF NORTH
DAKOTA; STATE OF OHIO; STATE OF
OKLAHOMA; STATE OF OREGON;
STATE OF PENNSYLVANIA; STATE OF
RHODE ISLAND; STATE OF SOUTH
DAKOTA; STATE OF TEXAS; STATE OF
UTAH; STATE OF VERMONT; STATE OF”
WASHINGTON; STATE OF WEST VIRGINIA;
STATE OF WISCONSIN; THE CITY AND
COUNTY OF SAN FRANCISCO; PUBLIC
CITIZEN; THE AMERICAN ACADEMY OF
PEDIATRICS; AMERICAN CANCER
SOCIETY; AMERICAN COLLEGE OF
PREVENTIVE MEDICINE; AMERICAN
HEART ASSOCIATION; AMERICAN LUNG
ASSOCIATION; AMERICAN MEDICAL
ASSOCIATION; AMERICAN MEDICAL
WOMEN'S ASSOCIATION; AMERICAN
PUBLIC HEALTH ASSOCIATION; AMERICAN
SOCIETY OF ADDICTION MEDICINE; THE
HMO GROUP; NATIONAL
ASSOCIATION OF ELEMENTARY SCHOOL
PRINCIPALS; NATIONAL ASSOCIATION OF
SECONDARY SCHOOL PRINCIPALS;
NATIONAL CENTER FOR TOBACCO-FREE
KIDS; STATE OF KENTUCKY;
WASHINGTON LEGAL FOUNDATION
("WLF"); MARIO ANDRETTI; DON
GARLITS; AL UNSER; RUSTY WALLACE;
CALE YARBOROUGH; RICHARD BURR,
CASS BALLENGER, HOWARD COBLE,
United States Representatives, LAUCH
FAIRCLOTH, United States Senator,
Amici Curiae.
COYNE BEAHM, INCORPORATED; BROWN
& WILLIAMSON TOBACCO CORPORATION;
PHILIP MORRIS, INCORPORATED; RJ
REYNOLDS TOBACCO COMPANY;
NATIONAL ASSOCIATION OF CONVENIENCE
STORES; ACME RETAIL, INCORPORATED;
UNITED STATES TOBACCO COMPANY;
CONWOOD COMPANY, LP; NATIONAL
TOBACCO COMPANY, LP; PINKERTON
TOBACCO COMPANY; SWISHER
INTERNATIONAL, INCORPORATED;
CENTRAL CAROLINA GROCERS,
INCORPORATED; J.T. DAVENPORT,
INCORPORATED; NORTH CAROLINA
TOBACCO DISTRIBUTORS COMMITTEE,
INCORPORATED; THE AMERICAN
ADVERTISING FEDERATION; AMERICAN
ASSOCIATION OF ADVERTISING AGENCIES;
No. 97-1581
ASSOCIATION OF NATIONAL ADVERTISERS,
INCORPORATED; MAGAZINE
PUBLISHERS OF AMERICA; THE OUTDOOR
ADVERTISING ASSOCIATION OF AMERICA,
INCORPORATED; POINT OF PURCHASE
ADVERTISING INSTITUTE; LORILLARD
TOBACCO COMPANY,
Plaintiffs-Appellees, and LIGGETT GROUP, INCORPORATED,
Plaintiff, v. FOOD & DRUG ADMINISTRATION; DAVID
A. KESSLER, M.D., Commissioner of
Food and Drugs,
Defendants-Appellants. ATTORNEYS GENERAL OF THE STATE OF
MINNESOTA; STATE OF ALASKA;
STATE OF ARIZONA; STATE OF
ARKANSAS; STATE OF COLORADO;
STATE OF CONNECTICUT; STATE OF
FLORIDA; STATE OF HAWAII; STATE OF
ILLINOIS; STATE OF INDIANA; STATE OF
IOWA; STATE OF LOUISIANA; STATE OF
KANSAS; STATE OF MAINE; STATE OF
MARYLAND; STATE OF MASSACHUSETTS;
STATE OF MICHIGAN; STATE OF
MISSISSIPPI; STATE OF MISSOURI;
STATE OF MONTANA; STATE OF NEVADA;
STATE OF NEW HAMPSHIRE; STATE OF
NEW JERSEY; STATE OF NEW MEXICO;
STATE OF NEW YORK; STATE OF NORTH
DAKOTA; STATE OF OHIO; STATE OF
OKLAHOMA; STATE OF OREGON;
STATE OF PENNSYLVANIA; STATE OF
RHODE ISLAND; STATE OF SOUTH
DAKOTA; STATE OF TEXAS; STATE OF
UTAH; STATE OF VERMONT; STATE OF
WASHINGTON; STATE OF WEST VIRGINIA;
STATE OF WISCONSIN; CITY AND
COUNTY OF SAN FRANCISCO; PUBLIC
CITIZEN; THE AMERICAN ACADEMY OF
PEDIATRICS; AMERICAN CANCER
SOCIETY; AMERICAN COLLEGE OF
PREVENTIVE MEDICINE; AMERICAN
HEART ASSOCIATION; AMERICAN LUNG
ASSOCIATION; AMERICAN MEDICAL
ASSOCIATION; AMERICAN MEDICAL
WOMEN'S ASSOCIATION; AMERICAN
PUBLIC HEALTH ASSOCIATION; AMERICAN
SOCIETY OF ADDICTION MEDICINE;
THE HMO GROUP; NATIONAL
ASSOCIATION OF ELEMENTARY SCHOOL
PRINCIPALS; NATIONAL ASSOCIATION OF
SECONDARY SCHOOL PRINCIPALS;
NATIONAL CENTER FOR TOBACCO-FREE
KIDS; STATE OF KENTUCKY;
WASHINGTON LEGAL FOUNDATION
("WLF"); MARIO ANDRETTI; DON
GARLITS; AL UNSER; RUSTY WALLACE;
CALE YARBOROUGH; RICHARD BURR,
CASS BALLENGER, HOWARD COBLE,
United States Representatives, LAUCH
FAIRCLOTH, United States Senator,
Amici Curiae.
COYNE BEAHM, INCORPORATED; BROWN
& WILLIAMSON TOBACCO CORPORATION;
LORILLARD TOBACCO COMPANY; PHILIP
MORRIS, INCORPORATED; RJ REYNOLDS
TOBACCO COMPANY; UNITED STATES
TOBACCO COMPANY; CONWOOD
COMPANY, LP; NATIONAL TOBACCO
COMPANY, LP; PINKERTON TOBACCO
COMPANY; SWISHER INTERNATIONAL,
No. 97-1606
INCORPORATED; CENTRAL CAROLINA
GROCERS, INCORPORATED; J.T.
DAVENPORT, INCORPORATED; NORTH
CAROLINA TOBACCO DISTRIBUTORS
COMMITTEE, INCORPORATED; THE
AMERICAN ADVERTISING FEDERATION;
AMERICAN ASSOCIATION OF ADVERTISING
AGENCIES; ASSOCIATION OF NATIONAL
ADVERTISERS, INCORPORATED; MAGAZINE
PUBLISHERS OF AMERICA; THE OUTDOOR
ADVERTISING ASSOCIATION OF AMERICA,
INCORPORATED; POINT OF PURCHASE
ADVERTISING INSTITUTE; NATIONAL
ASSOCIATION OF CONVENIENCE STORES;
ACME RETAIL, INCORPORATED,
Plaintiffs-Appellees,
and
LIGGETT GROUP, INCORPORATED,
Plaintiff,
v.
FOOD & DRUG ADMINISTRATION; DAVID
A. KESSLER, M.D., Commissioner of
Food and Drugs,
Defendants-Appellants.
ATTORNEYS GENERAL OF THE STATE OF
MINNESOTA; STATE OF ALASKA;
STATE OF ARIZONA; STATE OF
ARKANSAS; STATE OF COLORADO;
STATE OF CONNECTICUT; STATE OF
FLORIDA; STATE OF HAWAII; STATE OF
ILLINOIS; STATE OF INDIANA; STATE OF
IOWA; STATE OF LOUISIANA; STATE OF
KANSAS; STATE OF MAINE; STATE OF
MARYLAND; STATE OF MASSACHUSETTS;
STATE OF MICHIGAN; STATE OF
MISSISSIPPI; STATE OF MISSOURI;
STATE OF MONTANA; STATE OF NEVADA;
STATE OF NEW HAMPSHIRE; STATE OF
NEW JERSEY; STATE OF NEW MEXICO;
STATE OF NEW YORK; STATE OF NORTH
DAKOTA; STATE OF OHIO; STATE OF
OKLAHOMA; STATE OF OREGON;
STATE OF PENNSYLVANIA; STATE OF
RHODE ISLAND; STATE OF SOUTH
DAKOTA; STATE OF TEXAS; STATE OF
UTAH; STATE OF VERMONT; STATE OF
WASHINGTON; STATE OF WEST VIRGINIA;
STATE OF WISCONSIN; CITY AND
COUNTY OF SAN FRANCISCO; PUBLIC
CITIZEN; THE AMERICAN ACADEMY OF
PEDIATRICS; AMERICAN CANCER
SOCIETY; AMERICAN COLLEGE OF
PREVENTIVE MEDICINE; AMERICAN
HEART ASSOCIATION; AMERICAN LUNG
ASSOCIATION; AMERICAN MEDICAL
ASSOCIATION; AMERICAN MEDICAL
WOMEN'S ASSOCIATION; AMERICAN
PUBLIC HEALTH ASSOCIATION; AMERICAN
SOCIETY OF ADDICTION MEDICINE; THE
HMO GROUP; NATIONAL
ASSOCIATION OF ELEMENTARY SCHOOL
PRINCIPALS; NATIONAL ASSOCIATION OF
SECONDARY SCHOOL PRINCIPALS;
NATIONAL CENTER FOR TOBACCO-FREE
KIDS; STATE OF KENTUCKY;
WASHINGTON LEGAL FOUNDATION
("WLF"); MARIO ANDRETTI; DON
GARLITS; AL UNSER; RUSTY WALLACE;
CALE YARBOROUGH; RICHARD BURR,
CASS BALLENGER, HOWARD COBLE,
United States Representatives, LAUCH
FAIRCLOTH, United States Senator,
Amici Curiae.
NATIONAL ASSOCIATION OF CONVENIENCE
STORES; ACME RETAIL, INCORPORATED,
Plaintiffs-Appellants,
v.
DAVID A. KESSLER, Commissioner of
the Food & Drug Administration;
FOOD & DRUG ADMINISTRATION,
Defendants-Appellees,
ATTORNEYS GENERAL OF THE STATE OF
MINNESOTA; STATE OF ALASKA;
STATE OF ARIZONA; STATE OF
ARKANSAS; STATE OF COLORADO;
STATE OF CONNECTICUT; STATE OF
FLORIDA; STATE OF HAWAII; STATE OF
ILLINOIS; STATE OF INDIANA; STATE OF
No. 97-1614
IOWA; STATE OF LOUISIANA; STATE OF
KANSAS; STATE OF MAINE; STATE OF
MARYLAND; STATE OF MASSACHUSETTS;
STATE OF MICHIGAN; STATE OF
MISSISSIPPI; STATE OF MISSOURI;
STATE OF MONTANA; STATE OF NEVADA;
STATE OF NEW HAMPSHIRE; STATE OF
NEW JERSEY; STATE OF NEW MEXICO;
STATE OF NEW YORK; STATE OF NORTH
DAKOTA; STATE OF OHIO; STATE OF
OKLAHOMA; STATE OF OREGON;
STATE OF RHODE ISLAND; STATE OF
SOUTH DAKOTA; STATE OF TEXAS;
STATE OF UTAH; STATE OF VERMONT;
STATE OF WASHINGTON; STATE OF
WISCONSIN; STATE OF WEST VIRGINIA;
CITY AND COUNTY OF SAN FRANCISCO;
PUBLIC CITIZEN; THE AMERICAN
ACADEMY OF PEDIATRICS; AMERICAN
CANCER SOCIETY; AMERICAN
COLLEGE OF PREVENTIVE MEDICINE;
AMERICAN CANCER SOCIETY; AMERICAN
LUNG ASSOCIATION; AMERICAN MEDICAL
ASSOCIATION; AMERICAN MEDICAL
WOMEN'S ASSOCIATION; AMERICAN
PUBLIC HEALTH ASSOCIATION; AMERICAN
SOCIETY OF ADDICTION MEDICINE; THE
HMO GROUP; NATIONAL
ASSOCIATION OF ELEMENTARY SCHOOL
PRINCIPALS; NATIONAL ASSOCIATION OF
SECONDARY SCHOOL PRINCIPALS;
NATIONAL CENTER FOR TOBACCO-FREE
KIDS; STATE OF KENTUCKY;
WASHINGTON LEGAL FOUNDATION,
("WLF"); MARIO ANDRETTI, DON
GARLITS; AL UNSER; RUSTY WALLACE;
CALE YARBOROUGH; RICHARD BURR,
CASS BALLENGER, HOWARD COBLE,
United States Representatives, LAUCH
FAIRCLOTH, United States Senator,
Amici Curiae.
Appeals from the United States District Court
for the Middle District of North Carolina, at Greensboro.
William L. Osteen, Sr., District Judge.
(CA-95-591-2, CA-95-593-2, CA-95-665-6, CA-95-706-2)
UNITED STATES TOBACCO COMPANY;
BROWN & WILLIAMSON TOBACCO
CORPORATION; CONWOOD COMPANY, LP;
NATIONAL TOBACCO COMPANY, LP;
PINKERTON TOBACCO COMPANY;
SWISHER INTERNATIONAL, INCORPORATED;
CENTRAL CAROLINA GROCERS,
INCORPORATED; J.T. DAVENPORT,
INCORPORATED; NORTH CAROLINA
TOBACCO DISTRIBUTORS COMMITTEE,
INCORPORATED,
Plaintiffs-Appellants,
v.
FOOD & DRUG ADMINISTRATION; DAVID
A. KESSLER, M.D., Commissioner of
Food and Drugs,
Defendants-Appellees,
No. 97-1605
ATTORNEYS GENERAL OF THE STATE OF
MINNESOTA; STATE OF ALASKA;
STATE OF ARIZONA; STATE OF
ARKANSAS; STATE OF COLORADO;
STATE OF CONNECTICUT; STATE OF
FLORIDA; STATE OF HAWAII; STATE OF
ILLINOIS; STATE OF INDIANA; STATE OF
IOWA; STATE OF LOUISIANA; STATE OF
KANSAS; STATE OF MAINE; STATE OF
MARYLAND; STATE OF MASSACHUSETTS;
STATE OF MICHIGAN; STATE OF
MISSISSIPPI; STATE OF MISSOURI;
STATE OF MONTANA; STATE OF NEVADA;
STATE OF NEW HAMPSHIRE; STATE OF
NEW JERSEY; STATE OF NEW MEXICO;
STATE OF NEW YORK; STATE OF NORTH
DAKOTA; STATE OF OHIO; STATE OF
OKLAHOMA; STATE OF OREGON;
STATE OF PENNSYLVANIA; STATE OF
RHODE ISLAND; STATE OF SOUTH
DAKOTA; STATE OF TEXAS; STATE OF
UTAH; STATE OF VERMONT; STATE OF
WASHINGTON; STATE OF WISCONSIN;
STATE OF WEST VIRGINIA; CITY AND
COUNTY OF SAN FRANCISCO; PUBLIC
CITIZEN; THE AMERICAN ACADEMY OF
PEDIATRICS; AMERICAN CANCER
SOCIETY; AMERICAN COLLEGE OF
PREVENTIVE MEDICINE; AMERICAN
HEART ASSOCIATION; AMERICAN LUNG
ASSOCIATION; AMERICAN MEDICAL
ASSOCIATION; AMERICAN MEDICAL
WOMEN'S ASSOCIATION; AMERICAN
PUBLIC HEALTH ASSOCIATION; AMERICAN
SOCIETY OF ADDICTION MEDICINE; THE
HMO GROUP; NATIONAL
ASSOCIATION OF ELEMENTARY SCHOOL
PRINCIPALS; NATIONAL ASSOCIATION OF
SECONDARY SCHOOL PRINCIPALS;
NATIONAL CENTER FOR TOBACCO-FREE
KIDS; STATE OF KENTUCKY;
WASHINGTON LEGAL FOUNDATION
("WLF"); MARIO ANDRETTI; DON
GARLITS; AL UNSER; RUSTY WALLACE;
CALE YARBOROUGH; RICHARD BURR,
CASS BALLENGER, HOWARD COBLE,
United States Representatives; LAUCH
FAIRCLOTH, United States Senator,
Amici Curiae. Appeal from the United States District Court
for the Middle District of North Carolina, at Winston-Salem.
William L. Osteen, Sr., District Judge.
(CA-95-665-6)
Argued: June 9, 1998
Decided: August 14, 1998
Before WIDENER, Circuit Judge, HALL, Senior Circuit Judge, and
MICHAEL, Senior United States District Judge for the
Western District of Virginia, sitting by designation.
________________________________________________________________ _
Reversed by published opinion. Judge Widener wrote the opinion, in
which Senior Judge Michael joined. Senior Judge Hall wrote a dis-
senting opinion.
________________________________________________________________ _
COUNSEL
ARGUED: Gerald Cooper Kell, Civil Division, UNITED STATES
DEPARTMENT OF JUSTICE, Washington, D.C., for Government.
Richard Melvyn Cooper, WILLIAMS & CONNOLLY, Washington,
D.C.; Larry Bruce Sitton, SMITH, HELMS, MULLISS & MOORE,
L.L.P., Greensboro, North Carolina; John L. Oberdorfer, PATTON
BOGGS, L.L.P., Washington, D.C.; William C. McLeod, COLLIER,
SHANNON, RILL & SCOTT, Washington, D.C., for Private Parties.
ON BRIEF: Frank W. Hunger, Assistant Attorney General, Walter
C. Holton, Jr., United States Attorney, Stephen W. Preston, Deputy
Assistant Attorney General, George J. Phillips, Counselor to the
Assistant Attorney General, Eugene M. Thirolf, Douglas N. Letter,
Scott R. McIntosh, Christine N. Kohl, Civil Division, UNITED
STATES DEPARTMENT OF JUSTICE, Washington, D.C.; Marga-
ret Jane Porter, Chief Counsel, Karen E. Schifter, Patricia J. Kaeding,
Associate Chief Counsel, FOOD & DRUG ADMINISTRATION,
Rockville, Maryland, for Government. Robert R. Marcus, SMITH,
HELMS, MULLISS & MOORE, L.L.P., Greensboro, North Carolina;
Norwood Robinson, ROBINSON & LAWING, L.L.P., Winston-
Salem, North Carolina; John R. Jordan, Jr., JORDAN, PRICE,
WALL, GRAY & JONES, Raleigh, North Carolina; John F. Fithian,
G. Kendrick Macdowell, PATTON BOGGS, L.L.P., Washington,
D.C.; Eric Rowe, PATTON BOGGS, L.L.P., Greensboro, North Car-
olina; R. Timothy Columbus, Brian A. Dahl, COLLIER, SHANNON,
RILL & SCOTT, Washington, D.C.; Ray V. Hartwell, III, Douglas
W. Davis, HUNTON & WILLIAMS, Richmond, Virginia, for Private
Parties. Hubert H. Humphrey, III, Attorney General, Alan I. Gilbert,
Solicitor General, James S. Alexander, Assistant Attorney General,
Cheryl Heilman, Assistant Attorney General, STATE OF MINNE-
SOTA, St. Paul, Minnesota, for Amici Curiae State of Minnesota, et
al. Allison M. Zieve, David C. Vladeck, Alan B. Morrison, PUBLIC
CITIZEN LITIGATION GROUP, Washington, D.C., for Amici
Curiae Public Citizen, et al. Dennis B. Fleming, Jr., General Counsel,
Michael T. Alexander, Jack Conway, OFFICE OF THE GOVER-
NOR, Frankfort, Kentucky, for Amicus Curiae Commonwealth of
Kentucky. Daniel J. Popeo, David M. Young, WASHINGTON
LEGAL FOUNDATION, Washington, D.C., for Amici Curiae Foun-
dation, et al.
________________________________________________________________ _
OPINION
WIDENER, Circuit Judge:
On August 28, 1996, the Food and Drug Administration (FDA)
published a final rule entitled "Regulations Restricting the Sale and
Distribution of Cigarettes and Smokeless Tobacco to Protect Children
and Adolescents." 61 Fed. Reg. 44,396 (1996) (to be codified at 21
C.F.R. pt. 801, et al.). In general, this rule set out regulations restrict-
ing the sale and distribution of cigarettes and smokeless tobacco (col-
lectively referred to as tobacco products) to minors and limiting the
advertising and promotion of tobacco products. Plaintiffs (cigarette
and smokeless tobacco manufacturers, convenience store retailers,
and advertisers) filed these consolidated actions in federal district
court, challenging the FDA's jurisdiction over tobacco products and
seeking declaratory and injunctive relief.1 Plaintiffs then filed a
________________________________________________________________ _
1 When the complaint was filed on August 10, 1995, the FDA had only
issued a Notice of Proposed Rulemaking. 60 Fed. Reg. 41,314 (1995).
Following a comment period, the FDA adopted the proposed rule in
modified form. 61 Fed. Reg. 44,396 (1996). Unless noted otherwise, all
references in this opinion are to the final version of the rule published in
the Federal Register on August 28, 1996. Where italics appear here
within a quotation, they have been added for emphasis unless otherwise
indicated.
Motion for summary judgment in the district court, alleging that, as
a matter of law: (1) Congress has withheld from the FDA the jurisdic-
tion to regulate tobacco products as marketed by plaintiffs; and (2) the
Federal Food, Drug, and Cosmetic Act (Act) does not permit the FDA
to regulate tobacco products either as drugs or as devices. In denying
plaintiffs' motion for summary judgment in part and granting the
motion in part, the district court held that Congress did not "[intend]
to withhold from FDA" the jurisdiction to regulate tobacco products.
Coyne Beahm, Inc. v. FDA, 966 F. Supp. 1374, 1388 (M.D.N.C.
1997). The district court also concluded that the FDA had authority
to regulate tobacco products under the device provision of the Act,
but disapproved the FDA's restrictions on advertising as inconsistent
with its statutory authority. Coyne Beahm, 966 F. Supp. at 1393-1400.
Finally, the district court stayed implementation of the majority of the
FDA's regulations pending appeal.2 Coyne Beahm, 966 F. Supp. at
1400-01. The district court certified its order for immediate interlocu-
tory appeal pursuant to 28 U.S.C. S 1292(b), Coyne Beahm, 966 F.
Supp. at 1401, and by order dated May 13, 1997, this court granted
the S 1292(b) petitions for immediate appeal filed by two of the plain-
tiff groups and the FDA. In addition, the FDA had filed its Notice of
Appeal dated May 2, 1997 from the partial injunction granted by the
district court. Jurisdiction over the consolidated appeals is proper in
this court under 28 U.S.C. SS 1292(a)(1) and 1292(b).
Because this case arises from a motion for summary judgment, we
review the judgment of the district court de novo. Myers v. Finkle,
950 F.2d 165, 167 (4th Cir. 1991). For purposes of these appeals,
plaintiffs do not dispute the factual findings of the FDA. Based on our
review of the record and the relevant legal authorities, we are of opin-
ion that the FDA lacks jurisdiction to regulate tobacco products. For
the reasons set forth below, all of the FDA's August 28, 1996 regula-
tions of tobacco products are thus invalid. Accordingly, we reverse
the judgment of the district court.
________________________________________________________________ _
2 The district court left in place the FDA's proof of age requirement for
tobacco sales and the restrictions on sales to persons under age 18, which
had already gone into effect. Coyne Beahm, 966 F. Supp. at 1400. How-
ever, all 50 States have already banned the sale of tobacco to minors
under state law. See 61 Fed. Reg. at 44,419 (citing a joint letter from 25
state attorneys general and other comments submitted to the FDA).
I. FDA's Asserted Basis for Jurisdiction
The FDA3 has authority to regulate products only if they fall within
one of the categories defined by Congress in the Act.4 In the jurisdic-
tional determination attached to its August 28, 1996 regulations, the
FDA asserted jurisdiction over tobacco products under the drug5 and
device6 definitions in the Act. 61 Fed. Reg. at 44,628. According to
the FDA, tobacco products fit within these definitions because they
are "intended to affect the structure or any function of the body."
More specifically, the FDA concluded that tobacco products are
"combination products consisting of nicotine, a drug that causes
addiction and other significant pharmacological effects on the human
body, and device components that deliver nicotine to the body."7 61
________________________________________________________________ _
3 On most occasions, the Act refers to the authority of the Secretary of
the Department Health and Human Services (HHS) to take certain
actions. However, the Secretary acts through the Commissioner of Food
and Drugs. 21 U.S.C. S 393(d)(2). For simplicity, we will refer to any
legislative delegation as if made directly to the FDA.
4 The categories of products subject to regulation by the FDA are food,
drugs, devices, and cosmetics. 21 U.S.C. S 321.
5 The Act defines "drug" in pertinent part as "articles (other than food)
intended to affect the structure or any function of the body of man or
other animals." 21 U.S.C. S 321(g)(1)(C).
6 In relevant part, "device" is defined as an article which is:
intended to affect the structure or any function of the body of
man or other animals, and which does not achieve its primary
intended purposes through chemical action within or on the body
of man or other animals and which is not dependent upon being
metabolized for the achievement of its primary intended pur-
poses
21 U.S.C. S 321(h)(3).
7 A combination product is described as a product that contains a com-
bination of a drug, device, or biological product. 21 U.S.C. S 353(g).
Neither party contends that tobacco products contain any "biological
product," as that term is used in the Act. See 42 U.S.C. S 262(I) (defining
a biological product as a "virus, therapeutic serum, toxin, antitoxin, vac-
cine, blood, blood component or derivative, allergenic product, or analo-
gous product . . . applicable to the prevention, treatment, or cure of a
disease or condition of human beings").
Fed. Reg. at 44,628, 44,649-650. Based on its classification of
tobacco products as combination products, the FDA claimed that it
could exercise its discretion in deciding whether the drug provisions
or device provisions of the Act should apply. 61 Fed. Reg. at 44,400.
Although finding that tobacco products function primarily as drugs,
61 Fed. Reg. at 45,209-218, the FDA concluded that tobacco products
are most properly regulated under the device provisions of the Act,
in particular the restricted devices section, 21 U.S.C. S 360j(e).8 61
Fed. Reg. at 44,400. The FDA's jurisdictional determination encom-
passes over 600 pages in the Federal Register; however, its basic
premise can be fairly summarized in one sentence. That is, the FDA
asserted jurisdiction over tobacco products based on its conclusion
that tobacco products fit within the literal definitions of drug and
device as set forth in the Act. In short, the FDA's inquiry began and
ended with the definitions section of the Act.
We are of opinion that the FDA's limited, mechanistic inquiry is
insufficient to determine Congress' intent. Therefore, as directed by
Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467
U.S. 837 (1984), we employ the traditional tools of statutory con-
struction to ascertain congressional intent regarding whether the FDA
has authority to regulate tobacco products.
II. Jurisdictional Analysis
We begin with the basic proposition that agency power is "not the
________________________________________________________________ _
8 Section 360j(e) provides in relevant part:
(1) The Secretary may by regulation require that a device be
restricted to sale, distribution, or use --
. . .
(B) upon such other conditions as the Secretary may prescribe
in such regulation,
if, because of its potentiality for harmful effect or the collateral
measures necessary to its use, the Secretary determines that there
cannot otherwise be reasonable assurance of its safety and effec-
tiveness.
21 U.S.C. S 360j(e).
power to make law. Rather, it is `the power to adopt regulations to
carry into effect the will of Congress as expressed by the statute.'"
Ernst & Ernst v. Hochfelder, 425 U.S. 185, 213-14 (1976) (quoting
Manhattan Gen. Equip. Co. v. Commission, 297 U.S. 129, 134
(1936)). Thus, our initial inquiry is whether Congress intended to del-
egate to the FDA authority to regulate tobacco products as "customar-
ily marketed."9 The district court framed the issue as "whether
Congress has evidenced its clear intent to withhold from FDA juris-
diction to regulate tobacco products as customarily marketed." Coyne
Beahm, 966 F. Supp. at 1380. However, we are of opinion that the
issue is correctly framed as whether Congress intended to delegate
such jurisdiction to the FDA. See Bowen v. Georgetown Univ. Hosp.,
488 U.S. 204, 208 (1988) (stating that "[i]t is axiomatic that an
administrative agency's power to promulgate legislative regulations is
limited to the authority delegated by Congress"); INS v. Chadha, 462
U.S. 919, 953 n.16, 955 n.19 (1983) (providing that agency action "is
always subject to check by the terms of the legislation that authorized
it; and if that authority is exceeded it is open to judicial review" and
"Congress ultimately controls administrative agencies in the legisla-
tion that creates them"). This fundamental misconception by the dis-
trict court of the principal issue in the case unavoidably skewed the
remainder of its analysis.
Applying the principles set forth by the Supreme Court in Chevron,
we examine whether Congress intended to give the FDA jurisdiction
over tobacco products. Under Chevron, we first consider the intent of
Congress because "[i]f the intent of Congress is clear, that is the end
of the matter; for the court, as well as the agency, must give effect
to the unambiguously expressed intent of Congress." Chevron, 467
U.S. at 842-43. It is only if the intent of Congress is ambiguous that
we defer to a permissible interpretation by the agency. Chevron, 467
U.S. at 843. And we note, with emphasis, that the Supreme Court has
stated that "[a] precondition to deference under Chevron is a congres-
sional delegation of administrative authority." Adams Fruit Co. v.
________________________________________________________________ _
9 Plaintiffs use the term "customarily marketed" in their briefs to indi-
cate tobacco products marketed with customary claims such as smoking
pleasure as opposed to tobacco products marketed with specific thera-
peutic claims such as weight loss. Unless indicated otherwise, all refer-
ences in this opinion are to tobacco products as customarily marketed.
Barrett, 494 U.S. 638, 649 (1990). Accordingly, no deference is due
the FDA's construction of the Act unless it is acting within the
bounds of its congressionally-established authority. If the court can
ascertain Congress' intent on a particular question by applying the tra-
ditional rules of statutory construction, then it must give effect to that
intent. Chevron, 467 U.S. at 843 n.9; see also Cabell Huntington
Hosp., Inc. v. Shalala, 101 F.3d 984, 986 (4th Cir. 1996) (stating that
"[t]he goal of statutory interpretation is to implement congressional
intent"). We also note that ascertaining congressional intent is of par-
ticular importance where, as here, an agency is attempting to expand
the scope of its jurisdiction. See, e.g., Adams Fruit Co., 494 U.S. at
650 (quoting Federal Maritime Comm'n v. Seatrain Lines, Inc., 411
U.S. 726, 745 (1973)) (warning that "an agency may not bootstrap
itself into an area in which it has no jurisdiction"); ACLU v. FCC, 823
F.2d 1554, 1567 n. 32 (D.C. Cir. 1987) (stating that"[w]hen an agen-
cy's assertion of power into new arenas is under attack, therefore,
courts should perform a close and searching analysis of congressional
intent, remaining skeptical of the proposition that Congress did not
speak to such a fundamental issue"), cert. denied, 485 U.S. 959
(1988); Hi-Craft Clothing Co. v. NLRB, 660 F.2d 910, 916 (3d Cir.
1981) (noting that "[t]he more intense scrutiny that is appropriate
when the agency interprets its own authority may be grounded in the
unspoken premise that government agencies have a tendency to swell,
not shrink, and are likely to have an expansive view of their mis-
sion").
Although the task of statutory construction generally begins with
the actual language of the provision in question, Mead Corp. v. Tilley,
490 U.S. 714, 722 (1989), the inquiry does not end there.10 The
Supreme Court has often emphasized the crucial role of context as a
tool of statutory construction. For example, the Court has stated that
when construing a statute, courts "must not be guided by a single sen-
tence or member of a sentence, but look to the provisions of the whole
________________________________________________________________ _
10 In fact, if application of the plain language of a statute "would pro-
duce a result demonstrably at odds with the intent of Congress . . . the
intent of Congress rather than the strict language controls." Maryland
State Dep't of Educ. v. U.S. Dep't of Veterans Affairs, 98 F.3d 165, 169
(4th Cir. 1996) (citing United States v. Ron Pair Enter., Inc., 489 U.S.
235, 242 (1989)), cert. denied, 118 S. Ct. 43 (1997).
law, and to its object and policy." United States Nat'l Bank of Or. v.
Independent Ins. Agents of America, Inc., 508 U.S. 439, 455 (1993)
(quoting United States v. Heirs of Boisdore, 49 U.S. (8 How.) 113,
122, (1849)); see also Regions Hosp. v. Shalala , 66 U.S.L.W. 4125,
4129 n.5 (U.S. Feb. 24, 1998) (No. 96-1375); Massachusetts v.
Morash, 490 U.S. 107, 115 (1989). Thus, the traditional rules of statu-
tory construction to be used in ascertaining congressional intent
include: the overall statutory scheme, Offshore Logistics, Inc. v.
Tallentire, 477 U.S. 207, 220-221 (1986) (directing courts to examine
the language of the statute as a whole); legislative history, Atherton
v. FDIC, 65 U.S.L.W. 4062, 4067 (U.S. Jan. 14, 1997) (No. 95-928);
"the history of evolving congressional regulation in the area," Dunn
v. CFTC, 65 U.S.L.W. 4141, 4144 (U.S. Feb. 25, 1997) (No. 95-
1181); and a consideration of other relevant statutes, United States v.
Stewart, 311 U.S. 60, 64 (1940) (explaining that"all acts in pari
materia are to be taken together as if they were one law") (italics in
original). With these general principles in mind, we begin our inquiry
into the issue of whether Congress intended to delegate jurisdiction
over tobacco products to the FDA.
A. Intrinsic Evidence
The FDA correctly contends that the language of the statute must
be the starting point of our analysis. We agree that the first step of
statutory construction is determining the plain meaning of the statu-
tory text. In fact, the Court instructs that the inquiry ends with the
statutory language when the language is unambiguous and "the statu-
tory scheme is coherent and consistent." Robinson v. Shell Oil, 65
U.S.L.W. 4103, 4104 (U.S. Feb. 18, 1997) (No. 95-1376) (quoting
Ron Pair Enter., 489 U.S. at 240).
However, the flaw in the limited approach suggested by the FDA
and taken by the district court is that they examine only the literal
meaning of the statutory definitions of drug and device.11 See FDA
________________________________________________________________ _
11 For example, in its jurisdictional analysis, the district court purported
to examine the "Text of the Federal Food, Drug, and Cosmetic Act."
Coyne Beahm, 966 F. Supp. at 1380. However, the court mentioned only
the definitions sections of the statute and ignored the text of all of the
mandatory operative provisions of the Act.
Red Br. at 34 (stating that "the jurisdictional inquiry is at an end with
the conclusion that cigarettes and smokeless tobacco are `intended to
affect the structure of any function of the body' within the meaning
of the Act's drug and device provisions"); see also Coyne Beahm, 966
F. Supp. at 1380.
A mechanical reading of only the definitions provisions may
appear to support the government's position that tobacco products fit
within the Act's definitions of drugs or devices. However, an initial
problem with the government's theory is that the definitions of drug
and device require not only that the article "affect the structure or any
function of the body," but also that these effects be intended. 21
U.S.C. SS 321(g)(1)(C), 321(h)(3). As noted by the district court, "no
court has ever found that a product is `intended for use' or `intended
to affect' within the meaning of the [Act] absent manufacturer claims
as to that product's use." Coyne Beahm, 966 F. Supp. at 1390. Even
the FDA does not contend that tobacco manufacturers make any such
claims. Coyne Beahm, 966 F. Supp. at 1389 n.14.
Even if we were to accept the FDA's position that no other inquiry
is permissible if tobacco products fall within the literal definition of
drug or device, the jurisdictional inquiry would not end there. Both
the FDA and the district court failed to examine the literal definitions
in view of the language and structure of the Act as a whole. Such
holistic approach to statutory construction is well-supported by the
case law. See, e.g., Robinson, 65 U.S.L.W. at 4104 (stating that statu-
tory language must be examined by "reference to the language itself,
the specific context in which that language is used, and the broader
context of the statute as a whole"); Gustafson v. Alloyd Co., 513 U.S.
561, 570 (1995) (instructing that acts of Congress"should not be read
as a series of unrelated and isolated provisions"); United States Nat'l
Bank, 508 U.S. at 455 (quoting United Savings Ass'n of Texas v. Tim-
bers of Inwood Forest Assoc., Ltd., 484 U.S. 365, 371 (1988))
(explaining that statutory interpretation is a "holistic endeavor" that
must include, at a minimum, an examination of the statute's full text,
its structure, and the subject matter). Accordingly, our task is to
examine whether tobacco products fit into the overall regulatory
scheme created by Congress.
According to FDA Deputy Commissioner Schultz, "[a] fundamen-
tal precept of drug and device regulation in this country is that these
products must be proven safe and effective before they can be sold."
Statement by FDA Deputy Commissioner William B. Schultz before
the Senate Comm. on Labor and Human Resources, 104th Cong., p.
8 (Feb. 22, 1996). In fact, the FDA's congressionally-established mis-
sion statement provides that the FDA is charged with protecting the
public health by ensuring that human drugs are "safe and effective"
and that "there is a reasonable assurance of the safety and effective-
ness of devices intended for human use." 21 U.S.C. S 393(b)(2)(B),
(C). During its rulemaking, the FDA found that tobacco products are
"dangerous," "unsafe," and the cause of"great pain and suffering
from illness such as cancer, respiratory illnesses, and heart disease."
61 Fed. Reg. at 44,412. In addition, the FDA determined that over
400,000 people die each year from tobacco use. 61 Fed. Reg. at
44,412. Yet, the FDA has proposed to regulate tobacco products
under a statutory provision that requires conditions on sale and distri-
bution which provide a reasonable assurance of safety. 21 U.S.C.
S 360j(e). According to the FDA, a determination of safety under the
Act requires consideration of the risks of a product compared to the
"countervailing effects of use of that product, including the conse-
quences of not permitting the product to be marketed." 61 Fed. Reg.
at 44,412-13. Thus, the FDA concluded that withdrawal of tobacco
from the market poses significant health risks to addicted adults
which outweigh the risks of leaving tobacco products on the market.
61 Fed. Reg. at 44,405, 44,412-44,413.
But that test is contrary to the statute. The statutory provision, 21
U.S.C. S 360c(a)(2)(C), provides that safety and effectiveness are to
be determined by "weighing any probable benefit to health from the
use of the device against any probable risk of injury or illness from
such use." See also United States v. Rutherford, 442 U.S. 544, 556
(1979) (stating that "a drug is unsafe if its potential for inflicting
death and physical injury is not offset by the possibility of therapeutic
benefit"). According to the language of S 360c(a)(2)(C), the FDA's
obligation is to strike a balance between the risks and benefits of the
use of a certain product, not to weigh the risks of leaving a product
on the market against the risks of taking a product off the market. The
FDA is unable to state any real health benefit derived from leaving
tobacco products on the market. This is not to say that there are not
other public policy reasons, such as impact on the national economy
and the potential for a black market, weighing against a ban on
tobacco products. However, this type of decision involving counter-
vailing national policy concerns is just the type of decision left for
Congress. By statute, the FDA's authority is limited to the balancing
of health benefits and risks. 21 U.S.C. S 360c(a)(2)(C). Thus, its
attempted analogy between tobacco products and chemotherapy drugs
is not well taken. 61 Fed. Reg. at 44,413. These cancer-fighting drugs
may be considered high-risk, but they have not been deemed "unsafe"
by the FDA. Under the Act, the key to allowing these drugs to remain
on the market is that their use produces affirmative health benefits
which outweigh their risks. 21 U.S.C. S 360c(a)(2)(C). According to
the FDA's own findings, tobacco products do not meet this test, for
there is no health benefit from the use of tobacco. The FDA's inquiry
into whether the risks of removing tobacco products from the market
are greater than the risks of leaving them on the market is irrelevant
under S 360c(a)(2)(C).
In the proposed regulations, the FDA characterized tobacco prod-
ucts as combination products containing drug and device components,
but purported to regulate tobacco products as restricted devices under
S 360j(e) of the Act. Section 360j(e) permits the FDA to place restric-
tions on the sale, distribution or use of a product which are necessary
for a "reasonable assurance of safety" of the product. 21 U.S.C.
S 360j(e). However, based on the FDA's characterization of tobacco
products as unsafe, it is impossible to create regulations which will
provide a reasonable assurance of safety. Thus, the FDA cannot com-
ply with the terms of the very statutory provision it has chosen as its
basis for regulation. In addition to the fundamental conflicts described
above, at least six internal inconsistencies arise when tobacco prod-
ucts are forced into the drug or device regulatory schemes of the Act.
First, S 355(a) of the Act requires that all new drugs be approved
by the FDA before marketing. 21 U.S.C. S 355(a). The Act requires
the FDA to disapprove applications for new drugs 12 if the drug is
________________________________________________________________ _
12 In relevant part, the Act defines a "new drug" as:
Any drug . . . the composition of which is such that such drug
is not generally recognized, among experts qualified by scientific
training and experience to evaluate the safety and effectiveness
of drugs, as safe and effective for use under the conditions pre-
scribed, recommended, or suggested in the labeling thereof . . .
21 U.S.C. S 321(p)(1).
deemed unsafe or if there is not substantial evidence of its effective-
ness. 21 U.S.C. S 355(d). This mandatory approval process presents
an insurmountable problem for the FDA with respect to tobacco prod-
ucts because of the FDA's finding that they are unsafe. 61 Fed. Reg.
at 44,412. In fact, the FDA has conceded that under the mandatory
approval provisions, tobacco products would constitute unapproved
new drugs. 60 Fed. Reg. 41,348 (1995) (FDA Proposed Rulemaking).
As such, the Act would require the prohibition of the distribution and
marketing of tobacco products. 21 U.S.C. SS 331(d), 355(a).
The FDA attempts to avoid the problem inherent in the new drug
approval requirement by classifying tobacco products as combination
products and then choosing to regulate them as devices rather than as
drugs. The Act directs the FDA to determine the primary mode of
action of a combination product. 21 U.S.C. S 353(g)(1). If the FDA
determines that the primary mode of action is that of a drug, then it
must assign "primary jurisdiction" over the product to the persons
charged with premarket review of drugs. 21 U.S.C.S 353(g)(1)(A),
(B). The FDA concedes that the "primary mode of action" of tobacco
products is that of a drug.13 FDA Red Br. at 26 (citing 61 Fed. Reg.
at 45,209-18; 44,400-03). Yet, it chose to regulate tobacco products
devices under S 360j(e) of the Act. This transparent action by the
FDA, obvious sophistry, taken in order to avoid the new drug provi-
sions of the Act, reinforces the conclusion that regulation of tobacco
products under the Act was not intended by Congress. However, the
FDA's classification of tobacco products as devices could not avoid
similar problems caused by other provisions of the Act.
Section 331(a) of the Act prohibits the introduction into or delivery
in interstate commerce of any drug or device that is misbranded. 21
U.S.C. S 331(a). Under S 352(j), a drug or device is deemed to be
misbranded if it is dangerous to health when used in the manner sug-
gested in the labeling. 21 U.S.C. S 352(j). The FDA has concluded
that the use of tobacco products is dangerous to health. 61 Fed. Reg.
________________________________________________________________ _
13 Interestingly, the FDA chose to regulate tobacco products as devices
even though it has regulated the nicotine products within its jurisdiction
- nicotine patches, nicotine gum, and nicotine nasal sprays - as drugs.
Approved Drug Products with Therapeutic Equivalence Evaluations,
1762 Food Drug Cosm. L. Rep. (CCH) 3-220, 221 (FDA May 29, 1996).
at 44,412. Thus, it is impossible for the labeling of tobacco products
to suggest a nondangerous use. Accordingly, #8E8E # 331(a) and 352(j)
operate to make the continued marketing of tobacco products illegal.
A drug or device is also considered misbranded, and thus prohib-
ited under S 331(a), if it does not include"adequate directions for
use." 21 U.S.C. S 352(f)(1). According to the FDA, the requirement
of adequate directions for use means "directions under which the lay-
man can use a device safely and for the purposes for which it is
intended." 61 Fed. Reg. at 44,464. The FDA can exempt drugs and
devices from S 352(f)(1)'s directions requirement, but only if the
information is "not necessary for the protection of public health." 21
U.S.C. S 352(f). The FDA has previously interpreted S 352(f) to mean
that an exemption from the direction requirements may be granted
when other circumstances (such as a physician's prescription) can
reasonably assure safe use of the drug or device. 21 C.F.R.
SS 201.100-201.129, 801.109-801.127 (1996).
The FDA now contends that an exemption for tobacco products is
appropriate, 61 Fed. Reg. at 44,410, because everyone knows how to
use tobacco products and thus directions are not needed. See 61 Fed.
Reg. at 44,465 (stating that tobacco products are"one of the most
readily available consumer products on the market today. Conse-
quently, the way in which these products are used is common knowl-
edge."). However, the FDA violated its own interpretation of the Act
by exempting tobacco products under S 352(f) without any assurances
of safety. Because of the FDA's finding that tobacco products are
unsafe, 61 Fed. Reg. at 44,412, it is impossible to provide directions
for safe use as required by the statute. In addition, the exemption is
inapplicable because no assurance of safety can be given for inher-
ently unsafe products such as tobacco. Again, the FDA's need to
apply the statutory exemption demonstrates that the Act does not and
cannot apply to tobacco products.
Similarly, a drug or device is also considered misbranded, and thus
prohibited by S 331(a), if it fails to bear"adequate warnings against
use . . . by children where its use may be dangerous to health." 21
U.S.C. S 352(f)(2). Unlike S 352(f)(1), this section does not permit
any exemptions from the warning requirement. In support of its pro-
posed regulations, the FDA cited widespread use of tobacco products
by minors and focused on controlling youth use as a means of
decreasing tobacco-related illnesses and deaths. See 61 Fed. Reg. at
45,238-243 (characterizing youth use of tobacco products as a "pedi-
atric disease"). The FDA concluded that the warnings mandated by
other federal statutes satisfy the Act's requirement for adequate warn-
ings to children even though none of the statutorily-prescribed warn-
ings address the particular dangers of youth use repeatedly
emphasized by the FDA. See 15 U.S.C. S 1333, 4402 (requiring Sur-
geon General warnings about health risks posed by tobacco products);
see also 61 Fed. Reg. at 44,465. The FDA was constrained to find that
the warnings mandated by other federal statutes are sufficient because
the applicable federal statutes do not permit federal agencies to add
to or modify the congressionally-mandated warnings. 15 U.S.C.
SS 1334(a), 4406(a). Again, the contortions that the FDA has gone
through demonstrate that Congress did not intend its jurisdictional
grant to the FDA to extend to tobacco products.
Furthermore, under 21 U.S.C. S 360c(b)(1), all devices intended for
human use must be classified into one of three categories, Class I, II,
or III, based on ascending degrees of dangerousness. Placement is
appropriate in the class that will provide a "reasonable assurance of
the safety and effectiveness of the device." 21 U.S.C.
S 360c(a)(1)(A)-(C). As discussed above, safety and effectiveness are
determined by "weighing any probable benefit to health from the use
of the device against any probable risk of injury or illness from such
use." 21 U.S.C. S 360c(a)(2)(C). Three years after it first introduced
the proposed regulations, the FDA has yet to place tobacco products
into one of the three categories. However, the agency's own findings
with respect to dangers to health require classification of tobacco
products as a Class III device subject to premarket approval because
they "[present] a potential unreasonable risk of illness or injury." 21
U.S.C. S 360c(a)(1)(C)(ii)(II); see also 61 Fed. Reg. at 44,398, 44,412
(discussing dangers of tobacco use). Under the premarket approval
process, tobacco products could not be approved without a showing
that there is a reasonable assurance of safety and effectiveness of the
products when used in the manner suggested by the labeling. 21
U.S.C. S 360c(a)(1)(C). The FDA contends that it will classify
tobacco products at some point in the future and that the long delay
is consistent with both the statutory framework and the agency's prior
actions for other devices. 61 Fed. Reg. at 44,412; FDA Red Br. at 45.
However, the real problem with attempting a classification is that all
three categories of devices require reasonable assurances of safety
and effectiveness for the product. 21 U.S.C. S 360c(a)(1). As dis-
cussed earlier, the FDA cannot provide reasonable assurances of
safety for a product that it has found to be inherently unsafe and dan-
gerous. Thus, it has not, and more importantly, cannot comply with
Congress' statutory classification directive because complying with
the statute would trigger a ban on tobacco products, a result not
intended by Congress.
Finally, the Act requires the FDA to issue an immediate cease-
distribution order for all products found to cause"serious, adverse
health consequences or death." 21 U.S.C. S 360h(e)(1).14 This order
begins an agency process that may ultimately result in a recall order
for the device. 21 U.S.C. S 360h(e)(2). The FDA has found that "to-
bacco use is the single leading cause of preventable death in the
United States. More than 400,000 people die each year from tobacco-
related illnesses, such as cancer, respiratory illnesses, and heart dis-
ease, often suffering long and painful deaths." 61 Fed. Reg. at 44,398
(citations omitted). According to the terms of the Act, these findings,
standing alone, mandate that the FDA issue a cease-distribution order
for tobacco products. Nevertheless, the FDA has no intention of com-
plying with the requirements of the Act. See 61 Fed. Reg. at 44,419
(stating that the FDA will not ban tobacco products). The necessity
of the FDA's avoidance of the statutory directives again demonstrates
that Congress did not intend that the Act regulate tobacco products.
A faithful application of the statutory language would lead to a ban
on tobacco products - a result not intended by Congress.
________________________________________________________________ _
14 In relevant part, S 360h(e)(1) provides:
If the [FDA] finds that there is a reasonable probability that a
device intended for human use would cause serious, adverse
health consequences or death, the [FDA] shall issue an order
requiring the appropriate person (including the manufacturers,
importers, distributors, or retailers of the device) -
(A) to immediately cease distribution of such device;
. . .
21 U.S.C. S 360h(e)(1).
The FDA makes a linguistic argument in an attempt to avoid the
problem presented by this section. The statute provides that if the
FDA finds there is a reasonable probability that a device will cause
health problems or death, then the FDA "shall issue an order requir-
ing . . . [the immediate] cease distribution of such device." 21 U.S.C.
S 360h(e)(1)(A). However, the FDA contends that "shall" should be
interpreted to mean "may." FDA Red Br. at 42-43. Even if we were
to adopt this interpretation, the substance of our analysis would not
change. As discussed above, the FDA has made the requisite finding
of dangerousness under the statute. Thus, even if"shall" were inter-
preted as "may," the FDA still could exercise its discretion under the
statute and ban tobacco products. And a failure to ban a product as
dangerous as is tobacco, by the FDA's own findings, would necessar-
ily be an abuse of discretion. But because an absolute ban falls out-
side the scope of congressional intent, construing the Act to cover
tobacco products would be inconsistent with the will of Congress.
As demonstrated by the examples provided above, the FDA's need
to maneuver around the obstacles created by the operative provisions
of the Act reflects congressional intent not to include tobacco prod-
ucts within the scope of the FDA's authority. The FDA argues that
even if it has misapplied the Act, this error does not bear on the juris-
dictional issue. However, the point is not merely that the FDA misap-
plied the Act, but these examples demonstrate the FDA's need to
ignore and misapply the operative provisions of the Act before it can
attain its end, not the end contemplated by Congress. Cf. United
States v. Two Plastic Drums, 984 F.2d 814, 819 (7th Cir. 1993)
(rejecting another recent attempt by the FDA to enlarge its jurisdic-
tion and stating that "the only justification for this Alice-in-
Wonderland approach is to allow the FDA to make an end-run around
the statutory scheme"). The fact is that Congress did not equip the
FDA with tools appropriate for the regulation of tobacco because it
had no intention that the Act apply to tobacco products.
We do not dispute in this case that Congress has charged the FDA
with protecting the public health and that tobacco products present
serious health risks for the public. However, the Supreme Court has
warned that "[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."
62 Cases of Jam v. United States, 340 U.S. 593, 600 (1951). Based
on our examination of the regulatory scheme created by Congress, we
are of opinion that the FDA is attempting to stretch the Act beyond
the scope intended by Congress.
B. Extrinsic Evidence
Pursuant to Chevron's instruction to employ the traditional tools of
statutory construction, we now examine the events surrounding the
1938 passage of the Act as well as subsequent statements and actions
by Congress and the FDA. These individual events are like pieces of
a puzzle in that no single event is outcome determinative. However,
when viewed as a whole, it is clear that Congress did not intend to
give the FDA jurisdiction over tobacco products in 1938 when it
passed the Act. See MCI Telecomm. Corp. v. AT&T , 512 U.S. 218,
228 (1994) (stating that relevant time for determining congressional
intent on meaning of statute is when controlling statute enacted). As
discussed above, the fact that the operative provisions of the Act sim-
ply cannot accommodate tobacco products is a clear indication of
congressional intent. Cf. Gustafson, 513 U.S. at 569 (explaining that
an operative provision of the Securities Act of 1933 does not define
prospectus, the term at issue, but "does instruct us what a prospectus
cannot be if the Act is to be interpreted as a symmetrical and coherent
regulatory scheme"). Subsequent events outside the language of the
statute only confirm our understanding of Congress' intent.
1. Historical Actions of the FDA
>From 1914 until the present rulemaking attempt, the FDA had con-
sistently stated that tobacco products were outside the scope of its
jurisdiction. And, as early as 1898, the Supreme Court of Tennessee
acknowledged the dangerous nature of tobacco products, characteriz-
ing cigarettes as "wholly noxious and deleterious to health," "inher-
ently bad, and bad only," and "widely condemned as pernicious
altogether." Austin v. State, 48 S.W. 305, 306 (Tenn. 1898). Yet, the
statute preceding the Act, the Pure Food and Drugs Act of 1906, Pub.
L. No. 59-384, 34 Stat. 768 (1906), did not mention tobacco. As early
as 1914, the FDA's predecessor agency stated that it had authority to
regulate tobacco products if their labeling indicated use for "the cure,
mitigation, or prevention of a disease," but not if labeled or used for
"smoking or chewing or as snuff and not for medicinal purposes."
Bureau of Chemistry, U.S. Dept. of Agriculture, 13 Service and Regu-
latory Announcements 24 (Apr. 2, 1914). Enacted in 1938, the present
Act expanded the definition of drug from the definition provided in
the Pure Food and Drugs Act of 1906 and also granted the FDA new
authority to regulate "devices." Food, Drug, and Cosmetic Act, Pub.
L. No. 75-717, 52 Stat. 1040 (1938). However, neither the Act nor its
legislative history mention tobacco products.15
In the 60 years following the passage of the Act, the FDA has
repeatedly informed Congress that cigarettes marketed without thera-
peutic claims do not fit within the scope of the Act. Ever since its
beginning in the 1930s, the FDA has taken the position and made
statements indicating that the Act did not apply to cigarettes marketed
without specific health claims. FDA/Dep't of Justice Brief in ASH v.
Harris (No. 79-1397), at 16. Again, in 1963, an FDA Bureau of
Enforcement Guideline stated that "[t]he statutory basis for the exclu-
sion 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 in the Food, Drug,
and Cosmetic Act for food, drug, device or cosmetic." Letter to Direc-
tors of Bureaus and Divisions and Directors of Districts from FDA
Bureau of Enforcement (May 24, 1963), reprinted in Public Health
Cigarette Amendments of 1971: Hearings Before the Consumer Sub-
comm. of the Senate Comm. on Commerce on S. 1454, 92d Cong.
240 (1972). When Congress later examined the issue of the FDA's
jurisdiction during its consideration of tobacco-specific legislation,
FDA Commissioner Charles Edwards testified regarding the FDA's
lack of authority over cigarettes and stated that"if cigarettes were to
be classified as drugs, they would have to be removed from the mar-
ket because it would be impossible to prove they were safe for their
intended [use]."16 Hearings on S. 1454 at 239. The Commissioner
________________________________________________________________ _
15 Two of the main supporters of the Act were representatives from the
two leading tobacco States - Senator Bailey (D-NC) and Representative
Chapman (D-KY). See 83 Cong. Rec. 9094 (1938). In fact, Sen. Bailey
and Rep. Chapman were among Senate and House managers of the Act
in the Conference Committee. Had there been any indication that the Act
might apply to tobacco products, we can only assume that such members
of Congress would have expressed opposition to the Act.
16 The Commissioner cited several cases in support of the FDA's con-
clusion that it lacked authority over cigarettes as customarily marketed.
took the position that the Federal Cigarette Labeling and Advertising
Act, discussed in greater detail below, reinforced that "the regulation
of cigarettes is to be the domain of Congress." Hearings on S. 1454
at 242. The Commissioner then concluded that "labeling or banning
cigarettes is a step that can be take[n] only by Congress. Any such
move by the FDA would be inconsistent with the clear congressional
intent." Hearings on S. 1454 at 242.
In 1977, Action on Smoking and Health (ASH), a public health
group, petitioned the FDA to regulate cigarettes. ASH claimed that
cigarettes were drugs because they contain nicotine which produces
addiction in many smokers, and particularly in youth. Citizen Petition,
FDA Docket No. 77P-0185, at 4-11 (May 26, 1977)[G. Br. Att. 77].
In rejecting ASH's petition,17 the FDA cited a 1953 Second Circuit
opinion, FTC v. Liggett & Myers Tobacco Co., 203 F.2d 955 (2d Cir.
1953), affirming on opinion below, 108 F. Supp. 573 (S.D.N.Y.
1952), for the proposition that cigarettes marketed without health
claims by the vendor are not within the FDA's jurisdiction. Specifi-
cally, the FDA quoted with approval the following language from the
court's opinion:
The legislative history, such as it is, coupled with indica-
tions of contemporaneous administrative interpretation leads
me to the conclusion that Congress, had the matter been
considered, would not have intended cigarettes to be
________________________________________________________________ _
See, e.g., FTC v. Liggett & Myers Tobacco Co. , 203 F.2d 955 (2d Cir.
1953), affirming on opinion below, 108 F. Supp. 573 (S.D.N.Y. 1952);
United States v. 354 Bulk Cartons . . . Trim Reducing-Aid Cigarettes,
178 F. Supp. 847 (D.N.J. 1959); United States v. 46 Cartons . . . Fairfax
Cigarettes, 113 F. Supp. 336 (D.N.J. 1952).
17 A federal appeals court upheld the FDA's denial of jurisdiction. See
ASH v. Harris, 655 F.2d 236 (D.C. Cir. 1980). In upholding the FDA's
denial of jurisdiction, the court emphasized the relevance of the remarks
of the district court in Liggett. In construing the identical language of the
definitions in the Federal Trade Commission Act, the Liggett court
stated: "[s]urely, the legislators did not mean to be as all-inclusive as a
literal interpretation of [the definitions] would compel us to be." ASH,
655 F.2d at 240 (quoting Liggett & Myers, 108 F. Supp. at 576).
Second Half of Appeals Court Reversal |
