Lorillard
Coyne Beahm, Inc. Plaintiffs, V. United States Food & Drug Administration and David A. Kessler, M.D., Commissioner of Food and Drugs, Defendants. First Amended Complaint for Dec Laratory and Injunctive Relief Civil Action, File Number 2 95cv00591
Fields
- Author
- Furr, J.L.
- Holton, M.L. III
- Shirlen, D.A.
- Vaughn, K.W.
- Type
- PLEA, PLEADING
- Area
- SPEARS,ALEXANDER/OFFICE
- Alias
- 89278409/89278447
- Site
- G65
- Named Person
- Ballin, S.
- Banzhaf, J.F. III
- Clinton
- Durbin, R.
- Edwards, C.
- Georgiades, P.
- Hastings, W.
- Hutt, P.B.
- Kennedy, D.
- Kessler, D.A.
- Lancaster, H.M.
- Moss, F.E.
- Novitch, M.
- Scarlett, T.
- Smoot
- Surgeon General
- Synar, M.
- Thompson, D.E.
- Young, F.
- Named Organization
- Batf, Bureau of Alcohol,Tobacco and Firearms
- Bureau of Chemistry
- Bureau of Enforcement
- Bw, Brown & Williamson
- Centers for Disease Control + Prevention
- Comm for Legislative Affairs
- Comm on Appropriations
- Comm on Commerce
- Comm on Energy + Commerce
- Comm on Interstate + Foreign Commerce
- Congress
- Consumer Subcomm
- Coyne Beahm
- Dean Witter
- Dept of Justice
- Division of Adolescent + School Health
- Drug Abuse Advisory Comm
- FDA, Food and Drug Administration
- Ftc, Federal Trade Commission
- Hew, Dept of Health Education and Welfare
- Hhs, Dept of Health and Human Services
- House
- Interagency Comm on Smoking + Health
- Internal Revenue Service
- Lm, Liggett & Myers
- Ma Dept of Health
- NC State Bar
- NCI, Natl Cancer Inst
- PM, Philip Morris
- RJR, R.J.Reynolds
- Senate
- Sgc, Surgeon General's (Advisory) Comm
- Subcomm on Health + the Environment
- Subcomm Rural Development Agriculture Re
- Usda, U.S. Dept of Agriculture
- 60 Minutes
- Ash, Action on Smoking & Health
- Date Loaded
- 12 Feb 1999
- Document File
- 89278327/89278506/Briefing Book the Food and Drug
- Administration and Tobacco Regulation the Tobacco
- Institute 950900
- Master ID
- 89278328/8505
- 89278328-8505 Briefing Book the Food and Drug Administration and Tobacco Regulation
- 89278334-8336 Summary of Proposed FDA Regulations
- 89278337 Requirements for Commenting on Proposed FDA Regulations
- 89278338-8342 Department of Health and Human Services Food and Drug Administration 21 Cfr Parts 801, 803, 804, and 897 (Docket No. 95n-0253) Regulations Restricting Sale and Distribution of Cigarettes and Smokeless Tobacco Products to Protect Children and Adolescents
- 89278342A Department of Health and Human Services Food and Drug Administration (Docket No. 95n-0253j) Analysis Regarding the Food and Drug Administration's Jurisdiction Over Nicotine-Containing Cigarettes and Smokeless Tobacco Products
- 89278364 the Federal Tobacco Control Effort
- 89278367 State Tobacco Sales Restriction Laws 950900
- 89278374-8375 Daily Smoking Prevalence Among 12th Graders
- 89278380 An FDA Smoke Screen
- 89278381-8382 Can Gov't Stop Kids' Smoking?
- 89278383 Where There's Smoke
- 89278383A No Smoking at FDA
- 89278384 the President Versus Joe Camel
- 89278384A How to Fight Smoking
- 89278385 Nicotine Fit
- 89278386 Quit Regulating Our Lives
- 89278387 Tp Snuff Teens' Smoking
- 89278388 the Epidemic That Isn't
- 89278389-8390 Ban on Tobacco Ads Might Stall Auto Racing
- 89278391 Some Burning Questions About the Plan to Stop Teen-Age Smoking
- 89278392 Tobacco and Teens Clinton's Blowing Smoke
- 89278393 Clinton Preaching May Drive US to Anarchy
- 89278394 King Bill's Decree
- 89278395 Tackling Teen Smoking
- 89278395A Cut Back Kids' Smoking, Not the Rights of Adults
- 89278396 the Use and Abuse of Children
- 89278397 Cigarettes and Free Speech
- 89278397A Parents Should Teach Teens
- 89278398 If We Want to Curb Teen-Age Smoking, Here's What to Do
- 89278399-8401 FDA Draws First in Tobacco Wars
- 89278402 Advertisers Call Tobacco Proposal A Virtual Ban
- 89278403 Agencies Are Gearing Up to Fight Proposed Tobacco Regulations
- 89278404-8405 Ap Poll: Most Would Not Snuff Out Tobacco Advertising and Promotion
- 89278406 If We Want to Curb Teen-Age Smoking, Here's What to Do
- 89278407 Smoke Signals Teen Smoking Is Already Illegal
- 89278449-8475 United States Tobacco Company, Plaintiffs, V. Food and Drug Administration, and David A. Kessler, M.D., Commissioner O F Food and Drugs, Defendants. Complaint for Declaratory Jud Gement and Injunctive Relief
- 89278477-8479
- 89278480 News Release for Immediate Release
- 89278481-8483 Philip Morris U.S.A. Today Issued the Following Statement
- 89278484-8490 FDA Lawsuit Statement
- 89278491-8493 Tobacco Industry Files Suit Against Against FDA, Kessler
- 89278494-8497 Only Congress Can Change the Law to Give FDA the Authority to Regulate Cigarettes
- 89278498 Complaint Summary
- 89278500-8501 Advertising Industry Challenges FDA's Proposed Tobacco Advertising Restrictions As Violation of the First Amendment and Usurpation of Congressional Authority
- 89278502 A.N.A. Calls Administration Tobacco Proposal Blatantly Unconstitutional Censorship
- 89278503-8505 Statement by Harold A Shoup Executive Vice President American Association of Advertising Agencies
Related Documents:
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UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF NORTH i
GREENSBORO DIVISION
Civil Action, File Number 2:95CV00591
)
COYNE BEAHM, INC., )
BROWN & WILLIAMSON TOBACCO )
CORPORATION, LIGGETT GROUP INC., )
LORILLARD TOBACCO COMPANY, )
PHIL.IP MORRIS INCORPORATED, and )
RJ. REYNOLDS TOBACCO COMPANY, )
)
Plaintiffs, )
)
v. )
)
UNITED STATES FOOD & DRUG )
ADMINISTRATION and DAVID A. )
KESSLER, M.D., COMMISSIONER OF )
FOOD AND DRUGS, )
)
)
Defendants. )
1
For their Complaint, plaintiffs allege as follows:
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FIRST AMEPIDED
COMPIAINT FOR
DECLARATORY AND
INJUNC'TIVE RELIEF
NATURE OF ACTION
1. This is an action against defendant United States Food and Drug
Administration ("FDA" or "Agency") and defendant Dr. David A. Kessler, Commissioner of
Food and Drugs, seelong review of FDA's assertion of jurisdiction over cigarettes. FDA's
action is an unprecedented and unlawful effort to extend its regulatory reach far beyond its
statutory mandate and to usurp the legislative authority of Congress. FDA's action is
contrary to Congress's clear intent to withhold from FDA jurisdiction over cigarettes; is
irreconcilable with, and precluded by, the Federal Cigarette Labeling and Advertising Act
("FCLAA"), 15 U.S.C. $ 1331; violates FDA's enabling legislation, the Federal Food, Drug,
and Cosmetic Act (the "FFDCA" or the "Act"), 21 U.S.C. ff 301 et seq., and the
Administrative Procedure Act ("APA"), 5 U.S.C. f§ 701 gt L
M violates Articles I and II of
the United States Constitution; and violates the First, Fourth, Fi1`th, Eighth, Ninth, and Tenth
Amendments of the United States Constitution.
2. Plaintiffs seek a declaration that Congress has not granted FDA jurisdiction
over cigarettes and that the President's direction to FDA to assert jurisdiction and FDA's
consequent assertion of jurisdiction are tra vires and contrary to law. Plaintiffs also seek
an injunction requiring FDA to withdraw its assertion of jurisdicti on over cigarettes and
prohibiting FDA from asserting jurisdiction over, or initiating any rulemaking or enforcement
proceedings based on any illegal assertion of jurisdiction over, the manufacture, labeling, or
marketing of cigarettes.
3. Many authorities, including former FDA Commissioners, have stated that an
assertion of jurisdiction over cigarettes as a "drug" or "drug delivery device," if allowed to
stand, would empower FDA to control all aspects of cigarette ma.nufacturing, labeling and
marketing. Yet Congress has never granted FDA any jurisdiction over cigarettes. To the
contrary, Congress has repeatedly rejected proposed legislation that would have given FDA
such authority. Rather, Congress has made its own determinatiora of how a comprehensive
program for federal regulation of cigarettes should be structured - a program in which FDA
has absolutely no role. FDA's unilateral assertion of jurisdiction irreconcilably conflicts with
that regulatory regime on all issues related to smoking.
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4. FDA's assertion of jurisdiction over cigarettes has had, and will continue to
have, a substantial adverse impact on plaintiffs' business activities in this district and
throughout the United States. Indeed, even FDA has acknowledged that its assertion of
jurisdiction over cigarettes "could have dramatic effects on our saciety," including the creation
of a black market for cigarettes.
IM PARTIE.S
5. Plaintiff Coyne Beahm, Inc. ("Coyne Beahm") is a North Carolina
corporation with its principal place of business in Colfax, North Carolina. A substantial
portion of Coyne Beahm's revenue is derived from the marketing, advertising and promotion
of cigarettes and other tobacco products.
6. Plaintiff Brown & Williamson Tobacco Corporation ("Brown & Williamson")
is a Delaware corporation with major facilities in Reidsville and Winston-Salem, North
Carolina. Brown & Williamson purchases substantial quantities of tobacco in this district;
manufactures tobacco products at its facilities in Reidsville and Winston-Salem, within the
jurisdiction of this Court; and sells and distributes finished cigarettes in this district.
7. Plaintiff Iiggett Group Inc. ("Liggett") is a Delaware corporation with a
major facility in Durham, North Carolina. liggett purchases sub:,tantial quantities of tobacco
in this district; manufactures cigarettes at its facility in Durham, within the jurisdiction of this
Court; and sells and distributes finished cigarettes in this district.
8. Plaintiff Lorillard Tobacco Company ("Lorillard") is a Delaware corporation
with a major facility in Greensboro, North Carolina. Lorillard pu rchases substantial
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quantities of tobacco in this district; manufactures cigarettes at its facility in Greensboro,
within the jurisdiction of this Court; and sells and distributes finished cigarettes in this
district.
9. Plaintiff Philip Morris Incorporated ("Philip Morri;") is a Virginia corporation
with a major manufacturing facility in Concord, North Carolina. Philip Morris purchases
substantial quantities of tobacco in this district; manufactures cigarettes at its facility in
Concord, within the jurisdiction of this Court; and sells and distributes finished cigarettes in
this district.
10. Plaintiff R.J. Reynolds Tobacco Company ("Reynolds") is a New Jersey
corporation with a major facility in Winston-Salem, North Carolina. Reynolds purchases
substantial quantities of tobacco in this district; manufactures cigarettes at its facility in
Winston-Salem, within the jurisdiction of this Court; and sells and distributes finished
cigarettes in this district.
11. Defendant FDA is an executive agency within the Department of Health and
Human Services, established to carry out acts of Congress concerning foods, drugs, devices
and cosmetics. 21 U.S.C. § 393; 5 C.F.R. § 5.10(a)(7). FDA is subject to, and derives its
authority to regulate "drugs" or "medical devices" from, the FFDC.i
.
12. Defendant Dr. David A. Kessler is the Commissioner of Food and Drugs, the
head of FDA.
JURISDICTION AND VENUE
13. This Court has jurisdiction over this action pursuant to 28 U.S.C. § 1331.
Declaratory relief is authorized by 28 U.S.C. §§ :201-2202 and Fed. R. Civ. P. 57. Judicial
4
review is also authorized under the Administrative Procedure Act (the "APA"), 5 U.S.C.
§§ 701 et seg.
14. Venue in this district is proper pursuant to 28 U.S.C. § 1391(e).
BACKGROUND
15. On August 10, 1995, Commissioner Kessler issuai a Notice of Proposed
Rulemaking indicating that FDA has jurisdiction over cigarettes. Commissioner Kessler took
this action notwithstanding (a) that Congress has in fact withheld any such jurisdiction from
FDA and (b) that Commissioner Kessler, and his predecessors, had previously recognized that
FDA has no such authority over cigarettes sold without any ther-apeutic claims. Plaintiff
tobacco companies do not make any claims of therapeutic purpose for their cigarettes. Their
cigarettes are promoted solely for smoking pleasure.
16. In the name of preventing youth smoking, FDA's rule, among other things:
Imposes a $150 million tax on the manufacturers.
Establishes a national minimum age for smoking.
Holds cigarette manufacturers liable for any sale of cigarettes to
minors by retailers who are in no way subjea to the authority or
control of the manufacturers.
Bans certain forms of advertising.
Bans the sale of cigarettes in vending machines.
Regulates the sale of cigarettes in grocery stores, pharmacies,
gas stations, convenience stores, and other ;?laces.
Imposes federal (FDA) control over labelin,g and advertising as
is imposed over prescription drugs.
Requires a new warning in cigarette advertising. op
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Divests property interests in registered trademarks by placing
federal limits on brand advertising and the use of cigarette brand
names.
Precludes brand name sponsorship of artistic, cultural and
sporting events.
Prevents distribution of cigarettes in anything other than
federally approved package sizes.
Generally subjects cigarettes and cigarette manufacturers to
FDA enforcement mechanisms for medical devices, including
detention, judicial seizure, FDA-mandated re:call and FDA-
mandated cessation of marketing, safety notification to users,
civil money penalties, judicial injunction and criminal
prosecution.
Congress Has Withheld From FDA
Any Authority to Regulate ~,igarettes
17. For more than eight decades, Congress has made clear that cigarettes are not
subject to FDA jurisdiction. The issue of smoking and health has 'been a matter of
substantial scientific, public and congressional interest for many years. Consistent with this
attention, the issue of whether FDA can assert jurisdiction over cigarettes has been raised in
Congress many times. Each time, however; Congress has determined that FDA should. have
no jurisdiction over cigarettes.
- 18. The Pure Food and Drugs Act of 1906, P.L No. 59-384, 34 Stat. 763 (1906),
gave FDA's predecessor, the Bureau of Chemistry in the Department of Agriculture, no
authority over tobacco products.
6
19. As the Bureau of Chemistry stated in 1914, tobaixo products, which, like
plaintiffs' cigarettes, were not labeled for any "medicinal purpose," were beyond the scope of
the Food and Drugs Act of 1906:
"[T]obacco and its preparations, when labeled in such a manner
as to indicate their use for the cure, mitigation, or prevention of
disease, are drugs within the meaning of the act, and, as such,
are subject to the provisions thereof.
"On the other hand, tobacco and its prepararions which
are not so labeled and are used for smoking or che-win¢ or as
snuff and not for medicinal purnoses are not subject to the
provisions of the act."
Service and Re lu atorYAnnouncements. No. 13 (Feb. 1914;
issued Apr. 2, 1914) (emphasis added).
20. This fundamental position did not change following the enactment of the
FFDCA in 1938. Indeed, over a twelve year period from 1940 to 1952, FDA and its
predecessor agencies charged with interpretation of the FFDCA consistently stated in
correspondence to Congress that cigarettes are not "drugs" or "de:vices" under the Act absent
a claim by the manufacturer of some therapeutic benefit. See Biief for Appellee (FDA),
ASH v. Harris, 655 F.2d 236 (D.C. Cir. 1980) (No. 79-1397).
21. Just as clearly, every attempt to extend the scope of the FFDCA to cigarettes
has been rejected. In 1929, anti-tobacco forces introduced legishition to bring tobacco
products within the jurisdiction of the federal agencies that enforce the nation's drug laws.
S. 1468, 71st Cong., 1st Sess. (1929). See also 71 Cong. Rec. 2589 (June 10, 1929)
(comments and bill introduced by Sen. Smoot). That bill did not pass.
22. In 1956, another bill was introduced to amend the FFDCA to grant FDA
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authority over cigarettes. H.R. 11280, 84th Cong., 2d Sess. (1956). The bill did not pass. tv
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23. In 1963, bills to amend the FFDCA to grant FDA jurisdiction over cigarettes
were introduced in both Houses of Congress. S. 1682, 88th Conj;., 1st Sess. (1963);
H.R. 5973, 88th Cong., 1st Sess (1963). The purpose of this legiudation was to place "all
smoking products under the authority of the Food and Drug Ad=ninistration." 109 Cone.
Ze . 10316, 10317 (June 6, 1963) (statement of Sen. Moss). According to their sponsor, the
bills were introduced because it was clear that "smoking products do not come under the
protection of the FDA." Id. at 10318. Again, however, the bills did not pass.
24. In 1964, a report was published by the Advisory Committee to the Surgeon
General on Smoking and Health concerning the possible risks of smoking. Congress reserved
to itself the responsibility to respond to that report. As the Hou:,e Committee on Interstate
and Foreign Commerce observed: 'The determination of approp.nate remedial action in this
area, as7ecommended by the Surgeon General's Advisory Committee, is a responsibility
which should be exercised by Congress after considering all facets of the problem."
H.R. Rep. No. 449, 89th Cong., 1st Sess. 1, reprinted in 1965 U.S.C:.C:.A.N. 2350, 2351-52.
25. Once again, one of the proposed responses to the: Surgeon General's report
which was considered by Congress was to mctend FDA jurisdiction to include cigarettes.
H.R. 2448, 89th Cong., 1st Sess. (1965). Both the proponents and opponents of that
proposal recognized that, absent such new legislation, FDA has no authority over cigarettes.
Again, however, the proposed bills to give FDA jurisdiction over tobacco products did not
pass.
26. Instead, as described in greater detail below, Congress enacted the FCLAA.
Congress made clear that the FCLAA - not the FFDCA - established "a comprehensive ~
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Federal program to deal with cigarette labeling and advertising Mrith respect to in
relationship between smoking and health." 15 U.S.C. § 1331 (emphasis added).
27. Congress did not provide any role for. FDA in its "comprehensive Federal
program." To the contrary, Congress i ited any entity (including FDA) from requiring
any labels or warnings with respect to cigarettes other than those: which Congress specifically
set forth in the FCLAA. 15 U.S.C. § 1334.
28. Congressional consideration - and rejection - oi' proposals to have FDA
regulate cigarettes has continued since the enactment of the FCLAA:
(a) In 1977, 1978, and 1979, five different bills were introduced in
Congress to grant FDA jurisdiction over cigarettes. None of them passed.
(b) In 1984, the House Committee on Energy and Commerce observed
- that "Federal laws that protect the public from hazardous food, drugs and consumer
products do not apply to cigarettes ...." H. Rep. No. 98-805, 98th Cong., 2d
Sess. 12, revrinted in 1984 U.S.C.C.A.N. 3718, 3725. And no legislation to change
that situation was enacted.
(c) In 1987, H.R. 3294,was introduced to exp 3nd
FDA jurisdiction by creating a new regulatory category for tobacco products. The
bill did not pass.
(d) In 1989, H.R. 1494 and S. 769 were introduced to expand FDA
jurisdiction by creating a new regulatory category for tobacco products. The bills did
not pass.
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(e) Even Rep. Richard Durbin, a staunch critic of tobacco products,
conceded in 1989 that FDA's jurisdiction does not extend to tobacco:
"It would seem that if you looked at the spectrum of products
sold in America, [tobacco] stands out as an extraordinary
exception to your mandate under the FDA. ...
". .. There have been tests over the years in court as to
whether or not tobacco is included in the Food, Drug and
Cosmetics Act, and the courts have generally conc;luded it is not.
In fact, I think they have concluded unanimously that it is not an
ingested food, nor is it a drug taken for an illness !)r to change
some type of bodv 'structure."
Hearings before the Subcomm. on Rural Developen
AQriculture, and Related Agencies, of the House C~omm. on
Appropriations. 100th Cong., 2d Sess., part 8, at 408 (1989)
(emphasis added).
29. In the 1990s, Congress continued to confirm that FDA has no role in
regulating cigarettes:
(a) In 1992, H.R. 4350 and S. 2298 were introduced to expand FDA
jurisdiction by creating a new regulatory category for tob acco products. In
connection with that legislation, Rep. Michael Synar, a major opponent of cigarettes,
conceded that, "While the FDA has jurisdiction to prote:t consumers from unsafe
foods, drugs, cosmetics and medical devices, it is powerless to do anything about one
of the deadliest consumer products - tobacco." 138 Cong. Rec. E483 (1992)
(emphasis added). Neither bill passed.
(b) In 1993, H.R. 2147 and S. 672 were introduced to expand FDA
jurisdiction by creating a new regulatory categoi, for tobacco products. Again, the
bills did not pass.
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