Philip Morris Inc. v. Harshbarger ( 1997 )

For the First Circuit
No. 97-8022
PHILIP MORRIS INCORPORATED, R.J. REYNOLDS TOBACCO COMPANY,
BROWN & WILLIAMSON TOBACCO CORPORATION, AND LORILLARD TOBACCO COMPANY,
Plaintiffs, Appellants,
v.
L. SCOTT HARSHBARGER, ATTORNEY GENERAL OF THE COMMONWEALTH OF
MASSACHUSETTS, AND DAVID H. MULLIGAN, MASSACHUSETTS COMMISSIONER
OF PUBLIC HEALTH,
Defendants, Appellees.
No. 97-8023
UNITED STATES TOBACCO COMPANY, BROWN & WILLIAMSON TOBACCO
CORPORATION, CONWOOD COMPANY, L.P., NATIONAL TOBACCO COMPANY, L.P.,
THE PINKERTON TOBACCO COMPANY, AND SWISHER INTERNATIONAL, INC.
Plaintiffs, Appellants,
v.
L. SCOTT HARSHBARGER, ATTORNEY GENERAL OF THE COMMONWEALTH OF
MASSACHUSETTS, AND DAVID H. MULLIGAN, MASSACHUSETTS COMMISSIONER
OF PUBLIC HEALTH,
Defendants, Appellees.
APPEALS FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS
[Hon. George A. O'Toole, Jr., U.S. District Judge]
Before
Torruella, Chief Judge,
Campbell, Senior Circuit Judge,
and Stahl, Circuit Judge.
Henry
C.
Dinger,
P.C., with whom Cerise
Lim-Epstein, Goodwin,
Procter & Hoar, LLP, Verne W. Vance, Jr., Foley, Hoag & Eliot, Herbert
Dym, E.
Edward
Bruce, David
H.
Remes, Jarrett
A.
Williams, Jason
A.
Levine, and
Covington
&
Burling, were on brief for Philip Morris
appellants.
George
J.
Skelly, with whom Thomas
J.Dougherty, Skadden,
Arps,
Slate,
Meagher
&
Flom
LLP, A.
Hugh
Scott, Denise
W.
DeFranco, Choate,
Hall
&
Stewart, John
L.
Oberdorfer, Stuart
M.
Pape, G.
Kendrick
MacDowell, and
Patton
Boggs,
L.L.P., were on brief for United States
Tobacco Company appellants.
Rebecca
P.
McIntyre, Assistant Attorney General, with whom Thomas
A.
Barnico, Assistant Attorney General and L.
Scott
Harshbarger,
Attorney General, were on brief for appellees.
Carol
J.
Bennett, James
P.
Jacobson, Ann
Beimdiek
Kinsella, D.
Douglas
Blanke, Attorneys for State of Minnesota, Hubert
H.
Humphrey
III, Attorney General for State of Minnesota, Grant
Woods, Attorney
General for State of Arizona,
Winston Bryant
, Attorney General for State
of Arkansas, Daniel
E.
Lundgren, Attorney General for State of
California, Richard
Blumenthal, Attorney General for State of
Connecticut, Robert
A.
Butterworth, Attorney General for State of
Florida, Margery
S.
Bronster, Attorney General for State of Hawaii,
James
E.
Ryan, Attorney General for State of Illinois, Jeffrey
A.
Modisett, Attorney General for State of Indiana, Thomas
J.
Miller,
Attorney General for State of Iowa, J.
Joseph
Curran,
Jr., Attorney
General for State of Massachusetts, Frank
J.
Kelley, Attorney General
for State of Michigan, Mike
Moore, Attorney General for State of
Mississippi, Jeremiah
W.
(Jay)
Nixon, Attorney General for State of
Missouri, Joseph
P.
Mazurek, Attorney General for State of Montana,
Frankie
Sue
Del
Papa, Attorney General for State of Nevada, Peter
Verniero, Attorney General for State of New Jersey,
Tom Udall
, Attorney
General for State of New Mexico, Dennis C. Vacco, Attorney General for
State of New York, Heidi Heitkamp, Attorney General for State of North
Dakota, Betty
D.
Montgomery, Attorney General for State of Ohio, W.A.
Drew
Edmondson, Attorney General for State of Oklahoma, Hardy
Myers,
Attorney General for State of Oregon, D.
Michael
Fisher, Attorney
General for State of Pennsylvania,
Jeffrey B. Pine
, Attorney General for
State of Rhode Island,
Mark Barnett
, Attorney General for State of South
Dakota, Dan
Morales, Attorney General for State of Texas, Jan
Graham,
Attorney General for State of Utah, William
Sorrell, Attorney General
for State of Vermont,
Christine O. Gregoire
, Attorney General for State
of Washington, Darrell
V.
McGraw,
Jr., Attorney General for State of
West Virginia,
James E. Doyle
, Attorney General for State of Wisconsin,
Louise H. Renne
, City Attorney, City of San Francisco, CA,
Elizabeth D.
Laporte, Chief of Special Litigation, City of San Francisco, CA, and
Andrew Y.S. Cheng, Deputy City Attorney, City of San Francisco, CA, on
brief amici curiae.
August 18, 1997
STAHL, Circuit Judge. This appeal implicates the
constitutionality of a Massachusetts statute requiring
manufacturers of tobacco products to disclose the additives and
nicotine-yield ratings of their products to the state's public
health department. See Mass. Gen. Laws ch. 94, S 307B (the
"Disclosure Act"). Plaintiffs-appellants, various
manufacturers of cigarette and smokeless tobacco products
(collectively, "the manufacturers"), appeal the district
court's grant of summary judgment in favor of defendants-
appellees, the Attorney General of the Commonwealth of
Massachusetts and the Massachusetts Public Health Commissioner
(collectively, the "Commonwealth"). The district court ruled
that neither the Federal Cigarette Labeling and Advertising
Act, as amended (the "FCLAA"), 15 U.S.C. SS 1331-41, nor the
Comprehensive Smokeless Tobacco Health Education Act of 1986
(the "Smokeless Tobacco Act"), 15 U.S.C. SS 4401-08, preempts
enforcement of the Disclosure Act. We affirm the district
1. The specific plaintiffs-appellants are Philip Morris
Incorporated, R.J. Reynolds Tobacco Company, Brown & Williamson
Tobacco Corporation, and Lorillard Tobacco Company ("the
cigarette manufacturers") [case no. 97-8022], and United States
Tobacco Company, Brown & Williamson Tobacco Corporation,
Conwood Company, L.P., National Tobacco Company, L.P., The
Pinkerton Tobacco Company, and Swisher International, Inc.
("the smokeless tobacco manufacturers") [case no. 97-8023].
2. The specific defendants-appellees are L. Scott Harshbarger,
Attorney General of the Commonwealth of Massachusetts, and
David H. Mulligan, Massachusetts Commissioner of Public Health.
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court's ruling, and hold that the Massachusetts Disclosure Act
survives the manufacturers' preemption challenge.
I.
Prior Proceedings
On August 2, 1996, the day Massachusetts enacted the
Disclosure Act, the cigarette manufacturers and smokeless
tobacco manufacturers separately filed complaints in the
district court claiming that the FCLAA and the Smokeless
Tobacco Act preempt the state law by operation of the Supremacy
Clause of the U.S. Constitution. Their complaints also allege
that the Disclosure Act violates the Constitution's Commerce
Clause, Full Faith and Credit Clause, Fourteenth Amendment Due
Process Clause, and Takings Clause. The parties cross-moved
for summary judgment in each case on the preemption claim
only. After denying the manufacturers' motions and granting
the Commonwealth's motions, the district court amended its
orders to certify the rulings for immediate appeal. See 28
U.S.C. S 1292(b). We accepted interlocutory review of the
orders. This appeal, therefore, presents only the preemption
issue.
3. Because of the Disclosure Act's extended effective date,
now November 1, 1997, the district court deferred consideration
of the manufacturers' contemporaneously filed preliminary
injunction motion.
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II.
Standard of Review
We review the district court's summary judgment
ruling de novo. Grenier v. Vermont Log Bldgs., Inc., 96 F.3d
559, 562 (1st Cir. 1996). The ultimate determination whether
federal law preempts the Massachusetts Disclosure Act presents
a legal question subject to plenary review. See
United States
v. Rhode
Island
Insurers'
Insolvency
Fund, 80 F.3d 616, 619
(1st Cir. 1996).
III.
Background
We begin our discussion with a review of the
Massachusetts Disclosure Act and the allegedly preempting
federal laws, the FCLAA and the Smokeless Tobacco Act. In so
doing, we consider the statutes' respective texts along with
the relevant historical and legislative contexts in which they
were enacted. See
Wood v.
General Motors Corp.
, 865 F.2d 395,
404 (1st Cir. 1988) ("In determining questions of preemption,
a court 'must examine the [act's] language against the
4. When reviewing a district court's ruling on cross-motions
for summary judgment, normally we consider the record evidence
with respect to each motion separately "to determine whether
either of the parties deserves judgment as a matter of law on
facts that are not disputed."
Wightman v.
Springfield Terminal
Ry. Co.
, 100 F.3d 228, 230 (1st Cir. 1996).
See 10A Charles A.
Wright, et al.,
Federal Practice and Procedure
, S 2720 (1983).
Here, however, because no underlying issue of material fact
exists with respect to the legal preemption issue, we need not
consider each motion separately.
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background of its legislative history and historical context.'"
(quoting California
Federal
Sav.
&
Loan
Ass'n v. Guerra, 479
U.S. 272, 284 (1987))). Next, we set forth controlling
preemption principles. Finally, we turn to the question
whether the federal statutes in question either expressly or
impliedly preempt the state statute. We note here that the
Supreme Court's splintered decision in Cipollone v. Liggett
Group,
Inc., 505 U.S. 504 (1992) heavily influences, and in
part controls, much of our analysis.
A. The Disclosure Act
The Massachusetts Disclosure Act, the first state law
of its kind, requires "any manufacturer of cigarettes, snuff or
chewing tobacco sold in the commonwealth" to provide the
Massachusetts Department of Public Health with a yearly report
that lists for each brand of product (1) any added constituents
"in descending order according to weight, measure, or numerical
count," and (2) nicotine yield ratings "which shall accurately
predict nicotine intake for average consumers." Mass. Gen.
Laws ch. 94, S 307B. The Disclosure Act permits public access
to the information reported upon an appropriate finding by the
department. Specifically, the Disclosure Act provides:
The nicotine yield ratings so provided,
and any other such information in the
annual reports with respect to which the
department determines that there is a
5. See Appendix A for the full text of the Disclosure Act,
Mass. Gen. Laws ch. 94, S 307B.
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reasonable scientific basis for concluding
that the availability of such information
could reduce risks to public health, shall
be public records.
Id.The public health department may not reveal the
information, however, "unless and until the attorney general
advises that such disclosure would not constitute an
unconstitutional taking." Id. Despite the apparent
limitations on the public health department's ability to
disclose reported information, the record evidence strongly
indicates that Massachusetts officials intend to publicize the
information. At oral argument before us, the Commonwealth
avoided direct questions on this issue, asserting that the
department's potential publication of the information was
irrelevant for the purposes of preemption analysis. For the
purposes of this case, we assume that the department will make
the information publicly available at the first legal and
practical opportunity.
By all indications, the purpose of the Disclosure Act
is to further the public health and education in the use of
tobacco products. Most tellingly, the law prefaces its
requirements with the phrase, "For the purpose of protecting
the public health." Mass. Gen. Laws. ch. 94, S 307B. In
addition, a press release from the Massachusetts Executive
Department released the same day the law was enacted describes
the Disclosure Act as a "consumer protection law" intended to
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foster educated decision-making on the part of the consuming
public when choosing specific tobacco products and brands.
B. The Federal Laws
1. FCLAA
In 1964, the United States Surgeon General's advisory
committee issued a report that officially acknowledged the
health hazards of cigarette smoking. See Cipollone, 505 U.S.
at 513. In response, the Federal Trade Commission, as well as
several states, moved to impose various warning requirements in
the advertising and labeling of cigarettes. Id.; see also
Palmer v.
Liggett Group, Inc.
, 825 F.2d 620, 622 n.1 (1st Cir.
1987) (noting example of New York State's warning label
requirement). In light of "the potential maze of conflicting
state regulations" on the subject,
Palmer, 825 F.2d at 622, and
after "vigorous lobbying by all forms of interested groups and
business,"
id. at 623, Congress passed the first version of the
FCLAA in 1965 (the "1965 Act").
Congress expressly declared its "policy and purpose"
in passing the 1965 Act:
It is the policy of the Congress, and the
purpose of this chapter, to establish a
comprehensive Federal program to deal with
cigarette labeling and advertising with
respect to any relationship between
smoking and health, whereby --
(1) the public may be adequately
informed that cigarette smoking may be
hazardous to health by inclusion of a
warning to that effect on each package of
cigarettes; and
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(2) commerce and the national
economy may be (A) protected to the
maximum extent consistent with this
declared policy and (B) not impeded by
diverse, nonuniform, and confusing
cigarette labeling and advertising
regulations with respect to any
relationship between smoking and health.
15 U.S.C. S 1331.
The Cipollone majority determined that the
congressional purposes expressed in this provision were as
follows:
(1) adequately informing the public that
cigarette smoking may be hazardous to
health, and (2) protecting the national
economy from the burden imposed by
diverse, nonuniform, and confusing
cigarette labeling and advertising
regulations.
505 U.S. at 514. The Court explained that the 1965 Act
contained specific provisions "[i]n furtherance of" these two
congressional purposes. Id. To further the first purpose, the
1965 Act mandated a specific warning label on each cigarette
package: "CAUTION: CIGARETTE SMOKING MAY BE HAZARDOUS TO YOUR
HEALTH." Id. To further the second purpose, see id., the
statute included a preemption provision, which, in part,
prohibited the requirement of any "statement relating to
smoking and health . . . on any cigarette package" other than
the required warning. 15 U.S.C. S 1334(a). The 1965 Act's
preemption clause further provided:
6. At the time, the warning was not required in cigarette
advertisements.
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(b) No 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.
15 U.S.C. S 1334(b) (1966), amended by 15 U.S.C. S 1334(b)
(1969).
By its own terms, the 1965 Act's provisions
pertaining to advertising were to terminate on July 1, 1969.
See Cipollone, 505 U.S. at 514. As that date approached,
various federal agencies and states proposed new and differing
cigarette advertising regulations. See id. at 514-15. Faced
with these various initiatives, Congress amended the 1965 Act
by enacting the Public Health Cigarette Smoking Act of 1969
(the "1969 Act"). The 1969 Act strengthened the wording of the
required warning label: "WARNING: THE SURGEON GENERAL HAS
DETERMINED THAT CIGARETTE SMOKING IS DANGEROUS TO YOUR HEALTH."
15 U.S.C. S 1333 (1969). The 1969 Act also prohibited
cigarette advertising on television and radio and any other
"medium of electronic communication subject to the jurisdiction
of the Federal Communications Commission." 15 U.S.C. S 1335.
Relatedly, the 1969 Act replaced subsection (b) of the 1965
7. For example, the Federal Communications Commission
announced its intention to consider a proposed rule that would
ban radio and television cigarette commercials, while the
California Senate "passed a total ban on both print and
electronic cigarette advertisements." Cipollone, 505 U.S. at515 & n.11.
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Act's preemption provision with the following language, which
remains unmodified to this day:
(b) No requirement or prohibition based
on smoking and health shall be imposed
under State law with respect to the
advertising or promotion of any cigarettes
the packages of which are labeled in
conformity with the provisions of this
chapter.
15 U.S.C. S 1334(b).
The Senate Report accompanying the 1969 Act explained
that the revised preemption provision was necessary "to avoid
the chaos created by a multiplicity of conflicting [cigarette
advertising] regulations." S. Rep. No. 91-566 (1970),
reprinted in 1970 U.S.C.C.A.N. 2652, 2663. Senate Report 566
further explained:
The State preemption of regulation or
prohibition with respect to cigarette
advertising is narrowly phrased to preempt
only State action based on smoking and
health. It would in no way affect the
power of any State or political
subdivision of any State with respect to
the taxation or the sale of cigarettes to
minors, or the prohibition of smoking in
public buildings, or similar police
regulations. It is limited entirely to
State or local requirements or
prohibitions in the advertising of
cigarettes.
Id.
8. In part because the new preemption provision banned
restrictions imposed only "under State law," in 1972 the
Federal Trade Commission extended the warning requirements to
print advertisements, as well as package labels. See
Cipollone, 505 U.S. at 515.
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After thirteen years of scientific research following
the enactment of the 1969 Act, Congress further amended the
FCLAA in 1984. See H.R. Rep. No. 98-805, at 12 (1984),
reprinted
in 1984 U.S.C.C.A.N. 3718, 3725. Renewed
congressional action in this area was in part prompted by
Surgeon General reports identifying cigarette smoking as a
significant risk factor in certain health problems. See id.(citing various reports). In light of the Surgeon General's
findings and testimony before congressional committees on the
adverse health effects of smoking, Congress passed the
Comprehensive Smoking Education Act of 1984 (the "CSEA").
House Report 805 states that the CSEA's purpose was "to assist
the public to make an informed decision about whether or not to
smoke" "[b]y updating the cigarette warning, by giving
visibility and emphasis to smoking research and educational
activities at the Federal level, and by working closer with the
private voluntary health section." Id.Specifically, the CSEA amended the FCLAA by
establishing a new warning system employing four different
smoking and health messages that would alternate quarterly on
both cigarette packages and cigarette advertisements. See 15
U.S.C. S 1333. To reflect the new multiple-warning system,
9. Specifically, the new required warnings, all preceded by
the phrase "SURGEON GENERAL'S WARNING," are as follows:
Smoking Causes Lung Cancer, Heart Disease,
Emphysema, And May Complicate Pregnancy.
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Congress amended the language in the statute's purpose
provision from "a warning . . . on each package of cigarettes
[that] cigarette smoking may be hazardous to health" to
"warning notices on each package of cigarettes and in each
advertisement of cigarettes [to inform the public] about any
adverse health effects of cigarette smoking." S 1331(1); see
also H.R. Rep. No. 98-805, at 21, 1984 U.S.C.C.A.N. at 3734.
Significantly, the CSEA inserted an ingredient
reporting provision that requires cigarette manufacturers to
"annually provide the Secretary [of Health and Human Services]
with a list of the ingredients added to tobacco in the
manufacture of cigarettes which does not identify the company
which uses the ingredients or the brand of cigarettes which
contain the ingredients." S 1335a(a). The provision permits,
but does not mandate, "[a] person or group of persons required
to provide [the list] . . . [to] designate an individual or
entity to provide the list." Id. In other words, to satisfy
their respective reporting obligations, the manufacturers at
their option may submit ingredient lists to a designated agent
Quitting Smoking Now Greatly Reduces
Serious Risks to Your Health.
Smoking by Pregnant Women May Result in
Fetal Injury, Premature Birth, and Low
Birth Weight.
Cigarette Smoke Contains Carbon Monoxide.
15 U.S.C. S 1333(a).
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who, in turn, may transmit the information aggregately to the
Secretary. Based on the information provided, the Secretary
must transmit a report to Congress, "[a]t such times as the
Secretary considers appropriate," on research activities
regarding the health effects or risks of cigarette additives
and "any other information which the Secretary determines to be
in the public interest." S 1335a(b)(1).
The ingredient reporting provision sets forth
comprehensive procedures for the Secretary's handling of the
information provided. Specifically, S 1335(b)(2)(A) provides:
Any information provided to the Secretary
under subsection (a) of this section shall
be treated as trade secret or confidential
information subject to section 552(b)(4)
of Title 5 [providing a trade secret
exemption for disclosure under the Freedom
of Information Act] and section 1905 of
Title 18 [criminalizing disclosure of
confidential information by federal
officers or employees] and shall not be
revealed, except as provided in paragraph
(1) [respecting the Secretary's report to
Congress], to any person other than those
authorized by the Secretary in carrying
out their official duties under this
section.
10. The legislative history indicates that the ingredient
reporting provision was intended to supply statutory authority
to require the manufacturers to disclose such information and
to "supercede, in all respects, a voluntary agreement entered
into between the Department of [Health and Human Services] and
the tobacco industry in June, 1982." H.R. Rep. No. 98-805, at
21, 1984 U.S.C.C.A.N. at 3734. The House Report further
explains that the provisions "would permit the federal
government to initiate the toxicologic research necessary to
measure any health risk posed by the addition of additives and
other ingredients to cigarettes during the manufacturing
process." Id.-15-
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Despite the above-quoted section, a different section directs
that the Secretary may not withhold the ingredient information
from a requesting congressional committee or subcommittee.
See
S 1335a(b)(2)(B). When faced with such a request, the
Secretary must make the list available "and shall, at the same
time, notify in writing the person who provided the list of
such request." Id.Finally, the ingredient reporting provision requires
the Secretary to ensure the confidentiality of the provided
information through specified procedures, including (1) a
designated custodian of the information who, when the
information is not in use, "shall store it in a locked cabinet
or file" and shall keep a record of those inspecting or using
the information, S 1335a(b)(2)(C), and (2) a requirement that
persons "permitted access to the information shall be
instructed in writing not to disclose the information to anyone
who is not entitled to have access to the information." Id.
11. The extent to which members of Congress are bound, if at
all, by the disclosure prohibitions is unclear.
12. It appears, however, that the Secretary's efforts to
notify the "person who provided the list" may be made more
difficult by S 1335a(a)'s option for such persons to provide
the list anonymously through a third individual or entity.
13. In addition to amending the FCLAA, the CSEA also directed
the Secretary to "establish and carry out a program to inform
the public of any dangers to human health presented by
cigarette smoking." 15 U.S.C. S 1341. Pursuant to that
program, the Secretary must,
inter
alia, coordinate research on
smoking and health and disseminate pertinent information to the
public. See id. at S 1341(a). To carry out some of the
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2. Smokeless Tobacco Act
By the mid-1980's, Congress became concerned that the
federal government's activities regarding the health hazards of
cigarette smoking had no parallel with respect to smokeless
tobacco products such as chewing tobacco and snuff. See S.
Rep. No. 99-209, at 3-4 (1986),
reprinted
in 1986 U.S.C.C.A.N.
7, 9-10. According to the Senate Report, the almost-forgotten
smokeless tobacco industry had staged a recent resurgence, and
its products had become popular among youth who apparently
considered such products a safe alternative to cigarette
smoking. See id. Further evidence suggested that smokeless
tobacco products contained "significant levels of nicotine" and
were linked with serious health problems, including oral
cancer. S. Rep. No. 99-209, at 3, 1986 U.S.C.C.A.N. at 9.
These factors led to regulatory action on various fronts
regarding warning requirements. For example, a Massachusetts
executive order required warning labels on the packages and in
the advertisements of smokeless tobacco products. Id.
Additionally, prominent health organizations called for
legislation requiring warnings, and the FTC enlisted the
Surgeon General's help in considering a petition seeking
program's purposes, the CSEA established an Interagency
Committee on Smoking and Health. See id. at S 1341(b). The
Secretary also must transmit specified reports to Congress
regarding efforts made to inform the public of the health
hazards of smoking and other information. See id. at
S 1341(c).
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warning label requirements. See S. Rep. No. 99-209, at 4-5,
1986 U.S.C.C.A.N. at 10-11.
In response to such regulatory efforts, Congress
passed the Comprehensive Smokeless Tobacco Health Education Act
of 1986 (the "Smokeless Tobacco Act"). The Senate Report
explains that the Act, "for the most part, simply extends the
provisions of . . . the Comprehensive Smoking Education Act of
1984, to include smokeless tobacco products." S. Rep. No. 99-
209, at 5, 1986 U.S.C.C.A.N. at 11. Thus, the Smokeless
Tobacco Act contains features similar, but not identical, to
the FCLAA as amended by the CSEA.
Like the CSEA, the Smokeless Tobacco Act calls for
the Secretary of Health and Human Services to "establish and
carry out a program to inform the public of any dangers to
human health resulting from the use of smokeless tobacco
products." 15 U.S.C. S 4401. The statute bans the advertising
of smokeless tobacco on radio and television, see 15 U.S.C.
S 4402(f), and establishes a rotating warning requirement for
package labels and advertising, with specific warnings
regarding the potential adverse health effects of smokeless
tobacco products. See S 4402.
14. The specific texts of the alternative warnings, all
preceded by the word "WARNING," read:
THIS PRODUCT MAY CAUSE MOUTH CANCER.
THIS PRODUCT MAY CAUSE GUM DISEASE AND
TOOTH LOSS.
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Congress included in the Smokeless Tobacco Act an
express preemption provision which states, in pertinent part:
No statement relating to the use
of smokeless tobacco products
and health, other than the
statements required by [this
act], shall be required by any
State or local statute or
regulation to be included on any
package or in any advertisement
. . . of a smokeless tobacco
product.
15 U.S.C. S 4406(b). Unlike the FCLAA, the Smokeless Tobacco
Act contains a "savings clause," which provides: "Nothing in
this chapter shall relieve any person from liability at common
law or under State statutory law to any other person." 15
U.S.C. S 4406(c).
The Smokeless Tobacco Act similarly provides for
anonymous and aggregate ingredient reporting to the Secretary
THIS PRODUCT IS NOT A SAFE ALTERNATIVE TO
CIGARETTES.
15 U.S.C. S 4402(a)(1).
15. Additionally, the Smokeless Tobacco Act specifically
precludes any federal
agency from requiring any such
statements. See 15 U.S.C. S 4406(a).
16. Senate Report 209 explains that "the Committee [on Labor
and Human Resources" wants to emphasize that by including
provisions in [the Act] which require health warnings on
packages and advertisements for smokeless tobacco products, and
by preempting State and local laws requiring additional health
warnings, it does not intend to preempt a State's ability to
control the promotion or advertising of tobacco products and
does not intend to preempt product liability suits in State or
Federal courts based on failure to warn." S. Rep. No. 99-209,
at 14, 1986 U.S.C.C.A.N. at 13.
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of Health and Human Services. S 4403(a). Unlike the FCLAA,
however, the Smokeless Tobacco Act also requires smokeless
tobacco manufacturers to specify the nicotine quantity
contained in each product. Id. The statute's provisions for
the Secretary's handling of the information are essentially
identical to those in the FCLAA, except for the absence of a
cross reference to 18 U.S.C. S 1905, which criminalizes
unauthorized disclosure of confidential information. Compare
15 U.S.C. S 1335(b)(2)(A) with 15 U.S.C. S 4403(b)(2). The
statute also requires the Secretary to transmit informative and
advisory reports to Congress. See 15 U.S.C. S 4407.
C. Preemption Principles
Having reviewed the federal and state statutes at
issue in this case, we now consider the preemption principles
that control our analysis of the question whether federal law
either explicitly or impliedly preempts the challenged state
law. We begin by noting that the health and safety of each
state's citizens "are primarily, and historically, matters of
local concern." Medtronic v. Lohr, 116 S. Ct. 2240, 2245
(1996). Accordingly, "the States traditionally have had great
latitude under their police powers to legislate as to the
17. According to the Senate Report, the Smokeless Act's
ingredient reporting provision is "very similar" to that in the
CSEA and "is included to further the accumulation of knowledge
about the health risks of smokeless tobacco use, particularly
the possible hazards of substances added to tobacco to enhance
flavor and for other purposes." S. Rep. No. 99-209, at 14,
1986 U.S.C.C.A.N. at 13.
-20-
20
protection of the lives, limbs, health, comfort and quiet of
all persons." Id. (internal quotation marks, citations, and
alterations omitted). The Massachusetts Disclosure Act
comfortably falls within the "health and safety" realm of
traditional state police powers. Cf. Wisconsin Public
Intervenor v. Mortier, 501 U.S. 597, 605 (1991) (indicating
that regulation of hazardous pesticides are matters of the
states' "historic police powers"); Tart v. Massachusetts, 949
F.2d 490, 501 (1st Cir. 1991) (confirming state's "police
power" to regulate the transshipment of raw fish).
Nevertheless, Article VI of the United States
Constitution provides that federal law "shall be the supreme
Law of the Land; . . . any Thing in the Constitution or Laws of
any State to the Contrary notwithstanding." U.S. Const. Art.
VI, cl. 2. As a result, "any state law, however clearly within
a State's acknowledged power, which interferes with or is
contrary to federal law, must yield." Gade v. National Solid
Wastes Mgmt. Ass'n
, 505 U.S. 88, 108 (1992) (internal quotation
marks and citations omitted). Thus, in this case, we must
determine whether the Disclosure Act sufficiently interferes
with, and therefore must yield either to the FCLAA or the
Smokeless Tobacco Act, or both.
In any preemption analysis, "[t]he purpose of
Congress is the ultimate touchstone." Ingersoll-Rand
Co. v.
McClendon, 498 U.S. 133, 138 (1990) (internal quotation marks
-21-
21
and citations omitted). The Supreme Court recently framed the
crucial inquiry as follows: "Did Congress, in enacting the
Federal Statute, intend to exercise its constitutionally
delegated authority to set aside the laws of a State?"
Barnett
Bank v. Nelson, 116 S. Ct. 1103, 1107 (1996). To discern
Congress' intent, "we examine the explicit statutory language
and the structure and purpose of the statute." Ingersoll-Rand
Co., 498 U.S. at 138.
One method by which Congress may evince preemptive
intent is through explicit preemption language. See Jones v.
Rath Packing Co.
, 430 U.S. 519, 525 (1977). Although Congress
need not employ express preemption language to communicate such
intent,
see
International Paper Co.
v.
Ouellette, 479 U.S. 481,
492 (1987), when Congress so chooses, our task in divining its
intent with respect to the issue at hand may be "an easy one,"
English v. General Elec. Co., 496 U.S. 72, 79 (1990).
"More often, explicit pre-emption language does not
appear, or does not directly answer the question. In that
event, courts must consider whether the federal statute's
'structure and purpose,' or nonspecific statutory language,
nonetheless reveal a clear, but implicit, pre-emptive intent."
Barnett Bank
, 116 S. Ct. 1108 (quoting
Jones, 430 U.S. at 525).
Thus, for example, state law is impliedly preempted to the
extent it "actually conflicts" with federal law. See
Cipollone, 505 U.S. at 516. Actual conflict occurs where
-22-
22
compliance with both state and federal law is a "physical
impossibility," Florida Lime & Avocado Growers, Inc. v. Paul,
373 U.S. 132, 143 (1963), or where state law "stands as an
obstacle to the accomplishment and execution of the full
purposes and objectives of Congress,"
Hines v.
Davidowitz, 312
U.S. 52, 67 (1941). Additionally, the pervasiveness of a
federal scheme, the dominance of the federal interest, or the
federal goals and obligations may reasonably permit an
inference that Congress intended a federal law to "occupy a
field" of commerce exclusively, disallowing concurrent state
operation or supplementation even where the state law does not
otherwise "conflict" with federal law. See Rice v. Santa
Fe
Elevator Corp., 331 U.S. 218, 230 (1947).
Finally, there exists an assumption that federal law
does not supersede a state's historic police powers "'unless
that [is] the clear and manifest purpose of Congress.'"
Cipollone, 505 U.S. at 516 (quoting
Rice, 331 U.S. at 230);
see
Hillsborough
County v. Automated
Medical
Labs, 471 U.S. 707,
18. The preemption framework described, while providing a
useful backdrop for our analysis, does not reflect "rigidly
distinct" preemption categories. English, 496 U.S. at 79 n.5.
For example, "field pre-emption may be understood as a species
of conflict pre-emption: A state law that falls within a pre-
empted field conflicts with Congress' intent (either express or
plainly implied) to exclude state regulation." Id. See also
Hines, 312 U.S. at 67 (stating that "none of these expressions
provides an infallible constitutional test or an exclusive
constitutional yardstick"); Palmer, 825 F.2d 620, 625-26
(describing preemption labels as "[not] necessarily helpful"
and looking to Congress' intent and the effect of state law on
the federal scheme).
-23-
23
715 (1985) (noting "presumption that state or local regulation
of matters related to health and safety is not invalidated
under the Supremacy Clause"); see also Buono v. NYSA-ILA
Medical
&
Clinical
Svcs.
Fund, 117 S. Ct. 1747, 1751 (1997).
The "health and safety" presumption applies in both express and
implied preemption analyses. See Greenwood
Trust
Co. v.
Commonwealth, 971 F.2d 818, 823 (1st Cir. 1992) ("Even federal
statutes that contain express preemption clauses must be viewed
through the prism of [the] assumption.");
see
also
Vango Media,
Inc. v.
City of New York
, 34 F.3d 68, 72 (2d Cir. 1994) (noting
that presumption applies "[w]hether preemption under the
Supremacy Clause be explicit, or implied under field
preemption, or under conflict preemption") (involving
preemptive effect of FCLAA over city ordinance respecting
tobacco-product advertising). The Disclosure Act, being an
19. In
Cipollone, a majority of the Supreme Court employed the
presumption in analyzing and construing the 1965 Act's express
preemption provision. See 505 U.S. at 518. In Wilson v.
Bradlees of New Eng., 96 F.3d 552, 557 (1st Cir. 1996), cert.
denied, 117 S. Ct. 1083 (1997), however, we questioned the
force of the presumption "in the construction of express
preemption clauses" in view of the Justices' apparently
differing opinions on the subject in its post- Cipollone
decision, Medtronic v. Lohr. Compare 116 S. Ct. at 2250
(plurality confirming the presumption as "consistent with both
federalism concerns and the historic primacy of state
regulation of matters of health and safety");
with
id. at 2263
(four Justices, concurring in part and dissenting in part,
employing an analysis suggesting that normal statutory
construction principles apply when construing express
preemption clause). Just last Term, however, the Supreme Court
reaffirmed the applicability of the presumption in interpreting
even an expansive preemption clause. See California
Labor
Stds. Enforcement v. Dillingham Constr., 117 S. Ct. 832, 838,
-24-
24
exercise of the Commonwealth's police powers to protect the
health and safety of her citizens, benefits from the
presumption against preemption.
While these principles are readily enough stated,
their application in practice can be rather difficult because
each preemption scenario necessarily involves a unique
intersection of federal and state law. See
Hines, 312 U.S. at
67 (explaining that, with respect to preemption analysis, there
is no "rigid formula or rule which can be used as a universal
pattern to determine the meaning and purpose of every act of
Congress"). Thus, our task requires us to scrutinize the
relevant statutory language, in light of Congress' evident
purpose and pertinent case law, to determine whether Congress
intended to preempt state laws such as the Disclosure Act.
IV.
Analysis
A. Express Preemption
Because Congress included express preemption language
in both the FCLAA and the Smokeless Tobacco Act, "our initial
concern is with express preemption and with the reach of the
clause[s] in question." Wilson v.
Bradlees of New Eng., Inc.
,
96 F.3d 552, 554 (1st Cir. 1996),
cert.
denied, 117 S. Ct. 1083(1997). In this analysis, we compare the Disclosure Act with
842 (1997) (unanimous decision) (applying presumption in
interpretation of broad preemption language in the Employee
Retirement Income Security Act of 1974).
-25-
25
the language of the preemption clauses and cases interpreting
it to determine whether the state law falls within the intended
preemptive scope. See Grenier, 96 F.3d at 562. We discuss
each statute in turn.
1. FCLAA
Because the Disclosure Act does not require a
"statement relating to smoking and health . . . on
any
cigarette
package," 15 U.S.C. S 1334(a) (emphasis added), we
are concerned only with S 1334(b), which provides:
No requirement or prohibition based on
smoking and health shall be imposed under
State law with respect to the advertising
or promotion of any cigarettes the
packages of which are labeled in
conformity with the provisions of this
chapter.
15 U.S.C. S 1334(b).
a. Cipollone
We begin with Cipollone, which concerned the
viability of state common-law damages actions against cigarette
manufacturers for injuries stemming from the lung-cancer death
of Rose Cipollone. See 505 U.S. 504 (1992). The Court
analyzed the statutory preemption language of both the 1965 and
1969 Acts, but because the plaintiffs' claims arose before
1984, the Court did not consider the CSEA's potential effect on
those claims. See id. at 508. In the Court's mixed ruling,
Justice Stevens' opinion spoke for a majority of the Court in
certain sections, but largely represented the views of only a
-26-
26
plurality of the Court. The ruling also produced two separate
opinions concurring in part and dissenting in part.
Principally, the Justices disagreed over whether or not state
common-law damages actions, as opposed to positive enactments
by state legislatures or administrative bodies, fell within the
scope of the express preemption provisions in the 1965 and 1969
Acts. While a majority of the Court held that the 1965 Act did
not preempt state common-law damages actions, see Cipollone,
505 U.S. at 518-19, a plurality found that the 1969 Act's
"broader" preemption language did encompass some common law
claims, see id. at 520-21.
To determine whether or not a particular common law
claim fell within the express preemption clause, the plurality
formulated the following "central inquiry": "we ask whether
the legal duty that is the predicate of the common-law damages
action constitutes a 'requirement or prohibition based on
smoking and health . . . imposed under State law with respect
to . . . advertising and promotion,' giving that clause a fair
but narrow reading." Id. at 524. According to the plurality,
20. We acknowledge that the Cipollone plurality's "narrow"
reading of the preemption provision is not without disagreement
by other members of the Court. See 505 U.S. at 544 (Scalia,
J., concurring in part, dissenting in part) (stating that
preemption analysis requires the Court "to interpret Congress's
decrees of pre-emption neither narrowly nor broadly, but in
accordance with their apparent meaning");
see
also
id. at 545,
548 (Scalia, J., concurring in part, dissenting in part)
(explaining that, given the express preemption provision, "our
responsibility is to apply to the text ordinary principles of
statutory construction. . . . When [the ordinary meaning of the
-27-
27
"each phrase within that clause limits the universe of
common-law claims pre-empted by the statute." Id. In Lohr, a
Court majority approved a similar approach. See Lohr, 116 S.
Ct. at 2257 (parsing language in express preemption clause to
determine federal statute's preemptive scope); id. at 2258(looking to "[t]he legal duty that is the predicate for
[plaintiff's common-law state damages claim]" to determine
whether or not it was preempted by federal requirements).
On this basis, we apply a modified version of the
test in this case and ask whether or not the "predicate legal
duty" created by the Disclosure Act constitutes a (1) a
"requirement or prohibition . . . imposed under State law," (2)
"based on smoking and health," (3) "with respect to the
advertising or promotion of any [properly labeled] cigarettes."
S 1334(b).
statute's language] suggests that the pre-emption provision was
intended to sweep broadly, our construction must sweep broadly
as well. . . . And when it bespeaks a narrow scope of
pre-emption, so must our judgment." (citation omitted)); cf.
Laurence H. Tribe, American Constitutional Law S 6-29, p. 510
(2d ed.) (1988) (indicating that preemption analysis should be
approached as "a matter of statutory construction rather than
free-form judicial policymaking").
21. It is undisputed that the cigarette manufacturers'
cigarette packages are properly labeled under the FCLAA.
-28-
28
b. Application
(1) " Requirement or prohibition . . . imposed
under State law."
Although members of the Cipollone Court disagreed
over whether a state common-law damages action could constitute
a "requirement" under S 1334(b), the Court unanimously agreed
that "positive enactments" are state-imposed "requirement[s] or
prohibition[s]" within the meaning of that clause. See 505
U.S. at 521 (plurality opinion); 505 U.S. at 525 (Blackmun, J.,
concurring in part, dissenting in part); 505 U.S. at 548
(Scalia, J., concurring in part, dissenting in part). The
Disclosure Act, being a positive enactment by the Massachusetts
state legislature, therefore constitutes a state-imposed
"requirement" that falls within the universe of state action
potentially preempted by the S 1334(b).
(2) " Based on Smoking and Health"
We think it clear that the obligations imposed by the
Disclosure Act are "based on smoking and health," and the
Commonwealth does not dispute this position. The law's stated
purpose, "[f]or the purpose of protecting the public health,"
22. The Disclosure Act constitutes a "requirement" because
unless tobacco product manufacturers comply with its reporting
provisions, they must forgo selling their products in
Massachusetts. Cf. Vango Media, Inc. v. City of New York, 34
F.3d 68, 72 (2d Cir. 1994) (finding city ordinance pertaining
to tobacco product advertisements "plainly is a 'requirement'"
within the meaning of S 1334(b) because absent compliance with
the ordinance, plaintiff would have to forgo advertising
display).
-29-
29
and the accompanying text strongly imply that its anticipated
effect will be greater public awareness about the additives and
nicotine in tobacco products and the potential health effects
of those ingredients. Mass. Gen. Laws ch. 94, S 307B. The
Disclosure Act, therefore, bears the requisite relationship to
"smoking and health" within the meaning of S 1334(b). See
Vango
Media, 34 F.3d at 73 (finding city ordinance requiring
display of public health messages about health risks of smoking
was "based on smoking and health" because both its purpose and
effect centered on such risks);
Lacey v.
Lorillard Tobacco Co.
,
956 F. Supp. 956, 962 (N.D. Ala. 1997) (stating that a "list of
ingredients in cigarettes would most likely be material only as
it related to the health of a plaintiff"); Cf. Griesenbeck v.
American
Tobacco
Co., 897 F. Supp. 815, 823 (D.N.J. 1995)
(finding that "threat of self-immolation arising from the
negligent care of one's cigarette is a 'health risk'" bearing
the requisite relationship to smoking and health).
Courts have found the requisite link to smoking and
health lacking where the predicate duty was "a more general
obligation," for example, "the duty not to deceive,"
Cipollone,
505 U.S. at 528-29 (plurality), the "duty not to conspire to
commit fraud," id. at 530 (plurality), and the duty "to not
engage in unfair competition by advertising illegal conduct or
encouraging others to violate the law," Mangini v. R.J.
Reynolds
Tobacco
Co., 875 P.2d 73, 80 (Cal. 1994) (involving
-30-
30
claim that cigarette manufacturer's "Old Joe Camel advertising
campaign targets minors for the purpose of inducing and
increasing their illegal purchases of cigarettes"). Cf.
Lohr,
116 S. Ct. at 2258 (finding that plaintiffs' negligent
manufacturing claim was predicated on the "general duty of
every manufacturer to use due care to avoid foreseeable dangers
in its products" and thus, the state common-law requirements
were not "with respect to" medical devices).
Here, the Commonwealth does not argue that the
Disclosure Act imposes an obligation so general as to take it
out of the smoking-and-health nexus of S 1334(b). While the
argument could be made that the Disclosure Act predicates its
obligations upon the general duty to follow state statutory
reporting requirements rather than state-considerations that
are "based on smoking and health," we think such an argument
impermissibly raises the level of generality of the inquiry.
The logical extension of this argument would be that all
obligations stemming from state positive-enactments are
predicated on the "general duty" to "abide by state law," thus
bringing every such requirement outside the scope of the
preemption clause even if it squarely involved otherwise
preempted matters. Cf. Cipollone, 505 U.S. at 543 (Blackmun,
J., concurring in part, dissenting in part) (criticizing
plurality's "frequent shift in the level of generality at which
it examines the individual claims").
-31-
31
(3) " With
Respect
to
the
Advertising
or
Promotion of Any Cigarettes"
Having found that the Disclosure Act is a
"requirement or prohibition based on smoking and health . . .
imposed under State law," we turn to the main dispute
underlying our express preemption analysis: whether or not the
obligations imposed under the Disclosure Act are "with respect
to the advertising or promotion of any cigarettes" within the
meaning of S 1334(b). At first glance, the Disclosure Act's
reporting duties seem entirely unrelated to tobacco industry
advertising and promotion. Certainly, as the district court
found, the compelled furnishing of additive and nicotine-yield
lists to state authorities does not itself constitute
"advertising or promotion." Although the cigarette
23. In reviewing the FCLAA as a whole, see Crandon v. United
States, 494 U.S. 152, 158 (1990), we observe that the specific
references to the words "advertising," "advertisement," and the
phrase "advertising or promotion," in context, suggest an
interpretation of those concepts significantly more traditional
than furnishing ingredient and nicotine-yield reports to a
state agency. See, e.g., S 1331(1) (referring to the
"inclusion of warning notices on each package . . . and
in each
advertisement of cigarettes" (emphasis added)); S 1333(a)(2)
("It shall be unlawful for any manufacturer . . . of cigarettes
to advertise or cause to be advertised . . . any cigarette
unless the advertising bears [a required label]") (emphasis
added); S 1333(a)(3) (involving similar requirement for outdoor
billboard advertisements); S 1335 (making it illegal for
manufacturers "to advertise" on radio and television); S 1336
(acknowledging the Federal Trade Commission's authority in the
area of unfair practices "in the advertising of cigarettes")
(emphasis added); S 1337 (requiring the FTC to transmit annual
reports to Congress "concerning . . . current practices and
methods of "cigarette advertising
and
promotion") (emphasis
added).
-32-
32
manufacturers do not seriously dispute this conclusion, they
submit that the Disclosure Act's requirements are "with respect
to" advertising and promotion within the meaning of S 1334(b).
The cigarette manufacturers theorize that the
FCLAA, through its mandated warning labels and express
preemption language, exclusively delineates the necessary and
sufficient health information that cigarette manufacturers may
be compelled to communicate to the public. They contend that
section 1334(b), therefore, in addition to preempting
requirements to change cigarette labels or advertisements,
prohibits any additional requirement to communicate to the
public about smoking and health. The manufacturers reason that
the Disclosure Act, although styled as an agency reporting
requirement, essentially compels them to communicate additional
smoking and health information to the public because the health
department will make the information publicly available. They
assert that S 1334(b) would be rendered meaningless if the
Commonwealth may accomplish indirectly what it may not
accomplish directly by using the state agency "as a conduit"
for the manufacturers' compelled communication. In short, they
claim that the Disclosure Act impermissibly requires them to
participate in what amounts to a public service advertising
campaign intended to supplement the federally mandated
warnings.
-33-
33
In Cipollone, two of the Court's opinions
specifically analyzed the phrase "with respect to . . .
advertising and promotion": Justice Stevens' four-vote
plurality opinion, which interpreted the phrase narrowly, and
Justice Scalia's opinion concurring in part and dissenting in
part, in which Justice Thomas joined, which interpreted the
phrase more broadly. We note initially that the six Justices
represented by these two opinions apparently agreed that the
preemption clause reached plaintiffs' failure-to-warn claims,
at least insofar as they required proof that the manufacturers'
"post-1969 advertising or promotions should have included
additional, or more clearly stated, warnings." 505 U.S. at 524
(plurality); see id. at 554 (Scalia, J., concurring in part,
dissenting in part); see also Palmer, 825 F.2d at 627(explaining that successful failure-to-warn claim effectively
compels manufacturers to alter warning labels).
The four-member plurality further found, however,
that the preemption clause did not bar "[failure-to-warn]
claims that rely solely on [the cigarette manufacturers']
testing or research practices or other actions unrelated
to
advertising
or
promotion." Cipollone 505 U.S. at 524-25
(emphasis added). Moreover, under the plurality's reasoning,
24. Justice Blackmun's concurring and dissenting opinion,
joined by two other Justices, expressed the view that the 1969
Act's preemption clause did not reach state common law claims
at all. Thus, these three Justices expressed no view on the
meaning of the phrase at issue here.
-34-
34
fraudulent misrepresentation claims survived "insofar as those
claims rely on a state-law duty to disclose such facts
through
channels of communication other than advertising or promotion
."
Id. at 528 (emphasis added). Significantly, the plurality
offered the following by way of illustration: "Thus, for
example, if state law obliged respondents to disclose material
facts about smoking and health to
an
administrative
agency,
[sec. 1334(b)] would not pre-empt a state-law claim based on a
failure to fulfill that obligation." Id. (emphasis added).
Under the plurality's reasoning, there appears to be
little doubt that the Disclosure Act is not "with respect to"
advertising or promotion because the manufacturers do not
satisfy their obligation to file annual reports to the state
health department "through" an advertising or promotion
channel. See 505 U.S. at 528 (plurality). The agency's
potential release of the information to the public would seem
to raise no concern with the plurality, which was not otherwise
troubled about compelled communication to the public through
alternative, non-advertising, non-promotional channels (i.e.,
in duties underlying certain surviving failure to warn and
fraudulent misrepresentation claims), for the purposes of the
language at issue. Thus, we believe that the plurality's
reasoning militates towards the Commonwealth's position.
Justice Scalia's opinion, concurring in part and
dissenting in part, disagreed with the plurality's conclusion
-35-
35
that a state law claim based on the failure to warn consumers
"'through channels of communication other than advertising or
promotion'" would not come within S 1334(b)'s preemptive scope.
Id. at 554 (Scalia, J., concurring in part, dissenting in part)
(quoting plurality opinion, id. at 528). While acknowledging
that the FCLAA clearly does not preempt claims unrelated to
industry advertising and promotion, Justice Scalia reasoned
that it preempts "claims based on duties that can be complied
with by taking action either within the advertising and
promotional realm
or elsewhere
." Id. at 554. Thus, according
to Justice Scalia, although a product warning could be
communicated in many ways, S 1334(b) would preempt the duty as
a whole because it could be satisfied through advertising or
promotion. See id. at 554-55.
Justice Scalia's opinion also intimated, however,
that a hypothetical law requiring disclosure of product health-
hazards to a state public-health agency would bear "no
relation" to industry advertising and promotion. Id. at 554.
He further speculated that such a law "would seem to survive"
a proposed "practical compulsion" test to determine the
25. Noting that manufacturers normally communicate required
product warnings through advertising and promotion, Justice
Scalia found it "implausible that Congress meant to save
cigarette companies from being compelled to convey such data to
consumers through that means, only to allow them to be
compelled to do so through means more onerous still."
Cipollone, 505 U.S. at 555 (Scalia, J., concurring in part,
dissenting in part).
-36-
36
viability of a state law, which he phrased as: "whether the law
practically compels the manufacturers to engage in behavior
that Congress has barred the States from prescribing directly."
Id. at 555 (Scalia, J., concurring in part, dissenting in
part). Justice Scalia's opinion suggests that because the
hypothetical law's requirements could not possibly be satisfied
through advertising and promotional efforts, the law would not
"practically compel" the manufacturers "to relinquish the
advertising and promotion immunity accorded them by the Act."
Id. at 555.
In this case, of course, we are presented with an
agency reporting requirement coupled with the probability that
the information provided will be made public. Although the
health department will likely publicize the required reports,
the Disclosure Act does not "practically compel" the
manufacturers to communicate smoking and health information to
the public within Justice Scalia's explication because, while
the communicative action to consumers could alternatively be
achieved through advertising and promotional efforts, the
Disclosure Act itself admits of no such alternative to
compliance. There is no suggestion that the manufacturers
could somehow comply with the Disclosure Act simply by changing
their advertising or promotional materials. Moreover, direct
communication of the additive and nicotine-yield information to
the public through some other means would not excuse the
-37-
37
manufacturers' duties under the law. Thus viewed, the
Disclosure Act would survive even Justice Scalia's more
expansive, but distinct minority view of the preemption clause.
While our
Cipollone-based analysis necessarily draws
upon the dicta of six Justices who were not presented with an
actual agency-reporting scheme, much less a scheme that
contemplates the public release of the information reported, we
believe that the Justices' observations suggest a qualitative
difference, for S 1334(b) purposes, between direct
communication with the public and disclosure to a state agency.
The fact that public health agencies exist to serve the public,
and the absence of any secrecy mandates in the Cipollone
opinions discussing state agency reporting requirements,
further suggest that the agency's ultimate use of the
information does not bear on the question whether such a
reporting scheme relates to advertising and promotion. In the
end, we believe that
Cipollone weighs strongly in favor of the
Commonwealth's position.
In the wake of Cipollone, several courts have dealt
specifically with the question whether a state statute or
common-law damages action, in various contexts, implicates the
phrase, "with respect to . . . advertising or promotion."
S 1334(b). In general, the cases yield a broad interpretation
of the language at issue. Not surprisingly, therefore, the
manufacturers rely heavily on select language from them.
-38-
38
Although none of the cases involves a state-agency reporting
scheme, we review them to contextualize the manufacturers'
arguments and to indicate how the cases differ from the instant
dispute.
In
Vango Media, Inc.
v.
City of New York
, 34 F.3d 68,
70 (2d Cir. 1994), the Second Circuit held that the FCLAA
expressly preempted a city ordinance requiring an advertising
business to display a minimum of one public health message
about the dangers of smoking (or the benefits of not smoking)
for every four tobacco advertisements. The court reasoned that
the phrase "with respect to" in S 1334(b) is essentially
synonymous with "relating to," which, in turn, the Supreme
Court has interpreted broadly. Id. at 74 (citing definitions
such as "referring to" or "having a connection with").
Although the city ordinance did not require changes in the
content of tobacco advertisements, the court found that it
impermissibly impacted advertisers and promoters by "impos[ing]
conditions on their display of cigarette advertisements." Id.
at 75. The court concluded that the city ordinance directly
contravened the FCLAA's purpose of avoiding diverse advertising
regulations and "tread[ed] on the area of tobacco advertising,
even if . . . only at the edges." Id. at 74.
In this case, the cigarette manufacturers argue that
Vango Media
establishes that the FCLAA preempts any attempt to
require anyone to provide smoking and health messages to the
-39-
39
public through any
media, even media other than industry
advertisements. They argue that the Disclosure Act surely
comes within this vast preempted realm. We do not read Vango
Media so expansively. In Vango
Media, the very display of
tobacco advertisements invoked the city ordinance requirements,
thus evincing a direct and substantial connection between the
ordinance and industry advertising. See id. at 74-75. The
Disclosure Act, on the other hand, does not impose conditions
upon tobacco advertising or promotional decisions, which are
irrelevant to the Disclosure Act's obligations.
Moreover, even assuming (without deciding) that "with
respect to" is synonymous with "relate to," the Disclosure Act
does not "relate to" advertising or promotion because it lacks
the requisite "reference to" or "connection with" the preempted
realm. See California
Labor
Stds.
Enforcement v. Dillingham
Constr., 117 S. Ct. 832, 837-41 (1997) (analyzing "relate to"
phrase in express preemption language in Employee Retirement
Income Security Act of 1974 ("ERISA")); Buono v. NYSA-ILA
Medical
and
Clinical
Servs.
Fund, 117 S. Ct. 1747, 1751-52
(1997) (same). The Disclosure Act does not make "reference to"
advertising and promotion because it does not "act[]
immediately and exclusively" upon advertising and promotion,
and, unlike the ordinance in
Vango Media
, the existence of such
advertising is not "essential to the [state] law's operation."
Dillingham Constr.
, 117 S. Ct. at 838. The Disclosure Act does
-40-
40
not have a "connection with" advertising and promotion because
it does not mandate the structure and content of advertising,
see id. at 839, and, while it may somehow "alter[] the
incentives" in advertising decision-making, it "does not
dictate the choices,"
id. at 842. Thus, while the ordinance in
Vango Media
ran afoul of S 1334(b)'s "with respect to" language
by analogy to the Court's "relate to" jurisprudence, the
Disclosure Act does not.
Several other cases have involved state claims that
sought to impose liability on tobacco product manufacturers for
failing to disclose information to consumers through channels
other than traditional advertising or promotion. A few courts
have found general allegations in this regard insufficient to
escape S 1334(b)'s preemptive reach. See
Cantley v.
Lorillard
Tobacco
Co., 681 So.2d 1057, 1061 (Ala. 1996) (finding bare
allegation that cigarette manufacturers concealed material
facts was "inevitably based upon a state law duty to disclose
facts through advertising or promotion" because communication
with consumers normally occurs only through those channels
(internal quotation marks and citation omitted)); Griesenbeck
v. American
Tobacco
Co., 897 F. Supp. 815, 823 (D.N.J. 1995)
(finding that a claim that cigarette manufacturers "should have
warned [of health risk] . . . somehow, presumably through some
variety of mass-notification" was preempted because "[a]
company's attempt to notify its mass market of anything . . .
-41-
41
is considered 'advertising or promotion' under the general
usage of those terms"); cf. Grenier, 96 F.3d at 564 (finding
failure-to-warn claims preempted under Federal Insecticide,
Fungicide, and Rodenticide Act because plaintiff failed "to set
forth a coherent specific claim" that was not based on the
preempted realm of labeling or packaging).
In another case, a plaintiff creatively premised her
failure-to-warn claim on the failure to employ specific "non-
promotional communications," such as "public service messages,
seminars on smoking cessation and harmful smoking habits,
direct mail-outs . . ., public advocacy, and lobbying."
Sonnenreich v. Philip Morris Inc., 929 F. Supp 416, 418 (S.D.
Fla. 1996). The court rejected the proffered alternatives,
reasoning that they "employ the same techniques as a
traditional advertising or promotional campaign. . . . [and]
are all undertaken with the effect of promoting and fostering
a product or an ideology." Id. at 419. The court reasoned
that the plaintiff's theory would render the FCLAA
"meaningless" because it "suggest[ed] that at the same time
[the tobacco manufacturers] were providing the Congressionally-
mandated warnings, they were exposing themselves to state law
tort liability by failing to use 'non-promotional
communications' to disseminate material essentially duplicative
of the Surgeon General's warning." Id. at 418.
-42-
42
In yet another case more closely analogous to this
one, a plaintiff sought an injunction to compel cigarette
manufacturers to disclose to consumers "the nature, type,
extent and identity" of all cigarette additives. Lacey v.
Lorillard Tobacco Co., 956 F. Supp 956, 958 (N.D. Ala. 1997).
After reviewing the FCLAA's scheme and obligations, the court
found the claim preempted because it was "based upon an alleged
duty . . . to provide to consumers more information regarding
smoking and health than is required by the [FCLAA]," id. at
963, and because its additional disclosure obligations
"unavoidably attack[ed]" the manufacturers' advertising and
promotion, id. at 962.
Here, we are presented with more than a vague "tell-
the-consumers-any-way-you-wish" claim. Cipollone, 505 U.S. at
555 (Scalia, J., concurring in part, dissenting in part).
Specifically, the Disclosure Act requires that ingredient
reports be filed with a state agency; the reports themselves
are plainly outside the realm of advertising or promotion.
Unlike plaintiff's theory in Sonnenreich, the Disclosure Act
does not require the manufacturers to produce materials and
disseminate information to consumers through techniques, such
26. The Lacey court acknowledged the Cipollone plurality's
suggestion that the FCLAA would not preempt a state law
requirement to disclose smoking-and-health facts to an
administrative agency. See 956 F. Supp at 962. The court
explained, however, that the law of the pertinent state
(Alabama) imposed no such obligation. See id.-43-
43
as seminars or direct mailings, that resemble promotional
efforts and impel the fostering of a product ideology. Unlike
the plaintiff's claim in Lacey, the Disclosure Act does not
impose a duty upon manufacturers to provide additional smoking
and health information directly to the public.
There would arguably appear to be little difference
between requiring manufacturers to disseminate ingredient
information directly to the public and requiring them to file
such information with a state agency, which, in turn, will make
the information publicly available. Nevertheless, there is a
difference, and we are unpersuaded by the manufacturers'
argument that the difference is not substantively important.
Moreover, we find doubtful their expansive interpretation of
the with-respect-to-advertising-and-promotion condition.
While we need not decide the issue now, we are
skeptical of the manufacturers' sweeping proposition that the
FCLAA prescribes the exclusive means by which they may be
compelled to communicate health information directly to the
public. On this point, we find informative the Cipollone
plurality's preservation of some claims that were based, in
part, on the duty to communicate smoking-and-health information
to the public. See 505 U.S. at 524-25 (failure-to-warn
claims);
id. at 528 (fraudulent misrepresentation claims). The
survival of such claims undermines the premise that the FCLAA
delineates the exclusive scope of consumer-communication
-44-
44
duties, and furthermore suggests the very existence of a subset
of such requirements that are wholly unrelated to advertising
and promotion. We also find informative the legislative
history's repeated reference to the "narrow" and "limited"
nature of the preemption provision and declaration that the
provision "is limited entirely to State or local requirements
or prohibitions in the advertising of cigarettes." S. Rep. 91-
566, 1970 U.S.C.C.A.N. at 2663.
Our skepticism aside, significantly, the Disclosure
Act does not require the manufacturers to communicate directly
with consumers. Of course, a quintessential state requirement
"with respect to . . . advertising and promotion" would be a
law mandating changes or additions to the content of cigarette
advertisements. One step removed from such a law would be a
requirement that manufacturers mass-communicate additional
warnings or other smoking-and-health information directly to
consumers through channels other than advertising or promotion.
At this point, the argument in favor of preemption begins to
weaken given the
Cipollone plurality's seemingly narrow concern
with requirements specifically involving advertising and
promotional channels. See 505 U.S. at 524-25, 528. Further
removed yet would be a requirement to disclose such information
to some entity other than the consuming public. While one can
imagine subsequent intermediate steps, at some point we reach
the agency reporting scheme before us.
-45-
45
We think that the agency-reporting scheme prescribed
under the Disclosure Act is insufficiently related to the
advertising and promotion realm to bring the state law within
S 1334(b)'s preemptive scope. As noted above, the reports
required under the Disclosure Act do not themselves constitute
or resemble promotional material. Once the manufacturers file
the reports with the state public health agency, their
communicative obligation ceases. They will not be required to
disseminate further the reported information, which becomes
public (if at all), solely through agency action. Thus, unlike
an obligation to advise consumers
directly of any information,
which may compel the manufacturers to engage in activity
resembling advertising and promotional efforts, the Disclosure
Act requires no such exertion. In fact, the law separates the
normal source of product advertising and promotion, the tobacco
industry, from any direct communicative action to the public.
That the information contained in the report may eventually
become widely disseminated does not transform the
manufacturer's initial reporting obligation into an advertising
or promotional activity. In our view, an implied
transformation of this sort would distort the language of
S 1334(b) beyond Congress' intent. In short, the line between
"with respect to" and "no relation to" advertising and
promotion must be crossed at some point, and although we need
-46-
46
not pinpoint that exact location now, we think it has been
crossed here.
Moreover, we disagree with the manufacturers'
argument that the Disclosure Act meets this condition because
it reflects the Commonwealth's "impermissible judgment" that
the federally-mandated health warnings are inadequate and thus
constitutes an attack upon those warnings. The Cipollone
plurality specifically rejected the proposition that S 1334(b)
broadly preempts any claim that inevitably questions the
suitability of the manufacturers' advertising and promotion
activities. See 505 U.S. at 525 (discussing breach-of-express-
warranty claim). As the plurality stated: "The appropriate
inquiry is not whether a claim challenges the 'propriety' of
advertising and promotion, but whether the claim would require
the imposition under state law of a requirement or prohibition
based on smoking and health with respect to advertising or
promotion." Cipollone, 505 U.S. at 525. This observation
indicates that the relevant inquiry focuses not upon any
relation between advertising and the
motivation behind a state
27. See
Penn Advertising
v.
Mayor of Baltimore
, 63 F.3d 1318,
1320-21, 1324 (4th Cir. 1995) (holding that FCLAA did not
preempt city ordinance prohibiting placement of certain forms
of cigarette advertisements in publicly visible places because
the ordinance merely limited the location, and did not address
the content, of cigarette advertisements),
vacated and remanded
on other grounds
, 116 S. Ct. 2575 (1996),
modified by
101 F.3d
332 (4th Cir. 1996),
cert.
denied, 117 S. Ct. 1569 (1997);
see
also id. at 1324 (noting Cipollone plurality's declination to
focus on whether a claim contests the "propriety" of
advertising or promotion).
-47-
47
law, but upon the law itself and any connection it might have
with advertising activities. See Associated
Indus. v. Snow,
898 F.2d 274, 279 (1st. Cir. 1990) ("Rather than attempt to
divine the Massachusetts Legislature's intent in enacting its
. . . legislation, we look instead to the effect of the
regulatory scheme." (footnote omitted)) (involving express
preemption analysis). Thus, the mere suggestion that state
lawmakers sought passage of the Disclosure Act in part because
of their discontent with federal regulatory efforts does not
affect our preemption analysis.
We find, therefore, that the reach of the FCLAA's
express preemption clause, S 1334(b), does not preclude
enforcement of the Disclosure Act. We reach this conclusion
even assuming that underlying the state law is discontent with
the federally mandated warnings and the desire to communicate
the additive and nicotine-yield information to the public.
Looking to the actual effect of the state law, the Disclosure
Act does not require alterations in the industry's advertising
and promotional activities, or impose any duty to disclose
information through those channels. The state law's
obligations are neither triggered by advertising decisions, nor
could they be fulfilled by altering cigarette labels or
advertisements. The law does not direct the manufacturers to
employ any mass-marketing or other techniques even remotely
resembling advertising and promotion. In the end, we think
-48-
48
that had Congress intended to prohibit the public disclosure of
smoking and health information that, at some point, the
tobacco-product manufacturers had disgorged under state law,
the limited phrase "with respect to advertising and promotion"
would be an odd vehicle to reach this end. Thus, we find the
explicit preemption language and legislative history
insufficient to "clear[ly] and manifest[ly]" overcome the
presumption against preemption of a state's traditional powers
to legislate for the health and safety of its citizens.
Mortier, 510 U.S. at 606;
see
Dillingham Constr.
, 117 S. Ct. at
842 ("We could not hold pre-empted a state law in an area of
traditional state regulation based on so tenuous a relation
without doing grave violence to our presumption that Congress
intended nothing of the sort.") (construing express preemption
language).
2. Smokeless Tobacco Act
Our inquiry into the scope of the Smokeless Tobacco
Act's preemption clause is considerably simpler than the
preceding analysis. The Smokeless Tobacco Act provides that
No statement relating to the use of
smokeless tobacco products and health,
other than the statements required by
[this act], shall be required by any State
28. The manufacturers do not argue that the 1984 amendments to
the FCLAA wrought by the CSEA in any manner changed or affected
the meaning of the express preemption clause, last amended in
1969. Thus, we do not address the question whether the
ingredient reporting requirements or other amendments affect
the express preemption analysis.
-49-
49
or local statute or regulation to be
included on
any
package or in
any
advertisement (unless the advertisement is
an outdoor billboard advertisement) of a
smokeless tobacco product.]
15 U.S.C. S 4406(b) (emphasis added).
We find dispositive the phrases "
on any package" and
"in any advertisement," which differ significantly from the
broader "with respect to" language in the FCLAA's preemption
provision. Cf. Cipollone, 505 U.S. at 520 (plurality)
(explaining that the clause, "
with respect to
. . . advertising
and promotion," in the 1969 Act was notably broader than its
predecessor, "
in the advertising," in the 1965 Act);
id. at 554
(Scalia, J., concurring in part, dissenting in part)
(suggesting same). Because the Disclosure Act only requires
the manufacturers to file certain reports to the Massachusetts
Department of Public Health, plainly it does not require a
"statement" of any kind "to be included on any package or in
any advertisement." Cf. id. at 518 (majority opinion)
(explaining that similar language in 1965 Act "merely
prohibited . . . particular cautionary statements on cigarette
labels . . . or in cigarette advertisements"). The Smokeless
Tobacco Act's express preemption clause, therefore, does not
invalidate the Disclosure Act.
29. For the reasons stated in our FCLAA express preemption
analysis, we reject the manufacturers' argument that the
publicizing of the ingredient lists effectively transforms the
lists into an "advertisement" within the meaning of S 4406(b).
-50-
50
We observe that our holding is wholly consistent
with the Smokeless Tobacco Act's "savings clause" which
preserves,
inter
alia, state common-law failure to warn claims.
See 15 U.S.C. S 4406(c); S. Rep. No. 99-209, at 14, 1986
U.S.C.C.A.N. at 13 (also stating that Smokeless Tobacco Act is
not intended "to preempt a State's ability to control the
promotion or advertising of tobacco products"). If claims
directly attacking the adequacy of package labeling and
advertising survive the Smokeless Tobacco Act's express
preemption clause, then the reporting obligations under the
Disclosure Act surely survive as well.
We conclude that neither the FCLAA nor the Smokeless
Tobacco Act expressly preempts the Massachusetts Disclosure
Act.
B. Implied Preemption
1. A Proper Inquiry?
Before we turn to the manufacturers' implied pre-
emption arguments, we first address the Commonwealth's
contention that Cipollone precludes any preemption analysis
beyond the scope of the express preemption clause. In
Cipollone, the Court held that "the pre-emptive scope of the
1965 Act and the 1969 Act is governed entirely by the express
[preemption] language in . . . each Act" and explained that
"Congress' enactment of a provision defining the pre-emptive
reach of a statute implies that matters beyond that reach are
-51-
51
not pre-empted." 505 U.S. at 517. The Court further stated:
"In this case, the other provisions of the 1965 and 1969 Acts
offer no cause to look beyond [the express preemption
provision] of each Act. Therefore, we need only identify the
domain expressly pre-empted by each of those sections."
Id. at
517.
Subsequent to Cipollone, the Court clarified the
appropriate approach to implied preemption issues in cases in
which express preemption language exists. In Freightliner
Corp. v.
Myrick, 115 S. Ct. 1483 (1995), the Court acknowledged
Cipollone's holding "that the pre-emptive scope of the two
statutes at issue was governed by the language in each act,"
id. at 1487, but further explained that "[t]he fact that an
express definition of the pre-emptive reach of a statute
'implies' -- i.e., supports a reasonable inference -- that
Congress did not intend to pre-empt other matters does not mean
that the express clause entirely forecloses any possibility of
implied pre-emption,"
id. at 1488. Thus, the Court concluded,
"[a]t best, Cipollone supports an inference that an express
pre-emption clause forecloses implied pre-emption; it does not
establish a rule." Id. at 1488.
In this case, the manufacturers' implied preemption
arguments are largely based on the ingredient reporting
provisions added to the FCLAA by the CSEA in 1984, which were
not at issue in Cipollone. See 505 U.S. at 508. Thus, the
-52-
52
Cipollone Court's refusal to look beyond the express preemption
clauses for the purposes of analysis under the 1965 and 1969
Acts does not per se foreclose an implied preemption analysis
based on the 1984 amendments. Thus, while we might be tempted
to end our preemption analysis here, we feel compelled to
explore the manufacturers' implied preemption theories.
We are bound, however, by the Cipollone majority's
holding that S 1334(b) governs the preemptive scope of the 1965
and 1969 Acts. Having found that the Disclosure Act falls
outside the domain of S 1334(b), we engage in an implied
preemption analysis only to the extent it relies on the
amendments wrought by the CSEA in 1984. In other words, we are
not at liberty to address any implied preemption theories based
solely on the FCLAA in its 1965 or 1969 versions, independent
of the CSEA. Moreover, given that a majority of the Court has
indicated that the FCLAA's express preemption clause implies
that matters outside its scope are not preempted, see
Cipollone, 505 U.S. at 517, it becomes apparent that any
attempt to surmount the presumption against preemption of the
state's historic police powers under an implied preemption
theory faces a considerable obstacle. See Snow, 898 F.2d at
282 ("The burden of overcoming th[e] presumption in favor of
state law is heavy in those cases that rely on implied
preemption, which rests in turn on inference" (internal
quotation marks and citations omitted)).
-53-
53
2. Manufacturers' Arguments
As detailed above, both the FCLAA and Smokeless
Tobacco Act direct tobacco-product manufacturers to provide to
the Secretary of Health and Human Services an annual
ingredients list which does not identify the manufacturer or
the brand represented by the list, information which may be
submitted aggregately by more than one manufacturer through an
agent. See 15 U.S.C. SS 1335a(a), 4403(a). Under both
statutes, the information provided is "treated as a trade
secret or confidential information," and its unauthorized
disclosure is forbidden. See SS 1335a(b)(2)(A),
4403(b)(2)(A). The laws further require the Secretary to
establish written procedures by which the information will be
safeguarded and specifically mandates that those procedures
include certain custodial, storing, and access arrangements.
See SS 1335a(b)(2)(C), 4403(b)(2)(C). The manufacturers
contend that the Disclosure Act is impliedly preempted in light
of these provisions combined with the structure and purpose of
the statutes.
The manufacturers do not rely, nor could they rely,
on the theory that compliance with both the Disclosure Act and
federal law presents a "physical impossibility." See Florida
30. The FCLAA additionally makes such disclosure a felony by
explicit reference to 18 U.S.C. S 1905, which criminalizes
unauthorized disclosure of trade secret or confidential
information by federal officers or employees. See 15 U.S.C.
S 1335a(b)(2)(A).
-54-
54
Lime & Avocado Growers, Inc.
v.
Paul, 373 U.S. 132, 143 (1963).
Rather, they contend that the Disclosure Act impermissibly
conflicts with the purpose and objectives that underlie the
federal statutes. They further contend, albeit less
elaborately, that the state law invades a field of commerce for
which Congress intended exclusive federal regulation.
Specifically, the manufacturers argue that through
the FCLAA and the Smokeless Tobacco Act, Congress intended to
establish a careful balance between two national interests: (1)
educating the public about the use of tobacco products and
health and (2) limiting commercial burdens on the tobacco
industry. The ingredient reporting and safeguarding
provisions, they contend, further these purposes in a unique
and exclusive manner. They reason that, while the required
ingredient lists allow Congress, with the assistance of the
Department of Health and Human Services ("HHS") and its
research efforts, to determine the continued adequacy of the
mandated warning labels, nonetheless the information provided
is kept in strict confidence through elaborate statutory
protections. These comprehensive provisions, the manufacturers
claim, limit the impact upon commerce associated with reporting
and evaluating ingredient information.
The manufacturers assert that, by prescribing both an
anonymous form of ingredient disclosure and strict safekeeping
of the information provided, Congress intended to avoid
-55-
55
"unnecessary invasion of company-specific and brand-specific
trade secret information." They contend that Congress could
have required full ingredient disclosure on all product labels,
or, at the other extreme, no disclosure whatever. Instead, it
chose a specific intermediate position which represents a
"precisely calibrated balance" that, in Congress' judgment,
best served the public.
The manufacturers further contend that the anonymity
provided them when submitting the ingredient lists indicates
that the additional provisions protecting the confidentiality
of the collected information are not merely matters of
"custody" or "internal housekeeping." While conceding that the
federal statutes do not grant the information "trade secret
status" per se, the manufacturers nonetheless argue that, for
preemption purposes, the exacting confidentiality provisions
reflect Congress' concern for the potential loss of commercial
advantage, which itself is part and parcel of Congress' broader
intent to protect commerce and the national economy.
According to the manufacturers, enforcement of the
Disclosure Act's obligations to disclose brand-specific and
company-specific ingredient information, without guarantees of
confidentiality, would frustrate the purposes of the FCLAA and
Smokeless Tobacco Act. They contend that the federal statutes'
intricate information-safekeeping provisions "would be utterly
pointless" if a state were permitted to make publicly available
-56-
56
information that the federal government may not even collect,
much less reveal. Moreover, they claim, it would be "absurd"
for the HHS Secretary to continue to collect the federally
prescribed ingredient information when even more precise, brand
specific information collected pursuant to the Disclosure Act
would be readily available. Because Congress carefully limited
the collection and disclosure of cigarette ingredients in
furtherance of the balance between health education and trade
protection, they argue, collection and disclosure of the type
contemplated by the Disclosure Act would "stand[] as an
obstacle to the accomplishment and execution of the full
purposes and objectives of Congress."
Hines v.
Davidowitz, 312
U.S. 52, 67 (1941). They further assert that the comprehensive
manner in which Congress dealt with the health concern posed by
tobacco-product additives shows its intent to obtain uniformity
in ingredient disclosure requirements, supplanting any
supplemental state efforts, such as the Disclosure Act, in the
area.
The manufacturers also offer a closely related
argument: the Disclosure Act intrudes into a "field," albeit a
narrow one, that Congress intended federal law to occupy
exclusively. To this end, they assert that the HHS Secretary's
role to review cigarette ingredients from a health standpoint,
the stringent confidentiality procedures, and the balance of
national interests "evince Congress' intent to occupy the field
-57-
57
of cigarette ingredient reporting, monitoring and review." In
sum, they argue that the very comprehensiveness, complexity,
and specificity of the federal reporting provisions evince a
federal dominance and pervasiveness in ingredient reporting and
disclosure that allows no room for supplemental state laws such
as the Disclosure Act. Ultimately, we find the manufacturers'
arguments unpersuasive.
3. Actual Conflict
Topics that warrant congressional legislation
necessarily entail issues of national concern. See
English v.
General Elec. Co.
, 496 U.S. 72, 87 (1990);
Hillsborough County
v. Automated
Medical
Laboratories,
Inc., 471 U.S. 707, 719
(1985). "That cannot mean, however, that every federal statute
ousts all related state law."
Hillsborough County
, 471 U.S. at
719. Moreover, the mere fact that a subject of federal
legislation requires an "intricate and complex response[] from
the Congress" does not necessarily indicate that Congress
intended its response to be the exclusive means of addressing
the issue. Id. at 719 (quoting
Dublino, 413 U.S. at 717);
see
also
Ingersoll-Rand Co.
v.
McClendon, 498 U.S. 133, 143 (1990).
Rather, "we must look for special features warranting
preemption." Hillsborough County, 471 U.S. at 719 (involving
field-occupation preemption issues), quoted in English, 496
U.S. at 87 (involving conflict preemption issues); see
Ingersoll-Rand
Co., 498 U.S. at 144 (finding that exclusive
-58-
58
federal remedy "is precisely the kind of special feature that
warrants pre-emption" (internal quotation marks, alterations,
and citations omitted)). The manufacturers' implied preemption
arguments essentially identify into two purported "special
features" in the federal statutes warranting preemption: (1) an
asserted "balance of national interests" effected by the FCLAA
and Smokeless Tobacco Act, and (2) the detailed and stringent
statutory provisions for confidential reporting and protection
of ingredient information.
a. Balance of National Interests?
As indicated above, the FCLAA contains explicit
language setting forth its policy and purpose:
It is the policy of the Congress, and the
purpose of this chapter, to establish a
comprehensive Federal program to deal with
cigarette labeling and advertising with
respect to any relationship between
smoking and health, whereby --
(1) the public may be adequately
informed about any adverse health effects
of cigarette smoking by inclusion of
warning notices on each package of
cigarettes; and
(2) commerce and the national
economy may be (A) protected to the
maximum extent consistent with this
declared policy and (B) not impeded by
diverse, nonuniform, and confusing
cigarette labeling and advertising
regulations with respect to any
relationship between smoking and health.
15 U.S.C. S 1331.
31. Although the Smokeless Tobacco Act does not contain a
S 1331 counterpart, the smokeless tobacco manufacturers seek to
avail themselves of arguments related to this section because
-59-
59
The manufacturers' implied preemption arguments rely
heavily on select phrases from S 1331 and on certain language
in our pre-Cipollone decision, Palmer v. Liggett Group, Inc.,
in which we held that the FCLAA impliedly preempted state
common-law causes of action based on failure-to-warn theories.
See 825 F.2d at 626. In Palmer, we expansively interpreted
S 1331 and declared that, in passing the FCLAA, Congress sought
"to strike a fair, effective balance between . . . two
competing interests": "health protection (through education)
and trade protection." Id. at 626. We observed, "Congress ran
a hard-fought, bitterly partisan battle in striking the
compromise that became the [FCLAA]. It is inconceivable that
Congress intended to have that carefully wrought balance of
national interests superseded by the views of a single state .
. . ." Id. We further quoted favorably the Third Circuit's
assertion in
Cipollone, prior to Supreme Court review, that the
FCLAA "'presents a carefully drawn balance between the purposes
of warning the public of the hazards of cigarette smoking and
protecting the interests of [the] national economy.'" Id.(quoting Cipollone v. Liggett
Group,
Inc., 789 F.2d 181, 187
(3d Cir. 1986)) (alteration ours). It now appears, however,
of the similar substantive provisions in the two statutes.
Because a statute's substantive provisions carry out its
purpose, they argue, Congress must have intended the same
polices and purposes to animate the two statutes. For the sake
of argument, we accept their contention that the same pertinent
purposes animate the two statutes.
-60-
60
that in Palmer we overstated Congress' purposes evinced in
S 1331.
On review of the Third Circuit's
Cipollone opinions,
the Supreme Court acknowledged the S 1331-based "protection of
national economy" theory, quoting the same phrase we quoted in
Palmer when reviewing the prior proceedings of the case. See
Cipollone, 505 U.S. at 511. None of the court's opinions,
however, either affirmed or elaborated upon this theory.
Rather, a majority of the Court agreed that the two purposes
expressed in S 1331 were "(1) adequately informing the public
[of any adverse health effects of smoking
], and (2) protecting
the national economy from
the
burden
imposed
by
diverse,
nonuniform,
and
confusing
cigarette
labeling
and
advertising
regulations." 505 U.S. at 514 (emphasis added). Therefore,
when faced squarely with the opportunity, the majority
recognized neither a statutory purpose to protect the tobacco
industry from all state-imposed commercial burdens, nor some
32. The Third Circuit produced a number of published opinions
for the Cipollone case. Although the Supreme Court discussed
the Court of Appeals' opinion published at 789 F.2d 181 (1986),
it accepted review of the case published at 893 F.2d 541(1990).
33. The Court also cited Palmer as an example of a case
following the Third Circuit's analysis in Cipollone, 789 F.2d
181. See Cipollone, 505 U.S. at 508 n.2.
34. We modify the Court's language here in light of the 1984
amendment to S 1331(1) reflecting the new rotating warning
system.
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overarching "balance" from which an expansive domain of
preemption might flow.
The Court's evident rejection of the lower court's
"balance of national interests theory" is reflected in the
Court's refusal to engage in an implied preemption analysis
even as to those claims not expressly preempted. Had the Court
been inclined to recognize and give preemptive effect to the
asserted balance, it might have found preempted the surviving
failure-to-warn and fraudulent misrepresentation claims which,
if successful, would certainly inflict a burden upon the
tobacco trade. Instead, the Court recognized the limited
purpose of avoiding the burden on the national economy
specifically posed by nonuniform labeling and advertising
regulations. Moreover, the Court indicated that Congress
35. As indicated earlier, the
Cipollone Court did not address
the CSEA and its amendments to the FCLAA. We see no reason,
however, why the CSEA would change the Court's interpretation
of the text of S 1331(2), which has never been amended,
regarding the nature of the burden to the national economy
sought to be avoided under the FCLAA. While the CSEA
necessarily furthers the congressional purposes expressed in
S 1331, nothing in the 1984 amendments suggests that it alters
the scope of the protected interest expressed in S 1331(2), as
interpreted by the Court in Cipollone.
36. At this point, we will not speculate as to the nature and
character of the burden created should other states impose
differing reporting requirements. See English 496 U.S. at 90(finding certain imagined prospects "simply too speculative a
basis on which to rest a finding of pre-emption"). Although
the cigarette manufacturers cite dozens of pending tobacco-
disclosure bills in state legislatures, even if we assume the
bills will become law, see Minn. H.F. 117 S 5, the resulting
burden is qualitatively different, and seemingly significantly
lesser, than that created by varying warning requirements in
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addressed this concern largely, if not solely, through the
express preemption clause, which we have addressed above. See
Cipollone, 505 U.S. at 514; see also S. Rep. No. 91-566, 1970
U.S.C.C.A.N. at 2663 (explaining that preemption clause was
necessary "to avoid the chaos created by a multiplicity of
conflicting [cigarette advertising] regulations").
We cannot ignore the
Cipollone majority's reading of
the congressional purpose evinced in S 1331, which is
considerably more limited than our enunciation in Palmer and
the manufacturers' current contentions. Given the Court's
narrower interpretation, we conclude that the Disclosure Act
does not impede either purpose expressed in S 1331 because it
neither obstructs the congressionally mandated warning labels,
nor (for the reasons expressed previously) impedes the national
economy by imposing a diverse or nonuniform advertising
regulation. Although S 1331 may express some general concern
for protecting commerce and the national economy, we will not
find preemption where a state law merely creates some general
tension with a federal law's abstract objectives. See
Commonwealth Edison Co.
v.
Montana, 453 U.S. 609, 633-34 (1981)
(finding no "congressional intent to pre-empt all state
legislation that may have an adverse impact on the use of coal"
despite general national policy to encourage use of coal);
the production of labels and advertising for each product and
brand.
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Laurence H. Tribe,
American Constitutional Law
S 6-26, p. 487-
88 (2d ed.) (1988). Indeed, had Congress intended to protect
the tobacco industry from negative state action generally, then
surviving police regulations, such as prohibitions on smoking
in public buildings or on tobacco use by minors, or state
taxation, would also be preempted. See S. Rep. 91-566, 1970
U.S.C.C.A.N. at 2663.
Having found that the purported general national
policy does not yield a special statutory feature that warrants
preemption, we turn to specific statutory provisions with which
the Disclosure Act allegedly conflicts. Cf.
Montana, 453 U.S.
at 634.
b. Conflict with Federal Reporting Provisions?
The manufacturers contend that the Disclosure Act
conflicts with, and effectively "repeals," Congress' carefully
wrought ingredient reporting scheme. They argue that the
federal anonymity and confidentiality protections show
congressional intent to oust state laws such as the Disclosure
Act, which demand product-specific and brand-specific
information without protection of confidentiality. Normally,
however, state laws are not preempted "'solely because they
impose liability over and above that authorized by federal
law.'" English, 496 U.S. at 89 (quoting
California v.
ARC Am.
Corp., 490 U.S. 93, 105 (1989)). Rather, we must find "some
specific suggestion in the text or legislative history" of the
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allegedly preempting federal law to conclude that Congress
intended to preempt additional state liabilities. Id.On their face, the FCLAA and Smokeless Tobacco Act do
not protect generally the confidentiality of tobacco-industry
ingredient information. Rather, they secure only "information
provided to the Secretary under [the reporting provisions]."
15 U.S.C. SS 1335a(b)(2)(A), 4403(b)(2)(A). By like token, the
provisions mandating the Secretary to establish confidentiality
procedures, while notable for their specificity, apply only to
the information provided to her under the statutes. See
SS 1335a(b)(2)(C), 4403(b)(2)(C). Furthermore, as the
manufacturers concede, the statutes do not confer "trade
secret" or "confidential" status upon the information, but only
"treat[]" it as such. Id.While the statutes strictly forbid unauthorized
disclosure, the proscriptions govern the conduct of only
certain federal officers or employees. For example, the laws
bestow upon the collected information the benefit of the trade
secrets exemption in the Freedom of Information Act ("FOIA").
See 5 U.S.C. S 552(b)(4). The FOIA, however, by its own terms,
applies only to federal executive branch agencies. See 5
U.S.C. SS 551(1), 552(a). Thus, HHS employees and other
federal employees need not make publicly available the
37. The proscriptions against disclosure are subject to any
request by a congressional committee or subcommittee. See 15
U.S.C. SS 1335a(b)(2)(B), 4403(b)(2)(B).
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collected information under the FOIA, but the exemption would
not inhibit the conduct of state agencies possessing such
information, which are not governed by the FOIA in the first
instance. The FCLAA further indicates Congress' strong intent
to ensure the confidentiality of the collected information by
incorporation of 18 U.S.C. S 1905, which criminalizes
unauthorized disclosure of confidential or trade secret
information. Again, section 1905 itself applies only to "an
officer or employee of the United States or of any department
or agency thereof" and certain other persons not implicated
here. Id.Moreover, the legislative histories referencing the
reporting provisions make little or no mention of the ancillary
confidentiality protections and certainly do not reveal any
intent generally to safeguard industry ingredient-information
outside of the lists provided to the Secretary. With regard to
the reporting provision in the CSEA, House Report 805
accompanying the CSEA explains only that it "would permit the
federal government to initiate the toxicologic research
necessary to measure any health risk posed by additives and
other ingredients to cigarettes during the manufacturing
process." H.R. Rep. No. 98-805, at 21, 1984 U.S.C.C.A.N. at
3734. Senate Report 209 accompanying the Smokeless Tobacco Act
states only that the provision "is included to further the
accumulation of knowledge about the health risks of smokeless
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tobacco use, particularly the possible hazards of substances
added to tobacco to enhance flavor and for other purposes." S.
Rep. No. 99-209 at 14, 1986 U.S.C.C.A.N. p. 13. The reports
neither discuss nor elaborate upon the purpose of the
confidentiality protections.
The textual and historical indications lead to the
conclusion that Congress primarily intended the reporting
provisions in the FCLAA and Smokeless Tobacco Act to further
toxicological research. By "treat[ing]" the collected
information as a "trade secret" or "confidential," the statutes
further the primary research objective in a meaningful, but
limited, way: facilitating ready access to the ingredient
information required for research purposes by assuring the
tobacco industry that any trade secret interests in the
information provided to the Secretary will be safeguarded.
In
our view, the fact that Congress took great care to safeguard
reported ingredient information at most indicates that Congress
presumed the information's confidential nature for the purposes
of its regime. Perhaps Congress even assumed that there was no
question as to the trade secret status of the ingredient
information. Underlying assumptions, however, do not merit
preemptive force; legislative enactments do. Our review of the
38. Furthermore, the mere fact that Congress found an
aggregate form of ingredients disclosure sufficient for its
purposes is no indication that increased state requirements
would conflict with its own scheme.
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statutory text and legislative history does not yield the
requisite clear and manifest congressional intent to speak
nationally and finally on the general confidential status of
tobacco-product ingredients.
Thus, while Congress proceeded expeditiously with its
health research objectives by treating the ingredient
information as a trade secret, it did not thereby preempt
States from otherwise lawfully obtaining (or attempting to
obtain) such information. Moreover, that Congress did not
intend through the FCLAA and Smokeless Tobacco Act nationally
to protect all tobacco-product ingredients information does not
necessarily force the manufacturers to reveal their purported
trade secrets. The manufacturers may well have valid trade
secret interests that are threatened by the Disclosure Act.
The actual merit of any trade secret claim, however, is not
before us now, and we are not at liberty to speculate as to the
39. We are thus unpersuaded by the manufacturers' citation of
isolated bits of hearing testimony referring to the CSEA's
protection of "trade secret" ingredient information.
See
e.g.,
130 Cong. Rec. 24,626 (1984). Such statements, while
indicative of Congress' intent to protect the presumed
confidential status of the information provided to the
Secretary, do not reveal a purpose to grant tobacco-product
manufacturers nationwide immunity from state attempts to obtain
and publicize ingredient information.
Cf.
Mortier, 501 U.S. at
614-15 (finding no actual conflict where frustration of
purported federal purpose relied on "little more than snippets
of legislative history and policy speculations").
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resolution of the issue. Cf.
CSX Transp., Inc.
v.
Easterwood,
507 U.S. 658, 675 n.12 (1993) (after finding no preemption,
refusing to speculate as to outcome of state law action).
The manufacturers insist that enforcement of the
Disclosure Act will circumvent or otherwise nullify federal law
because it potentially allows widespread access to information
that, when in the federal government's hands, would not be
publicly available. Having found, however, that national
trade-secret protection of ingredient information is neither a
feature nor an objective of the statutes, the state law does
not "nullify" the federal confidentiality protections because
the information submitted under the federal regime itself is
not affected by it. In other words, enforcement of the
Disclosure Act neither directly nor indirectly allows access to
the information in the HHS's possession. Moreover, because the
Disclosure Act leaves completely unaffected the requirements,
procedures, and programs of the FCLAA and Smokeless Tobacco
Act, it does not interfere with the methods by which Congress
sought to reach its research and public-education goals. Cf.
Ouellette, 479 U.S. at 494 (finding preempted state common-law
water pollution action which would impermissibly circumvent the
Clear Water Act's permit system, the method by which federal
statute was designed to eliminate water pollution); Wood v.
40. From our review of the manufacturers' complaints, it
appears that the merits of any trade secret claims underlie
their takings and full faith and credit claims.
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General
Motors
Corp., 865 F.2d 395, 412 (1st Cir. 1988)
(finding preempted negligence lawsuit for failure to install
automobile air bag where claim would interfere with Congress'
scheme to subordinate the states' role in establishing safety
standards where pertinent federal standard exists).
The manufacturers seek solace in Hyde Park Partners
v. Connolly, 839 F.2d 837 (1st Cir. 1988), involving the
preemptive effect of the Williams Act, the sole purpose of
which is "the protection of investors confronted with a tender
offer." Id. at 849. The Williams Act requires takeover
bidders to disclose their acquisition of a 5% stake in a
corporation within ten days
after the acquisition,
id. at 851,
whereas the state law at issue penalized takeover bidders who
failed to disclose their intent before acquiring a 5% stake,
id. at 840. We explained that the Williams Act struck a
temporal balance "to provide shareholders with the best of both
worlds -- disclosure substantial enough and early enough to
ensure fully informed choices, but not so early that those
choices will be unduly restricted by the chilling effect on
takeover bids." Id. at 852. We held that the state law, which
would likely "discourage takeover attempts to a much greater
extent than that envisioned by Congress" to the detriment of
investors, would intrude upon the federal law's careful "point
of equipoise" and defeat the law's "essential purpose." Id.-70-
70
The manufacturers contend that, here, Congress
carefully chose a "point of equipoise" between ingredient
reporting and confidentiality, which the Disclosure Act
impermissibly alters. We disagree. First, unlike the temporal
public-disclosure balance in
Hyde Park
, the purported "point of
equipoise" itself is not directly disturbed because the
Disclosure Act has no effect on the federal laws' collection
and safeguarding efforts with respect to the information
provided to the Secretary. Second, even assuming the state law
somehow altered the purported balance, "[u]nder
Hyde Park
, the
question is not whether a congressionally calibrated system is
altered by state law, but if
altered,
whether
the
change
obstructs the purpose of Congress
." Associated Indus. of Mass.
v. Snow, 898 F.2d 274, 282 (1st Cir. 1990) (emphasis added).
Here, the controlling purpose of the reporting provisions,
which the confidentiality provisions further, is to permit
toxicological research to determine the health risks of
additives. See H.R. Rep. No. 98-805, at 21, 1984 U.S.C.C.A.N.
at 3734; S. Rep. No. 99-209 at 14, 1986 U.S.C.C.A.N. p. 13.
Any alterations to the "balance" between reporting and
confidentiality posed by the Disclosure Act would not frustrate
this purpose. Rather, if the manufacturers' trade secret and
other claims ultimately fail and the ingredient information
that the Disclosure Act mandates becomes public knowledge, the
state law arguably would further Congress' purpose.
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Finally, we find no evidence that Congress intended
to effect national "uniformity" in ingredient reporting and
disclosure regulations. In Wood, both the statutory language
and legislative history indicated Congress' intent to effect
uniform federal motor-vehicle safety standards throughout the
country. See 865 F.2d at 412; see also Rini v. United
Van
Lines, Inc.
, 104 F.3d 502, 504 (1st Cir. 1997) (explaining that
"the principal purpose of the [Carmack] Amendment was to
achieve national uniformity in the liability assigned to
carriers"), petition for cert. filed, 65 U.S.L.W. 3422 (U.S.
Mar. 28, 1997) (No. 96-1800). In this case, while the
statutory language and legislative history show that Congress
plainly intended to effect uniform labeling and warning
requirements,
see 15 U.S.C. SS 1331, 1333, 1334, 4402, 4406(b),
no such intent regarding ingredient disclosure is apparent.
Had Congress desired similar uniformity in reporting and
disclosure efforts, it plainly knew how to accomplish that end.
The fact remains, however, that it did not.
In sum, the reporting provisions protect only the
particular information provided to the HHS while in the hands
of HHS employees, and only from disclosure by HHS or certain
federal government employees. Congress considered the
41. We note the observation that a congressional determination
to effect a nationally uniform standard presents "a situation
similar in practical effect to that of federal occupation of a
field." Tribe, supra S 6-26, at 486.
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submission of aggregate and anonymous ingredient information
sufficient for its research purposes, and, to be sure, intended
to safeguard the confidentiality of the information once
provided. Although Congress apparently accepted any claim to
the trade secret status of tobacco industry ingredient-
information, it did not intend to immunize manufacturers
nationally from any additional reporting or disclosure
requirements, or to prevent the public from becoming aware of
such information other than that particularly provided to the
HHS under the federal schemes. While enforcement of the
Disclosure Act may ultimately make the confidentiality
protections somewhat redundant, it does not frustrate the
controlling congressional purpose to initiate toxicological
research on the effects of tobacco-product additives. In light
of the strong presumption against preemption of state health-
and-safety regulations that governs our analysis, we find that
the federal statutes' provisions to protect the confidentiality
of tobacco-product ingredient information do not constitute a
"special feature" overcoming that presumption. See English,
496 U.S. at 72; Snow, 898 F.2d at 282.
4. Field Occupation
Having found no actual conflict between the federal
laws and the Disclosure Act, we turn to the argument that the
Disclosure Act nonetheless treads upon an exclusive federal
regulatory domain. "'Where . . . the field which Congress is
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said to have pre-empted' includes areas that have 'been
traditionally occupied by the states,' congressional intent to
supersede state laws must be '"clear and manifest."'"
English,
496 U.S. at 79 (quoting Jones v. Rath
Packing
Co., 430 U.S.
519, 525 (1977)) (in turn quoting Rice v. Santa
Fe
Elevator
Corp., 331 U.S. at 230).
It is evident that the FCLAA and Smokeless Tobacco
Act preempt state regulation in the area of tobacco-product
labeling and warnings. The statutes do not purport, however,
to regulate exclusively all other aspects of tobacco-product
use or sales. While the reporting provisions address
ingredient collection and safekeeping "in considerable detail,"
id., those provisions simply further the statutory goal of
toxicological research on the part of HHS, with a view toward
potential additional federal regulatory action. Although the
federal scheme is in some respects comprehensive, it is not
"'so pervasive as to make reasonable the inference that
Congress left no room for the States to supplement it.'"
Mortier, 501 U.S. at 613 (quoting
Rice, 331 U.S. at 230). See
id. (explaining that while Federal Insecticide, Fungicide, and
Rodenticide Act had evolved into a "comprehensive regulatory
statute," it contains "ample room" for supplemental state
42. Although the statutes also contain provisions to further
health education through research, we find no indication that
Congress intended to oust supplemental state efforts in this
regard as well.
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efforts); Tart v. Massachusetts, 949 F.2d 490, 501 (1st Cir.
1991) (preserving state law prohibition on permitless landing
of raw fish in state because federal fishing licensing statute,
which authorizes the navigation and taking of fish from state
territorial waters, does not "occupy the field" of coastal
fishing).
Nor can the manufacturers maintain that the
Disclosure Act treads upon the preempted domain of labeling and
advertising. On this point, the Court's analysis in
English is
instructive. In English, respondent argued that a federal
provision forbidding retaliation for making a nuclear-safety
complaint was an integral part of the preempted field of
nuclear safety, and thus, state law remedies for conduct
covered under the federal retaliation provision were preempted.
See 496 U.S. at 82. The Court disagreed, acknowledging that
while the federal provision "obviously bears some relation to
the field of nuclear safety, its 'paramount' purpose was the
protection of employees." Id. at 83. Moreover, while the
state law "in some remote way may [have] affect[ed] . . .
nuclear safety decisions made by those who build and run
nuclear facilities," it did not fall within the preempted realm
because it did not have a "direct and substantial effect" on
the decisionmakers. Id. at 85.
Here, while the federal reporting provisions bear
some relation to the field of labeling and advertising, their
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"paramount purpose" is to initiate toxicological research into
the health hazards posed by additives. It would be
speculative, at best, to envision how the manufacturers'
reporting obligations to the Massachusetts Department of Public
Health under the Disclosure Act might have a remote effect,
much less a direct and substantial one, on federal efforts in
the area of labeling and advertising. Cf. Schneidewind, 485
U.S. at 308 ("Of course, every state statute that has some
indirect effect on [a preempted realm] is not pre-empted.").
Thus, we find no indication in the federal statutes
that Congress intended to supplant any and all state
involvement in the area of tobacco-product ingredient
collecting, monitoring, and review. In the absence of such
indication, the mere detail by which the statutes collect and
safeguard ingredient information is insufficient to establish
a "clear and manifest" intent on the part of Congress to
supersede state laws, English, 496 U.S. at 79, or otherwise
overcome the presumption against preemption, see Hillsborough
County, 471 U.S. at 715. "Given this statutory scheme, it is
for Congress to rethink the division of regulatory authority in
light of its possible exercise by the States to undercut a
federal objective." Pacific Gas & Electric
v.
Energy Resources
Comm'n, 461 U.S. 190, 223 (1983).
43. The cigarette manufacturers also assert that the
Disclosure Act is not a matter of "local concern" because it
addresses an issue of national significance as to which
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V.
Conclusion
Although Congress sought through the FCLAA and the
Smokeless Tobacco Act to achieve several goals on the subject
of tobacco-product use and health, preventing states from
obtaining information regarding product additives and
disclosing such information to the public was not one of them.
Congress is free, of course, to enact legislation to bar the
operation of laws such as the Disclosure Act. We are
satisfied, however, that it has not done so yet, and "[t]he
courts should not assume the role which our system assigns to
Congress." Pacific Gas & Electric, 461 U.S. at 223.
For the foregoing reasons, we affirm the district
court's ruling that the Massachusetts Disclosure Act survives
the manufacturers preemption challenge. Costs to Appellees.
Massachusetts has no special or unique interest and that, by
its very nature, it will necessarily have nationwide impact
thereby contradicting a policy decision made for the nation by
Congress. To the extent this argument touches upon the
"balance of national interests" theory, we have disposed of
that above for the purposes of preemption analysis. To the
extent the argument touches upon any Commerce Clause claims,
see generally Hyde Park, 825 F.2d at 843-48, the issue is not
properly before us here.
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Appendix A
In its entirety, the Massachusetts Disclosure Act provides:
S 307B. Manufacture of tobacco products; annual reports
including added constituents and nicotine yield ratings;
disclosure; exclusions
For the purpose of protecting the public health, any
manufacturer of cigarettes, snuff or chewing tobacco sold in
the commonwealth shall provide the department of public health
with an annual report, in a form and at a time specified by
that department, which lists for each brand of such product
sold the following information:
(a) The identity of any added constituent other than tobacco,
water or reconstituted tobacco sheet made wholly from tobacco,
to be listed in descending order according to weight, measure,
or numerical count; and
(b) The nicotine yield ratings, which shall accurately predict
nicotine intake for average consumers, based on standards to be
established by the department of public health.
The nicotine yield ratings so provided, and any other
such information in the annual reports with respect to which
the department determines that there is a reasonable scientific
basis for concluding that the availability of such information
could reduce risks to public health, shall be public records;
provided, however, that before any public disclosure of such
information the department shall request the advice of the
attorney general whether such disclosure would constitute an
unconstitutional taking of property, and shall not disclose
such information unless and until the attorney general advises
that such disclosure would not constitute an unconstitutional
taking.
This section shall not require a manufacturer, in its
report to the department or otherwise, to identify or disclose
the specific amount of any ingredient that has been approved by
the Food and Drug Administration, Public Health Service, United
States Department of Health and Human Services ("FDA"), or its
successor agency, as safe when burned and inhaled or that has
been designated by the FDA, or its successor agency, as
generally recognized as safe when burned and inhaled, according
to the Generally Recognized As Safe list of the FDA.
Mass. Gen. Laws ch. 94, S 307B.
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