Philip Morris Inc. v. Harshbarger

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.

-4-
4

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.

-5-
5

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.

-6-
6

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.

-7-
7

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

-8-
8

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

-9-
9

(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.

-10-
10

(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. at
515 & n.11.

-11-
11

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.

-12-
12

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.

-13-
13

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).

-14-
14

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-
15

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

-16-
16

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).

-17-
17

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.

-18-
18

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.

-19-
19

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.

-61-
61

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

-62-
62

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.

-63-
63

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

-64-
64

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).

-65-
65

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

-66-
66

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.

-67-
67

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").

-68-
68

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.

-69-
69

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.

-71-
71

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.

-72-
72

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

-73-
73

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.

-74-
74

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

-75-
75

"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

-76-
76

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.

-77-
77

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.

-78-
78