UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
PHILIP MORRIS
INCORPORATED; R.J. REYNOLDS TOBACCO COMPANY; BROWN & WILLIAMSON TOBACCO
CORPORATION; and LORILLARD TOBACCO COMPANY,
Plaintiffs,
v.
L. SCOTT
HARSHBARGER, ATTORNEY GENERAL OF THE COMMONWEALTH OF MASSACHUSETTS; and
DAVID H. MULLIGAN, MASSACHUSETTS COMMISSIONER OF PUBLIC HEALTH,
Defendants.
Civil Action No.: 96-11599-GAO
February 7, 1997
MEMORANDUM
AND ORDER
George E. O'Toole, Jr.
District Judge
Massachusetts has recently
adopted a statute that will require manufacturers of cigarettes to furnish
to the Commonwealth's Department of Public Health certain specific information
about the ingredients and nicotine yield ratings of their cigarettes. Mass.
Gen. L. ch. 94, § 307A ("Section 307A"). The manufacturers
brought this action to declare the new statute unconstitutional and to
enjoin its enforcement. The plaintiffs advance several reasons why the
statute should be declared invalid, one of which is presented now on the
parties' cross-motions for partial summary judgment.
In the first count of their
complaint, the plaintiffs contend that any state regulation requiring the
reporting of tobacco ingredients is pre-empted by the Federal Cigarette
Labeling and Advertising Act, 15 U.S.C. §§ 1331 et seq.
"FCLAA"). For the reasons that follow, this Court concludes that
Section 307A is not pre-empted by the federal statute.
The Pre-emption
Issue
Section 307A [ Section 307A
reads as follows: 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 basin 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 hen 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 or inhaled, according to the Generally Recognized As
Safe list of the FDA.] requires the plaintiff companies to disclose information
about the ingredients in their products to the Massachusetts Department
of Public Health. If the Department forms a reasonable scientific judgment
that the general availability of the ingredient information could reduce
public health risks, and if the state attorney general opines that public
disclosure of the information would not amount to an unconstitutional taking
of property, then the state authorities will make the information available
as a public record. The statute also requires the companies to determine
and report nicotine yield ratings for their products in accordance with
a methodology to be established by the Department. The reported nicotine
yield ratings will also be available as a public record. According to the
plaintiffs, the identity and relative amounts of the ingredients in their
cigarette "recipes" constitute highly confidential product information
the public disclosure of which would cause them serious economic harm.
The FCLAA mandates that cigarette
packaging and advertising contain warnings about the health risks of smoking.
15 U.S.C. § 1333. In order to assure national uniformity in the regulation
of cigarette labeling and advertising, the federal statute contains a pre-emption
provision:
(a) No statement relating to smoking and health, other
than the statement required by section 1333 of this title, shall be required
on any cigarette package.
(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 package. of which are labeled in conformity
with the provisions of this chapter.
15 U.S.C. § 1334.
The plaintiffs contend that
Section 307A is a "requirement
based on smoking and health
under
State law with respect to the advertising or promotion of
cigarettes''
and is therefore forbidden by § 1334(b). Moreover, they say, even
if the FCLAA does not pre-empt Section 307A expressly, it does so implicitly.
In addition to mandating specific health warnings, the federal statute
requires cigarette manufacturers to submit ingredient information to the
United States Department of Health and Human Services under rigorous assurances
of confidentiality. In contrast, the state statute permits confidential
ingredient information to be made public. The plaintiffs assert that there
is a conflict between the state and federal ingredient-reporting schemes
which amounts to an impermissible interference by Massachusetts with the
federal scheme.
Principles
of Pre-emption
The pre-emption doctrine
is rooted in the Supremacy Clause of the United States Constitution: "This
Constitution, and the Laws of the United States which shall be made in
Pursuance thereof . . . shall be the supreme Law of the Land; and the Judges
in every State shall be bound thereby, any Thing in the Constitution or
Laws of any State to the Contrary notwithstanding." U.S. Const. art.
VI, cl. 2. "It is basic to this constitutional command that all conflicting
state provisions be without effect." Maryland v. Louisiana,
451 U.S. 725, 746 (1981).
This does not mean, of course,
that the States may not enact legislation dealing with the same subjects
as federal law, or that a particular matter may not be the subject of simultaneous
federal and state regulation. See Retail Clerks Int'1 Ass'n v. Schermerhorn,
375 U.S. 96, 103-104 (1963). The existence of a federal interest in regulating
the matter does not exclude the possibility of a legitimate concurrent
state interest. "Undoubtedly, every subject that merits congressional
legislation is, by definition, a subject of national concern. That cannot
mean, however, that every federal statute ousts all related state law."
Hillsborough County v. Automated Medical Lab., Inc., 471 U.S. 707,
719 (1985).
In particular, the States
historically have ''exercised their police powers to protect the health
and safety of their citizens." Medtronic. Inc. v. Lohr, 116
S. Ct. 2240, 2245 (1996). "Consideration of issues arising under the
Supremacy Clause 'start[s] with the assumption that the historic police
powers of the States [are] not to be superseded by . . . Federal Act unless
that [is] the clear and manifest purpose of Congress.'" Cipollone
v. I.iggett Group, Inc., 505 U.S. 504, 516 (1992) (quoting Rice
v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947)). So, in evaluating
what preemptive effect, if any, to give a federal statute, what Congress
intended is "the ultimate touchstone." Cipollone, 505
U.S. at 516; Retail Clerks, 375 U.S. at 103.
It is plain that Congress
intended the FCLAA to pre-empt some state laws. 15 U.S.C. § 1334 (b).
That being so, the question is how broad Congress intended the pre-emption
to be. Medtronic, 116 S. Ct. at 2250; see Cipollone,
505 U.S. at 533 (opinion of Blackmun, J.) ("In such cases, the question
is not whether Congress intended to pre-empt state regulation, but to what
extent."). The question can be answered primarily by reference to
"the language of the pre-emption statute and the statutory framework
surrounding it
. Also relevant, however, is the structure and purpose of
the statute as a whole, as revealed not only in the text, but through the
reviewing court's reasoned understanding of the way in which Congress intended
the statute and its surrounding regulatory scheme to affect business, consumers,
and the law." Medtronic, 116 S. Ct. at 2251 (internal quotation
marks and citations omitted).
The inclusion in a statute
of an express pre-emption provision does not foreclose a range of implied
pre-emption as well. Freightliner Corp. v. Myrick, 115 S. Ct. 1483,
1488 (1995). "A federal statute, for example, may create a scheme
of federal regulation 'so pervasive as to make reasonable the inference
that Congress left no room for the States to supplement it.' . . . Alternatively,
federal law may be in 'irreconcilable conflict' with state law. . . . Compliance
with both statutes, for example, may be a 'physical impossibility,' . .
. or, the state law may 'stan[d] as an obstacle to the accomplishment and
execution of the full purposes and objective" of Congress.'"
Barnett Bank of Marion County, N.A. v. Nelson, 116 S. Ct. 1103,
1108 (1996) (citations omitted).
Finally, the inquiry into
the scope of pre-emption is guided by the presumption that Congress does
not "cavalierly" pre-empt state law, Medtronic, 116 S.
Ct. at 2250, especially "'in a field which the States have traditionally
occupied.'" Id. (quoting Santa Fe Elevator, 331 U.S.
at 230). This approach "is consistent with both federalism concerns
and the historic primacy of state regulation of matters of health and safety."
Medtronic, 116 S. Ct. at 2250.
Express
Pre-emption by § 1334 (b)
Other than the specifically
prescribed warnings about health risks from smoking required to be included
on cigarette package labels and in cigarette advertising, including outdoor
billboards, 15 U.S.C. § 1333, "[n]o statement relating to smoking
and health . . . shall be required on any cigarette package." 15 U.S.C.
§ 1334(a). Moreover, "[n]o 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'' FCLAA's labeling requirements. [ There is no dispute
that the plaintiffs' cigarettes are labeled in compliance with the FCLAA's
requirements] 15 U.S.C. § 1334 (b).
It is apparent that Section
307A is a "requirement . . . based on smoking and health . . imposed
under State law." It falls outside the pre-emption expressed in §
1334(b), however, because it is not a requirement "'with respect to
the advertising or promotion' of cigarettes.'" See Cipollone,
505 U.S. at 528 (opinion of Stevens, J ).
Certainly the compelled furnishing
of information to state authorities does not literally constitute "advertising
or promotion." Members of the Supreme Court who disagreed on the interpretation
of the FCLAA in other respects seem to agree on this. See Cipollone,
505 U.S. at 528 (opinion of Stevens, J.); id. at 554 (Scalia, J.,
dissenting).
The plaintiffs do not maintain
that furnishing information to state regulators is itself any form of "advertising
or promotion." Rather, their argument is that Section 307A represents
an evasion by the State of the pre-emption expressed in § 1334(b),
a device by which Massachusetts requires the plaintiffs to disclose via
an indirect route information that it may not directly require them to
disclose in their advertising and promotional materials. See New England
Legal Found. v. Massachusetts Port Auth., 883 F.2d 157, 174 (1st
Cir. 1989) (concluding that "Massport cannot do indirectly what it
is forbidden to do directly."). Instead of compelling the companies
themselves to disclose the information directly to the public, an attempt
that would clearly be pre-empted by § 1334(b), Section 307A compels
them to give the information to the department of public health, which
may then disclose it to the public. Thus, the plaintiffs say, although
Section 307A does not by its terms regulate cigarette advertising or promotion,
it accomplishes the functional equivalent.
The fault in this analysis
is that it wrongly equates the medium with the message and concludes that
regulation of the one must be equivalent to regulation of the other. The
FCLAA does not purport to pre-empt all state law requirements pertaining
to the dissemination of information about cigarette smoking and health;
it pre-empts only requirements "with respect to the advertising or
promotion." 15 U.S.C. § 1334(b); Cipollone, 505 U S. at
528 (opinion of Stevens, J.). Congress mandated exclusive federal authority
over the subject of smoking and health as it might be addressed in the
advertising and promotion of cigarettes. It does not follow, however, that
Congress must therefore have intended to exclude the States from regulating
in any other way the delivery of information to the public about smoking
and health. The proposition is neither logical nor supported by a "reasoned
understanding of . . . the statute and its surrounding regulatory scheme."
Medtronic, 116 S. Ct. at 2251.
A principal reason the FCLAA
was enacted was to avoid the prospect that various states would, on their
own, establish disparate labeling and health warning regulations applicable
to cigarettes. Cipollone, 505 U.S. at 513-14. Indeed, Congress expressed
its purpose to avoid "diverse, non-uniform, and confusing cigarette
labeling and advertising regulations with respect to any relationship between
smoking and health." 15 U.S.C. § 1331(2)(B). It is plain from
this statement of purpose that the uniformity Congress sought to promote
was limited to the media regulated by the federal statute: labels and advertising.
Congress expressed no concern about the possibility that "diverse,
non-uniform or confusing" information about smoking and health might
come to the public from other sources. By precluding the States from regulating
cigarette advertising, Congress did not preclude them from imposing a "duty
to disclose such facts through channels of communication other than advertising
or promotion." Cipollone, 505 U.S. at 52B (opinion of Stevens,
J.).
In sum, Section 307A does
not purport to regulate the advertising or promotion of cigarettes. Nor
do its provisions amount to the indirect imposition of a "requirement
. . . based on smoking and health . . . with respect to advertising or
promotion of . . . cigarettes." Section 307A is not pre-empted by
§ 1334(b).
Implied
Pre-emption by §1335a
In addition to prescribing
health warnings on labels and in advertising, the FCLAA also requires cigarette
manufacturers annually to provide the Secretary of Health and Human Services
with a list of the ingredients added to tobacco in the manufacture of cigarettes
without identifying the listed ingredients either to any particular manufacturer
or brand. 15 U.S.C. § 1335a(a). The information provided in the submitted
list is regarded as trade secret or confidential information the unauthorized
disclosure of which warrants criminal prosecution. 15 U.S.C. § 1335a(b)
(2)(A). The Secretary is directed to adopt specific procedures for insuring
that the confidentiality of the information will be maintained. 15 U.S.C.
§ 1335a(b)(2)(C).
Section 307A similarly requires
the manufacturers to submit ingredient lists, but the required information
must be identified to specific brands and the ingredients must be listed
in order according to "weight, measure or numerical count." Unlike
the federal statute, the Massachusetts act contemplates that, subject to
some conditions, ingredient information will be made public.
The plaintiffs contend that
the federal ingredient reporting scheme impliedly pre-empts the state scheme
for two reasons. First, by enacting the ingredient reporting scheme as
part of the FCLAA, Congress intended the federal provisions to "occupy
the field" of cigarette ingredient reporting. Second, because the
state and federal statutes deal differently with the subject of ingredient
information, and because the state statute goes farther than the federal
with respect to public disclosure of cigarette ingredients, the state statute
"interferes" with the congressional purpose in enacting §
1335a and operates as an "obstacle" to the achievement of that
purpose. If either proposition could be sustained, the plaintiffs would
have the benefit of implied pre-emption, but neither can be.
Congress may legislate in
a field which the States have traditionally occupied in such a way as to
make reasonable an inference that it was Congress' purpose to leave no
room for the States to supplement the federal legislation. Rice v. Santa
Fe Elevator Co., 331 U.S. 218, 230 (1947). This might be true, for
example, in the case of a field ''[where] the federal interest is so dominant
that the federal system will be assumed to preclude enforcement of state
laws on the same subject." Id. (citing Hines v. Davidowitz,
312 U.S. 52, 61 (1941)). Also, "the object sought to be obtained by
the federal law and the character of the obligations imposed by it may
reveal the same purpose. Id. (citing cases involving regulation
affecting interstate railroads).
Those principles do not help
the plaintiffs here. The Supreme Court has made clear in Cipollone
that the FCLAA is not so broad in purpose or mandate as to exclude all
state regulation in the field of smoking and health. Recognizing that,
the plaintiffs attempt a more narrow definition of the relevant "field."
However, it is not enough
simply to be able to give a name to the operational scope of a part of
the federal statute. Because § 1335a deals with "ingredient reporting"
does not mean that there ought to be a "field" identified as
"ingredient reporting," and still less that federal legislation
in that field should be held, without a strong indication of congressional
intent, to exclude state forays into the same field. This is especially
true where the state law is an exercise of traditional police power respecting
public health and safety, there being a "presumption against pre-emption"
in such circumstances. Medtronic, 116 S. Ct. at 2250; Cipollone,
505 U.S. at 523. There is no evidence in the text or structure of the FCLAA
that Congress intended to define "ingredient reporting" as an
exclusively federal domain.
"Conflict" pre-emption
rests on the sound proposition that the effectiveness of federal statutes
ought not be undercut or obstructed by inconsistent state legislation.
It would be impossible, for instance, to comply with contradictory prescriptions
of federal and state law. In such a case, the state law must yield to the
federal. Here, there is no claim that it would be impossible for the plaintiffs
to comply with both federal and state ingredient reporting requirements.
Alternatively, the state
law might operate as an obstacle to the achievement of the full purposes
of the federal law, and so again the state law would be required by the
Supremacy Clause to recede. For example, in Hyde Park Partners, L.P.
v. Connolly, 839 F.2d 837 (1st Cir. 1988), a Massachusetts statute
required takeover bidders to give notice of their intent to gain control
of the target company before they had acquired five percent of the target's
stock. The federal Williams Act, in contrast, required notice of takeover
intent to be given within ten days after their acquisition of five percent
of the stock. In these circumstances, the Court of Appeals concluded that,
while the state and federal requirements were not directly contradictory
because it was possible to comply with both, the enforcement of the state
timetable would nevertheless disturb the balance chosen by Congress to
accommodate competing policy considerations The Court said:
Congress explicitly and carefully established a preferred
balance in the Williams Act at a point where the benefit gained by shareholders
from early disclosure is not outweighed by the detriment to those same
investors if there is too great a deterrent to tender offers. Section 3
of the Massachusetts Act in effect second-guesses the balance struck by
Congress, by altering the point in time at which control intent should
be made public. There is, in other words, an 'actual conflict between federal
and state law' concerning a matter that directly implicates the central
purpose of the Congressional Act.
Hyde Park Partners, 839 F. 2d at
850.
The companies urge that in
enacting § 1335a Congress similarly struck a balance between competing
policies by requiring the disclosure of confidential ingredient information
to the Secretary, on the one hand, but requiring strict assurances to maintain
the confidentiality of that information, on the other.
It is undoubtedly a fact
of legislative life that enactments represent a compromise of competing
considerations, [ "All government -- indeed, every human benefit and
enjoyment, every virtue and every prudent act -- is founded on compromise
and barter." Edmund Burke, Second Speech on Conciliation with America,
March 22, 1775.] and the guess may be hazarded that Congress could
not have agreed on a proposal to require ingredient disclosure without
the specific assurance that the confidentiality of the disclosed information
would be protected. It is also likely true that Massachusetts lawmakers
had little motive to take account of the impact Section 307A would have
on economic interests that Congress, viewing matters from a national perspective,
recognized and accommodated in striking its balance.
Legislative compromise to
bring a law into being is not the kind of balance the First Circuit was
describing in Hyde Park Partners, however. In that
case, the statutes at issue both sought to regulate the timing of the public
disclosure of information that would likely affect market decisions. From
the range of possibilities, Congress determined that its purposes would
be properly advanced if the disclosure were to be made after the bidder
had already acquired five percent of the target's stock. In the Court's
words, Congress had established a "preferred balance" between
the possible benefits and the possible detriments to existing shareholders
of the target. To require disclosure at a different point in time, as the
Massachusetts statute did, would be to reweigh the relative benefits and
detriments and strike a different balance.
In contrast, the statutes
in this case do not involve different requirements governing the disclosure
of information to the same audience, as in Hyde Park Partners.
There is no danger that the plaintiffs' reporting of cigarette ingredients
to the Secretary will be disturbed by the enforcement of the Massachusetts
statute. What may be disturbed is the plaintiffs' ability to keep their
ingredient information confidential. That is a legitimate concern for them.
But while the confidentiality provisions of the federal statute may have
been important even essential, to achieving legislative consensus in support
of the federal reporting scheme, there simply is no basis for concluding
that it was Congress' purpose in enacting § 1335a to grant general
trade secret or confidentiality protection to the plaintiffs' ingredient
information.
The textual indications are
rather to the contrary. In the first place, the statute by its terms grants
protection only to confidential information that is submitted to the Secretary.
It places a duty on the Secretary to protect confidential information she
receives from manufacturers. It simply does not address whether or under
what conditions information about cigarette ingredients ought otherwise
to be given protection as confidential.
In addition, the FCLAA has
an express pre-emption provision. 15 U.S.C. § 1334. Ordinarily, Congress'
expression of a limited range of pre-emption fairly implies it meant to
go no farther. Freightliner, 115 S. Ct. at 1488; Cipollone,
505 U.S. at 517. In enacting (and presumably in amending) the FCLAA, Congress
fashioned "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." Palmer v. Liggett Group Inc,. 825
F.2d 620, 626 (1st Cir. 1987) (internal quotation marks and citation omitted).
The plaintiffs urge that the state ingredient reporting requirement disrupts
that balance. To the contrary, the limited pre-emption provision is part
of the balance; it expresses the congressional verdict as to how far pre-emption
should extend in these matters.
When Congress amended the
FCLAA to add the ingredient-reporting provision (and to make other substantial
changes to the FCLAA) it left the pre-emption clause alone. See
Pub. L. No. 98-474, 98 Stat. 2200 (1984) (the "Comprehensive Smoking
Education Act"). Congressional inaction might normally be regarded
an ambiguous indicator of intent, but not here. The Comprehensive Smoking
Education Act was an occasion for Congress to review the FCLAA as a whole.
It chose to make selected amendments to the statute, and it omitted to
make any amendment to broaden the scope of pre-emption. On a previous occasion,
Congress had broadened the pre-emption clause by amendment. Pub. L. No.
91-222, 84 Stat. 88 (1970). Congressional purpose is not to be discerned
from the statute's text evaluated in isolation, but in context. Medtronic,
116 S. Ct. at 2250-51. In context, it is not a reasonable inference that
Congress intended to expand the range of the FCLAA's pre-emption by mere
implication instead of express direction.
Finally, it might even be
said that the Massachusetts statute is in harmony with the purpose Congress
expressed when it adopted § 1335a: "to provide a new strategy
for making Americans more aware of any adverse health effects of smoking,
to assure the timely and widespread dissemination of research findings
and to enable individuals to make informed decisions about smoking."
Pub. L. No. 98-474, § 2, 98 Stat. 2200 (1984). Section 307A is not
an obstacle to the achievement of that purpose.
Conclusion
For the foregoing reasons,
the plaintiffs, motion for partial summary judgment is denied, and the
defendants' motion for partial summary judgment is granted.
The defendants shall be entitled
to a judgment under Count I of the complaint declaring that Mass. Gen.
L. ch. 94, § 307A is not pre-empted by any provision of the FCLAA.
It is SO ORDERED.
UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
UNITED STATES
TOBACCO CO.; BROWN & WILLIAMSON TOBACCO CORP.; CONWOOD CO., L.P., NATIONAL
TOBACCO CO., L.P.; THE PINKERTON TOBACCO CO.; and SWISHER INTERNATIONAL,
INC.,
Plaintiffs,
v.
L. SCOTT
HARSHBARGER, ATTORNEY GENERAL OF THE COMMONWEALTH OF MASSACHUSETTS; and
DAVID H. MULLIGAN, MASSACHUSETTS COMMISSIONER OF PUBLIC HEALTH,
Defendants.
Civil Action No.: 96-11619-GAO
February 7, 1997
MEMORANDUM
AND ORDER
O'Toole, D.J.
The plaintiffs are manufacturers
of smokeless tobacco products, such as chewing tobacco and snuff. Beginning
this year, they will be required by Mass. Gen. L. ch. 94, § 307A ("Section
307A") [ Section 307A reads as follows: 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 bands 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 or inhaled, according to the Generally Recognized As Safe list of
the FDA.] to disclose to the Massachusetts department of public health
specific information about the ingredients and nicotine content of their
products. They have brought this suit to have Section 307A declared unconstitutional
on a number of alternative grounds and to enjoin its enforcement. One of
the grounds asserted is that Section 307A has been pre-empted by a federal
statute, the Comprehensive Smokeless Tobacco Health Education Act, 15 U.S.C.
§§ 4401 et seq. (the "Smokeless Tobacco Act").
That statute requires the plaintiffs to disclose information about their
products' ingredients to the United States Secretary of Health and Human
Services under a prescribed procedure. The parties have filed cross-motions
for partial summary judgment on the pre-emption issue. [ Section 307A also
requires manufacturers of cigarettes to submit similar information to the
Department of Public Health. Several cigarette manufacturers have brought
a separate action asserting substantially the same constitutional challenges
to Section 307A as these plaintiffs. As here, the parties in that case
brought cross - motions for summary judgment on the pre - emption issue.
The Court's disposition of the motions is the same in both cases. The opinion
in the cigarette case contains a more detailed discussion of the common
issues; it is not necessary to duplicate the exposition here . See Philip
Morris. et al. v. Harshbarger , No. 96 - 11599 - GAO, slip op. (D. Mass.
Feb. 7, 1997).]
The pre-emption doctrine
represents the Supremacy Clause at work. That constitutional provision
declares 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. The power to pre-empt
state law is one that Congress may choose to employ or not. If it chooses
to do so, the pre-empted state law is "without effect.'' Maryland
v. Louisiana, 451 U.S. 725, 746 (1981).
Determining questions of
pre-emption is a matter of discerning congressional intent. Barnett
Bank of Marion County, N.A. v. Nelson, 116 S. Ct. 1103, 1107
(1996). Sometimes the question is easily answered, because Congress expresses
its intent clearly in the statute at issue. In those cases where such an
expression is absent or unclear, however, the question must be answered
by consideration of the statute's overall structure and evident purpose.
Medtronic, Inc. v. Lohr, 116 S. Ct. 2240, 2251 (l996); Barnett
Bank, 116 S. Ct. at 1108.
The Smokeless Tobacco Act
contains an express pre-emption clause. It provides:
No statement relating to the use of smokeless tobacco
products and health, other than the statements required by section 4402
of this title, shall be required by any state 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. § 4406 (b).
Given its plain meaning,
this pre-emption provision obviously does not help the plaintiffs. Quite
plainly, Section 307A does not require them to include any "statement
relating to the use of smokeless tobacco products and health . . . on any
package or in any advertisement." 15 U.S.C. S 4406(b).
The plaintiffs do not claim
that it does. Rather, their express pre-emption argument is that Section
307A is simply a way for Massachusetts to accomplish regulation without
coming literally within the scope of the § 4406(b) pre-emption language.
Perhaps it is. But that does
not mean Section 307A has been pre-empted. By limiting its description
of what state requirements it wanted to pre-empt, Congress chose less than
total pre-emption, and that necessarily means that some things are pre-empted
and some are not. That is as far as the express pre-emption inquiry need
go. The expressed limits of the pre-emption clause cannot be disregarded
just because a state law outside those limits might produce similar practical
effects as one described by the pre-emption language. The way to understand
the scope of an express pre-emption provision is not to judge by outcomes,
but rather by what Congress has said.
On the other hand, outcomes
are pertinent to the question of implied pre-emption. Specifically, the
enforcement of a state law may interfere with the congressional purpose
in enacting the federal statute and stand as an obstacle to the achievement
of that purpose. See Hines v. Davidowitz, 312 U.S. 52, 67 (1941).
That is not the case here,
however. Section 307A requires the plaintiffs to submit more specific and
detailed information about product ingredients than the federal statute
does, and, unlike the federal statute's careful protection of the ingredient
information, the state statute contemplates that the submitted information
will be made public if certain conditions are met. These are different
approaches to the same subject, but they do not amount to a conflict between
the state and federal schemes.
Surely, it is possible for
the plaintiffs to comply with both statutes. See Florida Lime and Avocado
Growers Inc. v. Paul, 373 U.S. 132, 142-43 (1963). More importantly,
it is possible for the Smokeless Tobacco Act's reporting scheme to be fully
carried out without any interference from the operation of Section 307A.
It is possible for the Secretary to receive all the information called
for under the federal statute, and it is possible for her to maintain the
confidentiality of that submitted information. The implied pre-emption
doctrine protects the federal scheme, not the plaintiffs' information.
Where there is not interference with the federal scheme, there is no need
for pre-emption.
The plaintiffs' real grievance
is that they will suffer serious harm from Massachusetts' public disclosure
of their confidential information. Unfortunately for them, that unhappy
prospect has no bearing on the pre-emption question, because it was not
Congress' purpose in enacting the Smokeless Tobacco Act to grant general
protection to their trade secrets or confidential product information.
No reasonable inference of such an unexpressed purpose arises from the
statute's text, nor from its "structure and purpose . . . as a whole,"
nor from a "reasoned understanding of the way in which Congress intended
the statute and its surrounding regulatory scheme to affect business, consumers,
and the law." Medtronic, 116 S. Ct. at 2251. In enacting the
confidentiality requirements set forth in the Smokeless Tobacco Act, Congress
was doing no more than undertaking to protect that sensitive information
of which the Secretary is the custodian.
The plaintiffs' motion for
partial summary judgment as to Count I is denied, and the defendants' cross-motion
is granted.
The defendants shall be entitled
to Judgment under Count I of the complaint declaring that Mass. Gen. L.
ch. 94, § 307A is not pre-empted, expressly or impliedly, by any provision
of the Smokeless Tobacco Act.
It is SO ORDERED.