Fellner v. Tri Union Seafoods ( 2008 )

Opinions of the United
2008 Decisions States Court of Appeals
for the Third Circuit
8-19-2008
Fellner v. Tri Union Seafoods
Precedential or Non-Precedential: Precedential
Docket No. 07-1238
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PRECEDENTIAL
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
NO. 07-1238
DEBORAH FELLNER, individually and
on behalf of those similarly situated
v.
TRI-UNION SEAFOODS, L.L.C.
d/b/a CHICKEN OF THE SEA
Deborah Fellner,
Appellant
On Appeal From the United States District Court
For the District of New Jersey
(D.C. Civil Action No. 06-cv-00688)
District Judge: Hon. Dennis M. Cavanaugh
Argued February 12, 2008
BEFORE: SLOVITER, SMITH and STAPLETON,
Circuit Judges
(Opinion Filed: August 19, 2008)
Kenneth A. Schoen
Scott H. Goldstein
Bonner, Kiernan, Trebach & Crociata
299 Cherry Hill Road, Suite 300
Parsippany, NJ 07054
John A. Kiernan (Argued)
Bonner, Kiernan, Trebach & Crociata
One Liberty Square, 6th Floor
Boston, MA 02109
Attorneys for Appellee
William O. Crutchlow
Khalid Elhassan
Eichen, Levinson & Crutchlow
40 Ethel Road
Edison, NJ 08817
Adina H. Rosenbaum (Argued)
Brian Wolfman
Public Citizen Litigation Group
1600 20th Street, NW
Washington, DC 20009
Attorneys for Appellant
2
OPINION OF THE COURT
STAPLETON, Circuit Judge:
Plaintiff Deborah Fellner filed this lawsuit against
defendant Tri-Union Seafoods, LLC (“Tri-Union”) in the
Superior Court of New Jersey seeking damages for harm she
allegedly sustained as a result of her consumption of
methylmercury and other harmful compounds contained in Tri-
Union’s tuna fish products. The case was removed to federal
court, and Tri-Union filed a motion to dismiss for failure to state
a claim asserting that Fellner’s lawsuit is preempted by
regulatory actions of the United States Food and Drug
Administration (“FDA”). The District Court granted the
motion, ruling that Fellner’s claims are preempted by the FDA’s
“regulatory approach” to the risks posed by mercury compounds
in tuna fish. Because we conclude that the FDA has taken no
regulatory action which preempts Fellner’s lawsuit, we will
reverse and remand for further proceedings.
I. Facts and Procedural Background
Fellner alleges that Tri-Union produces, cans and
distributes Chicken-of-the-Sea brand tuna fish and that, from
1999 to 2004, her diet consisted almost exclusively of Tri-
Union’s tuna products. She further avers that those products
contained methylmercury and other harmful compounds that can
3
result in mercury poisoning and that “[d]ue to the negligence
and statutory violations of the Defendant . . . Fellner contracted
severe mercury poisoning and suffered extreme physical and
emotional injuries.” App. at 30a, ¶ 28. She seeks recovery
under the New Jersey Products Liability Act, N.J.S.A. 2A:58C-
1, et seq. (“NJPLA”), based on Tri-Union’s failure to warn of
the risks incurred in consuming its products.1
The factual landscape of this case is colored by recent
litigation in California. On June 21, 2004, then-Attorney
General of California, Bill Lockyer, filed a lawsuit against Tri-
Union and other defendants under California’s “Proposition
65,” CAL. HEALTH & SAFETY CODE § 25249.6, seeking an
injunction and civil penalties for defendants’ failure to warn
consumers that their tuna products contain dangerous mercury
compounds. While that suit was pending, the Commissioner of
the FDA sent a letter to Mr. Lockyer expressing the opinion
that the FDA’s prior regulatory actions preempt the State’s
1
While the complaint refers to a design defect, we find it
unclear whether the alleged design defect is the failure to warn
or is a claim based on excessive mercury concentrations which
is distinct from the failure to warn. The District Court
apparently reached the former conclusion; it dismissed the
failure-to-warn claim without addressing whether the complaint
asserts a separate design-defect claim and whether any such
claim is preempted. Due to this posture, and because our
disposition of this appeal will result in remand to the District
Court, we decline to address the design defect claim, if one there
be, and instead will allow the parties to raise these issues before
the District Court if they so choose.
4
lawsuit. In the Commissioner’s view, the defendants would be
unable to comply both with that approach and state law and the
existence of the lawsuit would “frustrate the [FDA’s] carefully
considered federal approach” to the issue of mercury in fish.
See People v. Tri-Union Seafoods, 2006 WL 1544377 (Cal.
Super. Ct. May 12, 2006) (taking judicial notice of the letter).
In May 2006, following a bench trial, the Superior Court of
California found the Attorney General’s lawsuit preempted by
federal law. People v. Tri-Union Seafoods, 2006 WL 1544384
(Cal. Super. Ct. May 11, 2006), appeal docketed, No. A116792
(Cal. Ct. App. 1st Dist. Feb. 20, 2007).
Tri-Union removed Fellner’s lawsuit to the United States
District Court for the District of New Jersey and filed a motion
to dismiss for failure to state a claim accompanied by motions
requesting that the Court take judicial notice of four documents:
(1) a consumer advisory published by the FDA in 2004
regarding the risks of mercury in fish (“the Advisory”); (2) a
“backgrounder” for the FDA’s 2004 Advisory, which provides
further information about those risks (“the backgrounder”); (3)
Section 504.0600 of the FDA’s Compliance Policy Guide, a
guideline recommending that the FDA initiate enforcement
action if the concentration of mercury in fish exceeds “1 ppm”
(“the Compliance Guide”); and (4) the above-described letter
sent by the Commissioner of the FDA to the Attorney General
of California (“the Commissioner’s letter”).
The District Court took judicial notice of the four
documents submitted by defendant and granted defendant’s
motion to dismiss. Fellner v. Tri-Union Seafoods, 2007 WL
87633 (D.N.J. 2007). It found that the FDA had implemented
5
a “pervasive regulatory scheme” pertaining to the risks of
methylmercury in fish consisting of the FDA’s Advisory,
backgrounder, Compliance Guide, and the Commissioner’s
letter. It concluded that the FDA had deliberately declined to
require warnings in favor of a more “nuanced” and “balanced”
approach consisting of targeted advisories, and that the state law
duties relied upon by Fellner in her lawsuit would upset that
approach. As a result, the Court dismissed the complaint,
holding that the FDA’s regulatory scheme regarding mercury in
fish preempts Fellner’s state law claims. She timely appealed.
II. Jurisdiction and Standard of Review
We have jurisdiction pursuant to 28 U.S.C. § 1291. We
exercise plenary review of the District Court’s order granting
defendant’s motion to dismiss. Santiago v. GMAC Mortgage
Group, 417 F.3d 384, 386 (3d Cir. 2005). When reviewing a
motion to dismiss for failure to state a claim under Fed. R. Civ.
P. 12(b)(6), we accept as true all well-pled factual allegations in
the complaint and all reasonable inferences that can be drawn
from them, and we affirm the order of dismissal only if the
pleading does not plausibly suggest an entitlement to relief.
Wilkerson v. New Media Tech. Charter Sch., 522 F.3d 315, 321-
22 (3d Cir. 2008).
III. Discussion
The sole question presented in this appeal is whether
Fellner’s state claim for damages is preempted by federal law.
Tri-Union offers three distinct theories of preemption: (1) that
the FDA has adopted a “pervasive regulatory approach” –
6
embodied in the FDA’s Advisory, backgrounder and internal
enforcement guideline – with which Fellner’s state lawsuit
actually conflicts; (2) that the FDA has “reject[ed] the use of
warning labels” in favor of a more “nuanced” approach – that is,
that the FDA has reached a decision that warnings should not be
regulated, a decision which preempts the state from entertaining
a claim based on a duty to warn theory; and (3) that the FDA
would have rejected any warning as “misbranding,” a
determination which preempts Fellner’s failure-to-warn claim.
A. The Doctrine of Federal Preemption
The doctrine of federal preemption is rooted in the
Supremacy Clause of the United States Constitution, U.S.
Const. art. VI, cl. 2, which invalidates state laws that “interfere
with, or are contrary to, federal law.” Hillsborough County v.
Automated Med. Labs., 471 U.S. 707, 712 (1985) (quoting
Gibbons v. Ogden, 22 U.S. 1 (9 Wheat. 1, 211), (1824)). As
we recently explained,
[t]he Supreme Court has identified three major
situations where there is preemption . . . (1)
“express” preemption, applicable when Congress
expressly states its intent to preempt state law; (2)
“field” preemption, applicable when “Congress’
intent to pre-empt all state law in a particular area
may be inferred [because] the scheme of federal
regulation is sufficiently comprehensive” or “the
federal interest is so dominant that the federal
system will be assumed to preclude enforcement
of state laws on the same subject;” and (3)
7
“conflict” preemption, applicable when “state law
is nullified to the extent that it actually conflicts
with federal law,” even though Congress has not
displaced all state law in a given area.
Colacicco v. Apotex Inc., 521 F.3d 253, 261 (3d Cir. 2008)
(quoting Hillsborough County, 471 U.S. at 713). See also
English v. General Elec. Co., 496 U.S. 72, 78-79 (1990)
(summarizing the three types of preemption). Tri-Union has not
argued, nor could it, that Fellner’s lawsuit is expressly
preempted by the Food, Drug and Cosmetics Act (“FDCA”) or
by federal regulation.2 Similarly, we do not interpret Tri-
Union’s brief as asserting a field preemption claim, and any
such claim would be unavailing.3 If preemption exists in this
2
The Act includes an express preemption provision, 21
U.S.C. § 343-1, but Tri-Union does not urge that it governs this
case. The inclusion of express preemption provisions does not
preclude the operation of ordinary implied preemption
principles. Geier v. American Honda Motor Co., 529 U.S. 861,
869 (2000).
3
Courts rarely find field preemption, especially in areas
traditionally regulated by the states, unless the structure of a
regulatory program leaves little doubt that Congress intended
federal law to be exclusive in a particular field. See, e.g.,
Hillsborough County, 471 U.S. at 717 (“merely because the
federal provisions [are] sufficiently comprehensive to meet the
need identified by Congress [does] not mean that States and
localities [are] barred from identifying additional needs or
imposing further requirements in the field . . . . We are even
8
case it must be conflict preemption.
As the Supreme Court frequently reiterates, in all cases
“preemption fundamentally is a question of congressional
intent.” English, 496 U.S. at 78-79. See also Medtronic v.
Lohr, 518 U.S. 470, 485 (1996) (“‘[t]he purpose of Congress is
the ultimate touchstone’ in every preemption case”) (citation
omitted). However, “state laws can be preempted by federal
regulations as well as by federal statutes.” Hillsborough
County, 471 U.S. at 713. Where Congress has delegated the
authority to regulate a particular field to an administrative
agency, the agency’s regulations issued pursuant to that
authority have no less preemptive effect than federal statutes,
assuming those regulations are a valid exercise of the agency’s
delegated authority. Fidelity Fed. Savings and Loan Ass’n v. de
la Cuesta, 458 U.S. 141, 153-54 (1982).
Although federal administrative law as well as
Congressional enactments are the supreme law of the land, we
must reiterate, lest the analysis become unmoored, that it is
federal law which preempts contrary state law; nothing short of
federal law can have that effect. The Supreme Court’s
longstanding interpretation of the Supremacy Clause, and
indeed the Supremacy Clause itself, mandate this principle:
more reluctant to infer preemption from the comprehensiveness
of regulations than from the comprehensiveness of statutes . .
.”). In this case, the “regulatory scheme” identified by Tri-
Union and the Commissioner’s letter fall far short of the sort of
comprehensive federal program ordinarily addressed in field
preemption cases.
9
Article VI of the Constitution provides that the
laws of the United States “shall be the supreme
Law of the Land; . . . any Thing in the
Constitution or Laws of any states to the Contrary
notwithstanding.” Art. VI, cl.2. Thus, since our
decision in M’culloch v. Maryland, it has been
settled that state law that conflicts with federal
law is “without effect.”
Cipollone, 505 U.S. at 516 (emphasis added). See also
Colacicco, 521 F.3d at 261 (“[e]arly in our constitutional
history, the Supreme Court interpreted this language to
invalidate state laws that ‘interfere with, or are contrary to,’
federal law, the genesis of the preemption doctrine”) (emphasis
added; citation omitted).
As we have noted, there is no doubt that federal
regulations as well as statutes can establish federal law having
preemptive force. New York v. Fed. Commc’n Comm’n, 486
U.S. 57, 63 (1988) (“The phrase ‘Laws of the United States’ [in
the Supremacy Clause] encompasses both federal statutes
themselves and federal regulations that are properly adopted in
accordance with statutory authorization”). Although there is
some authority for the proposition that the only regulatory
process which can produce “federal law” for purposes of the
Supremacy Clause is formal, notice and comment rulemaking,
Good v. Altria Group, 501 F.3d 29, 51-52 (1st Cir. 2007), cert.
granted, 128 S. Ct. 1119 (2008) (collecting cases), we have
joined those courts which hold that, in appropriate
circumstances, federal agency action taken pursuant to
statutorily granted authority short of formal, notice and
10
comment rulemaking may also have preemptive effect over state
law. Colacicco, 521 F.3d at 271 (citations omitted).
It is clear, for example, that federal agency orders
resulting from quasi-judicial agency proceedings may constitute
“federal law” under the Supremacy Clause: “[i]t is well
established that when developing law on a subject, an agency
usually has a choice between the method of rulemaking and that
of adjudication,” General Motors Corp. v. Abrams, 897 F.2d 34,
39 (2d Cir. 1990) (citation omitted); both agencies’ quasi-
legislative as well as their quasi-judicial powers “have the
binding force of ‘federal law.’” Id. (citation omitted). See also
Chicago and Nw. Transp. Co. v. Kalo Brick & Tile Co., 450
U.S. 311, 314-15, 321-28 (1981) (Interstate Commerce
Commission order following quasi-judicial proceeding
governing abandonment of rail lines preempted state law).
Moreover, in addition to orders from formal adjudicatory
proceedings, we have recently given preemptive effect to a
federal agency order in a similar situation where a
comprehensive federal regulatory scheme authorized a process
for the agency to apply a federal standard to concrete
circumstances, and it had utilized that process in a manner
establishing a federal duty or policy. In Colacicco, the
plaintiffs’ alleged claims for failure to warn that a family of
drugs used to treat anxiety and depression caused an increased
risk of suicidality. The FDCA conferred jurisdiction upon the
FDA to regulate drug labeling. Regulations authorized by the
FDCA predicated the marketing of drugs on FDA approval of
the drugs’ labeling both at the time the drugs were initially
marketed and on an ongoing basis thereafter. Defendants’ labels
had received FDA approval both before and after the suicides at
11
issue. The plaintiffs pointed out, however, that the regulations
required that the labeling be revised by the manufacturer
unilaterally “to include a warning as soon as there is reasonable
evidence of an association of a serious hazard with a drug.” 21
C.F.R. § 201.57(c) (2003). Plaintiffs argued that this meant the
defendants could have complied with both the federal
regulations and the state duty to warn, and thus no conflict
existed. We rejected this argument because, although the
regulations allowed a manufacturer to amend warnings
unilaterally, all such amendments remained contingent on the
manufacturer ultimately receiving FDA approval, and the FDA
in a number of different agency proceedings had previously
considered the scientific evidence relied upon by plaintiffs and
had exercised its prerogative under the regulations to reject
suicidality warnings based on that evidence. The FDA had
“clearly and publicly stated its position [regarding the propriety
of the warning in the pertinent circumstances] prior to the
prescriptions and deaths at issue. . . .” Colacicco, 521 F.3d at
271. Although defendants had not been shown to be participants
in those proceedings, we concluded that a conflict existed
because, much like agency quasi-judicial proceedings, see
Security and Exchange Commission v. Chenery Corp., 332 U.S.
194, 201-03 (1947), the FDA’s actions in those proceedings
established a policy against the sought-after warnings applicable
not only to the immediate participants but also to others in like
circumstances, such as the defendants. Thus, defendants could
not have complied with the requirements of both federal and
state law.
This does not mean, however, that federal law capable of
preempting state law is created every time someone acting on
12
behalf of an agency makes a statement or takes an action within
the agency’s jurisdiction. As the Supreme Court has explained,
“[i]t is fair to assume generally that Congress contemplates
administrative action with the effect of law when it provides for
a relatively formal administrative procedure tending to foster the
fairness and deliberation that should underlie a pronouncement
of such force.” United States v. Mead Corp., 533 U.S. 218, 230
(2001) (addressing which types of agency actions should be
afforded Chevron deference). We believe that similar
considerations are pertinent here. We decline to afford
preemptive effect to less formal measures lacking the “fairness
and deliberation” which would suggest that Congress intended
the agency’s action to be a binding and exclusive application of
federal law. Courts with good reason are wary of affording
preemptive force to actions taken under more informal
circumstances. See, e.g., Good, 501 F.3d at 51-52; Wabash
Valley Power Assn. v. Rural Elec. Admin., 903 F.2d 445, 453-54
(7th Cir. 1990); General Motors Corp., 897 F.2d at 39.
Regularity of procedure – whether it be the rulemaking and
adjudicatory procedures of the APA or others which Congress
may provide for a particular purpose – not only ensures that
state law will be preempted only by federal “law,” as the
Supremacy Clause provides, but also imposes a degree of
accountability on decisions which will have the profound effect
of displacing state laws, and affords some protection to the
states that will have their laws displaced and to citizens who
may hold rights or expectations under those laws.
Tri-Union points to the Commissioner’s letter as both
establishing federal law capable of preemption and as
evidencing the agency’s interpretation of previously established
13
law, an interpretation to which we should defer. We evaluate
below the deference to which we believe that letter is entitled as
an interpretation of pre-existing federal law. With respect to
Tri-Union’s claim that it established federal law, we note that
we have found no case in which a letter that was not the product
of some form of agency proceeding and did not purport to
impose new legal obligations on anyone was held to create
federal law capable of preemption. See Wabash Valley, 903
F.2d at 453-54 (declining to give preemptive effect to an agency
letter where the prescribed procedures were not followed);
Thomas v. New York, 802 F.2d 1443 (D.C. Cir. 1986) (same).4
Finally, the Supreme Court occasionally has confronted
a claim that a federal agency’s decision not to regulate should be
granted preemptive effect because it constitutes a federal
determination that the issue shall be unregulated – here, the
decision not to require (or otherwise regulate) mercury
warnings. As the Court explained, “a federal decision to forego
regulation in a given area may imply an authoritative federal
determination that the area is best left unregulated, and in that
4
Contrary to Tri-Union’s suggestion, we do not read Geier as
indicating otherwise. Although Geier declined to require a
“specific, formal agency statement identifying a conflict in order
to conclude that [] a conflict in fact exists,” Geier, 529 U.S. at
884, it did require that state law actually conflict with a federal
law. The Court ruled that a state lawsuit was preempted because
it actually conflicted with a Department of Transportation
(“DOT”) regulation (FMVSS 208), id. at 874, and the Court
merely “place[d] some weight upon the DOT’s [informal]
interpretation of FMVSS 208’s objectives . . .,” id. at 883, to
help it determine whether the two in fact conflicted.
14
event would have as much preemptive force as a decision to
regulate.” Ark. Elec. Co-op v. Ark. Pub. Serv., 461 U.S. 375,
384 (1983) (emphasis in original).
However, the Supreme Court has since cautioned that this
statement in Arkansas Electric Co-op “was obviously not meant
in an unqualified sense; otherwise, deliberate federal inaction
could always imply preemption, which cannot be. There is no
federal preemption in vacuo, without a constitutional text or a
federal statute to assert it.” P.R. Dep’t of Consumer Affairs v.
Isla Petroleum Corp., 485 U.S. 495, 503 (1988). The Court
further explained,
[w]e are presented with the decidedly untypical
claim that federal pre-emption exists despite not
only the absence of a statutory provision
specifically announcing it, but the absence of any
extant federal regulatory program with which the
state regulation might conflict and which might
therefore be thought to imply pre-emption.”
Id. at 500. The Court rejected the claim, concluding that
“unenacted approvals, beliefs, and desires are not laws.
Without a text that can, in light of those statements, plausibly be
interpreted as prescribing federal pre-emption it is impossible
to find that a free market was mandated by federal law.” Id. at
501 (emphasis in original).
The Court again confronted, and rejected, a similar claim
just a few years ago. Although the Court acknowledged that the
agency had the authority to enact a regime free of any regulation
15
concerning the risk at issue, it declined to infer such a regime
from a mere decision not to regulate, absent an “‘authoritative’
message of a federal policy against [regulation].” Sprietsma v.
Mercury Marine, 537 U.S. 51, 67 (2002). The Court explained,
[i]t is quite wrong to view [the Coast Guard’s
decision not to adopt a regulation] as the
functional equivalent of a regulation prohibiting
all States and their political subdivisions from
adopting such a regulation . . . . Of course, if a
state common-law claim directly conflicted with
a federal regulation promulgated under the Act, or
if it were impossible to comply with any such
regulation without incurring liability under state
common law, pre-emption would occur. This,
however, is not such a case.
Sprietsma, 537 U.S. at 65 (emphasis added).5
5
Sprietsma discussed the agency’s informal,
contemporaneous explanation for its decision not to regulate and
also emphasized that the agency had taken an anti-preemption
position in briefings for the Court. Sprietsma, 537 U.S. at 67-
68. We do not interpret Sprietsma to have implied that, had the
agency adopted a pro-preemption stance in an informal
statement or briefings for the Court, those views alone would
have imbued the agency’s decision not to regulate with
preemptive force. Geier directs that courts should consider any
views expressed by the agency regarding the purposes and
objectives of its actions claimed to preempt state law, and
therefore it was only natural for Sprietsma to note the agency’s
16
Isla Petroleum and Sprietsma make clear that mere
deliberate agency inaction – an agency decision not to regulate
an issue – will not alone preempt state law. Furthermore, we
find no support for the proposition that an agency’s informal
explanation for its decision not to regulate can alone imbue such
a decision with preemptive force; in all cases concerning alleged
“federal determination[s] that [an] area is best left unregulated,”
Ark. Elec. Co-op, 461 U.S. at 384, the Supreme Court and
Courts of Appeals have inquired whether some extant law or
regulation evinced an “authoritative message of federal policy”
that an issue is to remain free of state regulation (or any
regulation at all); “unenacted approvals, beliefs, and desires”
will not suffice.6
agreement. Furthermore, Sprietsma emphasized a “stark
contrast” with Geier: unlike the case before it, in Geier it was
not mere inaction or a “decision not to regulate” combined with
informal agency views that preempted state law but rather a
federal regulation (FMVSS 208) that promulgated the
“affirmative policy judgment” – the “authoritative message of
a federal policy” – with which the state lawsuit was found to
conflict. Id. at 68 (internal quotation marks and citation
omitted).
6
We find only two situations in which courts have given
preemptive effect to decisions not to regulate. First, the
Supreme Court has found deliberate federal inaction to preempt
state law (so-called “negative preemption”) through what is
essentially a field preemption analysis: “[w]here a
comprehensive federal scheme intentionally leaves a portion of
17
the regulated field without controls, then the preemptive
inference can be drawn – not from federal inaction alone, but
from inaction joined with action.” Isla Petroleum Corp., 485
U.S. at 503 (emphasis in original). In such cases, courts have
concluded from the comprehensiveness of a statutory scheme
and their interpretation of the purposes and objectives of the
statute that Congress intended federal jurisdiction to be
exclusive or the field to be free of any regulation whatsoever.
See, e.g., Ark. Elec. Co-op, 461 U.S. at 384 (citing field
preemption case for the proposition that a federal decision to
forego regulation may imply an “authoritative federal
determination that the area is best left unregulated;” finding no
such determination); Transcontinental Gas Pipe Line v. State
Oil and Gas Bd., 474 U.S. 409, 422, 425 (1986) (finding this
brand of field preemption); Bldg. & Constr. Trades Council v.
Associated Builders & Contractors, 507 U.S. 218, 224-27
(1993) (discussing two lines of such field preemption cases
under the NLRA). Cf. Ray v. Atlantic Richfield Co., 435 U.S.
151, 178 (1978) (agency’s decision not to adopt a particular
regulation contributed to a finding of conflict preemption where
the agency took the subsequent step of adopting an alternate
federal standard governing the issue with which, the Court
found, the state rule would be inconsistent).
Second, other such cases appear to be simply express
preemption cases – Congress and federal agencies possessing
the appropriate authority certainly may announce by law or
regulation a federal policy that an issue is to remain unregulated.
See, e.g., Ark. Elec. Co-op, 461 U.S. at 388-89 (stating that the
federal agency could have announced a policy “that the area is
best left unregulated” in a “rule [] valid under the [Act]” but had
18
B. Presumption Against Preemption and Deference to the
Agency
The parties dispute the applicability of two familiar rules
of interpretation. Fellner asserts that we should apply a
presumption against preemption. Tri-Union asserts that
Fellner’s reliance on the presumption against preemption is
misplaced, and that in fact we should afford deference to the
agency’s views on preemption.
not done so); Wabash Valley Power Ass’n, 903 F.2d at 453-54
(discussing Ark. Elec. Co-op); Gracia v. Volvo Europa Truck,
112 F.3d 291, 296-97 (7th Cir. 1997), cert. denied, 522 U.S.
1050 (1998) (explaining that, in contrast to cases where an
agency simply declined to regulate an issue, “here there is a
specific federal standard . . . [which] determined that this type
of vehicle should be exempt from the affixing requirement . . .”);
Lynnbrook Farms v. Smithkline Beecham Corp., 79 F.3d 620,
625 (7th Cir. 1996), cert. denied, 519 U.S. 867 (1996) (agency
“declaration” of preemption issued in a formal rule); Evans v.
Bd. of County Comm’rs, 994 F.2d 755, 758-60 (10th Cir. 1993)
(agency issued a “limited preemption policy” via a
“Memorandum Opinion and Order” following notice and
comment); Ray, 435 U.S. 171-72 (stating that the federal agency
could promulgate “rules” announcing that it desired no
regulation of an issue but had not done so); Baltimore & Ohio
R.R. v. Oberly, 837 F.2d 108, 115-16 and n. 3 (3d Cir. 1988)
(citing Ray, 435 U.S. at 172-73 & n. 23, and other cases for the
same proposition).
19
1. Presumption Against Preemption
The Supreme Court historically has applied a
presumption against the preemption of state laws:
because the States are independent sovereigns in
our federal system, we have long presumed that
Congress does not cavalierly pre-empt state-law
causes of action. In all pre-emption cases, and
particularly in those in which Congress has
“legislated . . . in a field which the States have
traditionally occupied,” we “start with the
assumption that the historic police powers of the
States were not superseded by the Federal Act
unless that was the clear and manifest purpose of
Congress.”
Medtronic v. Lohr, 518 U.S. 470, 485 (1996) (citations omitted).
See also Hillsborough County v. Automated Med. Labs., 471
U.S. 707, 715 (1985) (“[w]here . . . the field that Congress is
said to have pre-empted has been traditionally occupied by the
States ‘we start with the [presumption];’”) (citation omitted);
Bates, 544 U.S. at 449 (similar).
Recent Supreme Court jurisprudence suggests that the
presumption remains applicable when preemption claims
concern areas of the law “which the States have traditionally
occupied,” but that it may not be applicable “where the interests
at stake are ‘uniquely federal’ in nature.” Buckman Co. v.
Plaintiffs’ Legal Comm., 531 U.S. 341, 348 (2001) (declining
to apply the presumption because “[p]olicing fraud against
20
federal agencies is hardly ‘a field which the States have
traditionally occupied’ . . . . To the contrary, the relationship
between a federal agency and the entity it regulates is inherently
federal in character”) (citations omitted). See also United States
v. Locke, 529 U.S. 89, 108 (2000) (presumption applies “in
field[s] which the states have traditionally occupied,” but
declining to apply it because “national and international
maritime commerce” is not such a field) (citations omitted).
In the present case, it is hard to imagine a field more
squarely within the realm of traditional state regulation than a
state tort-like action seeking damages for an alleged failure to
warn consumers of dangers arising from the use of a product.
See, e.g., Bates, 544 U.S. at 449 (“The long history of tort
litigation against manufacturers of poisonous substances adds
force to the basic presumption against pre-emption”).
Furthermore, state tort law and other similar state remedial
actions are often deemed complementary to federal regulatory
regimes, and this appears to be such a case. Federal regulatory
programs frequently do not include a compensatory apparatus,
and the Supreme Court has recognized that state tort law can
also play an important information-gathering role not easily
replicated by federal agencies.7 When a litigant asserts that a
7
See, e.g., Sprietsma, 537 U.S. at 64 (“It would have been
perfectly rational for Congress not to pre-empt common-law
claims, which – unlike most administrative and legislative
regulations – necessarily perform an important remedial role in
compensating accident victims.”); Bates, 544 U.S. at 449, 451
(“[p]rivate remedies that enforce federal misbranding
requirements would seem to aid, rather than hinder, the
21
private right of action, as opposed to a state statute or
regulation, is preempted, we are cognizant that preemption may
leave individuals with rights but no private remedy, where
traditionally there has been one. Although Congress certainly
can afford, and in some instances has afforded, federal
regulators exclusive jurisdiction over a particular subject matter,
and federal regulations will preempt state laws that actually do
conflict with them, we do not lightly infer such a result where
state compensatory regimes have traditionally played an
important role.
functioning of FIFRA . . . . FIFRA contemplates that pesticide
labels will evolve over time, as manufacturers gain more
information about their products’ performance in diverse
settings . . . tort suits can serve as a catalyst in this process;”
concluding that “[i]f Congress had intended to deprive injured
parties of a long available form of compensation, it surely
would have expressed that intent more clearly”); Medtronic, 518
U.S. at 487 (plurality opinion) (“because there is no explicit
private cause of action [in the federal Act] . . . [a finding of
preemption would mean] Congress would have barred most, if
not all, relief for persons injured by defective medical devices.
Medtronic’s construction of § 360k would therefore have the
perverse effect of granting complete immunity from design
defect liability to an entire industry that, in the judgment of
Congress, needed more stringent regulation”); Silkwood v. Kerr-
McGee Corp., 464 U.S. 238, 251 (1984) (“It is difficult to
believe that Congress would, without comment, remove all
means of judicial recourse for those injured by illegal
conduct.”).
22
Although we are aware that the Supreme Court has
applied the presumption in few conflict preemption cases of
late, and arguments have been raised that the conflict
preemption analysis subsumes or supplants the presumption, see
Colacicco, 521 F.3d at 265, we will continue to apply the
traditional presumption until the Supreme Court provides
guidance to the contrary. Id. See also Hillsborough County,
471 U.S. at 715 (applying the presumption to implied
preemption claims). However, even where the presumption
applies it will be overcome where a Congressional purpose to
preempt or the existence of a conflict is “clear and manifest.”
Id.
2. Deference to Federal Agency Views
Tri-Union argues that “the FDA’s findings and opinion
set forth in the FDA Preemption Letter as well as its regulatory
approach (the FDA Advisory and Backgrounder) should be
afforded a high level of deference and/or persuasion.”
Appellee’s Br. at 24.
As we recently explained, “[w]e would ordinarily be
leery of an agency’s view of what is essentially a legal issue,”
Colacicco, 521 F.3d at 274, but in Geier v. American Honda
Motor Co., 529 U.S. 861 (2000), the Supreme Court “place[d]
some weight,” on the agency’s informal views of the purposes
and objectives of the regulation at issue and the agency’s view
that the state lawsuit would “stand as an obstacle” to those
objectives. Id. at 883. We concluded that “such a position is
subject to a level of deference approximating that set forth in
Skidmore v. Swift & Co., 323 U.S. 134 [] (1944).” Colacicco,
23
521 F.3d at 275. As with Skidmore deference, the agency’s
informal views are entitled to “a respect proportional to [their]
‘power to persuade’ . . . . [Such informal interpretations] claim
the merit of its writer’s thoroughness, logic and expertness,
[their] fit with prior interpretations, and any other sources of
weight.” Mead Corp., 533 U.S. at 235 (citation omitted).
However, Geier does not suggest that courts abdicate their duty
to examine whether federal and state law actually conflict –
Geier did not rely exclusively on the agency’s views, explaining
that it found the conflict “clear enough” even absent those
views. Geier, 529 U.S. at 886.
The District Court concluded that “the FDA’s Advisory
and Backgrounder are entitled to deference and [] the FDA
Letter is persuasive.” Fellner v. Tri-Union Seafoods, 2007 WL
87633, *7 (D.N.J. 2007). Geier and cases applying it have
afforded some weight to an agency’s informal interpretation of
the purposes and objectives of its regulations which are claimed
to preempt state law. However, the FDA’s Advisory and
backgrounder are not agency interpretations of regulations
claimed to preempt state law but rather are the very agency
actions which are claimed to preempt state law. We fail to
understand how a court could defer to those documents; they
offer no interpretation to which we can defer.
The FDA (indirectly) has offered its interpretation of the
purposes and objectives of the regulatory measures at issue in
this case in the Commissioner’s letter. We agree with the
District Court that Geier directs us to consider the views
expressed in that letter and, as we have explained, those views
are entitled to consideration proportional to their ability to
persuade: “The weight [accorded to an administrative]
24
judgment in a particular case will depend upon the thoroughness
evident in its consideration, the validity of its reasoning, its
consistency with earlier and later pronouncements, and all of
those factors which give it power to persuade, if lacking power
to control.” Mead Corp., 533 U.S. at 228 (quoting Skidmore,
323 U.S. at 140) (bracketed text in original). Here, however, we
do not find the letter persuasive. The circumstances of this letter
suggest that it merits a particularly low level of deference. The
views the FDA there offers, and the significance it there
attributes to its prior administrative actions, have not been
shown to be the product of any agency proceeding,8 were not
expressed at the time those actions were taken nor even at the
time that Fellner’s damages allegedly arose, and are certainly
8
The District Court granted the motion to dismiss relying
solely on the four documents of which it took judicial notice.
Accordingly, our record does not provide a full context for the
Commissioner’s letter. We can only say that the letter does not
itself purport to be the product of an agency proceeding, and the
record here does not show it to be. The record in the California
litigation does reveal that the Commissioner’s letter follows, and
bears a striking resemblance to, a letter and memorandum that
counsel at a private law firm – counsel who, according to his
public law firm biography, represents the canned tuna industry
in the California litigation – sent to the agency’s chief counsel
urging the FDA to “issue[] an appropriately worded letter”
asserting preemption over the litigation in California and
offering suggestions for the content of such a letter. The agency
had never before expressed such views. Those views apparently
were formulated without the benefit of exposure to conflicting
views or critiques.
25
not self-evident from the nature of the actions themselves. The
FDA expressed those views only later, through a most informal
of methods – a letter offering a legal theory for the litigation in
California. Most importantly, we simply do not find the letter’s
reasoning persuasive, for the reasons we set forth below.
C. Tri-Union’s Three Theories of Conflict Preemption
As we have explained, this is a conflict preemption case.
Therefore, Fellner’s state law claims will be impliedly
preempted if they are “in actual conflict with federal law.”
Sprietsma, 537 U.S. at 64. The Supreme Court has identified
two varieties of “conflict” preemption: (1) where “it is
impossible for a private party to comply with both state and
federal requirements,” and (2) where “state law stands as an
obstacle to the accomplishment and execution of the full
purposes and objectives of Congress.” English, 496 U.S. at 79
(internal quotation marks and citations omitted).
We begin our analysis by taking note of the authority that
Congress has bestowed on the FDA and the extent to which it
has exercised that authority in a relevant manner. The FDCA
grants the FDA authority to regulate the field of food safety. 21
U.S.C. § 371. The FDA has the authority, inter alia, to
promulgate food definitions and standards of food quality, id. at
§ 341, and to set tolerance levels for poisonous substances in
food. Id. at § 346. The FDA is also delegated enforcement
authority, including the authority to take various steps to
enforce the Act’s ban on “adulterated” or “misbranded” food.
Id. at §§ 331-336, 342-343. The FDA has, however,
promulgated no pertinent regulations under this authority.
26
Nevertheless, it has employed various other means to address
the risk of mercury in fish, including issuing a consumer
advisory and related “backgrounder” regarding those risks, and
including in its internal Compliance Guide a provision
recommending that the agency initiate enforcement action if
mercury concentrations in fish exceed a specified level. Tri-
Union offers three theories of conflict preemption based on
these actions.
1. Theory 1: Conflict with a Federal Regulatory Scheme
Tri-Union first argues that the FDA has adopted a
“pervasive regulatory approach” with which Fellner’s lawsuit
actually conflicts. Appellee’s Br. at 13, 18-20. This argument
suffers from two infirmities. First, as we have explained, state
law is preempted only by federal law. The FDA has
promulgated no pertinent legal standard pertaining either to the
risks posed by mercury in fish or to warnings for that risk, and
it has not otherwise acted on the issue in a manner that could be
deemed an exclusive application of federal law. Second, even
accepting arguendo the FDA’s “regulatory scheme” were of a
type that could preempt state law, Tri-Union has identified no
actual conflict between Fellner’s claims and the pertinent FDA
actions.
We cannot agree with the District Court that the FDA’s
Advisory and backgrounder “specifically regulate[]” the levels
of methylmercury in tuna and “specifically rejected the notion
that warning labels should be included on cans of tuna.”
Fellner, 2007 WL 87633 at *4. That Advisory, titled “What
You Need to Know About Mercury in Fish and Shellfish,” and
27
the related backgrounder, offer “[a]dvice” for “women who
might become pregnant[,] women who are pregnant[,] nursing
mothers[, and] young children,” App. at 35a, and provide “3
recommendations for selecting and eating fish” that such people
are advised to follow. Id. We are unable to conclude that the
Advisory and backgrounder “specifically regulate[]” anything
– they simply give non-binding advice to a class of consumers
and do not promulgate a federal legal standard with which
Fellner’s state law claims could potentially conflict.
Fellner’s lawsuit does not conflict with the “advice” in
those documents – the concerns expressed therein are entirely
consistent with, and arguably complementary to, a duty state law
may impose on manufacturers to warn consumers of the risks
posed by tuna consumption. See Bates, 544 U.S. at 449-51.
The mere fact that the FDA chose to warn only certain “at risk”
consumers, rather than all consumers, does not create a conflict.
Nothing in these documents indicates that consumers other than
those “at risk” individuals are not at risk of harm from mercury
in fish or that they should not be warned. The Advisory does
recommend continued fish consumption within certain
parameters, but that recommendation is clearly not inconsistent
with a warning against excess consumption.
Tri-Union also points to the FDA’s internal enforcement
guideline suggesting mercury levels which might prompt FDA
enforcement action, and the District Court similarly referenced
an FDA “tolerance level” of “1 ppm.” Fellner, 2007 WL 87633
at *2. See FDA Compliance Policy Guide, Section 540.600.9
9
Under the heading “Regulatory Action Guidance,” this
section offers “criteria for recommending legal action to
28
Based on this guideline, Tri-Union argues that “[t]he FDA has
determined that there is no hazard associated with
methylmercury concentrations of less than 1 ppm.” Appellee’s
Br. at 37. We find no such determination. Although the FDA
has authority to promulgate standards for food quality and
tolerance levels for poisonous foods, 21 U.S.C. §§ 341, 346, it
has not done so. The internal guideline for allocation of agency
resources “recommend[ed]” in the Compliance Policy Guide
will not alone preempt state law.
Furthermore, even if this guideline were deemed a
federal standard, Tri-Union fails to explain how Fellner’s
lawsuit would conflict with it. The guideline states that the
FDA may recommend enforcement action if methylmercury
concentrations in fish exceed “1 ppm.” Much like the Advisory,
the guideline appears entirely consistent with, and arguably
complementary to, a state claim that Tri-Union wrongfully
failed to warn consumers of the risks posed by those
compounds. We are aware of no facts establishing the precise
mercury concentrations in Tri-Union’s tuna products. Even if
Fellner had alleged a specific concentration lower than the FDA
guideline – for example, if Fellner had specifically averred that
Tri-Union’s tuna was dangerous because it contained mercury
at a concentration of 0.7 ppm – such a claim would not
necessarily be in conflict with this federal “standard.” On its
face the guideline does not state that tuna with mercury levels
CFSAN/Office of Compliance/Division of Enforcement: The
composite analyzed in accordance with the applicable methods
. . . shows: Mercury expressed as Methyl Mercury in excess of
1 ppm (edible portion only).” Id.
29
below 1 ppm poses no risk nor that a manufacturer has met any
particular standard of care if its tuna does not exceed 1 ppm; it
merely suggests that the FDA recommend enforcement action
if mercury levels exceed 1 ppm.10
In support of its “pervasive regulatory approach”
argument, Tri-Union also points to the Commissioner’s letter, in
which the Commissioner explains that the FDA prefers to
address the risks of mercury in fish through advisories rather
than warnings requirements due to the risk of overexposure to
warnings and the agency’s desire to promote moderate fish
consumption. We presume that this is a fair concern. However,
the FDA has not acted to regulate it in a manner that could
10
Tri-Union’s brief before us emphasizes that the FDA has
also conducted an educational campaign regarding mercury in
fish and that the FDA discussed mercury in its response to a
citizen’s petition. We have not been asked to take judicial
notice of these facts, and it is not clear to us that we could do so
in the context of a motion to dismiss and a complaint that does
not refer to them directly or indirectly. In any event, we fail to
see how an educational campaign might preempt Fellner’s
lawsuit, and we do not read the response to the citizen’s petition
to speak to a relevant issue. The citizen’s petition concerned not
the risks of mercury in fish specifically but rather the impact of
dietary supplements of “omega-3 fatty acids” on heart disease.
It discusses mercury risks only briefly, in the context of
mercury’s impact on the health effects of omega-3 fatty acids.
The FDA merely explained that it would decline to require that
the omega-3 fatty acid health claim be accompanied by a
mercury warning, not that all mercury warnings should be
affirmatively prohibited.
30
preempt Fellner’s claims. As we have explained, the letter itself
does not establish a federal policy against warnings capable of
preempting state law. As we have also explained, we do not
find persuasive the letter’s characterization of the FDA’s prior
actions on the subject as a “regulatory scheme” capable of
preempting Fellner’s claims.
We conclude that the FDA has regulated neither the risk
of mercury in tuna nor the permissible warnings regarding that
risk in a manner that conflicts with Fellner’s lawsuit.
2. Theory 2: A Federal Decision Not To Regulate
Tri-Union’s second theory of preemption is that the FDA
has “reject[ed] the use of warning labels,” Appellee’s Br. at 32
– that the FDA reached a “federal decision to forego regulation”
amounting to “an authoritative federal determination that the
area is best left unregulated,” a decision which preempts any
state standard or duty requiring such warnings. Id. at 31
(quoting Ark. Elec. Co-op., 461 U.S. at 384) (emphasis in
original). In Tri-Union’s view, just such a decision was made
when the Commissioner’s letter was dispatched. In that letter,
the Commissioner expressed the view that, because the FDA
after “studying the issue of methylmercury in fish for several
years,” App. at 42a, declined to require a warning and instead
issued an advisory, the California lawsuit would “frustrate the
carefully considered federal approach to advising consumers of
both the benefits and possible risks of eating fish and shellfish.”
Id. Although the federal government certainly may promulgate
a regulatory regime in which it decides that a particular issue is
best left unregulated, as the Supreme Court has explained, “to
say that [such a regime] can be created is not to say it can be
31
created subtly.” Isla Petroleum, 485 U.S. at 500. A mere
decision by the FDA not to adopt a federal warnings
requirement certainly does not alone preclude states from
imposing a duty to warn, and, as we have earlier indicated, we
find no authority for the proposition that the FDA could institute
a regime affirmatively proscribing all warnings obligations via
mere informal expressions of policy such as those in the
Commissioner’s letter. Id. at 501, 503 (“[t]here is no federal
preemption in vacuo, without a constitutional text or a federal
statute to assert it;” “unenacted approvals, beliefs, and desires
are not laws”).
While the FDA may well have the authority to
promulgate a regulatory scheme which would preclude any state
duty to warn consumers of the risks of mercury in tuna, it
simply has not done so. Tri-Union points to the
Commissioner’s letter, but as we have explained courts have
declined to permit agencies to promulgate express preemption
decisions by informal letter. In any event, we do not read the
letter as purporting to declare a new preemption policy; it
purports to be an explanation of what the FDA determined to do
in the past. As we have indicated, however, nothing in the
agency’s past actions indicates that it made an “authoritative
federal determination that the area is best left unregulated.”
We have no reason to doubt that the FDA has studied the
risks of mercury in fish, as the District Court found. However,
it made no “conclusive determination” of the sort which will
preempt state law – neither that mercury in fish poses no
adverse health consequences, nor to prohibit some or all
warnings. State law is not preempted whenever an agency has
32
merely “studied” or “considered” an issue; state law is
preempted when federal law conflicts with state law. As we
have explained, the cases leave no doubt that a mere decision
not to regulate – in this case, a decision not to require a federal
methylmercury warning – alone will not preempt state law. See
supra note 6 and accompanying text. As we have also
explained, we find no federal standard, mandate or regulatory
action on the subject with which Fellner’s claim conflicts nor
any federal determination precluding state regulation of the
issue.
3. Theory 3: The FDCA’s Food Misbranding Provision
Finally, Tri-Union contends that Fellner’s failure-to-warn
claim is preempted because that claim is premised on the theory
that it should have provided a warning regarding mercury in
fish, but the FDA would have deemed any such warning
“misbranding,” creating a conflict between the asserted state
duty and federal law. Appellee’s Br. at 33-37. Tri-Union
argues that the FDA would deem a warning false and misleading
because any such warning would not “specify the scientific basis
as to the cause of the harm warned of, and/or the amounts of
such food that were required to cause this harm,” Appellee’s Br.
at 34-35, and because a warning would not “balance out the
negative methylmercury information with positive information
about the numerous healthy attributes of canned tuna,” id. at 35,
resulting in overexposure to warnings and scaring consumers
away from a useful product. Id. In support of this claim, Tri-
Union points to the Commissioner’s letter, in which the
Commissioner opined that the “Proposition 65 warnings” – the
warnings requirement underpinning the California Attorney
33
General’s lawsuit – would be false or misleading for similar
reasons.
The FDCA’s general misbranding provision for food
provides, in pertinent part, that “[a] food shall be deemed
misbranded -- (a) False or misleading label[:] If (1) its labeling
is false or misleading in any particular . . . .” 21 U.S.C. §
343(a). FDA regulations further provide that “labeling of a
food, drug, device, or cosmetic shall be deemed to be misleading
if it fails to reveal facts that are: (1) Material in light of other
representations made or suggested by statement, word, design,
device, or any combination thereof . . . .” 21 C.F.R. § 1.21. The
FDCA renders unlawful, inter alia, the misbranding of food and
the distribution of misbranded food, id. at § 331(a)-(b), and it
authorizes the FDA to enforce those prohibitions via
enforcement actions in the United States District Courts for
injunctions or criminal penalties. Id. at §§ 332, 333. The FDCA
also delegates to the FDA certain additional tools to prevent
misbranding. The FDA may, and indeed must, officially express
its concerns with a warning or label before reporting a violation
to a United States Attorney for criminal proceedings, to afford
the regulated entity notice and an opportunity to present its
views. Id. at § 335. In the case of “minor violations,” the
agency may issue “a suitable written notice or warning.” Id. at
§ 336. The FDA is also delegated the authority affirmatively to
regulate food labels and warnings.11
11
See id. at §§ 341, 346, 371. The FDA has, for certain other
foods, exercised this authority by affirmatively requiring
particular warnings, see, e.g., 21 C.F.R. § 101.17, but it has not
exercised its regulatory authority in any manner pertinent to this
34
Had the FDA considered the factual basis for the alleged
duty to warn and exercised its misbranding authority to establish
that a warning based on that data would be false or misleading
under federal law – not merely that the FDA had failed to
require the warning, but had exercised its authority specifically
to reject it – our recent decision in Colacicco would govern and
a state failure-to-warn lawsuit would be preempted. However,
Tri-Union’s misbranding theory suffers from the same
shortcomings as its prior theories: it identifies no regulatory
action establishing mercury warnings as misbranding under
federal law, and it fails to explain how the regulatory concerns
it has identified actually conflict with Fellner’s lawsuit.
The FDA has taken no misbranding action pertaining to
the risk of mercury in tuna whatsoever. In the above-listed
provisions, Congress provided a broad spectrum of ways in
which the FDA may act in order to enforce the statutory
prohibition on misbranded food – “a suitable written notice or
warning;” an administrative proceeding of the type required to
precede a criminal prosecution; a federal court action seeking an
injunction or criminal penalties, and affirmative regulation.12
However, the FDA has taken no action pursuant to this
authority. Instead, the FDA merely expressed an informal
policy opinion in a letter, and it did so only after Fellner’s
injuries were allegedly suffered. We need not decide at what
point a particular warning becomes established as false and
case.
12
Ultimately, misbranding liability may be imposed only by
federal courts.
35
misleading for preemption purposes. Suffice it to say that the
FDA must actually exercise its authority in a manner in fact
establishing the state warning as false or misleading under
federal law; the informal views expressed in the Commissioner’s
letter will not preempt Fellner’s lawsuit.
Furthermore, as with its other preemption theories, Tri-
Union fails to identify an actual conflict between the FDA’s
concerns and Fellner’s claims. We perceive no actual conflict
between those concerns and Fellner’s lawsuit. Had Tri-Union
wished to warn consumers of those risks, as Fellner alleges it
should have, it is not apparent that Tri-Union would have been
unable to do so in a manner that satisfied both the alleged state
law duty and the FDA’s concerns. For example, a warning
certainly could have specified that the risks become material
only with frequent tuna consumption, and that moderate fish
consumption offers positive health benefits. For these reasons,
we find no actual conflict between the FDA’s misbranding
authority and Fellner’s lawsuit.
IV. Conclusion
This is a situation in which the FDA has promulgated no
regulation concerning the risk posed by mercury in fish or
warnings for that risk, has adopted no rule precluding states
from imposing a duty to warn, and has taken no action
establishing mercury warnings as misbranding under federal law
or as contrary to federal law in any other respect. Fellner’s
lawsuit does not conflict with the FDA’s “regulatory scheme”
for the risks posed by mercury in fish or the warnings
appropriate for that risk because the FDA simply has not
36
regulated the matter. Fellner’s duty-to-warn claim does not
conflict with an FDA determination deliberately to forego
warnings because the FDA took no action to preclude state
warnings – at least, no binding action via ordinary regulatory
procedures, and no action whatsoever until after Tri-Union
allegedly wrongfully failed to warn. Finally, Fellner’s lawsuit
does not conflict with the FDCA’s food misbranding provision
or the FDA’s actions thereunder because the FDA has not
exercised its misbranding authority under the FDCA with
respect to methylmercury warnings for fish.
The FDA has only issued a consumer advisory regarding
the risks posed by mercury in fish and established a guideline
regarding mercury concentrations to guide its enforcement
decisions. Neither of these agency acts constitutes a federal
legal standard or binding regulatory action on the subject which
could give rise to a conflict, and indeed neither expresses a
policy or viewpoint or approach inherently inconsistent with
Fellner’s lawsuit. In the final analysis, this case involves an
agency effort to preempt an area of law traditionally within the
states’ police powers via informal letter, and to do so only after
the conduct at issue in this case occurred. We understand the
precedent to require more of federal agencies to institute a
policy expressly precluding state regulation than a mere
informal letter, and neither the Commissioner’s letter nor Tri-
Union’s brief identifies any federal law with which Fellner’s
lawsuit might conflict. Although the Supremacy Clause
provides that state laws will give way when they actually
conflict with federal law, on this record we find no federal law
with which the alleged state duty to warn conflicts.
37
For the foregoing reasons, we will reverse the judgment
of the District Court and remand the case for further proceedings
consistent with this opinion.
38