Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca3-07-01238/USCOURTS-ca3-07-01238-0/pdf.json

Nature of Suit Code: 365
Nature of Suit: Personal Injury - Product Liability
Cause of Action: 

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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

Case: 07-1238 Document: 00312021951 Page: 1 Date Filed: 08/19/2008
2

(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

 

Case: 07-1238 Document: 00312021951 Page: 2 Date Filed: 08/19/2008
3

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 TriUnion’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 TriUnion’s tuna products. She further avers that those products

contained methylmercury and other harmful compounds that can

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 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

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:58C1, 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 TriUnion 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

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5

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

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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” –

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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)

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 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).

 3Courts 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

“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 TriUnion’s brief as asserting a field preemption claim, and any

such claim would be unavailing.3

 If preemption exists in this

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more reluctant to infer preemption from the comprehensiveness

of regulations than from the comprehensiveness of statutes . .

.”). In this case, the “regulatory scheme” identified by TriUnion and the Commissioner’s letter fall far short of the sort of

comprehensive federal program ordinarily addressed in field

preemption cases. 

9

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: 

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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

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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’ quasilegislative 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

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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

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13

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

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 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

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

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15

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

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 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

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

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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

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

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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

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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

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. 

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20

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

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 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

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

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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. KerrMcGee 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

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. 

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23

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,

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24

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]

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 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

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

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26

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.

Case: 07-1238 Document: 00312021951 Page: 26 Date Filed: 08/19/2008
27

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. TriUnion 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

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 9

Under the heading “Regulatory Action Guidance,” this

section offers “criteria for recommending legal action to

28

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

Case: 07-1238 Document: 00312021951 Page: 28 Date Filed: 08/19/2008
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

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

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 10Tri-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

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

Case: 07-1238 Document: 00312021951 Page: 30 Date Filed: 08/19/2008
31

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

Case: 07-1238 Document: 00312021951 Page: 31 Date Filed: 08/19/2008
32

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

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33

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, TriUnion points to the Commissioner’s letter, in which the

Commissioner opined that the “Proposition 65 warnings” – the

warnings requirement underpinning the California Attorney

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 11See 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

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

Case: 07-1238 Document: 00312021951 Page: 34 Date Filed: 08/19/2008
case. 

 12Ultimately, misbranding liability may be imposed only by

federal courts.

35

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

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36

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, TriUnion 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

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37

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 TriUnion’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.

Case: 07-1238 Document: 00312021951 Page: 37 Date Filed: 08/19/2008
38

For the foregoing reasons, we will reverse the judgment

of the District Court and remand the case for further proceedings

consistent with this opinion.

Case: 07-1238 Document: 00312021951 Page: 38 Date Filed: 08/19/2008