Opinion ID: 3035915
Heading Depth: 3
Heading Rank: 2

Heading: Deference to Federal Agency Views

Text: 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,  (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. 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 . 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 . 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, TriUnion 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, 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.