The court rejected the FDA's assertion of a "pervasive regulatory approach" that consisted only of a consumer advisory, an internal enforcement guideline, and informal correspondence outlining its theory of preemption. The court held that it could not defer to the FDA's interpretations when there was no federal law to be interpreted. Fellner v. Tri-Union Seafoods LLC, --- F.3d ---, 2008 WL 3842925 (3d Cir. Aug. 19, 2008) (No. 07-1238).

This issue previously arose in California, where the state Attorney General sued Tri-Union to force compliance with state labeling standards. The FDA Commissioner sent the AG a letter outlining its view that California law was preempted. A state court agreed with the FDA, but the case is on appeal. People v. Tri-Union Seafoods, 2006 WL 1544384 (Cal.Super. 2006). Fellner is a Pennsylvania woman who ate almost nothing besides Tri-Union tuna for five years, and contracted severe mercury poisoning.

The FDA pointed to four documents to establish preemption: 1) a 2004 consumer advisory  on mercury risks; 2) a "backgrounder"  accompanying the advisory; 3) an internal guideline recommending enforcement action when the concentration of mercury in fish exceeds 1 part per million; and 4) the Commissioner's letter to the California AG.

The court noted that the Supreme Court has not applied the traditional presumption against preemption in a number of recent cases. Indeed, in the 2007-08 term, only the dissenters even mentioned the presumption. However the court said it would "continue to apply the traditional presumption until the Supreme Court provides guidance to the contrary."

On the question of Chevron deference, the federal court refused to defer to the FDA. The court said that the agency's advisory and backgrounder were not interpretations of regulations, "but rather are the very agency actions which are claimed to preempt," and therefore "they offer no interpretation to which we can defer." To the extent that the Commissioner's letter offered interpretation of the FDA's actions, it did not merit deference because it has "not been shown to be the product of any agency proceeding," was apparently "formulated without the benefit of exposure to conflicting views," and was issued after the alleged injuries in this case

The court began its analysis with the proposition that only federal law can preempt. That law can arise from a statute, a regulation, or an agency order arising from a "quasi-judicial" proceeding. The court recently found preemption when the FDA had repeatedly considered and consistently refused to require certain drug warnings in the context of formal approval decisions. Colacicco v. Apotex Inc., 521 F.3d 253 (3d Cir. 2008) (summary here ). However, "federal law" is not created "every time someone acting on behalf of an agency makes a statement or takes an action within the agency's jurisdiction."

Accordingly, the FDA's "non-binding advice" to consumers is not a federal legal standard. Similarly, an internal enforcement guideline is not federal law, because it does not set a standard of care but rather suggests an appropriate use of agency resources. Similarly, the Commissioner's letter does not create a preemptive federal policy against certain warnings. Because the agency's decision not to regulate was never formalized in a regulation or quasi-judicial proceeding, it is not federal law. While preemption would occur if the agency used its misbranding authority to forbid warnings required by state law, the FDA has not done so here. Accordingly there is no federal law that can preempt.

This case illustrates the increasingly aggressive approach of federal agencies to preemption. The scope of the FDA's authority to preempt remains unclear, and will be clarified by the Supreme Court next term in Wyeth v. Levine. But the Third Circuit makes clear in this case that whatever the agency's authority to preempt, it cannot do so through inaction or mere opinion