Selected passages from the lengthy ruling in R.J. Reynolds Tobacco v. FDA, drafted by Judge Don Willett and joined, to the extent relevant, by Judges Leslie Southwick and James Ho:
When Congress enacts laws in broad terms, constitutional concerns can ensue. This case presents the converse: Congress laid down a precise framework, while the agency treated that precision as if it were optional. Under the Family Smoking Prevention and Tobacco Control Act (TCA), Congress established a detailed scheme with nine mandated warning statements that must appear on cigarette packaging and advertising, while giving the Food and Drug Administration (FDA) only limited, conditional power to modify it. The FDA’s rule, however, mandates eleven warnings, prompting several cigarette manufacturers and retailers (the Plaintiffs) to challenge it.
At this initial stage, the statutory language points in one direction: the FDA may require only the nine warnings Congress prescribed—no more. The district court concurred and stayed the Rule’s effective date after concluding that the Plaintiffs had shown a substantial likelihood of success on the claim that the FDA exceeded its statutory authority. Because that interim relief rested on proper discretion, we AFFIRM….
In this context, the TCA prohibits it as unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution cigarettes if the packaging fails to bear… one of the following labels[.]” The statute then enumerates nine warning labels addressing specific health risks associated with smoking:
- WARNING: Cigarettes are addictive.
- WARNING: Tobacco smoke can harm your children.
- WARNING: Cigarettes cause fatal lung disease.
- WARNING: Cigarettes cause cancer.
- WARNING: Cigarettes cause strokes and heart disease.
- WARNING: Smoking during pregnancy can harm your baby.
- WARNING: Smoking can kill you.
- WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
- WARNING: Quitting smoking now greatly reduces serious risks to your health….
Congress also directed the FDA to “issue regulations that require color graphics depicting the negative health consequences of smoking to accompany the label statements specified in subsection (a)(1).” These text-and-graphic pairings must appear on the top 50 percent of the front and rear panels of cigarette packages and at least 20 percent of cigarette advertisements. The warning statements must also comply with precise placement, rotation, and formatting requirements. Despite the TCA’s intricate specification, it grants the FDA only modest authority to adjust the warnings in two limited ways….
[A later FDA Rule] discarded all but two of Congress’s nine statutory warnings and substituted statements drafted by the FDA itself. As a result, the Rule requires cigarette manufacturers and retailers to display a rotating total of eleven warning statements—rather than the nine enumerated in § 1333(a)(1)—each paired with a graphic image illustrating a smoking-related health harm… [:]
… As always, the accusation begins with the statutory text—”the alpha and the omega of the interpretive process.” The operative provision here, § 1333(a)(1), declares it unlawful to sell or distribute cigarettes whose packaging “fails to bear, in accordance with the requirements of this section, one of the following labels.” It then immediately prescribes the specific labels to be used. Seldom is statutory language so precise. The directive requires a package to bear “one of the following labels” and then enumerates nine; yet the FDA would interpret that as eleven. Nine is not a placeholder for eleven….
Take a familiar comparison: if a restaurant menu offers customers the option to choose “one of the following sides” and the list shows nine choices, an ordinary diner does not take that as authority to request a tenth non-listed item. Some trendy spots may publish a secret menu; the United States Code does not. Congress supplied a list of nine labels and mandated that sellers and manufacturers use one of them on a rotating basis. But the Rule deviates from that instruction. Instead, it requires packages and advertisements to rotate among eleven warnings—two beyond what Congress enumerated. A package bearing one of the extra labels thus fails to carry “one of the following labels” as Congress defined it. That plain reading suffices here….
Congress sometimes speaks in broad, general terms. Yet in the TCA, Congress avoided such vagueness. And when Congress chooses precision, agencies must honor that preference, not rewrite it. Precision in legislation leaves no room for improvisation in its execution….
Amelia DeGory, Christian George Vergonis, and Ryan Jeffrey Watson (Jones Day) represent plaintiffs.
