In the majority opinion, the appeals court wrote that the case raises "novel questions about the scope of the government's authority to force the manufacturer of a product to go beyond making purely factual and accurate commercial disclosures and undermine its own economic interest - in this case, by making `every single pack of cigarettes in the country (a) mini billboard' for the government's anti-smoking message." The court also wrote that the FDA "has not provided a shred of evidence" showing that the warnings will "directly advance" its interest in reducing the number of Americans who smoke

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Mediation was assessed separately for each outcome using the Karlson-Holm-Breen (KHB) method that extends the linear regression framework to the ordinal logistic regression framework 30
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