Cigar Industry Loses Appeal in Latest FDA Lawsuit Ruling


Another part of the challenge came with the Deeming Rule’s effective date. The trade associations argued that the Deeming Rule was “arbitrary and capricious” because the FDA based the Deeming Rule’s effective date and the substantial equivalence reports’ due date on the assumption that it “could set an initial due date for substantial equivalence reports, as it could always adjust the due date later.”

To this, the court responded: “This contention fails on its own terms. Even assuming the FDA misconceived the law, appellants fail to show that FDA set Rule’s effective date and due date for substantial equivalence reports ‘based on’ those misconceptions.”

The court also goes on to state the FDA only has the authority to exempt tobacco products from premarket review that “are modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive.” Current regulations, the court argues, do not grant the FDA “authority to eliminate any of the Tobacco Control Act’s premarket review requirements, including the grandfather date.”

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