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Washington Supreme Court hears dispute over Walgreens’ “non drowsy” label

Supreme Court of Washington · September 26, 2024
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Summary

The Washington Supreme Court on Sept. 26, 2024, heard arguments in Tracy Hall v. Walgreens over whether Walgreens’ prominent “non drowsy” label on a DXM-containing cough medicine is protected by the Consumer Protection Act’s safe-harbor exemption because the FDA has regulated drowsiness labeling. Counsel disagreed about whether the FDA’s monograph constitutes specific permission for an affirmative label claim.

The Washington Supreme Court heard oral argument on Sept. 26, 2024, in Tracy Hall v. Walgreens Boots Alliance Inc., a case about whether Walgreens’ prominent “non drowsy” label on an over‑the‑counter cough medicine is shielded from the state Consumer Protection Act by a statutory safe harbor for conduct "permitted, prohibited, or regulated" by federal regulators.

Emily Weisenberger, counsel for Walgreens Boots Alliance Inc., told the court the FDA has already addressed drowsiness labeling for antitussive drugs and that the agency’s monograph places dextromethorphan (DXM) products in a category that does not require a drowsiness warning. “The FDA specifically regulated the labeling on drowsiness,” Weisenberger said in opening, arguing that the existence of that federal regulation informs…

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