Appeals court revives false advertising claims over 'maximum strength' decongestants |
A U.S. federal appeals court has revived parts of consumer litigation against major drugmakers and retailers, allowing claims to proceed over over-the-counter decongestants marketed as "maximum strength" despite containing oral phenylephrine, an ingredient the FDA concluded is no more effective than a placebo. The court also reinstated claims involving brand-name drugs approved through the FDA's New Drug Application process, ruling manufacturers could have updated product labels to reflect evolving scientific evidence. However, the court dismissed most state law claims, finding they were preempted because manufacturers complied with FDA labeling requirements, and rejected a civil racketeering claim. The litigation, involving companies including Procter & Gamble, Haleon, Bayer, GSK, Kenvue, CVS, Walgreens, Walmart, Target, and Costco, returns to the district court after the FDA proposed removing oral phenylephrine from over-the-counter oral cold medicines in 2024.