Federal Appeals Court Revives 'Maximum Strength' Claims in Oral Phenylephrine Decongestant False Advertising Litigation
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A 2nd U.S. Circuit Court of Appeals panel revived portions of nationwide litigation alleging drugmakers sold billions of dollars in oral phenylephrine decongestants that were no better than placebo.
The court allowed claims over "maximum strength" labeling and brand-name drugs approved through the New Drug Application process to proceed, while preempting most state law-based claims.
An FDA advisory panel concluded in September 2023 that oral phenylephrine was ineffective as a decongestant, and the FDA proposed removing the ingredient from OTC cold medications in November 2024.
A federal appeals court on Thursday revived key portions of nationwide consumer litigation against major drugmakers and retailers over over-the-counter decongestants containing oral phenylephrine, an ingredient that a U.S. Food and Drug Administration advisory panel determined in September 2023 was no better than a placebo.
The litigation, comprising approximately 100 lawsuits, targets companies including Procter & Gamble, CVS, Bayer (search), GSK, Kenvue (search), Haleon, Costco, Target, Walgreens, and Walmart. Consumers allege the defendants sold billions of dollars of decongestant products that were entirely ineffective at relieving nasal congestion (search).
A three-judge panel of the 2nd U.S. Circuit Court of Appeals in Manhattan ruled that the Federal Food, Drug and Cosmetic Act preempted most of the consumers' state law-based claims, finding that the defendants had followed FDA labeling requirements. However, the court carved out two significant exceptions.
The panel revived claims specifically targeting decongestants labeled "maximum strength," determining that various defendants added that phrase on their own initiative rather than pursuant to FDA mandate. The court also revived claims over brand-name drugs approved through the federal New Drug Application process, reasoning that the defendants could have updated labels to reflect the latest scientific evidence.
"The limitations on consumer plaintiffs' state law remedies may appear unfair, particularly when the FDA's own agency review has confirmed that oral PE does not work as a decongestant and when studies have impugned oral PE's efficacy for 20 years," Circuit Judge Denny Chin wrote. "The fix, however, must flow not from litigation but from the FDA."
The court also held that consumers lacked standing to pursue a civil racketeering claim accusing the defendants of defrauding the public and the FDA.
Jonathan Selbin, a lawyer representing the consumers, expressed disappointment with portions of the ruling but emphasized the litigation is ongoing. "For over a decade these manufacturers made billions of dollars selling products with a decongestant that they long knew — in many cases based on their own studies — was entirely ineffective at decongesting," Selbin said. "This case is far from over."
The products at issue include widely used brands such as Vicks NyQuil Severe Cold & Flu, manufactured by Procter & Gamble, and Advil Sinus Congestion & Pain, made by Haleon. Lawyers for the defendant companies did not immediately respond to requests for comment.
The appeals court returned the litigation to U.S. District Judge Brian Cogan in Brooklyn, who had dismissed it in October 2024. In November 2024, the FDA formally proposed removing oral phenylephrine as an ingredient in over-the-counter oral cold medications, signaling a potential regulatory resolution to the long-running scientific debate over the ingredient's efficacy.