US Courts Allow Decongestant False Advertising Lawsuits to Proceed

The U.S. Second Circuit Court of Appeals largely upheld a lower‑court ruling that state‑law claims against manufacturers of oral phenylephrine‑based decongestants are preempted by the Food and Drug Administration (FDA) because the companies complied with FDA labeling requirements. However, the court allowed claims challenging the use of "maximum strength" or "max strength" on product labels to move forward, finding that the FDA has not required or endorsed such wording.

Separately, a U.S. district judge cleared the way for class‑action lawsuits against major drugmakers and retailers, alleging they marketed oral phenylephrine as an effective nasal decongestant despite scientific evidence that the ingredient provides little to no benefit in pill form. The litigation also targets the "maximum strength" label as a potentially misleading claim that may have deceived consumers.

Both decisions leave open the possibility of further litigation on non‑monograph, brand‑name drugs and on false‑advertising allegations, while RICO claims were dismissed for lack of standing.