FDA proposes ban on ineffective oral phenylephrine for decongestion

In November 2024, the U.S. Food and Drug Administration (FDA) announced a significant regulatory decision regarding oral phenylephrine, a common ingredient in over-the-counter nasal decongestants. The FDA's review, which included recent scientific data, concluded that oral phenylephrine is not effective in relieving nasal congestion. This finding marks a notable shift from when it was first deemed effective 30 years prior. Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, highlighted the FDA's commitment to ensuring drug safety and efficacy. The proposed removal of orally administered phenylephrine hydrochloride and phenylephrine bitartrate would amend the FDA's over-the-counter monograph, impacting products that contain phenylephrine solely or in combination with other active ingredients. The FDA has been proactive in ensuring clarity for consumers, stating that the presence of phenylephrine does not negatively affect the efficacy of alternative active ingredients in multi-ingredient products. Prior to this proposal, a Nonprescription Drug Advisory Committee convened last fall and unanimously agreed that new scientific data did not support phenylephrine's effectiveness as a nasal decongestant. The next steps involve the FDA finalizing this proposed order, which would require public comments through to May 7, 2025, allowing stakeholders to voice their opinions on the matter. Meanwhile, manufacturers can continue marketing products containing phenylephrine as nasal decongestants until the regulation is finalized. This decision underscores the FDA's role as a regulatory body focused on drug effectiveness. While there are no safety concerns regarding the use of phenylephrine reported, the FDA's finding raises significant implications for consumers who rely on these products for relief. The landscape of over-the-counter nasal decongestants may change profoundly if the FDA's proposal is enacted, as it challenges a product that has been in widespread use for decades.