WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has taken a pivotal step in consumer protection by proposing the removal of oral phenylephrine as an active ingredient in over-the-counter (OTC) monograph drug products intended for nasal decongestion. This proposed order follows a rigorous evaluation of existing data, which led the agency to conclude that oral phenylephrine is not an effective remedy for nasal congestion.
Oral phenylephrine has been a staple in many OTC medications, marketed for its decongestant properties. However, the FDA’s comprehensive review—which included decades-old data as well as more recent clinical studies—has cast doubt on its efficacy. This analysis was further supported by the unanimous decision of the Nonprescription Drug Advisory Committee, which, after examining the current scientific evidence, agreed that oral phenylephrine does not meet the effectiveness criteria at the recommended dosages.
Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, emphasized the agency’s commitment to ensuring that drugs available to the public are both safe and effective. She stated that the decision to propose removing oral phenylephrine aligns with expert advice and a thorough review process.
The FDA’s proposal is significant not only for consumers but also for manufacturers. While consumers are assured of a plethora of alternative treatments for congestion due to colds or allergies, manufacturers face the decision to either reformulate products containing oral phenylephrine or remove them from the market altogether, should a final order be issued.
In the interim, consumers are advised to continue reading Drug Facts labels to ascertain the contents of their medications, especially since some products may combine phenylephrine with other active ingredients. Importantly, this proposal does not affect the nasal spray form of phenylephrine, which remains a viable treatment option.
The FDA is currently soliciting public comments on this proposed order, with instructions for submission available on the OTC Monographs@FDA platform. The feedback gathered will influence the final decision, determining whether oral phenylephrine will be excised from the OTC monograph as a nasal decongestant.
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