FDA Issues Proposed Order to Remove Oral Phenylephrine from OTC Nasal Decongestants and Seeks Public Comment

The U.S. Food and Drug Administration (FDA) announced today a proposal to eliminate oral phenylephrine as an approved active ingredient in over-the-counter (OTC) monograph drug products used for temporary nasal congestion relief. Following a detailed review of existing data, the FDA determined that oral phenylephrine is not effective as a nasal decongestant. For the time being, manufacturers may continue selling OTC products containing oral phenylephrine. However, if this proposed order is finalized, only a subsequent final order would restrict the marketing of these products.

Oral phenylephrine is currently a common ingredient in many OTC nasal decongestants, sometimes as a single active ingredient and at other times combined with other ingredients, such as acetaminophen or dextromethorphan, which remain unaffected by this proposed change.

“As part of the FDA’s mission to ensure drug safety and effectiveness, we are moving forward with this proposal to remove oral phenylephrine as a nasal decongestant,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER). “Our review aligns with the Nonprescription Drug Advisory Committee’s conclusion that oral phenylephrine does not effectively relieve nasal congestion.”

The FDA reviewed a comprehensive body of data, including both historical and recent clinical studies, to assess oral phenylephrine’s efficacy. Last fall, the FDA held an advisory committee meeting to discuss the status of oral phenylephrine as a ‘Generally Recognized as Safe and Effective’ (GRASE) ingredient for nasal decongestion. The committee’s unanimous conclusion was that current scientific data do not support the effectiveness of oral phenylephrine at recommended OTC doses.

“Consumers should be aware that various safe and effective treatments are available to alleviate nasal congestion from common colds or allergies,” said Dr. Theresa Michele, director of the Office of Nonprescription Drug Products in CDER. “Patients should consult their doctor or pharmacist to find effective symptom relief options.”

The FDA encourages consumers to read the Drug Facts label to confirm ingredients and understand important usage directions, especially since some products may share the same brand name but contain different ingredients. It’s also essential to note that this proposed action only affects orally administered phenylephrine, not phenylephrine in nasal spray form.

The FDA is currently seeking public comments on this proposed order. Instructions for submitting comments are available on OTC Monographs@FDA. Should the FDA decide to finalize the order, manufacturers would be given time to either reformulate or remove products with oral phenylephrine as a nasal decongestant from the market.