FDA Declares Oral Phenylephrine Ineffective, Proposal Could Impact Key OTC Decongestants

The U.S. Food and Drug Administration (FDA) has put forth a proposal to exclude oral phenylephrine from the list of approved active ingredients in over-the-counter (OTC) products meant to provide short-term relief for nasal congestion. This recommendation follows a review by the agency, which found that oral phenylephrine does not effectively alleviate this condition. At this stage, however, companies are permitted to continue selling OTC nasal decongestants containing oral phenylephrine, as this is only a proposed change, not a final ruling. This proposal arises from concerns over efficacy rather than safety.

Oral phenylephrine is currently a common ingredient in many OTC nasal decongestants. Some products contain only phenylephrine, while others include it alongside ingredients like acetaminophen or dextromethorphan. Importantly, the presence of phenylephrine does not impact the effectiveness of these additional ingredients for their intended uses.

Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER), said in a statement, “It is the FDA’s role to ensure that drugs are safe and effective. Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”

Theresa Michele, M.D., director of the Office of Nonprescription Drug Products in CDER, mentioned, “Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold. Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms.”

The FDA recently undertook a thorough evaluation of all existing research on the safety and effectiveness of oral phenylephrine, revisiting older studies that led to its initial approval as an effective nasal decongestant 30 years ago and examining newer clinical findings. 

Last fall, the agency also convened a meeting with its Nonprescription Drug Advisory Committee to assess whether oral phenylephrine should still be classified as ‘Generally Recognized as Safe and Effective’ (GRASE) for use as a nasal decongestant. After reviewing updated data on its effectiveness, the committee unanimously agreed that the current scientific evidence does not validate the effectiveness of orally administered phenylephrine at the recommended dosage found in OTC cold, cough, allergy, bronchodilator, and antiasthmatic medications.

To ensure safe and effective use of medications, it's essential for consumers to check the Drug Facts label, as different products with the same brand name may contain various ingredients and may come with specific warnings and usage instructions. Phenylephrine, for example, is commonly found in nasal sprays for congestion relief. However, the FDA’s current focus is on oral phenylephrine products, not those administered via nasal spray.

The FDA is also inviting public feedback on a proposed rule regarding oral phenylephrine, with details on how to submit comments available in the proposal on OTC Monographs@FDA. Should the agency determine, after review, that oral phenylephrine lacks efficacy as a nasal decongestant, a final ruling would be issued to remove it from the OTC monograph. This would mean that future over-the-counter products could no longer include oral phenylephrine as a decongestant, giving manufacturers a set timeframe to reformulate or discontinue these products.