The U.S. Food and Drug Administration (FDA) has proposed the removal of over-the-counter (OTC) nasal decongestants.
The FDA announced its intention to remove oral phenylephrine, an active ingredient in many over-the-counter drugs.
After reviewing comprehensive scientific data, the FDA determined that oral phenylephrine is ineffective in relieving nasal congestion despite being widely used for this purpose.
Companies may continue selling OTC products containing oral phenylephrine, but the proposed order signals a major shift.
If finalized, the decision would mean that drug manufacturers could no longer market products with oral phenylephrine as a nasal decongestant.
The FDA says that the proposal is based on concerns about effectiveness, not safety.
“It is the FDA’s role to ensure that drugs are safe and effective,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER).
“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.”
Oral phenylephrine has been a common ingredient in numerous OTC products for decades, including those targeting symptoms of colds, allergies, and asthma.
After reviewing data from 30 years ago as well as recent clinical findings, an FDA Nonprescription Drug Advisory Committee concluded that current scientific evidence does not support oral phenylephrine’s effectiveness as a nasal decongestant.
“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,” said Theresa Michele, M.D., director of the Office of Nonprescription Drug Products in CDER.
“Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms.”
Importantly, the FDA clarified that its proposal affects only orally administered phenylephrine and not phenylephrine nasal sprays, which remain effective for nasal congestion relief.
Consumers are advised to carefully read drug labels to understand ingredient lists, especially since some products contain oral phenylephrine alongside other active ingredients like acetaminophen or dextromethorphan, which remain effective for their intended uses according to the FDA.