The U.S. Food and Drug Administration(FDA) has proposed to ban oral phenylephrine, an active ingredient in popular decongestants and cold medications, citing its lack of effectiveness.
Several cold medications, including Advil, Vicks NyQuil, Sudafed PE, Robitussin, Benadryl Allergy Plus Congestion, Tylenol, and Theraflu, contain oral phenylephrine. In some, it is the only active ingredient, while others combine it with acetaminophen or dextromethorphan.
Officials clarified that the proposed ban is unrelated to the safety of phenylephrine and does not affect the nasal spray form of phenylephrine.
Companies may continue selling products containing oral phenylephrine until the order is finalized. The public can submit feedback on the FDA’s proposal until May 7, 2025. However, after this comment period, if the FDA finalizes its decision to revoke oral phenylephrine’s status as “generally recognized as safe and effective” (GRASE), manufacturers would need to either remove or reformulate products containing the ingredient. The FDA stated it would allow manufacturers an appropriate transition period in such cases.
“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,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER) in a news release.
Meanwhile, officials urge consumers to be mindful of the ingredients in over-the-counter (OTC) medications, advising them to read the drug facts label and follow important warnings and directions for use.
“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,” said Dr. Theresa Michele, director of the Office of Nonprescription Drug Products in CDER.
However, the Consumer Healthcare Products Association’s (CHPA) officials said they are “disappointed” with the proposed ban and maintained its position that “no changes to the GRASE status of oral PE (Phenylephrine) for nasal decongestion are warranted.”
“PE should remain an available option for consumers because Americans deserve the option to choose the safe and effective OTC medicines they prefer and rely on,” CHPA said in a news release.
