The Food and Drug Administration (FDA) has announced a proposal to ban oral phenylephrine, an ingredient widely used in over-the-counter (OTC) nasal decongestants. This decision follows new research suggesting the ingredient is ineffective when taken orally, either as a pill or syrup, raising questions about its utility in treating nasal congestion.
Ineffective Oral Decongestant
The FDA's proposal is rooted in the assessment of available data, including a September 2023 conclusion by the agency's Non-Prescription Drug Advisory Committee. The committee determined that newly available data did not support the effectiveness of oral phenylephrine as a decongestant. Studies indicated that less than 1% of the ingested ingredient is absorbed into the bloodstream, casting doubt on its ability to provide meaningful relief from nasal congestion.
Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, stated, “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.”
Impact on Common Medications
Oral phenylephrine is a common component in numerous cough and cold medications, including well-known brands such as NyQuil, Benadryl, Sudafed, and Mucinex. In some formulations, it is the sole active ingredient, while in others, it is combined with other drugs like acetaminophen or dextromethorphan. The FDA has clarified that there are no safety concerns associated with the use of these drugs.
Industry Response and Next Steps
In anticipation of the FDA's action, CVS, a major pharmacy chain, had already removed decongestants containing only oral phenylephrine as the active ingredient from its shelves. The FDA's proposal will be subject to a period of public comment before the agency makes a final determination. If the ban is implemented, manufacturers will be given sufficient time to reformulate their products or remove them from the market. It is important to note that nasal sprays containing phenylephrine are not affected by this proposal.
The Consumer Healthcare Products Association (CHPA), a trade group representing consumer healthcare product manufacturers, expressed disappointment with the FDA’s proposal. They argue that the decision contradicts the agency's long-held view on oral phenylephrine and should be considered within the context of the broader body of evidence.
Alternative Treatments
Dr. Theresa Michele, director of the FDA’s Office of Nonprescription Drug Products, highlighted 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.” This suggests that consumers have alternative options for managing nasal congestion while the FDA's proposal is under consideration.
