The U.S. Food and Drug Administration (FDA) proposed a significant regulatory change to ban oral phenylephrine on Thursday, November 7th, a popular ingredient in over-the-counter (OTC) cold and allergy medications. The decision comes after an extensive review concluding that oral phenylephrine does not effectively relieve nasal congestion, a finding supported by a unanimous vote from FDA advisors last year. This proposal impacts well-known products like NyQuil, Sudafed, and Benadryl, which would need reformulation if the order becomes final.
The FDA’s proposed ban is based on efficacy rather than safety. Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, stated, “We are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.” Though companies can still sell products containing phenylephrine for now, the ban would force drugmakers such as Procter & Gamble and Bayer to consider alternatives for their popular medications.
This move follows a petition by University of Florida researchers, whose studies indicated that phenylephrine was no better than a placebo in treating nasal congestion. FDA staff have noted that only a minimal amount of the drug reaches the nasal passages, even in higher doses. The FDA panel found no new evidence from the Consumer Healthcare Products Association to counter these findings, though the group warned that removing oral phenylephrine could inconvenience consumers.
Phenylephrine became a staple in OTC medicines in 2006 after its predecessor, pseudoephedrine, was moved behind pharmacy counters due to its potential for misuse in methamphetamine production. With phenylephrine now on the chopping block, patients may need to turn to alternatives like nasal sprays or pseudoephedrine, both of which the FDA’s proposal does not affect.
This potential shift could disrupt the industry, with retailers like CVS and Walgreens possibly impacted as well. In 2022 alone, sales of phenylephrine-based products reached $1.8 billion. A final order from the FDA would require these products to be pulled from shelves, reshaping the OTC cold and allergy market significantly.
