The FDA announced on Wednesday its intent to remove a widely used ingredient, oral phenylephrine, from the market after concluding that it’s ineffective as a nasal decongestant. This proposal follows a recommendation from the agency’s advisers over a year ago, who questioned the initial data supporting its approval and highlighted recent studies casting doubt on its effectiveness.
Oral phenylephrine, found in many common over-the-counter medications like Advil, NyQuil, Sudafed, Robitussin, Tylenol, and Theraflu, has been a key ingredient in cold and cough products for years. However, according to Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, the agency’s review confirmed that oral phenylephrine does not effectively relieve nasal congestion. The FDA has now proposed removing it from the approved ingredient list for over-the-counter cough and cold products.
The public has until May 7 of next year to comment on this proposal. If finalized, the decision would require drugmakers to reformulate or remove products containing oral phenylephrine. The FDA has committed to providing manufacturers with a transition period.
The Consumer Healthcare Products Association expressed disappointment, claiming no changes to the ingredient are needed and that Americans deserve access to their preferred over-the-counter medications. However, CVS had already begun pulling products solely containing phenylephrine after the advisory committee’s vote last year.
Researchers from the University of Florida, who have long advocated for phenylephrine’s removal, cited data indicating that very little of the drug is absorbed when taken orally, unlike nasal sprays which deliver a higher concentration to the bloodstream. The FDA’s recent scientific review supported these findings, revealing that outdated methods likely overestimated absorption rates, with less than 1% of the drug reaching the bloodstream in pill form.
Though oral phenylephrine poses no safety risks at current doses, achieving meaningful results might require dangerously high dosages. The FDA’s scientists stated that no clinical data support the effectiveness of oral phenylephrine as a nasal decongestant at any dosage.