Sept 12, 2023 – Phenylephrine, first permitted for use in 1938, didn’t go through the rigorous clinical trials that regulators require today for medications, and more recent studies found the ingredient to be ineffective at relieving congestion. The latest research prompted pharmacists and physicians to call for ending the sales of the drugs. 

“I do not believe that the evidence that was presented supports in any way the efficacy of this product remaining on the market,” said Diane Ginsburg, a panel member and associate dean for Healthcare Partnerships at the University of Texas at Austin College of Pharmacy. “We really should not have products on the market that are not effective.”  

The FDA panel’s unanimous vote clears the way for the agency to remove oral phenylephrine from its list of approved over-the-counter ingredients. That would mean that products containing the ingredient couldn’t be sold in the U.S. 

The FDA doesn’t have to follow the recommendations of its advisory panels, but it often does. 

Over-the-counter products that treat cough, sinus and flu symptoms, including phenylephrine pills, generated about $5 billion in sales in 2021, according to the research firm IRI.