The U.S. Food and Drug Administration (FDA) has proposed the removal of oral phenylephrine—a common active ingredient in many over-the-counter cold and cough medicines—from products marketed as treatments for nasal congestion, citing its lack of effectiveness.
Phenylephrine is widely used in household brands such as Benadryl, Advil, and Tylenol, among others. While the ingredient is also present in nasal sprays, the FDA’s proposal applies only to orally administered phenylephrine and not to nasal spray formulations.
Expert Panel’s Verdict
This move follows a unanimous decision last year by an external panel of experts, which concluded that oral phenylephrine is ineffective as a nasal decongestant. The panel deemed additional clinical trials unnecessary to reaffirm this finding.
Legal and Consumer Implications
Pharmaceutical giants, including Procter & Gamble and GSK, have faced lawsuits alleging they misled consumers by marketing products containing oral phenylephrine as effective treatments for congestion.
The FDA has opened the proposal for public comment, inviting stakeholders to share their perspectives on the matter.
Next Steps for Manufacturers
For now, companies may continue to sell over-the-counter products containing oral phenylephrine. However, the FDA plans to provide manufacturers with a transition period to either reformulate their products or withdraw them from the market.
In response, the Consumer Healthcare Products Association expressed disappointment, stating:
“We are disappointed in the FDA’s proposal to reverse its long-standing view of oral phenylephrine. We will thoroughly review the proposed order and submit our comments.”
Leading manufacturers, including Kenvue, GSK, Haleon, and Procter & Gamble, have yet to issue public statements on the proposal.
This development could signal significant changes in the over-the-counter cold medicine market, impacting both manufacturers and consumers as the industry adapts to the FDA’s proposed regulations.
