Skip to main content
Press Release Published: Dec 4, 2023

McClain Probes FDA’s Response to Common Over-the-Counter Decongestant Deemed Ineffective

WASHINGTON—Subcommittee on Health Care and Financial Services Chairwoman Lisa McClain (R-Mich.) sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Robert Califf requesting a staff-level briefing on the efficacy of over-the-counter drugs after a recent advisory committee concluded a commonly used oral decongestant is ineffective.

“Since 2006, phenylephrine has been branded as an oral decongestant ingredient in popular OTC drugs branded as Sudafed, Theraflu, and Vicks DayQuil and NyQuil. We are concerned that phenylephrine has remained approved by the Food and Drug Administration (FDA) as an OTC drug ‘generally recognized as safe and effective’ (GRASE) for nearly fifty years despite strong scientific evidence supporting the contrary,” Subcommittee Chairwoman McClain said.

According to data from FDA officials, popular oral decongestants containing phenylephrine in the United States generated almost $1.8 billion in sales last year. These drugs are used to temporarily relieve nasal congestion. Despite the data declaring phenylephrine ineffective, it remained designated by the FDA as “generally recognized as safe and effective” (GRASE) for nearly fifty years, allowing it to continue to be sold over the counter.

“In the last two decades, pharmaceutical researchers, skeptical that phenylephrine met FDA’s effectiveness standard, performed a meta-analysis of over fifty years of clinical research and concluded that these drugs provide no relief for nasal congestion when administered orally,” Subcommittee Chairwoman McClain continued. “It is concerning that the NPDAC, and thereby the FDA, relied upon outdated and insufficient evidence regarding phenylephrine’s use as a decongestant for so many years, despite numerous appeals by the scientific community. Americans seeking OTC relief should not have to worry whether they are wasting their hard-earned money on ineffective drugs.”

Read the letter to Commissioner Califf here.