The U.S. Food and Drug Administration has announced a proposal to remove oral phenylephrine, a popular ingredient in over-the-counter (OTC) cold and flu medications, from the market.
The health agency’s move follows findings that phenylephrine, when taken orally, doesn’t effectively relieve nasal congestion—a claim that could significantly impact products like Benadryl, Advil, and Tylenol Cold.
Phenylephrine has long been marketed as a nasal decongestant in both oral and nasal spray forms. However, the FDA’s current proposal only affects oral phenylephrine, the New York Post reported.
Nasal sprays containing the ingredient are not being considered for removal. The agency’s new stance comes after years of debate over the ingredient’s actual benefits, as some experts have suggested it offers minimal relief.
An FDA advisory panel reviewed phenylephrine’s effectiveness last year, unanimously voting against its use in oral form for nasal decongestion. Their vote reinforced earlier findings, which indicated that the ingredient likely provides little to no benefit when taken by mouth. The panel also concluded that further trials wouldn’t be necessary, as they were unlikely to produce different results.
For now, the FDA is seeking public input on the proposal, allowing healthcare groups, consumers, and manufacturers to weigh in. The Consumer Healthcare Products Association, which represents the OTC industry, voiced disappointment, arguing that the FDA is reversing its decades-long approval of oral phenylephrine without sufficient cause.
The FDA’s proposed removal has sparked concern among major pharmaceutical companies, including Procter & Gamble, GSK, and others, who now face the possibility of reformulating or even discontinuing popular cold medicines if the rule is implemented. Although the companies have yet to respond publicly, some are also grappling with lawsuits alleging they misled consumers about the ingredient’s effectiveness.
The Consumer Healthcare Products Association indicated it would review the FDA’s proposed changes and submit a formal response. The group believes the FDA’s decision may harm consumers by reducing available options for cold and flu relief, especially as flu season approaches.
Manufacturers of OTC products with phenylephrine will likely have some time to adapt, as the FDA has indicated it will provide a transition period if the rule is finalized. This would allow companies either to reformulate their products with alternative ingredients or phase out products that contain oral phenylephrine.
The FDA’s decision could reshape the OTC cold and flu medication market, impacting millions of Americans who rely on these medications. If approved, this change would mean some of the most popular brands may no longer offer the same formula that consumers have trusted for years.
Written with the assistance of artificial intelligence.