FDA moves to pull popular decongestant from shelves amid effectiveness concerns

The US Food and Drug Administration announced a proposal to remove oral phenylephrine – a common ingredient in many popular over-the-counter decongestants – from the market, citing evidence that it doesn’t work.

The US Food and Drug Administration announced a proposal to remove oral phenylephrine – a common ingredient in many popular over-the-counter decongestants – from the market, citing evidence that it doesn’t work. Phenylephrine, found in products like Sudafed PE, Vicks DayQuil and Mucinex Sinus-Max, has been widely used as a nasal decongestant for decades. The FDA’s proposal isn’t an immediate order; it launches a six-month public comment period, after which the agency will make a final decision on whether to pull it from shelves. In a preemptive move, CVS stopped selling products with phenylephrine last year after an FDA advisory committee declared that it was ineffective. Other major pharmacies, including Walgreens and Rite Aid, still stock products containing the drug for now. Although phenylephrine received FDA approval for over-the-counter use in the 1970s, its popularity surged in 2005 after legislation moved products that use a similar decongestant, pseudoephedrine – which, in large quantities, can also be used to make methamphetamine – behind pharmacy counters. The safety of phenylephrine isn’t a concern, but its effectiveness has been debated for years. In 2007, an FDA advisory panel that reviewed available studies deemed that phenylephrine “may be effective” as a decongestant, although it recommended further research. Since then, several large clinical trials have shown that the drug is ineffective when taken orally. In September 2023, an FDA advisory committee concluded that the evidence was clear that phenylephrine is ineffective at its typical oral dosage.