Common oral medicines that have been used for decades as decongestants such as Sudafed, NyQuil and Benadryl may soon be cleared from shelves as the FDA has proposed to discontinue the sale of products containing the active ingredient phenylephrine.
Following up on a unanimous advisory committee vote last year, the FDA has asked for feedback on its proposal to outlaw the use of phenylephrine as an oral med.
In a 16-0 vote, the Nonprescription Drugs Advisory Committee (NDAC) said in September 2023 that phenylephrine is ineffective when taken as a liquid or in a pill. The ingredient does work however when it is delivered as a nasal spray, the panel agreed. There is no concern with the safety of phenylephrine, the FDA said.
“Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant,” Patrizia Cavazzoni, M.D., the director of the FDA’s Center for Drug Evaluation and Research (CDER), said in a release.
The advisory committee recommendation was based on data that showed that phenylephrine performed no better than placebo in relieving congestion when taken orally. The compound is designed to reduce the swelling of blood vessels, but the NDAC concluded that when it is received by way of the mouth, not enough of the drug reaches the nasal passages.
If the agency makes a final determination—after reviewing public comments—that phenylephrine is not effective, it will issue a final order banning its inclusion in oral medicines. The agency said it would provide manufacturers a grace period to either reformulate their drugs or remove them from the market.
The Consumer Healthcare Products Association CEO Scott Melville said in a statement that the organization was “disappointed” by the FDA’s proposal and pointed out that it was “at odds with previous FDA decisions and Advisory Committee recommendations.”
For decades, people have relied on oral PE to relieve their nasal congestion,” Melville said. “We believe Americans deserve access to safe and effective OTC medicines and the option to choose the products they prefer for self-care.”
Products that include the ingredient—roughly 250 of them—generated approximately $1.8 billion in sales in 2022. Some products contain phenylephrine as a single active ingredient. Others include phenylephrine in combination with other agents.
Last year, a month after the NDAC made its recommendations, pharmacy giant CVS said that it would no longer sell meds that contain phenylephrine as its only active ingredient. One such product is Kenvue’s Sudafed PE.
“Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold,” Theresa Michele, M.D., director of the Office of Nonprescription Drug Products in CDER, said.
Phenylephrine is one of two oral decongestants available without prescription. Sales of the other, pseudoephedrine, were restricted in 2006 because it can be misused to make methamphetamine. Products with pseudoephedrine are still available OTC but are often behind store counters or locked away, out of the reach of consumers. There also are limitations on how many pills can be purchased during a store visit.
The restrictions led to a boom in products containing phenylephrine. But soon after their rise in popularity, the FDA’s scrutiny of phenylephrine began. In 2007, the NDAC came to a similar conclusion on its ineffectiveness. While four subsequent studies showed the ineffectiveness of phenylephrine when taken as a pill, there was enough variability in the results to raise questions about how the studies were conducted.