The Food and Drug Administration (FDA) is proposing to remove oral phenylephrine (PE) as an active ingredient in over-the-counter (OTC) products after an extensive review found it is not effective as a nasal decongestant.
Officials stressed the proposal is not based on safety concerns.
FDA leaders announced Thursday the agency is issuing a proposed administrative order to amend the requirements for cold, cough, allergy, bronchodilator and anti-asthmatic drug products for OTC human use. If finalized, the order would remove orally administered PE as a nasal decongestant active ingredient.
The action is related only to PE that is administered orally and not the nasal spray form, said Peter Stein, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER) Office of New Drugs.
“Today’s proposed order demonstrates the continued role of the FDA to ensure that Americans have access to medicines that are not only safe but that are safe and effective,” Dr. Stein said.
Last year, members of the FDA Nonprescription Drugs Advisory Committee unanimously agreed PE is not effective at relieving nasal congestion. While the drug was approved in 1976, studies conducted in 2009, 2015, 2016 and 2017-’18 showed no significant difference between PE treatments and placebo.
Oral PE is widely used as an active ingredient in many OTC drug products used to treat nasal congestion. Some of those products contain oral PE and another active ingredient such as acetaminophen or dextromethorphan. The presence of PE in these medicines does not affect how other active ingredients work to treat symptoms for which they are intended, and consumers can continue to use those products, said Theresa Michele, M.D., director of CDER’s Office of Nonprescription Drug Products.
FDA officials said consumers should read the drug facts label on medications carefully to determine if PE is an ingredient.
“Because a variety of different drug products may be sold under the same brand name, consumers should always read the drug facts label to determine which ingredients are in a medication, as well as important warnings and directions for use,” Dr. Michele said.
The FDA will be seeking public comments on the proposed order until May 7, 2025. The FDA will issue a final order after the 180-day comment period. Manufacturers then will have time to reformulate products containing oral PE or remove them from the market.
The FDA has removed approved products from market before. A 2016 final rule established that OTC consumer antiseptic wash products containing certain active ingredients, including triclosan, no longer could be marketed.
"As you may remember, there were a number of antiseptic active ingredients that were found not generally recognized as safe and effective," Dr. Michele said. "Then, there was a phase-out period for those ingredients."
