FDA panel says OTC decongestant ingredient doesn't work

Sept. 13, 2023

An FDA advisory panel has unanimously agreed that the country's most popular oral nasal decongestant ingredient, phenylephrine, is ineffective.

After reviewing the latest research, the Nonprescription Drugs Advisory Committee voted 16-0 against the effectiveness of oral phenylephrine as a nasal decongestant.

Phenylephrine, approved for OTC use back in 1976, is an ingredient in many common medicines, such as the allergy and cold formulations of Pfizer's Benadryl, Procter & Gamble's Vicks, Reckitt's Mucinex and J&J's Tylenol Sinus and Sudafed.

If the agency decides to reclassify phenylephrine from Generally Recognized as Safe and Effective (GRASE), drugmakers would be allowed to submit additional data. But if they can't make their case, they will have to either remove products with phenylephrine from store shelves or reformulate them.