The US Food and Drug Administration (FDA) announced on Thursday plans to remove oral phenylephrine from the over-the-counter (OTC) monograph for nasal decongestants following an “extensive review” which found that the ingredient is ineffective.
This action follows the recommendation of FDA’s Nonprescription Drug Advisory Committee, which voted unanimously against the drug’s effectiveness as an orally administered nasal decongestant during a meeting in September 2023. Phenylephrine is a common ingredient in combination OTC cold and sinus relief medicines and can be found in branded cold products including NyQuil, Advil, Tylenol, and Mucinex.
In a statement opposing FDA’s proposal, the Consumer Health Care Products Association (CHPA) said there is not enough evidence to support the drug’s removal…
