Oral Phenylephrine Study Results Spell Nasal Decongestion Failure To Critics, GRASE To Industry

FDA officials, joined by supporters of deeming ingredient non-GRASE, note problems with research referenced in initial GRASE designation. CHPA explained studies used to support GRASE designation for phenylephrine hydrochloride in 1976, for addition of bitartrate salt in 2006 and other results published since show ingredient’s efficacy for nasal decongestion.