In this episode, HBW Insight speaks to its own OTC expert, managing editor Malcom Spicer, about recent controversy in the US surrounding oral nasal decongestant active ingredient phenylephrine. Used widely and safely by US consumers for around a half century, the efficacy of oral phenylephrine has come under question following a 2015 citizen petition by University of Florida pharmaceutical researchers, which asked the FDA to remove the ingredient from the final OTC CCABA monograph. Only recently addressing this petition, prompted Spicer points out by reforms to the US OTC monograph system, an FDA advisory panel has unanimously voted that research the FDA presented during a two-day meeting in September didn’t support oral phenylephrine’s efficacy for nasal decongestion at the CCABA monograph dose of 10mg. Drawing on his extensive experience and writing on this topic, Spicer takes us beyond the headlines to the key points you need to know about this crucial development, which may or may not have wider implications beyond the US.

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“What did the council decide on item 42?” — answered with the speaker and the moment.

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