Stuffy nose? Common OTC nasal decongestants with phenylephrine don’t work in tablet form, experts say
Fox News
The FDA is deliberating on removing the "generally recognized as safe and effective" designation for a common ingredient, phenylephrine, in popular over-the-counter nasal decongestants. Here's why.
The GRASE designation allows manufacturers to market phenylephrine without filing an FDA application. The 16-member committee unanimously voted "no" to the following question: "Do the current scientific data that were presented support that the monograph dosage of orally administered phenylephrine is effective as a nasal decongestant?" "There should be no concern on the part of patients since there are many effective alternatives, including a topical nasal spray containing phenylephrine."
Their impending decision could upend the market for the cold and allergy industry, which generated almost $1.8 billion in sales last year, according to data presented by FDA officials.
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