Decongestant Deception: FDA Advisers Expose Ineffective Ingredient in Popular Remedies

As the chilly air signals the onset of cold and flu season, it’s the perfect time to refresh our medicine cabinets. However, before you stock up on those go-to remedies, you might want to think twice about one long-standing favorite that is still hanging around store shelves: phenylephrine. This decongestant, commonly found in products from brands like Sudafed PE, Vicks DayQuil, and Theraflu, has been deemed ineffective by a panel of FDA advisers for over a year now. So, what's the reasoning behind its continued presence on pharmacy shelves?

In September 2023, an insightful two-day meeting was held by an FDA advisory committee, featuring 16 experts who concluded that oral phenylephrine does not effectively relieve congestion and works no better than a placebo. This revelation aligns with previous reports from Yahoo Life, detailing how the body metabolizes oral phenylephrine so rapidly that less than 1% of the intended dose actually makes it into the bloodstream, ultimately rendering it ineffective.

It's crucial to highlight that this FDA committee's findings pertained solely to the oral form of phenylephrine; nasal sprays and drops containing the ingredient remain unaffected. Moreover, the advisory panel did not identify any safety concerns surrounding oral phenylephrine, meaning past users needn’t raise alarms about their experiences.

Many industry experts had long voiced similar concerns regarding the ineffectiveness of oral phenylephrine. Brigid Groves, the Vice President of Professional and Regulatory Affairs at the American Pharmacists Association (APhA), noted that the APhA had advocated for the removal of oral phenylephrine from decongestant formulations even before the advisory committee’s review. “Pharmacists encounter the ineffectiveness of oral phenylephrine daily,” Groves remarked.

It’s important to note that the advisory panel’s conclusion is nonbinding. The ultimate decision lies with the FDA, which has yet to issue a final ruling to mandate the reformulation or discontinuation of products containing oral phenylephrine. An FDA spokesperson confirmed to Yahoo Life, “As of now, the status of phenylephrine as generally recognized as safe and effective (