FDA Proposes Removing Ineffective Decongestant From Shelves

Signage is seen outside of FDA headquarters in White Oak, Maryland

The US Food and Drug Administration has put forth a proposal to eliminate oral phenylephrine, a common ingredient in various over-the-counter decongestants, due to evidence suggesting its lack of efficacy.

Phenylephrine, present in popular products like Sudafed PE, Vicks DayQuil, and Mucinex Sinus-Max, has been a staple nasal decongestant for many years. The FDA's proposal initiates a six-month public comment period before a final decision is made regarding its removal from shelves. CVS took a proactive stance last year by discontinuing the sale of phenylephrine-containing products following an FDA advisory committee's declaration of its ineffectiveness. However, other major pharmacies such as Walgreens and Rite Aid continue to offer products with phenylephrine for the time being.

Although phenylephrine received FDA approval for over-the-counter use in the 1970s, its popularity surged in 2005 after legislative actions restricted access to pseudoephedrine, a similar decongestant with potential for misuse in methamphetamine production.

Clinical trials show oral phenylephrine ineffective for congestion relief.

FDA proposes removing oral phenylephrine from OTC decongestants.

Phenylephrine's popularity rose after restrictions on pseudoephedrine.

The safety of phenylephrine is not in question, but its effectiveness has been a subject of debate. Recent clinical trials have demonstrated that oral phenylephrine is ineffective for congestion relief. In September 2023, an FDA advisory committee confirmed the lack of efficacy at typical oral dosages.

If the FDA proceeds with the ban, manufacturers will be given time to either reformulate their products or remove those containing oral phenylephrine from the market. Dr. Theresa Michele, director of the FDA's Office of Nonprescription Drugs, emphasized that the proposal specifically targets oral forms of the drug, not nasal sprays containing phenylephrine.

The Consumer Healthcare Products Association expressed disappointment with the FDA's decision, arguing that the data since the last review in 2007 does not warrant a change in the generally recognized as safe and effective (GRASE) status of oral phenylephrine. The association believes that consumers should have the freedom to choose safe and effective over-the-counter medicines, including those containing phenylephrine.