FDA Proposes Ban on Common Cold Medicine Ingredient
A Shift in the Treatment of Nasal Congestion
The Food and Drug Administration (FDA) has taken a significant step towards removing a widely used ingredient from over-the-counter cold and allergy medications. Oral phenylephrine, found in popular brands like NyQuil, Benadryl, Sudafed, and Mucinex, has been deemed ineffective in relieving nasal congestion.
The Science Behind the Decision
According to the FDA’s extensive review of available data, oral phenylephrine does not provide the promised relief from nasal congestion. Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, stated that the agency is proposing to remove the ingredient due to its lack of effectiveness.
What This Means for Consumers
If the proposal is finalized, pharmacies will need to clear their shelves of hundreds of products containing oral phenylephrine. This could lead to a scramble for alternative medications, such as spray versions of the drug or products with different ingredients. Retail stores like CVS and Walgreens, which sold 242 million bottles of phenylephrine-containing drugs in 2022, may also take a hit.
The Road to This Decision
The FDA’s advisors reached a unanimous conclusion over a year ago, prompting the agency to take action. Researchers at the University of Florida had petitioned the FDA to remove phenylephrine products from the market, citing studies that showed they were no more effective than placebo pills in treating cold and allergy congestion.
Industry Response
Representatives from the Consumer Healthcare Products Association, which represents over-the-counter drug manufacturers, argued that removing oral phenylephrine would burden consumers. They cited a survey showing that 1 in 2 households in the U.S. used an oral decongestant over the last year, with a strong preference for oral decongestants over nasal sprays.
A Brief History of Phenylephrine
Phenylephrine became the main decongestant in over-the-counter cold and allergy medicines in 2006, after sales of pseudoephedrine were restricted due to its potential use in making methamphetamine.
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