The next time you grab some medicine over-the-counter to deal with your runny nose, you may find that the options available to you are slightly different. The Food and Drug Administration has its eye on these ailments for allergies and the common cold, and it just proposed a new order that could change decades-old recipes.
Phenylephrine. The reason the FDA is scrutinizing over-the-counter cold and allergy medicine lies in one ingredient: phenylephrine. The nasal decongestant is included in popular tablet formulations for brands like DayQuil, Mucinex, Benadryl, and more. In fact, phenylephrine is the most common ingredient in oral nasal and sinus products, according to the American Academy of Allergy, Asthma, & Immunology.
Phenylephrine works by reducing the swelling of blood vessels in the nasal passages, which purportedly helps fluids drain. It’s sold in products as the single, active ingredient and in combination products with additional ingredients.
There’s just one problem: Experts say it doesn’t work. That’s what an FDA committee determined unanimously last year after analyzing current scientific data on phenylephrine. The committee’s conclusion coincided with one reached by the American Academy of Allergy, Asthma & Immunology. In 2022, the academy supported a citizen petition asking the FDA to remove phenylephrine from over-the-counter cold and allergy medicine.
The FDA's proposed order. The agency has issued a proposed order that would ban drugmakers from including phenylephrine as an ingredient in their products. In a statement, FDA officials said the agency was taking this step because phenylephrine is not effective as a nasal decongestant. Notably, the agency said there were no safety concerns regarding the ingredient.
Officials added that customers should know that there are a range of other effective drugs available to treat congestion symptoms.
The future of phenylephrine. As can be expected, drug makers aren’t happy. The Consumer Healthcare Products Association, an industry group that represents companies that manufacture over-the-counter drugs, said it was disappointed with the FDA's proposal. The association believes phenylephrine should remain available for use in over-the-counter products.
“Consumers need options for self-care, and freedom of choice for self-care is a core attribute of our nation’s healthcare system,” the association said in a statement. “[Phenylephrine] should remain an available option for consumers, because Americans deserve the option to choose the safe and effective OTC medicines they prefer and rely on.”
The FDA is currently seeking comments on its proposed order, so whether the agency will end up banning phenylephrine isn’t clear yet. If the agency approves the order, it will provide drug manufacturers with a period of time to reformulate their products and remove products containing phenylephrine from the market.
Image | Quinn Dombrowski
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