FDA Targets Decongestants That Don't Actually Work

When you purchase something in a pharmacy to help you with sleep, allergies or another minor ailment, you’ll inevitably see some sort of message from the Food and Drug Administration on the packaging. It might have to do with the recommended dosage and possible side effects, or it might advise you that the FDA has not, in fact, evaluated how effective it is.

So what happens when the FDA changes course on an ingredient? We’re watching that unfold right now. Earlier today, the FDA released a proposed update to its guidelines on “the requirements for cold, cough, allergy, bronchodilator and antiasthmatic drug products for over-the-counter (OTC) human use.” Specifically, the agency is seeking to remove two categories of products from its guidelines — “oral phenylephrine hydrochloride and oral phenylephrine bitartrate as nasal decongestant active ingredients.” Why? The agency is blunt about the answer: “because they are not effective.”

This change has been in the works for almost 20 years. The proposal points to a petition directed to the FDA in 2007 as the first time there was a concerted effort to question the efficiacy of phenylephrine hydrochloride and phenylephrine bitartrate. More petitions followed over the course the years, along with several meetings and scientific studies, which brought us to the current proposal to revise the guidelines.

As Ars Technica’s Beth Mole pointed out, several of the studies that first led to phenylephrine hydrochloride and phenylephrine bitartrate being recommended as decongestant ingredients have not held up over time.

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This follows an FDA ruling from earlier this year

The FDA’s proposal is now accepting public comments and will continue to do so until May 7, 2025. What’s less clear is whether this might be affected by the change in presidential administrations, though the previous actions related to over-the-counter decongestant guidelines took place when both Republicans and Democrats occupied the White House.