FDA proposes ban on ineffective decongestant phenylephrine

A big part of the FDA's mandate is to ensure that the over-the-counter drugs on the market are both safe and effective.

Yet the oral decongestant phenylephrine has remained in dozens of formulations of cold medicine despite there being no evidence that it actually works. In fact, the drug does not even reach the bloodstream in a meaningful way as 99 percent of it is metabolized and never gets that far.

FDA's action today is consistent with the unanimous thumbs down from the agency's Non-prescription Drug Advisory Committee on September 11-12, 2023. It's a welcome and overdue move on the part of the agency, spurred in large part by years of advocacy by Drs. Leslie Hendeles and Randy Hatton of the University of Florida.

The 2020 CARES Act provided the FDA with the streamlined tools for action it is using today. It's time for the agency to now train its attention on other potentially ineffective or unsafe ingredients.

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Dr. Hatton can be contacted at [email protected]

Topics

• Government Accountability