FDA Cracks Down on Popular Cold Medicines: Ineffective Phenylephrine in Brands Like Advil, NyQuil, Sudafed, and Robitussin Could Be Banned from Shelves!

FDA Proposes Removal of Ineffective Nasal Decongestant Ingredient in Cold Medicines

FDA Moves to Pull Oral Phenylephrine, Citing Ineffectiveness

The U.S. Food and Drug Administration (FDA) has announced plans to remove oral phenylephrine, a common ingredient in over-the-counter cough and cold medicines, from the market. This decision comes after FDA scientists concluded that the oral form of phenylephrine is ineffective as a nasal decongestant, leading the agency to propose a formal withdrawal.

Background and Advisory Committee Findings

The FDA’s move follows a vote by its advisory committee last year, which recommended against the continued use of oral phenylephrine. This vote cast doubt on the original data used for the drug’s approval and highlighted newer studies questioning its effectiveness. Phenylephrine has long been used in popular cold and flu medications like Advil, NyQuil, Sudafed, and Robitussin.

“Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant,” said Dr. Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research.

FDA’s Proposed Changes and Public Comment Period

If the FDA finalizes its proposal after the public comment period ending on May 7, 2025, oral phenylephrine will be removed from the list of approved ingredients for over-the-counter cough and cold medications. The FDA has assured manufacturers sufficient time to reformulate products or discontinue those containing oral phenylephrine.

Industry Pushback and Consumer Concerns

The Consumer Healthcare Products Association (CHPA), which represents manufacturers of over-the-counter medicines, voiced disappointment with the FDA’s proposal. CHPA President Scott Melville argued that phenylephrine should remain an available option, referencing previous studies that did not suggest removal. “Americans deserve the option to choose the safe and effective OTC medicines they prefer and rely on,” said Melville.

Scientific Support for FDA’s Decision

For years, pharmacy experts from the University of Florida have advocated for the removal of oral phenylephrine, citing studies showing it performs no better than a placebo. According to the FDA, only a tiny fraction—less than 1%—of phenylephrine is absorbed into the bloodstream when ingested, rendering it largely ineffective as a decongestant. This contrasts with nasal spray forms of the drug, which deliver higher concentrations directly into the bloodstream.

In its recent review, the FDA concluded that older studies had overestimated the absorption rates of oral phenylephrine, based on outdated technology. Newer data indicate that the amount absorbed when ingested is too low to be effective for nasal decongestion.

What’s Next for Consumers?

As consumers and drugmakers await the FDA’s final decision, some retailers, like CVS, have already started removing products containing only phenylephrine from their shelves. Should the FDA finalize its proposal, the market may see an accelerated transition as manufacturers reformulate or discontinue affected products.

The FDA’s decision, once final, could reshape the over-the-counter decongestant landscape, potentially leading to a search for more effective alternatives for those seeking relief from colds and congestion.