FDA proposes removing oral phenylephrine from use in nasal decongestants

The US Food and Drug Administration (FDA) announced on Thursday plans to remove oral phenylephrine from the over-the-counter (OTC) monograph for nasal decongestants following an “extensive review” which found that the ingredient is ineffective.

This action follows the recommendation of FDA’s Nonprescription Drug Advisory Committee, which voted unanimously against the drug’s effectiveness as an orally administered nasal decongestant during a meeting in September 2023. Phenylephrine is a common ingredient in combination OTC cold and sinus relief medicines and can be found in branded cold products including NyQuil, Advil, Tylenol, and Mucinex.

In a statement opposing FDA’s proposal, the Consumer Health Care Products Association (CHPA) said there is not enough evidence to support the drug’s removal.

FDA said that since it determined 30 years ago that oral phenylephrine was effective as a nasal decongestant, newer clinical data has emerged that raised questions about the effectiveness of the ingredient.

The agency’s action is only related to orally administered phenylephrine and does not affect nasal sprays.

“It is the FDA’s role to ensure that drugs are safe and effective,” said Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research (CDER). “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.”

Speaking on a call with reporters, Peter Stein, director of the Office of New Drugs, said the action stems from the lack of effectiveness of these ingredients and that “there is no safety concern” posed by their use in nasal decongestants.

The FDA is seeking public comments on the proposed order to remove oral phenylephrine from the monograph of cold, cough, allergy, bronchodilator, and antiasthmatic drug products. After considering the comments, FDA will make a determination as to whether to issue a final order removing oral phenylephrine from the monograph.

These products can continue to be marketed until the final order takes effect.

During the call, Theresa Michele, director of the Office of Nonprescription Drug Products, said that “FDA will provide manufacturers with enough time to reformulate these drugs.”

Yet CHPA said it was “disappointed” with the proposal, arguing that “no changes to the GRASE [generally recognized as safe and effective] status of oral [phenylephrine] PE for nasal decongestion are warranted based on data made available since the previous review in 2007.”

The group further noted that oral phenylephrine “is the only oral OTC decongestant available without purchase restrictions and is included in numerous OTC cough and cold medicines labeled with a decongestant claim. Consumers need options for self-care, and freedom of choice for self-care is a core attribute of our nation’s healthcare system.”

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FDA proposes removing oral phenylephrine from use in nasal decongestants

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