FDA Proposes Removal of Ineffective Oral Phenylephrine from Over-the-Counter Cough and Cold Medicines

The FDA plans to remove oral phenylephrine from over-the-counter cold medicines. Oral phenylephrine, commonly used in medications like NyQuil, Sudafed, and Theraflu, is deemed ineffective as a nasal decongestant.

According to the FDA, oral phenylephrine does not work in treating nasal congestion when taken orally. The decision follows over a year of debate after an FDA advisory committee voted against continued use of the ingredient due to concerns over initial approval data and new evidence questioning its effectiveness[1][2][5].

The FDA’s proposal is based on a comprehensive review of all available data on oral phenylephrine, including data from 30 years ago that showed it might be effective, as well as newer clinical data. However, these newer data indicate that only a small amount of the drug is absorbed into the bloodstream, making it ineffective at any dosage[2][4][5].

The public has until May 7, 2025, to provide comments on the proposal. If finalized, drugmakers would need to either reformulate or remove products containing oral phenylephrine from the market[1][2][4].

The Consumer Healthcare Products Association is disappointed in the FDA’s decision, arguing that consumers should have the option to choose safe and effective over-the-counter medicines, including those with oral phenylephrine[1][2][4].

Despite this, alternative treatments for nasal congestion remain available, such as nasal spray phenylephrine or pseudoephedrine, which is still effective as an oral decongestant[3][5].

The FDA aims to ensure that all drugs used are both safe and effective, making this decision part of their broader role in protecting public health[2][4][5].