FDA Proposes Removal of Oral Phenylephrine from OTC Nasal Decongestants

The US Food and Drug Administration (FDA) has announced in a new press release that it is proposing to remove oral phenylephrine as an active ingredient in over-the-counter (OTC) products for nasal decongestant, citing a lack of effectiveness.

Oral phenylephrine is currently used in products for the temporary relief of nasal congestion due to illnesses such as the common cold. It is included in many OTC products, both alone and combined with other active ingredients.

To reach this conclusion, the FDA reviewed extensive data, including historical and recent clinical studies. In fall 2023, the FDA held a Nonprescription Drug Advisory Committee meeting to discuss the “Generally Recognized as Safe and Effective” (GRASE) status of this agent. The committee unanimously concluded that oral phenylephrine, at recommended OTC doses, is ineffective as a nasal decongestant. In October 2023, CVS Health announced that it was voluntarily removing some of the most commonly purchased OTC cold and cough medication from it stores due to this finding.

The FDA is accepting public comments on the proposed order and will issue a final order if it concludes that oral phenylephrine is ineffective, allowing time for manufacturers to reformulate or remove affected products. Until the final order is issued, companies can still market products with oral phenylephrine as a nasal decongestant.

“Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold,” advised Theresa Michele, MD, director of the Office of Nonprescription Drug Products in CDER. “Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms.”

Reference

FDA proposes ending use of oral phenylephrine as OTC monograph nasal decongestant active ingredient after extensive review. News release. FDA. November 7, 2024. Accessed November 14, 2024. https://www.fda.gov/news-events/press-announcements/fda-proposes-ending-use-oral-phenylephrine-otc-monograph-nasal-decongestant-active-ingredient-after