The U.S. Food and Drug Administration (FDA) has proposed an order to ban oral phenylephrine, a common ingredient in many over-the-counter (OTC) cold and flu decongestants. This decision comes after the FDA determined that oral phenylephrine is no more effective than a placebo in relieving nasal congestion.
The proposal, which is now open for public comment, could dramatically alter the landscape of the OTC decongestant market, valued at approximately $1.76 billion in 2022. Affected products include popular brands such as Advil Sinus Congestion & Pain, Sudafed PE Nasal Decongestant, Vicks DayQuil and NyQuil, and Tylenol Cold & Flu Severe.
Years of Scrutiny Lead to Proposed Ban
The FDA's decision follows years of scientific debate and an unanimous conclusion by an independent advisory body that oral phenylephrine provides no significant decongestant benefit. "It is the FDA's role to ensure that drugs are safe and effective," said Patrizia Cavazzoni, director of the administration'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."
The Rise of Phenylephrine
Phenylephrine was initially approved by the FDA in 1976 based on industry-funded studies. Its use became widespread after 2006, when pseudoephedrine, the primary ingredient in decongestants at the time, faced restrictions due to its use in methamphetamine production. This led manufacturers to replace pseudoephedrine with phenylephrine in many OTC products.
However, studies since 2005 have questioned the efficacy of oral phenylephrine. A 2007 citizen's petition requested the FDA to demand better proof of efficacy, but the agency initially called for research into higher dosages. Clinical trials starting in 2015, which quadrupled the dosage of oral phenylephrine, still found the medicine ineffective as a decongestant.
Clinical Evidence of Ineffectiveness
Recent analysis by the FDA committee of three large clinical trials confirmed that oral phenylephrine is not effective at any dose. These studies indicated that very little of the drug reaches the nasal passages when taken orally, as it is largely broken down in the gut.
Implications for Consumers and Manufacturers
The proposed ban does not apply to nasal sprays or eye drops containing phenylephrine, as these delivery methods are considered more effective. Despite this, in 2022, over 242 million cold remedy products containing phenylephrine were sold in the U.S., significantly more than those containing pseudoephedrine.
While the FDA's order is currently a proposal, manufacturers are now on notice to potentially withdraw products containing phenylephrine as the sole active ingredient. The FDA will consider public comments before finalizing the order.
