The US Food and Drug Administration (FDA) proposed on Thursday to remove the ingredient phenylephrine from over-the-counter (OTC) cold and flu medications, stating it is ineffective in its oral form for treating nasal congestion.
This proposal follows an advisory committee’s recommendation last year, which unanimously concluded that oral phenylephrine does not relieve nasal congestion, and no additional trials were deemed necessary to validate its effectiveness.
Phenylephrine is a common ingredient in several well-known OTC brands, such as Benadryl, Advil, and Tylenol, and gained popularity after 2005 legislation restricted the sale of pseudoephedrine, a more effective decongestant, due to its potential use in methamphetamine production. The FDA’s current proposal applies only to the oral form of phenylephrine; nasal sprays containing the ingredient are unaffected and will remain on shelves.
The proposal initiates a six-month public comment period, during which the FDA will gather input from stakeholders before making a final decision. If the proposal proceeds, manufacturers would be given time to reformulate or withdraw products containing oral phenylephrine from the market.
Some manufacturers and retailers, such as CVS, have already responded to questions about phenylephrine’s effectiveness. CVS removed products with the ingredient last year, while other major retailers, including Walgreens and Rite Aid, continue to carry these medications. Representatives from Kenvue, GSK, Haleon, and Procter & Gamble, which produce products containing phenylephrine, did not immediately comment on the FDA’s announcement.
In response, the Consumer Healthcare Products Association (CHPA), which represents manufacturers of OTC drugs, expressed disappointment. The CHPA noted that phenylephrine has been deemed “generally recognized as safe and effective” (GRASE) since a prior FDA review in 2007, and argued that it should remain available to provide consumers with an unrestricted oral decongestant option.
The FDA’s proposal follows studies showing that phenylephrine is ineffective in its typical oral dosage. While earlier reviews allowed phenylephrine to remain in the market under “possibly effective” status, recent trials have cast more doubt on its utility. FDA official Dr. Theresa Michele emphasized that if the ingredient is removed, companies would be given time to adapt to the new regulation.
New York Post and CNN contributed to this report.
