Washington, D.C. – The US Food and Drug Administration has put forth a proposal to remove oral phenylephrine from the market due to evidence indicating its lack of effectiveness. This common ingredient is found in many over-the-counter decongestants, such as Sudafed PE, Vicks DayQuil, and Mucinex Sinus-Max. The FDA’s proposal initiates a six-month public comment period before a final decision is made regarding the removal of these products from store shelves.
In response to the FDA’s advisory committee’s declaration that phenylephrine is ineffective, CVS took a proactive stance by discontinuing the sale of products containing this ingredient last year. However, other major pharmacies like Walgreens and Rite Aid continue to carry products with phenylephrine for now. Phenylephrine gained popularity in 2005 after changes in legislation moved pseudoephedrine, a similar decongestant that can be used in the production of methamphetamine, behind pharmacy counters.
Although phenylephrine was approved by the FDA for over-the-counter use in the 1970s, its effectiveness as a decongestant has been under scrutiny for years. Recent large clinical trials have indicated that the drug is ineffective when taken orally. In light of this evidence, an FDA advisory committee confirmed in September 2023 that phenylephrine is not effective at typical oral dosages.
Should the FDA decide to ban oral phenylephrine, manufacturers will have the opportunity to reformulate their products or remove them from the market. Dr. Theresa Michele, the director of the FDA’s Office of Nonprescription Drugs, emphasized that the proposal specifically applies to oral forms of phenylephrine and does not impact nasal sprays containing the ingredient.
The Consumer Healthcare Products Association, representing over-the-counter medicine manufacturers, expressed disappointment over the FDA’s proposed action. They argue that the data available since the last review in 2007 does not warrant any changes to the generally recognized as safe and effective (GRASE) status of oral phenylephrine. The association believes that consumers should have the option to choose oral phenylephrine for nasal decongestion, as it is a common ingredient in various over-the-counter cough and cold medications. They stress the importance of preserving consumer choice and access to safe and effective over-the-counter medicines.