The U.S. Food and Drug Administration (FDA) has proposed removing oral phenylephrine, a common ingredient in decongestants, from the market due to evidence suggesting it is ineffective. Phenylephrine is found in popular over-the-counter products like Sudafed PE, Vicks DayQuil, and Mucinex Sinus-Max. The FDA’s proposal is not an immediate ban, but it begins a six-month public comment period. After this period, the agency will make a final decision on whether to remove the drug from store shelves.
The effectiveness of phenylephrine has been under scrutiny for years. Although the drug was approved for over-the-counter use in the 1970s, its use skyrocketed in 2005 after the government moved pseudoephedrine products, which could be used to make methamphetamine, behind the pharmacy counter. Despite widespread use, concerns over its effectiveness have persisted, and an FDA advisory committee concluded in 2023 that oral phenylephrine does not effectively relieve nasal congestion.
Pharmacies have reacted differently to these findings. CVS, in anticipation of the FDA’s stance, stopped selling products with phenylephrine in 2023 after an FDA advisory committee ruled that the drug was ineffective. Other major pharmacies like Walgreens and Rite Aid continue to sell products containing phenylephrine, pending further regulatory developments. The proposal specifically targets the oral form of phenylephrine, with nasal sprays containing the drug remaining unaffected for now.
If the FDA decides to proceed with removing phenylephrine, manufacturers will have time to reformulate or withdraw products containing it. The drug’s safety has never been a major concern, but its inability to work effectively when taken orally has led to calls for its removal. The public comment period will allow stakeholders, including manufacturers and consumers, to weigh in before any final action is taken.
The Consumer Healthcare Products Association (CHPA), which represents the manufacturers of over-the-counter drugs, has expressed disappointment with the FDA’s move. The CHPA argues that the evidence available does not justify removing phenylephrine and asserts that the drug remains a safe, effective option for consumers. They emphasize the importance of consumer choice in healthcare and believe phenylephrine should remain available as a widely accessible over-the-counter decongestant.
