The FDA’s proposals to ban oral phenylephrine-an essential ingredient in some of the most popular brands of decongestants-over its ineffectiveness have sparked debate regarding consumer choice and the future of cold remedies.
The U.S Food and Drug Administration recently dared to go where few have tread by suggesting oral phenylephrine – the ubiquitous ingredient in many over-the-counter decongestants — be pulled from the market.
This ruling could change pharmacy aisles upside down. It is the result of mounting evidence that phenylephrine is safe but does not relieve nasal congestion as it claims to do.
Phenylephrine has long been a mainstay in cold and flu remedies, appearing in well-known brands such as Sudafed PE, Vicks DayQuil, and Mucinex Sinus-Max.
The FDA’s proposal starts a six-month public comment period before the agency issues a final decision, so it is not yet a complete prohibition.
For more than ten years, doubts have been raised concerning the efficacy of phenylephrine. An FDA panel stated in 2007 that it “may be effective” and recommended more investigation.
Recent research, however, has called into question the drug’s effectiveness, and a 2023 FDA advisory group came to the conclusion that, at standard dosages, it is no more effective than a placebo.
Some pharmacies are already taking action while the FDA considers its next course of action. Last year, CVS stopped carrying phenylephrine-containing products, while other large retailers like Walgreens still carry them.
The Consumer Healthcare Products Association has expressed dissatisfaction and stated that consumers ought to be able to choose the treatments that they want. Manufacturers will have to rework their products or discontinue them completely if the FDA moves forward with the restriction, which might alter the availability of cold and allergy remedies in the United States.
