The US Food and Drug Administration (FDA) has unveiled a proposal to withdraw oral phenylephrine, a staple ingredient in numerous popular over-the-counter decongestants, from the market due to evidence suggesting its inefficacy. Phenylephrine, present in brands such as Sudafed PE, Vicks DayQuil, and Mucinex Sinus-Max, has been a go-to nasal decongestant for several decades. However, the FDA's proposal is not a definitive decree; it initiates a six-month period for public commentary, post which the agency will render a final verdict on the ingredient's retail fate.

In a preemptive strategy, CVS halted the sale of phenylephrine-containing products last year following an FDA advisory committee's declaration of the ingredient's ineffectiveness. Meanwhile, other leading pharmacies like Walgreens and Rite Aid continue to stock these products for the time being. Although phenylephrine gained FDA approval for over-the-counter use in the 1970s, its usage skyrocketed in 2005 after legislation relocated products containing a similar decongestant, pseudoephedrine—which can be used to manufacture methamphetamine in large quantities—behind pharmacy counters.

The safety of phenylephrine is not under scrutiny; rather, its efficacy has been a subject of debate for years. In 2007, an FDA advisory panel, after reviewing existing studies, concluded that phenylephrine "may be effective" as a decongestant but called for further research. Since then, several extensive clinical trials have indicated that the drug is ineffective when ingested orally. In September 2023, an FDA advisory committee reaffirmed that the evidence overwhelmingly demonstrates phenylephrine's ineffectiveness at standard oral doses.

Should the FDA ultimately decide to ban the ingredient, it will grant manufacturers a grace period to "either reformulate or withdraw drug products containing oral phenylephrine from the market," as stated by Dr. Theresa Michele, director of the FDA’s Office of Nonprescription Drugs. It's important to note that while phenylephrine is also utilized in nasal sprays for congestion relief, the FDA's proposal is specifically targeting oral forms of the drug.

The Consumer Healthcare Products Association (CHPA), representing manufacturers of over-the-counter medications, expressed disappointment with the FDA's move. "CHPA maintains its stance that no alterations to the GRASE [generally recognized as safe and effective] status of oral PE for nasal decongestion are justified based on data available since the last review in 2007. … PE remains the sole oral OTC decongestant without purchase restrictions and is a component in many OTC cough and cold remedies that claim decongestant properties," the association stated. "Consumers require options for self-care, and the freedom to choose is a fundamental aspect of our healthcare system. PE should continue to be an option for consumers, as Americans deserve the right to select the safe and effective OTC medicines they prefer and trust."