In a significant move, the U.S. Food and Drug Administration (FDA) has proposed ending the use of a key ingredient found in many over-the-counter (OTC) cold and allergy medications: oral phenylephrine. Following extensive reviews, the FDA concluded that oral phenylephrine doesn’t effectively relieve nasal congestion, despite its widespread use in products like NyQuil, Sudafed, Benadryl, and Mucinex. This proposal could reshape the cold and allergy drug market, affecting millions of Americans.
The FDA’s proposal follows a unanimous advisory panel decision last year that cast doubt on the efficacy of oral phenylephrine. This decongestant, which was once hailed as an effective solution for stuffy noses, has recently been shown to have minimal impact. According to Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, the ingredient doesn’t reach the nasal passages in high enough concentrations to work as intended, effectively making it no more effective than a placebo.
The FDA’s proposal is not based on any safety concerns. Rather, it targets the ingredient’s ineffectiveness, meaning that for now, OTC products with phenylephrine can stay on store shelves until a final decision is made.
Impact on Consumers and Retailers Should the FDA’s recommendation become final, the impact would be felt widely. Millions of consumers may see their familiar decongestant products disappear, forcing them to explore alternative options, such as nasal sprays or products containing other active ingredients. Retailers, including major chains like CVS and Walgreens, may face challenges as they move to remove these products from shelves. In 2022 alone, over 240 million bottles containing phenylephrine were sold, generating nearly $1.8 billion in revenue.
Drugmakers like Procter & Gamble, Bayer, and Johnson & Johnson’s spinoff, Kenvue, would likely need to reformulate their cold and allergy products, a costly and time-consuming endeavor.
A Shift in Consumer Preferences A recent survey conducted by the Consumer Healthcare Products Association (CHPA), a group representing OTC drug manufacturers, revealed that half of all U.S. households had used an oral decongestant in the past year, with many preferring pills over nasal sprays by a margin of three to one. Despite this preference, experts believe that removing phenylephrine from the market may steer consumers toward more effective options, even if they come in a different format.
Phenylephrine replaced pseudoephedrine as the primary ingredient in decongestants in 2006 after pseudoephedrine was moved behind pharmacy counters due to its potential for misuse in making methamphetamine. However, this transition occurred despite emerging doubts about phenylephrine’s effectiveness. For years, research—including studies from the University of Florida—suggested that phenylephrine was ineffective at standard doses, but it wasn’t until recently that the FDA made moves toward formally recommending its removal.
The FDA’s proposal has stirred debate within the healthcare industry, with some consumer groups expressing concern about the inconvenience to the public. The CHPA argued that removing oral phenylephrine would be a burden for many Americans who rely on these OTC medications. However, the FDA’s decision-making process, based on scientific evidence, underscores its commitment to consumer protection and ensuring that OTC drugs offer real therapeutic value.
As the FDA moves closer to a final decision, consumers are encouraged to consult healthcare providers about the most effective alternatives for managing cold and allergy symptoms.
Read more:
- What Are The Stages Of A Chest Cold In Children?
- Affordable Care Act Subsidies At Risk: What Trump’s Win Could Mean For Health Coverage
- Is Fluoride On The Way Out? Experts Sound Alarm Over Potential Public Health Risks
