FDA Faces New Pressure to Remove Diphenhydramine from Over-the-Counter Market

Kenvue Inc is facing a significant regulatory hurdle as it navigates a $40 billion acquisition by Kimberly-Clark Corp. While the company is already contending with political commentary regarding Tylenol, a new challenge has emerged centered on Benadryl. Three medical experts recently filed a formal petition with the Food and Drug Administration (FDA) requesting the removal of diphenhydramine — the active ingredient in Benadryl — from over-the-counter cold, cough, and allergy medications.

The petition, made public on December 11, argues that diphenhydramine poses a substantial public health risk. The authors, including experts from Johns Hopkins University and the University of Florida, contend that adverse reactions occur even at recommended dosages. They highlight severe outcomes such as seizures, potential abuse, and death, suggesting that the drug has reached the end of its therapeutic life cycle given the availability of safer alternatives.

Central to the doctors’ argument is the existence of newer, more effective products that carry fewer side effects. Unlike modern antihistamines, diphenhydramine is known for significant central nervous system impacts. The petitioners assert that the prevalence of adverse clinical events makes the drug a “public health hazard” when compared to other therapies in its class, leading them to call for its total removal from the allergy and cold medicine market.

The FDA has long been aware of the risks associated with this specific ingredient. The agency has previously issued warnings regarding the dangers of diphenhydramine, noting that doses exceeding recommendations can lead to serious heart problems, comas, and fatalities. Furthermore, external research has suggested that long-term use of the medication could potentially be associated with an increased risk of dementia in older adults.

In response to these concerns, the Consumer Healthcare Products Association (CHPA) has come to the defense of the ingredient. The trade group argues that millions of Americans rely on diphenhydramine for safe, effective relief from allergy and cold symptoms. They emphasize that the product provides well-established benefits when used properly for short-term therapeutic purposes and warn that removing it would unnecessarily limit consumer options for self-care.

The CHPA maintains that the issues surrounding the drug often stem from misuse or recreational use rather than the drug’s inherent profile when used as directed. Rather than a ban, the group advocates for increased education for parents and caregivers to prevent accidental misuse. They believe that maintaining diphenhydramine as a regulated, over-the-counter option remains a critical component of the healthcare landscape for many patients.

The FDA now faces a 180-day window to respond to the petition, though it historically grants such requests only in rare circumstances. For Kenvue and Kimberly-Clark, the timing is delicate; investors have already shown skepticism about their pending merger, with stock prices dipping 14% since the announcement. As the regulatory review unfolds, the future of one of the world’s most recognizable allergy medications remains uncertain.