The FDA has proposed removing phenylephrine, a common ingredient in cold and flu medications like Vicks Sinex, Sudafed, and Benadryl, from over-the-counter products due to its lack of effectiveness in relieving symptoms.
After reviewing studies since March 2023, the FDA concluded that phenylephrine, when taken orally, is no more effective than a placebo because it cannot reach the bloodstream in sufficient quantities.
This proposal applies only to the oral form of phenylephrine, not when used in nasal sprays, where it remains effective.
The proposal could significantly impact the $1.8 billion market for these products, although it is not yet a final order.
The FDA’s decision follows a comprehensive review of data, including research dating back decades and more recent findings.
The FDA’s advisory committee found that phenylephrine does not work as a nasal decongestant when taken orally, though it remains effective in nasal spray form.
This review, which considers the ingredient’s safety and efficacy, led the FDA to propose the removal of phenylephrine from oral decongestant products.
Industry representatives, such as the Consumer Healthcare Product Association, have expressed disappointment, arguing that phenylephrine provides an important option for consumers seeking over-the-counter relief. However, studies show that the ingredient only works in nasal sprays and not in oral form, which has led to mounting calls for its removal.
If the FDA finalizes the proposal, manufacturers will be given time to reformulate their products or remove them from the market. In the meantime, consumers are advised to consult their healthcare providers for alternative treatments for congestion.
