FDA Proposes Ban on Oral Phenylephrine Due to Ineffectiveness as Decongestant

Key Insights

• The FDA is proposing to remove oral phenylephrine from over-the-counter cold medications due to its ineffectiveness as a nasal decongestant.
• The decision follows a review of scientific data, including older determinations and recent research, indicating a lack of efficacy.
• The FDA emphasizes that the proposed ban is based on ineffectiveness, not safety concerns, regarding oral phenylephrine.

The Food and Drug Administration (FDA) has proposed a ban on oral phenylephrine, a common ingredient in many over-the-counter cold medications, after determining it is ineffective as a nasal decongestant. This decision follows a comprehensive review of scientific data spanning several decades.

The FDA's evaluation included the original determination made 30 years ago, as well as more recent research. An advisory committee also weighed in, concluding that there was insufficient evidence to support the efficacy of oral phenylephrine in relieving nasal congestion. The agency highlighted that the proposed ban is solely based on the drug's lack of effectiveness and not on any safety concerns.

While the removal of oral phenylephrine might limit options for consumers seeking over-the-counter relief from cold symptoms, the FDA has emphasized the availability of alternative treatments. Individuals experiencing cold and allergy symptoms are encouraged to consult with healthcare professionals to explore other safe and effective medications and remedies to alleviate congestion.