FDA Moves to Ban Ineffective Oral Phenylephrine from Cold Medicines

The FDA has proposed removing oral phenylephrine, found in many over-the-counter cold remedies, due to its ineffectiveness as a decongestant.

The FDA's decision follows a review that found oral phenylephrine no more effective than a placebo for nasal congestion relief.
Phenylephrine became a common ingredient in decongestants after pseudoephedrine was restricted due to methamphetamine production concerns.
The FDA's proposal allows for public comment until May 2025, with a final decision expected thereafter.
Major U.S. pharmacies have begun removing products containing oral phenylephrine, while Canadian health regulators are reviewing the situation.
Alternatives for congestion relief include nasal sprays, intranasal steroids, and products with pseudoephedrine, which remain effective.