The U.S. Food and Drug Administration (FDA) began a review of oral phenylephrine in September 2023. Phenylephrine is a common ingredient in over-the-counter decongestants, used for many years to relieve nasal congestion. Recent studies suggest that phenylephrine may not effectively treat congestion, leading the FDA to re-evaluate its approval for use in such products. This review process aims to protect public health by ensuring consumers are not relying on treatments that may not work.

The review will take several months, with a six-month period for public comments. During this time, consumers, researchers, and pharmaceutical companies can share their opinions and present supporting data. After analyzing the feedback, the FDA will decide whether to keep phenylephrine in approved products or recommend changes. Experts believe that ensuring the effectiveness of treatments is important for maintaining public trust in medicines. This careful approach also gives manufacturers time to adapt, preventing supply issues.