The U.S. Food and Drug Administration (FDA) has started a review of oral phenylephrine, a common ingredient found in over-the-counter decongestants. This decision was made after studies suggested that phenylephrine may not effectively relieve nasal congestion, even though it has been used in medicines for many years. The review, which began in September 2023, is happening across the United States and seeks to determine if phenylephrine should continue to be approved for use in such products. This review process aims to address concerns about consumers depending on treatments that may not work and their potential impact on public health.

The FDA’s review process will take several months and includes a six-month period for public comments. During this time, consumers, researchers, and pharmaceutical companies can share their opinions and provide supporting data. After analyzing the feedback, the FDA will decide whether to remove phenylephrine from the list of approved ingredients or suggest reformulating the products. This careful approach allows manufacturers time to adjust and prevent disruptions in the supply of these medications. Experts agree that consumer trust in medicines is vital and that reliance on ineffective treatments could undermine public confidence.