An independent advisory committee to the US Food and Drug Administration has determined that phenylephrine, a common ingredient in over-the-counter allergy and cold medicines, is ineffective in tablet form. The committee’s vote was unanimous among its 16 members, who agreed that further study of the issue is unnecessary. Despite being considered safe to use, many doctors have questioned the effectiveness of phenylephrine for years. These products generated nearly $1.8 billion in sales last year alone. If the FDA agrees with the committee’s decision, companies may be required to remove products with phenylephrine from store shelves or reformulate them. In the past, the FDA has favored phenylephrine for OTC use, but recent studies have shown that the orally administered ingredient is not effective as a decongestant. The committee did not address nasal spray products that use phenylephrine, as studies have shown them to be effective, at least temporarily.
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