The proposed order is based on FDA findings that oral phenylephrine is ineffective as a nasal decongestant and is not due to safety concerns.
Over-the-counter medications containing phenylephrine may remain on the market as the FDA seeks public comment on the proposed order. After reviewing comments, the FDA will determine whether to issue a final order revoking oral phenylephrine’s classification as “generally recognized as safe and effective.”
If a final order is issued, the FDA will give manufacturers time to reformulate drugs containing phenylephrine or remove them from the market. Such reformulations may present supply chain challenges, according to research published Feb. 8 in JAMA.
The FDA has been evaluating data on oral phenylephrine since 2007. In September 2023, an FDA advisory committee found that the drug does not relieve congestion. Following the committee’s decision, CVS announced it would stop selling cold and flu medicines containing the ingredient.
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