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# Group Criticizes FDA Foot Dragging on Phenylephrine
- URL: https://www.fdaweb.com/group-criticizes-fda-foot-dragging-on-phenylephrine/
- Published: 2024-11-08T12:00:00.000Z
- Updated: 2026-09-14T14:46:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158151

Advocacy group Public Citizen is [criticizing](https://www.citizen.org/news/fda-slow-to-ban-ineffective-over-the-counter-oral-phenylephrine/?source=email) FDA for dragging its feet in removing “ineffective, albeit safe, over-the-counter oral formulations of phenylephrine from the U.S. market.” On 11/7, FDA issued a[ proposed rule](https://u7061146.ct.sendgrid.net/ls/click?upn=u001.gqh-2BaxUzlo7XKIuSly0rCx1XOztg-2F0cz8fBfnIoof2f9api3SRRaXknuKxMBz0BG4ncKMRAkKF1oURECwwM6YA-3D-3D8xWs%5FU90yIN-2F9vtaly96Ud-2F63diIekSicLmFwEKTc7P1HgIo756xt-2FGhk8H-2F1E1-2FauYnOZ6-2BxHVVCAbjWvkyWIeiSVQsVNC0fztbRx-2FNfvWv5k-2BloydQn0MXAY3DXfGzK3Cmf-2FibJ4UO-2BNGHhbPAtNREKahv4wW9Y9R5AP-2BfDy0g8PwkHLREJw-2FsTwSVjHEBIbdShJBNuMwfmOIuK65jNnjh4qcSiVoXS4FDntIQiMjTQ43bQynIGNT1mMaBno-2BZwUs3BUy1hAi8cxe19fxeAKtqVOIiyyBUw81i9nAqP9AuxhzCQKgLwtLRHSZUvMxwDU05gs9dtCpMFjGosc1iBosgclA-3D-3D&ref=fdaweb.com) to remove the ingredient found in cough and cold medicines, either alone or in combination with other ingredients, for temporary nasal congestion relief.

The group says FDA moved too slowly to propose the action considering that a 9/2023 advisory committee unanimously[ voted](https://u7061146.ct.sendgrid.net/ls/click?upn=u001.gqh-2BaxUzlo7XKIuSly0rCyLXbo-2FQ3PwiyrwhPlXG8Rw8jo5koeWmHB7ySa4SYRuwnS-2FgHYBtnvFMa9-2FZGpHy9ndDvln1kjQ7J7gflx-2FwMrhPeR8W-2FdAcvQmf3PbTQdwqBRqU1yKnb5PjYVk9SrisYmM8LdBNN59CZvgalxq2t893alDrCHzo2ydcgoJEuwhpW90iCs5hBN-2Fe6jZ5qf3eaP6ogH3HMclBMrTDiS7XU7Y-3DDD8K%5FU90yIN-2F9vtaly96Ud-2F63diIekSicLmFwEKTc7P1HgIo756xt-2FGhk8H-2F1E1-2FauYnOZ6-2BxHVVCAbjWvkyWIeiSVQsVNC0fztbRx-2FNfvWv5k-2BloydQn0MXAY3DXfGzK3Cmf-2FibJ4UO-2BNGHhbPAtNREKahv4wW9Y9R5AP-2BfDy0g8PwkHLREJw-2FsTwSVjHEBIbdShPLAFGBGx7XaNirIYFOC7XFqTUMe72sQWR7P-2Bocw28XLyo2tPn8N9Wnq88Bj-2BCIecSrcg6IxEW0DyG9QfcJ2zIiy3fjKmdSdU9IrOlVNjzez9S580J1yy0Qyi2qeEiHE75Rw5yg-2Bw3P-2F6nxyvOFUhDg-3D-3D&ref=fdaweb.com) (16-0) that the current dosage of orally administered phenylephrine is not effective for nasal congestion relief. “The fact that it took the FDA over a year to propose removing oral phenylephrine demonstrates how unacceptably tardy the agency is,” Public Citizen says. “By dragging its feet in issuing the proposed rule and continuing to allow labeling of oral phenylephrine products to indicate that they are ‘effective’ for the 180-day public comment period and until a final rule is issued, the agency is failing the public.”