Dr. Patrizia Cavazzoni stated, "Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant."
The FDA's proposed order would remove oral phenylephrine from the "monograph" of ingredients that drugmakers are allowed to use in cough and cold medicines which are sold on store shelves without a prescription.
The public has until May 7 next year to weigh in on the proposal. After that comment period, if the FDA decides to finalize its proposal to revoke oral phenylephrine's status as "generally recognized as safe and effective," over-the-counter drugmakers would be forced to stop using the ingredient.
The Consumer Healthcare Products Association expressed its disappointment, stating that the industry traditionally relies on ingredients like phenylephrine for cold and cough medicines, and the removal would impact their offerings significantly.
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