★★☆Single study — solid evidence, such as one good trial or a large observational dataset, but not replicated at the top tier.
FDA advisers voted 16 to 0 that the evidence doesn't back the pill
In September 2023, all 16 voting advisers found that current data do not show the labelled oral dose works as a decongestant. Safety was not the question.
What the study found
FDA advisers voted 16 to 0 that the data fail the labelled dose
In September 2023 the FDA's outside advisers on nonprescription drugs voted 16 to 0 that current data do not support oral phenylephrine at its labelled dose as a nasal decongestant. They found the newer trials credible. The question put to them was whether it works, not whether it is safe.
The caveat · Advice to the FDA, not a ruling
An advisory vote is advice to the FDA, not a ruling; the agency decides separately. Members noted that no data measure the drug in the nasal lining.