“after an agency review of the available data determined that oral phenylephrine is not effective for this use.”
The FDA ruled oral phenylephrine effective 30 years ago. Its own advisory committee voted unanimously in September 2023 that the data never supported the dose. Fourteen months later the agency has a proposal, not a ban, and manufacturers get “appropriate time” to reformulate. Pharmacies keep selling a placebo with a decongestant label until then.