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The FDA notes the proposed order is not based on safety concerns, and that the presence of oral phenylephrine in these medicines does not affect how other active ingredients treat symptoms.
In September 2023, an FDA advisory committee of 16 experts held a two-day meeting, which culminated with the announcement that oral phenylephrine is not effective, and works no better than a ...
The Food and Drug Administration (FDA) is proposing to remove from the market a common ingredient found in most oral over-the-counter cold medicines because it doesn’t work. The move brings FDA ...
The FDA announced a proposal to remove oral phenylephrine, found in many popular OTC decongestants, from shelves. The reason for the ban is that the ingredient just isn’t effective, the FDA says.
On Thursday, the FDA proposed removing oral phenylephrine from the list of approved active ingredients for over-the-counter (OTC) nasal decongestants, citing concerns over its effectiveness. After ...
The US Food and Drug Administration announced a proposal to remove oral phenylephrine – a common ingredient in many popular over-the-counter decongestants – from the market, citing evidence ...
But recent FDA-sponsored testing hasn't uncovered any safety issues. Since 2021, laboratory analysis of more than 150 cosmetic samples has come back negative for asbestos, according to the FDA. Still, concerns about the risk prompted Congress to pass a 2023 law requiring the FDA to release new industry standards for asbestos testing.
The stakes are high, experts say, because a committee vote declaring phenylephrine ineffective as an oral decongestant could push the FDA to revoke the drug’s over-the-counter designation as ...