Kenvue Urges FDA to Reject Request for Autism Warning on Tylenol

Oct. 20, 2025, 4:04 PM UTC

Kenvue Inc. urged US regulators to deny a request warning against Tylenol’s use during pregnancy, laying out the most detailed defense of its biggest product after Trump administration officials tied its use to autism.

A citizen petition filed last month asked for changes to the label “that are unsupported by the scientific evidence and legally and procedurally improper,” the company said in an Oct. 17 submission to the US Food and Drug Administration. The “overwhelming weight of the evidence” contradicts any claim that the nonprescription medicine used to treat pain and reduce fevers is a risk for neurodevelopmental disorders, ...

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