Kenvue Urges FDA to Reject Request for Autism Warning on Tylenol

By Kelly Cloonan

Kenvue urged the Food and Drug Administration to deny a proposal to add further warnings to acetaminophen products after the Trump Administration linked Tylenol use during pregnancy to autism.

The Tylenol maker said the labeling changes, requested by a citizen petition filed last month, are not supported by existing science.

The FDA, and Kenvue itself, have repeatedly found no causal association between acetaminophen use in pregnancy and neurodevelopmental disorders, the company said.

"The labeling request is unsupported by scientific evidence and would represent an unexplained departure from FDA's longstanding position on acetaminophen during pregnancy," Kenvue said.

The petition's proposed consumer label changes include adding claims of an increased risk of acetaminophen use during pregnancy and neurodevelopmental disorders. The label changes would direct that use during pregnancy should be limited in terms of dose, duration and frequency.

The petition was filed by the Informed Consent Action Network (ICAN) on Sept. 22, the same day that President Trump warned that acetaminophen is a potential cause of autism and urged expecting mothers to "tough it out" without the drug if they could.

Kenvue said it strongly believes that the existing instruction, "if pregnant or breast-feeding, ask a health professional before use," is the most appropriate warning.

Write to Kelly Cloonan at kelly.cloonan@wsj.com

(END) Dow Jones Newswires

October 20, 2025 13:30 ET (17:30 GMT)