Kenvue urges FDA to reject request for autism warning on Tylenol

Kenvue urged U.S. 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 U.S. 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, the company said.

The 42-page submission came in response to the Informed Consent Action Network’s citizen petition, a formal request to the FDA to take action that must be responded to within 180 days. It asked the agency to require Tylenol and other products containing acetaminophen warn that they’ve been associated with disorders including autism and attention-deficit hyperactivity disorder, and that they should be taken at the lowest effective dose for the shortest possible time when taken during pregnancy.

“The expansive scientific evidence developed over many years does not support a causal link, as confirmed in the Food and Drug Administration’s own public statements,” Kenvue said. “For over a decade, and as recently as August, FDA has fully evaluated the emerging scientific evidence and repeatedly concluded that the data do not support a causal association.”

The debate over Tylenol’s safety adds to Kenvue’s mounting woes and puts its largest brand by revenue at significant risk. The company has struggled with falling sales since being spun out of Johnson & Johnson in 2023, leading to the ouster of its former chief executive officer after several activist investors built stakes.

ICAN, a nonprofit organization with ties to Health and Human Services Secretary Robert F. Kennedy Jr. that has questioned the safety of vaccines, filed the petition on Sept. 22, the same day President Trump linked Tylenol’s use during pregnancy to rising rates of autism.

The claims quickly spread confusion about the drug’s safety. For years pregnant women have been told that acetaminophen is the safest medicine to treat fevers, which have been linked to complications.

Kenvue laid out a legal response to the request, saying that any action beyond denying the petition would be an “arbitrary and capricious” violation of the Administrative Procedure Act and would improperly intervene in the practice of medicine.

The government’s changing stance toward acetaminophen has opened the door for potential lawsuits against Kenvue, claiming damages from the use of Tylenol. In its filing, the company said the citizen petition was submitted by “plaintiff-side lawyers” and laid out its case why the proposed label changes would be “contrary to law.”

Last week, Kenvue’s shares sank to an all-time low, shedding $4 billion in market value, after UK plaintiffs filed a suit against the company and its former parent claiming its talc-based baby powder caused cancer.

Brown writes for Bloomberg.