Maker Of Tylenol Pushes Back On Label Change Proposal

Kenvue asked the FDA to deny the petition, saying the suggested label changes are unsupported by scientific evidence.

The maker of Tylenol is pushing back on proposed changes to the product’s safety label.

Last month, President Trump claimed that Tylenol use during pregnancy was linked to an increased risk of autism.

The FDA responded by asking Kenvue to include the warning to the safety label on Tylenol. The company says that acetaminophen, the generic name for the painkiller, is “one of the most studied medicines in history” and that the “adoption of the proposed labeling revisions would be arbitrary, capricious, and contrary to law.”

The current label instructs people who are pregnant or breastfeeding to “ask a health professional before use.” Kenvue asked the FDA to deny the petition, saying the suggested label changes are unsupported by scientific evidence.