Kenvue Urges FDA to Reject Autism Warning on Tylenol Label

Kenvue, the maker of Tylenol, is actively opposing efforts to change the drug's labeling to include warnings about a potential link between acetaminophen use during pregnancy and autism, a claim associated with the Trump administration. The company argues that there is no conclusive causal relationship proven and cites substantial scientific evidence and endorsements from major health organizations refuting such claims. Kenvue submitted detailed filings to the FDA urging regulators to reject the citizen petition requesting the warning, describing it as unsupported by scientific evidence and procedurally improper. Despite the controversy, Kenvue remains a strong market presence with a diverse portfolio and significant revenue in consumer health products. The FDA is reviewing the matter, but no label changes have been mandated so far. The debate reflects ongoing tensions between regulatory scrutiny and industry defense concerning drug safety and public health communications.