Overview
- Kenvue submitted a detailed response dated Oct. 17–18 asking the FDA to deny an ICAN citizen petition seeking stronger pregnancy warnings about autism and ADHD.
- The company argued the proposed language lacks scientific support and called any such change arbitrary, capricious, and contrary to the agency’s longstanding position.
- Federal officials had said the FDA would move to update labels after the president urged pregnant women to avoid Tylenol, though the FDA’s website still says it has not found clear evidence of harm with appropriate use.
- An FDA letter to clinicians noted studies reporting a possible increased risk of neurodevelopmental conditions but emphasized that a causal relationship has not been established.
- Major U.S. medical groups and regulators in the EU, UK, and Canada continue to advise judicious, clinician‑guided acetaminophen use in pregnancy, citing mixed research that includes a large Swedish study finding no causal link.