Overview
- Kenvue filed a formal Oct. 17 response urging the FDA to deny ICAN’s citizen petition seeking an autism and ADHD warning for acetaminophen use during pregnancy, calling the request unsupported and procedurally improper.
- The company argued that adopting the proposed label language would be "arbitrary and capricious" under the Administrative Procedure Act and an unexplained break from the agency’s long‑standing position.
- In recent communications to clinicians, the FDA said some studies report associations but a causal relationship has not been established, and its public guidance on acetaminophen remains unchanged.
- Major U.S. medical groups, including ACOG and the Society for Maternal-Fetal Medicine, continue to advise judicious, clinician‑guided use of acetaminophen during pregnancy as untreated fever or pain carries risks.
- International regulators in the European Union, the United Kingdom and Health Canada reiterated that acetaminophen remains acceptable in pregnancy, after President Trump’s warning and ICAN’s petition intensified public concern.