On September 22, 2025, President Donald Trump and Health and Human Services Secretary Robert F. Kennedy Jr. made public statements linking the use of acetaminophen (the active ingredient in Tylenol) during pregnancy to a possible increased risk of autism and other neurodevelopmental disorders such as ADHD. They also announced that the FDA has initiated a process to change the safety labeling for acetaminophen to reflect this possible association, and that physicians will be notified. The Trump administration emphasized that pregnant women should limit acetaminophen use unless medically necessary, especially in cases like high fever. However, they acknowledged that no definitive scientific proof of causation has been established.
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Scientific Evidence Overview
A recent systematic review led by Mount Sinai used the Navigation Guide methodology to assess 46 studies (over 100,000 participants) and found an association between prenatal acetaminophen exposure and increased risks of autism and ADHD.
Medical Community Response
Major medical groups, including the American College of Obstetricians and Gynecologists (ACOG), have pushed back, saying acetaminophen remains the safest over-the-counter option during pregnancy for managing pain and fever under typical conditions.
Policy Impact
The FDA is starting label changes and issuing physician notices to reflect “possible association,” not established causation. The administration is also promoting research and therapeutics (for example, leucovorin for autism-like symptoms in select cases). Still, global health bodies like the WHO, and regulatory agencies in other countries, have said the evidence is inconsistent.
