Trump and RFK Jr. announce new autism-related actions, linking Tylenol and proposing treatment

President Donald Trump and Health and Human Services Secretary Robert F. Kennedy Jr. unveiled a series of initiatives on Sept. 22 aimed at addressing the rising rates of autism spectrum disorder (ASD) in the United States. The announcement included claims about prenatal use of Tylenol (acetaminophen), warnings for pregnant individuals and regulatory changes to support autism treatments.

The U.S. Food and Drug Administration (FDA) has approved leucovorin, a folic acid derivative, for treating symptoms associated with cerebral folate deficiency (CFD), which often overlap with autism-like neuropsychiatric symptoms. This move formalizes a treatment pathway for children showing speech, social or adaptive deficits where CFD is identified.

President Trump asserted in a White House briefing that acetaminophen use during pregnancy appears to be "a very big factor" in autism risk. He advised pregnant individuals to limit their use of Tylenol unless it is medically necessary, especially for cases like high fever. The administration plans to issue updated safety labeling for acetaminophen and to share guidance with clinicians.

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Officials acknowledged that the literature on acetaminophen and autism risk is mixed. Some studies suggest a statistical association; others do not, and many experts say there is no proof of causation.

Kenvue, the maker of Tylenol, strongly pushed back on the claims, asserting that the existing scientific record does not support the administration's suggestion that prenatal acetaminophen causes autism. The company also expressed concerns about the potential public health impact of such recommendations.

The administration is funding a broader research initiative called the Autism Data Science Initiative (ADSI), which involves grants to multiple teams to investigate environmental, genetic, nutritional, and medical factors in autism, with an emphasis on reproducibility and rigorous scientific methods.

The evidence for a connection between acetaminophen during pregnancy and autism is based largely on observational studies. Some analyses show a slight increase in risk; others show that once familial and environmental factors are accounted for, that increase either shrinks or disappears.

Leucovorin has shown promise in small studies, particularly for children identified with cerebral folate deficiency, in improving speech or behavior deficits. But large randomized trials are still lacking and it is not seen by experts as a cure for autism.

The Trump administration has taken formal steps to treat leucovorin for certain autism-related symptoms and has raised concerns about acetaminophen use during pregnancy. The claims about Tylenol are controversial and not supported by definitive scientific proof of causation.

For now, the new policies seem intended to increase awareness, adjust prescribing and labeling and push for more research.

Sources

• AP News

• The Washington Post

• Wall Street Journal

• Financial Times