HHS Announces Three Autism Actions as FDA Begins Acetaminophen Safety Label Change
On September 22, 2025, President Donald J. Trump and U.S. Health and Human Services Secretary Robert F. Kennedy Jr. announced three actions on autism from the Roosevelt Room of the White House in Washington. HHS said autism spectrum disorder has surged nearly 400 percent since 2000 and now affects 1 in 31 American children.
First, the Food and Drug Administration published a Federal Register notice outlining a label update for leucovorin for cerebral folate deficiency, which has been associated with autism. HHS said the action establishes the first FDA-recognized therapeutic pathway for children with cerebral folate deficiency and autistic symptoms. After the label update, state Medicaid programs will be able to cover leucovorin for the autism indication in partnership with the Centers for Medicare & Medicaid Services, and the National Institutes of Health will launch confirmatory trials and safety studies. HHS noted that leucovorin is not a cure for autism and may only improve speech-related deficits for a subset of children, and must be given under close medical supervision.
Second, the FDA will issue a physician notice and begin the process to initiate a safety label change for acetaminophen (Tylenol and similar products), and HHS will launch a nationwide public service campaign. HHS said the FDA is responding to prior clinical and laboratory studies that suggest a potential association between acetaminophen use during pregnancy and adverse neurodevelopmental outcomes. HHS also stated that there are contrary studies showing no association, and that untreated fever in pregnancy carries risks for both mother and fetus. Given the conflicting literature and lack of clear causal evidence, HHS said it wants clinicians to exercise their best judgment, prescribing the lowest effective dose for the shortest duration when treatment is required, and noted that acetaminophen is often the only tool for fever and pain in pregnancy, as alternatives such as NSAIDs have well documented adverse effects.
Third, NIH announced the recipients of the Autism Data Science Initiative, funding 13 projects totaling more than $50 million, integrating large-scale biological, clinical and behavioral data with environmental, nutritional, medical and social factors.
Secretary Kennedy said families had been left without answers or options, and that the actions open the door to the first FDA-recognized treatment pathway, inform doctors and families about potential risks, and invest in research. FDA Commissioner Dr. Marty Makary said a growing body of evidence suggests some children with autism are folate deficient within the brain, a problem that can be treated with leucovorin, and that physicians should immediately have the option available for candidate children.
(Source: U.S. Department of Health and Human Services)
Source: U.S. Department of Health and Human Services
Published by GSM · USA (original Chinese edition)
Photo: 图：2025年9月22日，卫生与公众服务部长 Robert F. Kennedy Jr. 在白宫 Roosevelt 室就自闭症行动发表讲话，特朗普在旁。白宫官方照片，公共领域，经 Wikimedia Commons。 / Photo: HHS Secretary Robert F. Kennedy Jr. gives remarks on the autism actions in the Roosevelt Room of the White House on September 22, 2025, with President Donald Trump standing by. Official White House photo, public domain, via Wikimedia Commons.
