WASHINGTON—In a coordinated push to address the escalating autism epidemic, President Donald J Trump and U.S. Health and Human Services (HHS) Secretary Robert F Kennedy, Jr. unveiled on Monday, September 22, three major initiatives aimed at advancing treatments, informing families on potential health risks, and accelerating research into the disorder’s root causes.
“For too long, families have been left without answers or options as autism rates have soared,” Secretary Kennedy said. “Today, we are taking bold action—opening the door to the first FDA-recognized treatment pathway, informing doctors and families about potential risks, and investing in groundbreaking research. We will follow the science, restore trust, and deliver hope to millions of American families.”
Speaking from the Roosevelt Room, the leaders highlighted a new FDA-recognized pathway for a speech-improving drug, enhanced warnings on acetaminophen—also known as Tylenol—use during pregnancy, and a $50 million NIH-funded data science effort.
Despite the sharp rise in autism prevalence— from 1 in 150 children in 2000, to now affecting 1 in 31 American children, up from 1 in 36 just two years prior, according to the Centers for Disease Control and Prevention (CDC)—there remains no scientific consensus on the underlying causes, leaving families with limited tools for prevention or intervention.
According to the National Survey of Children’s Health (2018–2019 data, as analyzed by Autism Speaks), autism spectrum disorder among children in Washington State is estimated at 2.9%, or about 1 in 34 children aged 3–17 years.
Kenvue, the maker of Tylenol, issued a firm rebuttal to the Trump administration’s announcement linking prenatal use of acetaminophen (the active ingredient in Tylenol) to potential autism risks arguing a lack of scientific backing for the administration’s claims.
Axios reports that in a statement, a spokesperson for Kenue stated that “acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy,” adding that “We believe independent, sound science clearly shows that taking acetaminophen does not cause autism. We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers.”
According to the company’s 2024 Annual Report, Kenvue generated $15.5 billion in net sales in 2024 earning just over $1 billion in net profits.
The Trump administration’s response to what HHS Secretary Kennedy Jr calls an autism epidemic, launches a trio of initiatives, marking historic cooperation among the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), and the Centers for Medicare and Medicaid Services (CMS).
The FDA is acting on a potential treatment for speech-related deficits in autism spectrum disorder (ASD). The agency published a Federal Register notice on September 22 outlining a label update for leucovorin, a generic drug linked to addressing cerebral folate deficiency associated with autism symptoms. This establishes the first FDA-recognized therapeutic for children with cerebral folate deficiency and autistic traits.
While the pathophysiology of autism is still being unraveled, research points to disruptions in the brain’s folate transport system—stemming from genetic or autoimmune factors—as a key area of interest. These impairments can hinder folate absorption in the central nervous system, even when body-wide levels appear normal, leading to developmental delays akin to ASD. Leucovorin, an inexpensive prescription available for decades with a strong safety profile, bypasses these blockages to aid healing in some cases.
Peer-reviewed studies and randomized clinical trials indicate that up to 60 percent of folate-deficient children with ASD may see improved verbal communication with leucovorin, particularly those with folate receptor antibodies.
Though not a cure, it targets speech deficits and authorizes continued use for children showing gains in language, social skills, or adaptive behaviors. In tandem, CMS will enable state Medicaid programs to cover leucovorin for ASD indications. The NIH will follow with confirmatory trials, safety assessments, and broader research on its impacts.
Promising as it is, leucovorin applies only to a subset of children and requires close medical oversight alongside therapies like behavioral interventions.
“As a physician, I have seen how devastating autism spectrum disorder can be for children and their families,” CMS Administrator Dr. Mehmet Oz said. “Today’s actions represent an unprecedented, comprehensive approach to deepen our understanding of the causes of autism, share what we know and don’t know based on current research, and ensure that every child has a better chance to thrive. By providing access to a drug to treat symptoms associated with autism, we are providing hope to families and providers who have until today had very limited options.”
In a second initiative, HHS is targeting acetaminophen (also known as Tylenol), the active ingredient in Tylenol and similar products. The FDA issued a physician notice today and launched the process for a safety label update, while HHS kicks off a nationwide public service campaign to educate families and safeguard public health.
This stems from clinical and laboratory studies suggesting a possible link between prenatal acetaminophen exposure and neurodevelopmental risks, including autism.
Countervailing research shows no such association, and untreated fever in pregnancy poses its own dangers to mothers and fetuses. With the evidence mixed and no proven causality, HHS urges clinicians to prescribe the lowest effective dose for the shortest time when needed—acknowledging acetaminophen’s role as a safer alternative to options like NSAIDs, which carry documented risks. The FDA is collaborating with manufacturers on labeling revisions and spurring fresh studies to protect maternal and child health.
“A growing body of evidence suggests that some children suffering from autism are folate deficient within the brain—a problem that can be treated with leucovorin,” FDA Commissioner Dr. Marty Makary said. “Given the extent of the current autism epidemic, physicians should immediately have this treatment option available for candidate children. We are also sharing new information about the potential risks of acetaminophen so patients can make a more informed decision with their health care provider.”
Rounding out the announcements, the NIH revealed recipients of its Autism Data Science Initiative (ADSI), awarding more than $50 million to 13 projects out of nearly 250 applicants. This effort integrates vast biological, clinical, and behavioral datasets with an “exposomics” lens, probing environmental, nutritional, medical, and social influences alongside genetics to pinpoint ASD’s drivers and therapies.
Selected via rigorous peer review, the projects emphasize root causes and interventions, incorporating replication studies for scientific integrity. They leverage tools like machine learning and organoid models, span pediatric and adult populations, and include community input to ensure relevance for autistic individuals, families, and providers.
“Millions of American families who care for autistic kids need scientists to apply gold standard science, expertise, and open minds to figure out how to help these kids,” NIH Director Dr. Jay Bhattacharya said. “With the Autism Data Science Initiative, NIH is harnessing cutting-edge science to uncover the root causes of autism. We are building knowledge that can improve lives and restore hope for families.”
Washington State Department of Health Response to HHS Announcement on Autism
Below is a statement provided by Raechel Sims, spokesperson for Washington State Department of Health to the Lynnwood Times on President Trump’s recommendation of not taking Tylenol during pregnancy to prevent autism in children:
“DOH is aware of the White House’s statements regarding acetaminophen (commonly known by the brand name Tylenol) and claims that its use during pregnancy may increase the risk of autism in children. Years of research have shown that acetaminophen is a safe and reliable treatment for fever and mild pain, including when used during pregnancy.
“DOH also reaffirms that vaccines remain a critical tool for protecting maternal and child health.
“We’re committed to ensuring that all our information and guidance is based on the best science available. We’re reviewing the materials presented today. We continue to recommend that pregnant people speak with their health care providers about all medications taken during pregnancy.”
White House releases causal evidence linking acetaminophen to autism
The White House on Monday released its evidence suggesting acetaminophen use in pregnant women, especially late in pregnancy, may cause long-term neurological effects in their children.
▪ Large-scale cohort studies
https://pubmed.ncbi.nlm.nih.gov/30923825/
https://pubmed.ncbi.nlm.nih.gov/31664451/
▪ Prenatal acetaminophen exposure to altered brain development
https://pubmed.ncbi.nlm.nih.gov/35450103/
▪ Andrea Baccarelli, M.D., Ph.D., Dean of the Faculty at Harvard T.H. Chan School of Public Health
https://ehjournal.biomedcentral.com/articles/10.1186/s12940-025-01208-0
https://hsph.harvard.edu/news/using-acetaminophen-during-pregnancy-may-increase-childrens-autism-and-adhd-risk/
▪ Johns Hopkins University
https://hub.jhu.edu/2019/11/05/acetaminophen-pregnancy-autism-adhd/
▪ Mount Sinai Study
https://www.mountsinai.org/about/newsroom/2025/mount-sinai-study-supports-evidence-that-prenatal-acetaminophen-use-may-be-linked-to-increased-risk-of-autism-and-adhd
▪ 2021 International consensus statement
https://pubmed.ncbi.nlm.nih.gov/34556849/
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Author: Mario Lotmore
