White House targets Tylenol in sweeping autism change

In the most profound federal autism policy shift ever, President Donald Trump this week declared acetaminophen — commonly sold as Tylenol — to be a major risk factor for autism, if taken by women during pregnancy and given to very young children.

Trump also fingered vaccines in general as potential autism triggers and announced the first federally recognized treatment for autism symptoms, as well as a massive new $50 million research effort.

The announcement, made at the the White House by Trump, who was joined by Health and Human Services (HHS) secretary Robert F. Kennedy, Jr., marks the first time the federal government has formally linked America’s still mushrooming autism rates to the use of an over-the-counter pain reliever.

It is also the first time a sitting president and his administration have targeted the nation’s vaccines and vaccine protocols as potential culprits. Officials announced a three-track strategy: FDA authorization of a treatment pathway for some autistic children, new federal warnings and labeling changes for acetaminophen, and a $ 50-million National Institutes of Health (NIH) research initiative.

The press conference came with plenty of blunt talk from the president.

“So taking Tylenol is not good,” Trump said. “All right. I’ll say it. It’s not good. For this reason, they are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary. That’s, for instance, in cases of extremely high fever, that you feel you can’t tough it out. You can’t do it. I guess there’s that.”

Trump strayed beyond prepared remarks to suggest that vaccines may contribute to autism and that the administration would continue its research and address that issue as well. Trump had sharp words for the current vaccine schedule.

“And they pump so much stuff into those beautiful little babies, it’s a disgrace,” the president said. “I don’t see it. I think it’s very bad. They’re pumping — it looks like they’re pumping into a horse. You have a little child, a little fragile child, and you get a vat of 80 different vaccines, I guess, 80 different blends and they pump it in.”

Trump also criticized the addition of heavy-metal adjuvants to vaccines, as well as the combinations of shots administered.

“We want no mercury in the vaccine,” Trump said. “We want no aluminum in the vaccine. The MMR, I think should be taken separately. This is based on what I feel. The mumps, measles and the three should be taken separately. And it seems to be that when you mix them, there could be a problem. So there’s no downside in taking them separately. In fact, they think it’s better.”

Trump said it was obvious that autism is, at least in part, an environmental disorder.

“I mean, I’ve been so into this issue for so many years just because I couldn’t understand how a thing like this could happen and you know it’s artificially induced,” he said.

For his part, Kennedy said the explosive surge in autism prevalence could no longer be swept under the rug, either its existence or its causes.

“Autism has surged nearly 400 percent since 2000 and now affects 1 in 31 American children,” Kennedy said. “For too long, families have been left without answers or options. Today, we are taking bold action — opening the door to treatment, informing families about potential risks, and investing in groundbreaking science. We will follow the evidence, restore trust, and deliver hope to millions.”

The first recognized therapeutic

At the center of last Monday’s announcement was the FDA’s decision to recognize leucovorin, a compound that is a form of folate (vitamin B9) that has long been used for cerebral folate deficiency, as a treatment pathway for children with autism spectrum disorder (ASD) who show folate-related deficits.

The agency published a Federal Register notice updating leucovorin’s labeling, authorizing doctors to prescribe it for children with ASD and allowing Medicaid coverage under the Centers for Medicare & Medicaid Services (CMS) partnership. NIH will conduct confirmatory trials, along with long-term safety studies HHS announced.

Officials emphasized that leucovorin is not a cure for autism, though research suggests it can improve speech and social deficits for a subset of children. 

“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.”

Makary said autism may also be due to an autoimmune reaction to a folate receptor on the brain, not allowing that important vitamin to get into the brain cells. 

“It’s a fairly established mature pathway,” Makary said. “Again, we have a duty to let doctors and the public know. We are going to change the label to make it available. Hundreds of thousands of kids in my opinion will benefit.”

One study found that with children with autism and chronic folate deficiency, two-thirds of the children with autism symptoms had improvement and some marked improvement, Makary said. 

“Mr. President, you told us to do what’s medically right, to go bold and not worry about the corporations and the lobbyists, so that’s what we’re here doing today,” he said.

Makary said the new approach represented the start of a historic shift in medical culture. 

“This administration is working together to ask big questions about why our nation’s children are getting sick so fast,” he said. “Too often, medicine is doing small little studies giving us answers we already knew, but we’ve got to make a difference.”

It's hard to watch something that might be entirely preventable, Makary said. 

FDA takes on Tylenol

There was a lot of political electricity surrounding the announcements, both inside and outside the White House, but perhaps the most politically charged component, at least immediately, was the FDA’s push to update the safety label for acetaminophen. 

That change will be accompanied by a physician advisory notice and a nationwide HHS public service campaign, warning families about potential neurodevelopmental risks.

During the press conference, Kennedy said the FDA was responding to clinical and laboratory studies that suggest an association between acetaminophen use during pregnancy and adverse neurodevelopmental outcomes, including later diagnosis for ADHD and autism. Scientists have analyzed biological mechanisms linking prenatal acetaminophen exposure to altered brain development.

Kennedy also said the FDA has evaluated contrary studies that show no association. 

In a 2025 Environmental Health review led by Diddier Prada of the Icahn School of Medicine at Mount Sinai, a meta-analysis of 46 studies evaluated acetaminophen exposure. Twenty-seven reported significant associations between prenatal acetaminophen exposure and neurodevelopmental disorders, nine showed no link, and four suggested protective effects. 

Specifically with respect to autism spectrum disorder, the researchers found a steady link between prenatal exposure to acetaminophen and ASD.

“The reviewed studies consistently reported a positive association between prenatal acetaminophen use and ASD, with an exposure–response relationship observed in four of the five studies that evaluated the relationship,” the researchers wrote. “Ultimately, there was strong evidence of a relationship between prenatal acetaminophen use and increased risk of ASD in children.”

And that wasn’t all, the researchers found: “Many studies consistently reported a positive association between prenatal acetaminophen use and other NDDs (neurodevelopmental disorders), with an exposure–response relationship observed in some studies,” they wrote. “Ultimately, there was strong evidence of an association between prenatal acetaminophen use and increased risk of other NDDs in children, including nine high-quality studies that provided very strong evidence of an association.”

Higher-quality studies were more likely to show positive associations, the researchers wrote, concluding that “appropriate and immediate steps should be taken to advise pregnant women to limit acetaminophen consumption to protect their offspring’s neurodevelopment.”

What was striking in the studies, the researchers reported, was the consistency of association in the findings, despite many variables.

“The majority of the studies show consistency between their results,” the researchers wrote. “Most results are consistent across different time periods, datasets, and patient populations: when a mother takes acetaminophen while pregnant, the odds of her child having an NDD, including ADHD or ASD, increased, and these associations were also formally statistically significant.”

Other research includes Schultz et al.’s 2008 parental survey, which found children given Tylenol after the measles-mumps-rubella (MMR) vaccine were six times more likely to later be diagnosed with autism, compared with no association for ibuprofen.

In his remarks, Kennedy said the FDA recognizes that acetaminophen is often the only tool for fevers and pain in pregnancy, as other alternatives have well-documented adverse effects. 

“HHS wants, therefore, to encourage clinicians to exercise their best judgment in the use of acetaminophen for fevers and pain in pregnancy by prescribing the lowest effective dose for the shortest [time] necessary and only when treatment is required,” he said. “Furthermore, thanks to the politicization of science, the safety of acetaminophen against the risk of neurodevelopmental disorders in young children has never been validated. Prudent medicine therefore suggests caution [in] acetaminophen use by young children, especially since strong evidence has also associated it with liver toxicity.”

The third element of the administration’s program is the Autism Data Science Initiative (ADSI), a $50-million NIH program that funds 13 projects to integrate biological, clinical, and environmental data. NIH director Dr. Jay Bhattacharya said the initiative would employ machine learning, organoid modeling, and exposomics — tracking how environmental and nutritional exposures interact with genetics.

Projects will also build replication hubs to address past concerns of irreproducibility in autism research. 

“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,” 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.”  

Kenvue responds

Kenvue, the maker of Tylenol and formerly the consumer health division of Johnson & Johnson that became a fully independent company in 2023, responded immediately.

“We believe independent, sound science clearly shows that taking acetaminophen does not cause autism,” the company said in a statement. “We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers. Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy.”

Without it, the company stated, women face a dangerous choice of suffering through conditions like fever that are potentially harmful to both mom and baby or using riskier alternatives. 

“The facts are that over a decade of rigorous research, endorsed by leading medical professionals and global health regulators, confirms there is no credible evidence linking acetaminophen to autism,” the company stated.

The medical establishment joined in a chorus of support. 

Dr. Céline Gounder, a medical contributor for KFF Health News, warned to CBS that expectant mothers may be harmed if they avoid treating fever or pain, which itself can cause complications.

“The medical community, the scientific community has the same consensus, which is that Tylenol, acetaminophen, is safe in pregnancy,” Gounder said.

Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists, agreed.

“Suggestions that acetaminophen use in pregnancy causes autism are not only highly concerning to clinicians but also irresponsible when considering the harmful and confusing message they send to pregnant patients, including those who may need to rely on this beneficial medicine during pregnancy,” Fleischman said. 

Some public health experts also expressed concern about Trump’s vaccine comments. 

Katelyn Jetelina, an epidemiologist and healthcare communicator, compared vaccines to car safety, speaking to Stat News.

“The vaccine schedule is like a seatbelt,” Jetelina said. “You don’t wait four years to buckle your child in.” 

The president of the American Academy of Pediatrics, Susan Kressly, said that the White House event on autism was filled with dangerous claims and misleading information that sent a confusing message to parents and expecting parents.

“Studies have repeatedly found no credible link between life-saving childhood vaccines and autism,” Kressly said. “This research, in many countries, involving thousands of individuals, has spanned multiple decades. Any effort to misrepresent sound, strong science poses a threat to the health of children.”    

No matter the viewpoint, the administration’s moves will be seismic. FDA’s labeling changes will force drugmakers to update product inserts, advertising, and physician materials for the nation’s most widely used analgesic. Medicaid coverage of leucovorin for ASD could affect hundreds of thousands of children. 

It also marks a departure for NIH research, from endorsing industry assertions of primarily genetic causes of autism to scrutinizing environmental and pharmaceutical contributors to autism.

The FDA has initiated a labeling update process for acetaminophen to reflect possible neurodevelopmental risks during pregnancy. NIH’s ADSI is slated to begin in late 2025, as early as September, with project periods ranging 24–36 months. 

For leucovorin, federal announcements suggest that state Medicaid programs may begin coverage in coordination with CMS, especially once the drug’s label is updated.

Richard Moore is the author of “Dark State” and may be reached at richardd3d.substack.com.