President Donald Trump announced on Monday, September 22, 2025, that the US Food and Drug Administration will inform doctors that women’s use of Tylenol while pregnant can be connected with children being diagnosed with autism. 

Despite expert opinion and years of evidence to support that the use of Tylenol is safe, Trump stated, “They are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary,” because it can come with a “very increased risk of autism.” He used a fever as an example in his incomprehensible statement claiming women should avoid it unless “you can’t tough it out.”  

Experts Weigh In

During pregnancy, a fever can be harmful to both the fetus and the pregnant person, and could lead to miscarriage, birth defects, and high blood pressure. Studies show that acetaminophen is commonly used during pregnancy as a pain reliever, and Tylenol is considered the safest option. Other options like ibuprofen or regular-dose aspirin, have proven to increase the risk of serious complications. 

Experts say that there are multiple causes of autism; however, the connection between autism and Tylenol has not been fully determined. Trump also made remarks regarding all vaccines, advocating for breaking up childhood vaccinations and pushing back against them. It is “too much liquid, too many different things are going into that baby,” Trump stated. Without further evidence to back up his claims, experts weighed in, stating extensive research has been conducted and shows there is no link between vaccines and autism. 

Trump continued on his Tylenol rant, thanking Robert F. Kennedy Jr. for bringing autism to the “forefront of American politics, along with me.” Kennedy has been consistently against vaccines and promotes disproven theories that vaccines are responsible for autism. He was more moderate in his approach during Monday’s briefing, stating the FDA will encourage clinicians to use their best judgment when situations arise, but to use the lowest effective dose when treatment is required.

Tylenol Maker Kenvue Responds

The FDA said they are in the process of changing the safety label on acetaminophen products and sending a letter to physicians stating that the responsibility for administering Tylenol “still belongs with parents.” The maker of Tylenol, Kenvue, responded that it “strongly disagrees” with the connection between acetaminophen and autism, stating it is “deeply concerned about the health risks and confusion this poses for expecting mothers and parents.”

“Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy,” Kenvue said in a statement. “Without it, women face dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives. High fevers and pain are widely recognized as potential risks to a pregnancy if left untreated.”

Evidence Proves Trump’s Statements False

The connection between Tylenol and autism has not been determined. Science-based studies have proven that there is no evidence to provide a clear connection between the two. JAMA published a 2024 peer-reviewed Swedish study, which included over two million children, in which no connection was found between acetaminophen taken during pregnancy and autism, or any other neurodevelopmental disorder, such as ADHD.

More recently, a BMC Environmental Health study was published in August where 46 studies were conducted on acetaminophen use during pregnancy and neurodevelopmental disorders. The overall conclusion was that there was “strong evidence of an association,” but authors were careful to avoid saying the research showed acetaminophen caused autism because there is no evidentiary proof. 

“We recommend judicious acetaminophen use — lowest effective dose, shortest duration — under medical guidance, tailored to individual risk–benefit assessments, rather than a broad limitation,” the researchers wrote in their analysis. In other words, too much of anything is never good, and one should be aware of the common and individualized risks. 

Organizations Speak Out

The Autism Science Foundation’s president, Alison Singer, made a statement following RFK and Trump’s announcement, saying their organization is “deeply concerned” and characterized it as unsafe. “We are unsure why this announcement came today and how the conclusions were drawn,” Singer said.

“No new data or scientific studies were presented or shared. No new studies have been published in the literature. No new presentations on this topic were made at scientific or medical conferences. Instead, President Trump talked about what he thinks and feels without offering scientific evidence.

He said, ‘tough it out,’ meaning don’t take Tylenol or give it to your child. It took me straight back to when moms were blamed for autism. If you can’t take the pain or deal with a fever, then it’s your fault if your child has autism. That was shocking. Simply shocking.”

The president of the American College of Obstetricians and Gynecologists, Dr. Steven J. Fleischman, said the announcement was reckless and ill-advised. “Today’s announcement by HHS is not backed by the full body of scientific evidence and dangerously simplifies the many and complex causes of neurologic challenges in children,” Fleischman said. “It is highly unsettling that our federal health agencies are willing to make an announcement that will affect the health and well-being of millions of people without the backing of reliable data.”

FDA Approves Autism Drug

The FDA said it approved a prescription called leucovorin to treat autism in children. The drug is a high-dose calcium folinic acid that is typically used to treat cancer patients undergoing chemotherapy and is now “the first FDA-recognized treatment for autism.” Medicaid programs will now allow it to be covered under their plans. Unfortunately, there are only a few studies testing leucovorin and children with autism, so there is no evidence to prove it will help or be harmful, but experts believe it is promising.