Trump Claims Tylenol Causes Autism When Taken Early in Pregnancy

President Donald Trump and Health and Human Services Secretary Robert F. Kennedy Jr. said that autism is caused by prenatal exposure to Tylenol.

During a press conference on Monday, Sept. 22, Trump said that “effective immediately,” the FDA will notify physicians that the use of acetaminophen during pregnancy “can be associated with a very increased risk of autism.”

The relationship between acetaminophen and autism has been the subject of many research studies, but most have delivered inconclusive results. And, acetaminophen is considered one of the few safe options to treat pain or fever during pregnancy. 

Tylenol’s parent company Kenvue told PEOPLE in a statement: “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 expectant mothers,” a spokesperson from the company said.

Many experts agree.

“People have been taking Tylenol since 1960, and there’s a very long history of safety here,” Dr. Karam Radwan, Director of the UChicago Medicine Neurodevelopmental Clinic, tells PEOPLE.

Trump’s claims about Tylenol are fueled by a study published in August in Environmental Health, which examined the data of numerous studies. Researchers claim there is a “positive association” between prenatal exposure to acetaminophen — the active ingredient in Tylenol — and neurodevelopmental disorders like autism. 

But researchers also said that they “cannot establish causation for any single exposure.”

What that means, Radwan says, is that “if you’re taking Tylenol for weeks, that does indicate by itself that there is probably something like an inflammation, infection, some autoimmune problem that’s causing people to take Tylenol extensively during pregnancy. These underlying problems could be the issue — rather than Tylenol itself.”

“That doesn’t mean the Tylenol is the cause,” he said. The cause “could be the reason why you’re taking Tylenol.“

Radwan has a strong message for moms whose kids have autism.

“I want to make sure that all the mothers who have kids with autism and don’t blame themselves for taking Tylenol during pregnancy because again, I don’t think that’s a source of causality,” Radwan tells PEOPLE.

”It’s more of an association that we’re going to continue to learn about, and people have been taking Tylenol since 1960. It’s not like we just started taking Tylenol,” Radwan continues. “The safety profile for Tylenol is impressive. There’s very few things that have a safety profile like that.”

The study’s authors also acknowledge that certain conditions that would normally be treated with Tylenol can also be risky for the fetus. “Untreated pain or fever can also harm the baby,” says Mount Sinai’s Dr. Diddier Prada, Assistant Professor of Population Health Science and Policy, and Environmental Medicine and Climate Science, at the Icahn School of Medicine at Mount Sinai, in a press release.

“Our study highlights the importance of discussing the safest approach with health care providers and considering non-drug options whenever possible.”

While the link between medications taken while pregnant and neurodevelopmental disorders has long been studied, most scientists reject the notion that just one thing causes autism. Factors can include genetics, pregnancy complications, environmental exposure and more.

Kennedy — who had previously given himself a September deadline to find the cause of autism — has sparked controversy with his approach to the neurodevelopmental disorder, a condition related to brain development that can cause limited and repeated patterns of behavior, challenges in communicating with others, and a breakdown of speech, according to Mayo Clinic.

Kennedy announced plans for a national registry of people with autism, compiled with private medical records. He also sparked intense backlash in April after saying people with autism will “never pay taxes. They’ll never hold a job. They’ll never play baseball.” And, he has previously promoted a scientifically debunked claim that autism is caused by vaccines. 

Other studies also debunk the link between Tylenol and autism. Additional research published in the Journal of the American Medical Association, which looked at acetaminophen use during pregnancy with siblings, said “Acetaminophen use during pregnancy was not associated with children’s risk of autism, ADHD, or intellectual disability in sibling control analysis. This suggests that associations observed in other models may have been attributable to familial confounding.” 

And, doctors already caution against long-term use of acetaminophen. “On large evidence, I will continue to say that Tylenol is pretty safe to use and but remind people  don’t take Tylenol unless you really need it — like if you have fever or you have severe headache or pain that you can’t tolerate,” Radwan said, explaining that, as with any medication, “you don’t want to take something more than you should.”

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In their statement to PEOPLE, Kenvue further defended their claims:

“Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy. Without it, women face dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives,” they added.

They continued, “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.”

“We stand with the many public health and medical professionals who have reviewed this science and agree. We will continue to explore all options to protect the health interests of American women and children,” the spokesperson concluded.

The American College of Obstetricians and Gynecologists (ACOG) also voiced their support for the use of acetaminophen during pregnancy.

“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,” Steven J. Fleischman, MD, MBA, FACOG, president of the ACOG, said in a statement.