What Is the Supplement RFK Jr. Recommends to Treat Autism?

The Trump administration has announced a treatment for autism.

During a press conference on Monday, Sept. 22, President Donald Trump and Health and Human Services Secretary Robert F. Kennedy Jr. said the FDA will approve the drug leucovorin, a folinic acid supplement.

Kennedy touted it as an “exciting therapy that may benefit large numbers of children who suffer from autism.”

Leucovorin is a form of vitamin B first used in the 1950s to treat the side effects of chemotherapy. The F.D.A. issued an official notice saying it was approving the tablet form of the folinic acid drug to help with symptoms for a subset of children with autism who have “cerebral folate deficiency.”

As the Washington Post explains, leucovorin is typically used to treat vitamin B9 deficiency or manage side effects from other medications. Ongoing clinical trials have shown it may help children with autism who struggle with communication: “It’s something that we think might be able to help a lot of children,” Richard Frye, a pediatric neurologist, told the outlet. But he also said that the research is still in its early stages, explaining, “We’re still on the 10-yard line.” 

The way it works, Dr. Karam Radwan, Director of the UChicago Medicine Neurodevelopmental Clinic tells PEOPLE, is that some patients with autism “have genetic variation that prevents them from fully utilizing folic acid or vitamin B9.”

“This leucovorin, or the scientific name that we use for it is folinic acid, is a version of vitamin B9 that bypasses some of these additional steps that your body needs to make in order to convert folic acid to something that can cross your brain barrier,” Radwan explained. “There are some studies showing some benefit in improving communication with these kids.”

However, he said, “the benefits were often modest” adding that the problem with leucovorin’s studies is that “there are not many, and these studies have like 50 patients here, 40 patients there.”

“We also need to develop better testing for what we call folates receptors alpha autoantibodies,” Dr. Radwan tells PEOPLE, explaining these keep your body from utilizing vitamin B. “I hope that they will get insurance to approve the test because right now the folate receptor alpha autoantibody [test] is not approved [or] covered by insurance. So hopefully if they get insurance to cover that test and get insurance to cover leucovorin — which is like a prescription strength vitamin — that’s a step in the right direction.”

But, he cautions, “it’s not a cure.”

“You’re not gonna see people improving in days when we start using it,” he said, adding that “I use it in my practice when it’s appropriate and then find the right patient.”

It’s not a once-size-fits-all medication, Radwan says, adding that it can also cause irritability and aggression in the wrong patient, but for those with the “genetic pathways” that are “well-known identified issues when they cannot convert folic acid to the final product. That’s definitely an appropriate use for folic acids.”

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But not everyone with autism has that issue, he explains. “We have to test for it and not give [it] universally [thinking] everybody should get leucovorin if you have autism,” Radwan tells PEOPLE. “That would be the wrong message to send.”

Some have raised issues with the potential for the supplement’s recommendation to financially benefit some within the government. The medication is sold by Dr. Mehmet Oz’s supplement company iHerb; Dr. Oz holds a government position, overseeing the Centers for Medicare and Medicaid Services.

“Think about that: A government health official tied to the very supplement company that benefits from RFK Jr’s bogus ‘cure,’ organic chemist Dr. Simon Maechling said on X. “This isn’t public health. It’s corruption dressed up as wellness.”