“They are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary,” such as to treat fever, “if you can’t tough it out,” Trump was quoted as saying by CNN.

The US Food and Drug Administration on Tuesday said it has initiated the process for a label change for acetaminophen (Tylenol and similar products) to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children.

The agency also issued a related letter alerting physicians nationwide.

“The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Even with this body of evidence, the choice still belongs with parents. The precautionary principle may lead many to avoid using acetaminophen during pregnancy, especially since most low-grade fevers don’t require treatment. It remains reasonable, however, for pregnant women to use acetaminophen in certain scenarios.”

In a statement to the BBC, Tylenol maker Kenvue said the 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."

Meanwhile, the Autism Science Foundation said it is deeply concerned by announcements from President Trump and HHS Secretary Robert F. Kennedy, suggesting that taking acetaminophen (Tylenol) during pregnancy causes autism, that a medicine derived from folate can be used to treat symptoms of autism, and that vaccines should be broken up over multiple visits and MMR broken into separate shots.

“Any association between acetaminophen and autism is based on limited, conflicting, and inconsistent science and is premature,” said Autism Science Foundation Chief Science Officer Dr Alycia Halladay. “This claim risks undermining public health while also misleading families who deserve clear, factual information. For many years, RFK and President Trump have shared their belief that vaccines cause autism, but this is also not supported by the science, which has shown no relationship between vaccines and autism.”

“We are unsure why this announcement came today and how the conclusions were drawn,” added Alison Singer, President of the Autism Science Foundation. “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 mums 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.”