WASHINGTON D.C. (Michigan News Source) – If you scrolled X this week or caught President Trump’s Roosevelt Room soundbites on Monday from his press conference on autism, you might think Tylenol (a.k.a. acetaminophen) had just been branded Public Enemy No. 1 for pregnant women.
The cameras flashed and Trump’s team rolled out its presser with trademark bravado. But the Department of Health and Human Services’ actual press release? Far drier, more restrained, and buried in bureaucratic language.
What’s really going on.
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On September 22, Trump stood alongside HHS Secretary Robert F. Kennedy Jr., CMS Administrator Dr. Mehmet Oz along with others in his administration to announce new autism initiatives. Their plan includes advancing the first FDA-recognized autism treatment, funding research, and examining environmental and medical risk factors.
One of those risk factors: a possible link between acetaminophen use during pregnancy and impaired child neurodevelopment. The HHS release explains that the FDA will add new label language noting a possible association with neurodevelopmental risks when used during pregnancy.
The release stated: “HHS will act on acetaminophen. Today, the FDA will issue a physician notice and begin the process to initiate a safety label change for acetaminophen (Tylenol and similar products).”
That means a drug safety communication to doctors and pharmacists – not a prohibition as some media suggested, but a caution to recommend the lowest effective dose for the shortest necessary time, stating that a young child’s liver may still be developing and thus a child’s ability to metabolize the drug may be limited. They go on to recommend that they should consider the use of the drug during pregnancy for routine low-grade fevers and balance it with the fact that it’s the safest over-the-counter alternative among other similar drugs.
The science: still unsettled.
The Trump administration and the FDA point to prior studies suggesting a potential association between acetaminophen use in pregnancy and neurodevelopmental disorders such as autism and ADHD (Attention-Deficit/Hyperactivity Disorder). At the same time, it acknowledges contrary studies, along with risks of untreated fever in pregnancy.
As the release noted: “Given the conflicting literature and lack of clear causal evidence, HHS wants to encourage clinicians to exercise their best judgment in use of acetaminophen for fevers and pain in pregnancy by prescribing the lowest effective dose for the shortest during when treatment is required.”
Conflicting reports.
However, since this is a Trump administration initiative, left-leaning media outlets quickly pounced, with CNN, NBC, ABC and others running headlines accusing Trump of exaggerating or distorting facts. The Coalition for Autism Scientists, representing more than 250 researchers, also gave a statement, telling Reuters the administration’s data “do not support the claim that Tylenol causes autism … and only stoke fear and falsely suggest hope when there is no simple answer.”
In short, the science is far from conclusive. It’s more of a whodunit than a smoking gun. That’s why the FDA is preparing to change the acetaminophen label instead of making sweeping declarations or bans. But that didn’t stop President Trump or the media from making sweeping declarations.
The bigger picture.
Notwithstanding all the noise from Trump’s podium and the media echo chamber, the reality is less dramatic and the feds do present scientific evidence for their decisions. The HHS press release highlighted research showing autism rates climbing, with 1 in 31 children born in 2014 now diagnosed, nearly five times higher than in 2000. Several large-scale studies, including the Nurses’ Health Study II and Boston Birth Cohort, have reported associations between prenatal acetaminophen exposure and later autism or ADHD diagnoses. Johns Hopkins, and Mount Sinai have also echoed those concerns.
In the 2020 PubMed study pointed to in the HHS press release, it shows a study of nearly 1,000 mother-infant pairs and found that higher levels of acetaminophen metabolites in a baby’s umbilical cord blood at birth are linked with increased risk of being diagnosed later with ADHD, autism spectrum disorder (ASD), or both. Children whose cord blood acetaminophen burden was in the middle or highest third had roughly 2-3 times the odds of ADHD, and 2-4 times the odds of ASD, compared with those in the lowest third.
At Trump’s press conference, Martin A. Makary, who is currently the Commissioner of the U.S. Food and Drug Administration (FDA),said, “To quote the dean of the Harvard School of Public Health, there is a causal relationship between prenatal acetaminophen use and neurodevelopmental disorders of ADHD and autism spectrum disorder.”
However, to quote the New York Post, “A Harvard researcher whose study about Tylenol’s effects on pregnant women underpinned President Trump’s Monday warning to expectant mothers to avoid the drug was once a paid expert witness in a lawsuit against the manufacturer – and was ripped by a federal judge for unreliable, sloppy work.”
Bottom line.
Yes, acetaminophen will be getting a label update – but it’s not being banned, restricted or put behind the counter of your local pharmacy. Expect wording along the lines of “consult your healthcare provider,” not a giant red warning label. That’s the same kind of advice they have been giving about 2025-26 COVID-19 vaccines.
The White House presented its autism-related announcement as a breakthrough, while media coverage often framed it as a controversy. In practice, the update reflects routine regulatory changes, ongoing scientific debate, and political messaging. The research remains inconclusive, but adding a precautionary reminder for patients and providers is a common step and not necessarily unjustified.
Although that kind of cautionary language isn’t new in the pharmaceutical world, it appears that Tylenol itself took a harsher stand. In a 2017 post on Twitter, the brand wrote, “We actually don’t recommend using any of our products while pregnant. Thank you for taking the time to voice your concerns today.” Michigan News Source has reached out to Tylenol for comment on whether this position still reflects the company’s official guidance.
