Lead: On Sept. 5, 2025 U.S. Health Secretary Robert F. Kennedy Jr. indicated a forthcoming report will say use of Tylenol (acetaminophen) during pregnancy may be associated with autism in children and will also raise the possibility that folinic acid could improve symptoms for some people, a claim that has already affected Kenvue’s shares and drawn scrutiny from federal health agencies.
Key Takeaways
- The Wall Street Journal reported Secretary Kennedy will link prenatal Tylenol use to autism in a pending report.
- Kenvue, maker of Tylenol, says no causal link exists and its shares fell about 14% after the report surfaced.
- The U.S. Department of Health and Human Services called details before the final report speculative and said the administration will use established science.
- Some observational studies have reported associations between prenatal acetaminophen and neurodevelopmental conditions; other large studies have not found causal evidence.
- The report reportedly mentions low folate and use of folinic acid as a possible treatment avenue for some individuals with autism.
- Legal challenges over claims that Tylenol causes autism have previously been barred by a federal judge and are under appeal.
- The NIH is conducting a $50 million Autism Data Science Initiative to analyze large datasets for potential contributors and treatments.
Verified Facts
The Wall Street Journal reported on Sept. 5, 2025 that Secretary Robert F. Kennedy Jr. plans to highlight a potential association between acetaminophen use in pregnancy and later autism diagnoses. The U.S. Department of Health and Human Services described any descriptions of the report’s contents as speculative until the final document is published.
Kenvue, the company behind the Tylenol brand, issued a statement asserting there is no proven causal link between Tylenol taken during pregnancy and autism. The company reiterated guidance that pregnant people consult healthcare professionals before taking over-the-counter drugs and noted agreement from the U.S. Food and Drug Administration and medical organizations on current label guidance.
Market reaction was immediate: Kenvue shares dropped roughly 14% after reports of the administration’s findings circulated on Sept. 5, 2025. Public and scientific responses have been mixed because the evidence in the literature is not consistent.
| Study | Sample/Year | General Finding |
|---|---|---|
| Unspecified August study | Referenced in public discussion | Reported an association between prenatal acetaminophen and neurodevelopmental disorders |
| JAMA study | 2.4 million Swedish births, 2024 | No evidence supporting a causal link between prenatal acetaminophen and autism |
Context & Impact
Secretary Kennedy has prioritized identifying environmental contributors to autism and has previously questioned vaccine safety without mainstream scientific support. His leadership has shaped initiatives such as the NIH Autism Data Science Initiative, a $50 million effort receiving over 100 proposals with up to 25 awards expected by the end of September 2025.
The topic carries legal as well as public-health implications. In December 2023 a U.S. federal judge excluded expert testimony in hundreds of lawsuits claiming prenatal Tylenol exposure causes autism, finding the experts lacked sufficient scientific basis. Those federal cases were dismissed last August and an appeals court is scheduled to hear arguments in October 2025, according to court records.
Medical groups and many researchers caution against changing clinical guidance without stronger causal evidence. The American College of Obstetricians and Gynecologists has said there is no clear proof that prudent use of acetaminophen during pregnancy causes developmental harm.
Official Statements
“Until the final report is released, claims about its contents are speculation. We are using gold-standard science to get to the bottom of America’s unprecedented rise in autism rates,”
U.S. Department of Health and Human Services spokesperson
“We believe there is no causal link between Tylenol use during pregnancy and autism. Expectant mothers should consult healthcare professionals about OTC medication use,”
Kenvue statement
“We have no understanding of why there might be a biological reason that Tylenol would cause autism,”
Dr. David Mandell, University of Pennsylvania
Unconfirmed
- No definitive causal relationship between prenatal acetaminophen use and autism has been established.
- The effectiveness of folinic acid as a treatment for autism symptoms remains unproven.
- Specific report language and conclusions are unverified until the administration releases the final document.
Bottom Line
The administration’s pending report has reignited debate about prenatal acetaminophen and autism, prompted market movement for Kenvue, and underscored continuing scientific disagreement. Policymakers, clinicians, and pregnant people will likely await the full report and peer-reviewed research before altering clinical guidance.