Extended Summary of the Article: "Tylenol, FDA Knew About Autism Risk For Years, Newly Surfaced Emails Show"
The article, published by Children's Health Defense on September 29, 2025, reveals through internal emails and documents that Johnson & Johnson (J&J), the original manufacturer of Tylenol (acetaminophen), and the U.S. Food and Drug Administration (FDA) were aware of potential links between acetaminophen use during pregnancy and neurodevelopmental disorders like autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) for over a decade. This reporting draws heavily from a September 26, 2025, investigative piece by the Daily Caller News Foundation's Emily Kopp, who obtained emails spanning more than a decade from Keller Postman LLC, the law firm representing plaintiffs in a federal class action lawsuit against Kenvue, J&J's spun-off consumer health company that took over Tylenol production in 2023. The disclosures come amid recent events, including President Donald Trump's September 22, 2025, statement advising pregnant women to avoid Tylenol unless medically necessary, citing a comprehensive review of toxicology, epidemiology, and animal studies indicating a plausible association with neurodevelopmental risks. Concurrently, the FDA announced plans to update product labels with warnings about potential higher risks of neurological conditions, including autism and ADHD, in children exposed prenatally, and to inform physicians and the public. However, mainstream media and public health entities criticized these warnings as unfounded or exaggerated, with some outlets quoting researchers like University of Massachusetts epidemiologist Ann Bauer—who co-authored studies linking acetaminophen to autism risks and previously advocated for precautions—but who now emphasizes continued safe use when needed.
Cross-checked evidence shows J&J's internal concerns dating back to 2008, when Andre Mann, the Office of Consumer Medical Safety Lead, flagged consumer and physician inquiries about an acetaminophen-autism link as a "safety signal that needs to be evaluated." By 2012, Leslie Shur, head of the side effects monitoring division, noted another consumer complaint on the issue. In 2014, emails indicate the matter reached CEO Alex Gorsky (name misspelled in the correspondence). A pivotal 2018 email from Rachel Weinstein, U.S. Director of Epidemiology at J&J's Janssen division, stated that the "weight of evidence is starting to feel heavy" based on multiple studies showing associations between prenatal acetaminophen exposure and neurodevelopmental disorders. Internal 2018 presentations, marked "privileged and confidential," acknowledged "somewhat consistent" associations in observational studies and larger meta-analyses, while highlighting weaknesses such as confounding variables and subjective measurements of autistic traits. J&J considered but ultimately rejected funding additional research, expressing reluctance to "stick their necks out" due to fears that their studies might confirm the links and the lack of viable alternatives for pain relief in pregnancy.
The company actively tracked scientific literature, including a 2016 Danish cohort study in JAMA Pediatrics that found prenatal acetaminophen associated with ASD accompanied by hyperkinetic symptoms (hazard ratio [HR]=1.51 for any use, increasing with duration). A 2018 literature review also recommended caution against casual use in pregnancy due to elevated risks of ADHD, ASD, or reduced IQ. From January 2020 to October 2023, J&J conducted "social listening" research, monitoring Google searches and social media posts about Tylenol and autism, initiated after a 2021 consensus statement in Nature Reviews Endocrinology by 13 U.S. and European experts urging precautionary measures given the "serious consequences of inaction" amid mounting evidence. An internal 2023 review, dubbed "Project Cocoon," addressed urogenital and neurological side effects, noting impacts on "every aspect of the brand." Despite these internal acknowledgments, a Kenvue spokesperson told the Daily Caller there is "no causal link" between acetaminophen use during pregnancy and autism, affirming products are "safe and effective" when used as directed. The company's website echoes this, stating "credible, independent scientific data continues to show no proven link."
The FDA's awareness began with a 2014 JAMA Pediatrics study linking prenatal acetaminophen to ADHD-like behaviors and hyperkinetic disorders at age 7 (HR=1.37 for ADHD symptoms). Subsequent major publications built on this. Internal FDA meta-analyses from 2019 and 2022, obtained via Freedom of Information Act requests in a related lawsuit (where psychiatrist David Healy is an expert witness against Kenvue and Safeway), identified consistent links to urogenital disorders and neurodevelopmental issues in 2019, and ADHD in 2022. The 2019 analysis recommended revising labels to advise pregnant women to avoid casual use when not strongly needed. The 2022 document suggested precautionary measures, though parts are redacted. These align with the FDA's 2025 actions, including a physician notice and label updates, supported by a 2025 evidence evaluation confirming associations with ASD and other disorders. Healy stressed that drugmakers must warn consumers when there are grounds for concern, not just proven causation, highlighting a failure in duty to inform.
In conclusion, the article argues that despite accumulating evidence from studies and internal recognitions, J&J and the FDA delayed warnings, prioritizing caution over action, amid ongoing scientific debate—as seen in a 2024 JAMA sibling analysis finding no association—potentially exposing consumers to risks without adequate disclosure.
