Tylenol-Autism Warning Spurs Legal Surge: FDA Orders New Label After Trump’s Public Call to Action

Winter Garden, FL – September 30, 2025  – A major public health and legal storm erupted last week after President Donald Trump publicly urged pregnant women to avoid Tylenol, citing mounting scientific evidence linking prenatal acetaminophen use to autism and ADHD. Just hours later, the U.S. Food and Drug Administration (FDA) confirmed it will require new warnings on all acetaminophen products  a watershed decision after more than a decade of internal concern and scientific debate.

Evidence Long Hidden From the Public

Internal company emails and FDA analyses first reported by the Daily Caller News Foundation show that both the makers of Tylenol and federal regulators had grappled privately for years with evidence linking prenatal acetaminophen use to neurodevelopmental disorders.

In one 2008 email, Rachel Weinstein, U.S. Director of Epidemiology for Johnson & Johnson’s (J&J) Janssen division, wrote after reviewing multiple studies, “The weight of evidence is starting to feel heavy to me.” J&J produced Tylenol until 2023, when it spun off production to Kenvue.

The Daily Caller News Foundation obtained the emails from Keller Postman LLC, which represents plaintiffs in a federal class action lawsuit against Kenvue. Those records reveal that J&J executives repeatedly reviewed emerging studies and debated whether to fund additional research but opted not to, citing reputational and legal risks.

An internal 2018 J&J presentation labeled “privileged and confidential” acknowledged that observational studies showed a “somewhat consistent” association between prenatal Tylenol exposure and neurodevelopmental disorders, though company scientists noted methodological limits.

At the FDA, Freedom of Information Act documents shared with The Defender show the agency’s own scientists conducted meta-analyses in 2019 and 2022. They identified links between acetaminophen and both urogenital and neurodevelopmental risks but did not add warnings at the time.

Despite these private concerns, Kenvue has continued to state publicly that there is “no causal link between acetaminophen use during pregnancy and autism.” Yet, internal records cited by reporter Emily Kopp indicate company teams tracked social media trends and consumer questions about Tylenol and autism from 2020 through 2023 and even produced an internal review called “Project Cocoon” examining neurological side effects.

Litigation and Accountability Ahead

These revelations are fueling thousands of lawsuits alleging corporate negligence and failure to warn. Legal experts predict individual settlements could range from $50,000 to over $500,000 per family, making this one of the most consequential pharmaceutical liability waves of the decade.

“For families blindsided by these revelations, this is a moment of shock and a demand for accountability,” said Jacob Malherbe, Founder of Mass Tort Ad Agency. “When news like this breaks, parents deserve to know their options and law firms need trusted, ethical ways to reach and support them.”

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Mass Tort Ad Agency
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