FDA Declines to Weigh In on Proposed Tylenol Autism Warning Label

Published September 13, 2026

The U.S. Food and Drug Administration told the federal judge overseeing the Tylenol acetaminophen autism/ADHD multidistrict litigation that it will not offer an opinion on whether the drug's label should carry a pregnancy warning about autism and ADHD risk. The agency's filing, submitted September 8, 2026 in response to a request from U.S. District Judge Denise Cote, was reported by Lawsuit Legal News.

Judge Cote had asked the FDA to address two specific questions about the accuracy of a warning label plaintiffs proposed back in April 2023. Rather than answering directly, the roughly 34-page filing — submitted by Assistant U.S. Attorney Jacob Lillywhite — politely declined to take a position and instead resubmitted the FDA's March 2023 literature review, which found existing observational research on prenatal acetaminophen use limited and inconsistent, and insufficient to establish that the drug causes autism or ADHD.

Defendants sought a status conference — and were turned down fast

According to the same report, Tylenol-maker Kenvue and its co-defendants moved quickly after the FDA's filing, sending a letter to the court that morning asking for a status conference — a move plaintiffs' counsel and legal observers read as an attempt to argue the case should be narrowed or dismissed in light of the FDA's non-position. Judge Cote denied that request within about two hours, confirming that the litigation's existing schedule, including a September 19, 2026 deadline tied to the parties' Daubert (expert-evidence) motions, would stand.

The FDA's declination leaves the core scientific dispute exactly where it was: unresolved by the agency that regulates the drug, and now squarely in the hands of Judge Cote and the expert witnesses both sides plan to rely on ahead of the Daubert deadline. Plaintiffs' co-lead counsel reportedly responded the next day, reiterating the need for a clear risk disclosure to pregnant women.

What this means for pending and future claims

This case follows a July 2026 ruling from the Second Circuit that revived roughly 550 previously dismissed acetaminophen autism and ADHD lawsuits, finding the trial court had been too quick to exclude plaintiffs' expert testimony. The FDA's refusal to weigh in doesn't resolve that appeal or set any new legal standard, but it does remove one potential shortcut defendants might have used to argue the case should be cut short before the Daubert hearing. For families who used acetaminophen during pregnancy and had a child later diagnosed with autism or ADHD, the litigation remains active and ongoing.

See Atumio's Tylenol Autism/ADHD case page for a free eligibility review, or start a case review directly.