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The maker of Tylenol is urging the U.S. Food and Drug Administration (FDA) to reject a citizen petition seeking a warning label stating that Tylenol use during pregnancy may be linked to autism in children, Bloomberg reported Monday.
Kenvue last week submitted a 42-page response to the FDA, stating that scientific evidence does not support claims of a connection between acetaminophen and autism and that labeling the drug to suggest such a link would be “legally and procedurally improper.”
According to Kenvue:
“For over a decade — and as recently as August — FDA has fully evaluated the emerging scientific evidence and repeatedly concluded that the data do not support a causal association between acetaminophen use in pregnancy and neurodevelopmental disorders such as autism.”
The Informed Consent Action Network (ICAN) submitted the petition to the FDA on Sept. 22 — the same day the White House announced its intention to add warnings to Tylenol and other products containing acetaminophen about their potential link to autism.
According to the petition, “there is substantial evidence, developed over a decade, demonstrating that prenatal acetaminophen exposure may pose a risk to fetal neurodevelopment.”
The evidence “supports the need for a labeling amendment that warns consumers of the potential neurodevelopmental risks associated with frequent acetaminophen use during pregnancy,” ICAN stated.
However, Kenvue warned the FDA that it would consider any action other than rejecting ICAN’s petition to be an “arbitrary and capricious” violation of the Administrative Procedure Act — a federal law governing how administrative agencies propose, develop and issue regulations and allow for judicial review of agency actions.
Elizabeth Brehm, an attorney with Siri & Glimstad, a law firm representing ICAN, told The Defender:
“As ICAN’s petition lays out, there is ample science that justifies providing full informed consent to pregnant women concerning their use of acetaminophen. That is what the petitions seeks — nothing more, nothing less.
“No one is looking to ban Tylenol or any other product. The petition simply seeks a change on the warning label so that pregnant women can be made aware of all of the potential risks.”
Although the Trump administration announced plans to add warnings to products containing acetaminophen, the FDA told doctors in a letter sent after the announcement that the evidence linking acetaminophen to autism remains inconclusive.
“To be clear, while an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature,” the FDA stated.
The FDA has 180 days to respond to ICAN’s citizen petition.
Documents show FDA was aware of acetaminophen-autism link for years
Attorney Ashley Keller, who represents hundreds of plaintiffs suing Kenvue and other acetaminophen manufacturers and retailers for knowingly selling the drug to pregnant women, despite being aware of the risks, called Kenvue’s warning to the FDA groundless.
“It is not ‘arbitrary and capricious’ to disagree with Kenvue,” Keller said. “Indeed, FDA epidemiologists wanted to warn pregnant women about the risks Tylenol poses years ago.”
Documents from the lawsuits show that Johnson & Johnson — which last year sold its remaining stake in Tylenol to Kenvue — and the FDA knew for years about the likely link between the drug’s use during pregnancy and neurodevelopmental disorders, including autism, but they concealed the risk.
In August 2024, a federal court dismissed the lawsuits after declining to hear the testimony of the plaintiffs’ expert witnesses. An appeal is pending before the 2nd U.S. Circuit Court of Appeals. A hearing scheduled for earlier this month was rescheduled to Nov. 17, according to Keller.
In September, the families involved in the lawsuits petitioned a federal court to hear testimony from expert witnesses, citing the Trump administration’s statements earlier that month indicating a possible link between acetaminophen use and autism.
According to pediatrician Dr. Sherri Tenpenny, there is a substantial body of research indicating such a link. She said:
“There have been many articles published that suggest an association, including a large study evaluating about 2.48 million children, published in JAMA in 2024.
“They’ve known since the mid-2010s that prenatal acetaminophen may be associated with neurodevelopmental disorders. We published a well-documented article about the possible connection in 2019.”
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‘The precautionary principle should be our guide’
Several experts suggested that pregnant women and expectant mothers should err on the side of caution when considering whether to take acetaminophen products during pregnancy.
“The precautionary principle should be our guide,” said biologist Christina Parks, Ph.D. “Including labeling that instructs pregnant women to restrict their use to the lowest dose and least amount of time is common sense.”
Parks said that while acetaminophen may not harm all pregnant women or all babies, the risk is significant enough that people shouldn’t ignore it. She said:
“Parents need to know medications, such as Tylenol, are not ‘one-size fits all.’ While many people may not suffer deleterious effects from taking Tylenol during pregnancy, a significant portion of people have genetic predispositions which may increase their risk — and the risk to their unborn child — of neurodevelopment harm from this medication.”
William Parker, Ph.D., CEO of WPLab and a researcher who has studied acetaminophen risks for the last 10 years, said he encourages “parents and caregivers to educate themselves about the connection between acetaminophen and autism.”
“The overwhelming scientific evidence has been summarized in easy-to-understand formats in several places,” he said.
Parker said parents and caregivers should develop “a well-informed plan regarding acetaminophen use” to help them “avoid having to make split-second decisions during a crisis that they may later regret.”
Parks questioned why Kenvue would oppose amending Tylenol’s label to encourage safe use of the product. She said:
“One would think that Kenvue would support careful use of their product during this vulnerable time, yet they want to leave the consumer in the dark about the potential risks of using their product rather than include a common sense warning that will give consumers a head’s up that there may be potential health risks associated with indiscriminate use of Tylenol during pregnancy.”
The Wall Street Journal reported last month that Kenvue “is preparing for an explosion of litigation” over the possible acetaminophen-autism link following the White House’s announcement.
On Monday, Bloomberg reported that legal troubles have pushed Kenvue’s shares “to an all-time low.”
“Kenvue is flailing and refuses to acknowledge publicly what it recognized internally years ago,” Keller said.
Related articles in The Defender- RFK Jr. Blasts Tylenol-Chugging TikTokkers as Experts Explain Why Taking Acetaminophen During Pregnancy May Be as Risky as Drinking Alcohol
- ‘Uncompromising and Relentless’: HHS to Study All Possible Causes of Autism, Including Vaccines
- Families Behind Hundreds of Tylenol Lawsuits Ask Court to Let Experts Testify
- Unsafe for Kids at Any Dose? New Review of Science Supports Link Between Tylenol and Autism
- Tylenol, FDA Knew About Autism Risk For Years, Newly Surfaced Emails Show
- Tylenol Use in Babies, Children Raises Risk of Autism, New Review Shows
