CEO of Tylenol Maker Lobbied RFK Jr. Not to Cite Drug as Autism Cause in Report
In a hastily scheduled meeting, Kenvue’s Kirk Perry sought to dissuade the health secretary, arguing there is no clear link
Kenvue CEO met with Robert F. Kennedy Jr. to argue there’s no clear link between Tylenol and autism, ahead of an upcoming report.
Kenvue defends Tylenol’s safety for pregnant women, citing a lack of safe alternatives and research.
The FDA has not found clear evidence to date that the appropriate use of acetaminophen during pregnancy causes adverse effects, according to its website.
Kirk Perry, the interim CEO of Tylenol maker Kenvue, had a private meeting with Robert F. Kennedy Jr. this week to deliver a message: There is no clear link between the drug and autism.
In a hastily scheduled meeting, Perry sought to dissuade the health secretary from including the over-the-counter medication as a potential cause in a coming report about the causes of autism, according to a person familiar with the matter.
The Wall Street Journal reported last week that Kennedy plans to cite the use of acetaminophen—the active ingredient in Tylenol—by pregnant women as a potential cause of autism in their children, among other potential causes. The autism report is expected from the Department of Health and Human Services later this month.
The news knocked Kenvue’s stock price down 9% in one day—and sparked concern among its leaders.
Kenvue is the Summit, N.J.-based consumer-health products company that was spun out of Johnson & Johnson in 2023. The pain reliever Tylenol is one of its top-selling brands, along with Band-Aid and Johnson’s Baby Shampoo. The product has famously withstood reputational challenges, including the 1982 cyanide poisonings of Tylenol bottles, and a series of product recalls for defective manufacturing in 2009. Its possible inclusion in the autism report could pose yet another significant challenge for the brand.
In the meeting with Kennedy, Perry and Chief Scientific Officer Caroline Tillett made the case that there is no clear link between acetaminophen and autism, according to the person familiar with the matter.
Kenvue executives also argued that there are few safe alternatives to acetaminophen to reduce fevers in pregnant women. Medical societies and the U.S. Food and Drug Administration say that taking alternatives such as ibuprofen and other nonsteroidal anti-inflammatory drugs at certain times of a pregnancy can cause birth defects. Some studies have suggested that fevers during pregnancy can cause autism, neural tube defects and other issues in children.
HHS didn’t respond to a request for comment.
Kenvue said in a statement: “As we would with any regulator who reaches out to us, we engaged in a scientific exchange with the Secretary and members of his staff as it relates to the safety of our products. Our position remains the same: in evaluating available science, we continue to believe that taking acetaminophen does not cause autism, and global health regulators, independent public health organizations, and medical professionals agree.”
Concerns about Tylenol and autism have been mounting for several years as studies have suggested a link. A study published in JAMA Psychiatry in 2019 found that higher concentrations of acetaminophen in umbilical cord blood samples taken at birth were associated with higher risk of autism and attention-deficit hyperactivity disorder.
Still, when the link was studied further, scientists’ findings have been inconclusive. An August analysis published in BMC Environmental Health found that a majority of past studies reported associations between acetaminophen exposure during pregnancy and increased risk of neurodevelopmental disorders, including autism. The researchers said their analysis wasn’t evidence of causation, but recommended that women should use the drug judiciously during pregnancy.
A study published in JAMA in 2024 of nearly 2.5 million children born in Sweden between 1995 and 2019, found no increased risk of autism in children whose mothers used acetaminophen during pregnancy. This analysis compared the children exposed to acetaminophen prenatally with their siblings who weren’t exposed to the ingredient while in the womb—a type of comparison that researchers said reduces confounding factors like differences in the health of the mothers.
Some families are still convinced that products like Tylenol are behind their child’s autism diagnosis. Hundreds of people filed lawsuits against Kenvue and pharmacy chains selling private-label acetaminophen, alleging prenatal exposure to the drug caused autism or ADHD. A federal judge, however, ruled in 2023 that there wasn’t sufficient evidence of a link, leading to the dismissal of the federal suits, though some lawsuits have been filed in state courts.
Some medical societies, including the American College of Obstetricians and Gynecologists, have continued to recommend acetaminophen for pain relief during pregnancy. “Despite recent unfounded claims, there is no clear evidence linking prudent use to issues with fetal development,” ACOG said in a statement last week.
The FDA hasn’t found clear evidence to date that the appropriate use of acetaminophen during pregnancy causes adverse effects, according to its website. The FDA recommends women speak to a healthcare professional before using it in pregnancy.
If the autism report does cite acetaminophen, the company plans a full-throated defense of Tylenol, according to the person familiar with the matter.
The challenge to Tylenol comes at a tumultuous time for Kenvue. Activist investors have pressured the company to improve its performance. Earlier this year, Kenvue agreed to appoint three new directors as part of a settlement with one of the investors, Starboard Value. The company’s shares are trading about 15% lower than their initial public offering pricing in 2023.
Kenvue’s former CEO, Thibaut Mongon, was pushed out in July, and the company launched a strategic review of the business. Some analysts see the company as a takeover target, with possible buyers including Procter & Gamble.