The Trump administration has thrust one of the world’s most widely used painkillers into controversy, with President Donald Trump declaring that Tylenol use during pregnancy carries “a very increased risk of autism.”
Speaking from the Oval Office alongside Health and Human Services Secretary Robert F. Kennedy Jr., Trump said the FDA would soon update guidance on acetaminophen, known in Australia as paracetamol, to reflect the alleged risk. The announcement, made with sweeping rhetoric but seemingly little evidence, has already rattled consumers, medical authorities and investors.
“Taking Tylenol is not good,” Trump declared. “With Tylenol, don’t take it, don’t take it.”
By midday Monday, Kenvue, the Johnson & Johnson spinoff that manufactures Tylenol, had seen its share price drop 7.5%, wiping $2.6 billion off its market value.
Trump has long sought to frame himself as a truth-teller on autism. Over the weekend, at the memorial service for conservative activist Charlie Kirk, he teased the announcement: “I think we found an answer to autism”.
On Monday, he doubled down, calling the decision “one of the most important things that we will do.”
Kennedy, who has built his political persona around questioning mainstream science, said the Department of Health and the FDA would work to change the label on acetaminophen products.
Kennedy’s actions appear to have been provoked by a recent paper by epidemiologists from the Harvard T.H. Chan School of Public Health and Mount Sinai’s Icahn School of Medicine. The paper suggested “an association between acetaminophen exposure during pregnancy and increased incidence of NDDs [neurodevelopmental disorders]” but the authors clearly stated that their work did not prove a definitive link.
Officials also flagged a new line of research into leucovorin, a cancer drug, as a possible “treatment” for autism.
Science Pushes Back Hard
The medical and regulatory response was swift and unequivocal with Kenvue backing its product. “We believe independent, sound science clearly shows that taking acetaminophen does not cause autism,” the company said in a statement. “We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers.”
Australia’s Therapeutic Goods Administration (TGA) issued its own response, noting that “the TGA has no current active safety investigations for paracetamol and autism, or paracetamol and neurodevelopmental disorders more broadly.”
It confirmed paracetamol remains Pregnancy Category A (considered safe for use in pregnancy) and pointed to rigorous evaluation and post-market surveillance systems.
Dr Steven Fleischman, president of the American College of Obstetricians and Gynecologists, condemned the administration’s announcement as irresponsible and “unsettling”.
“Today’s announcement by HHS is not backed by the full body of scientific evidence and dangerously simplifies the many and complex causes of neurologic challenges in children,” Dr. Fleischman said in a statement. “It is highly unsettling that our federal health agencies are willing to make an announcement that will affect the health and well-being of millions of people without the backing of reliable data.”
B&T reached out to Panadol in Australia for comment on the matter, but did not receive a response prior to publication.
A Brand Long Tested by Crisis
For Tylenol, this is not the first time a crisis has threatened its standing. In 1982, seven people in the Chicago area died after cyanide-laced Tylenol capsules were placed on store shelves. Johnson & Johnson pulled 31 million bottles from the market, introduced tamper-proof packaging and ran mass communication campaigns. The company’s response became a benchmark in corporate crisis management and is still taught in business schools.
The brand has also faced waves of litigation, most recently from families claiming Tylenol use during pregnancy led to autism or ADHD. A federal judge dismissed the suits, citing unreliable evidence, but appeals are ongoing.
Despite those challenges, Tylenol has retained dominance. Each week, nearly a quarter of American adults use acetaminophen products, and Tylenol alone generates roughly $1 billion in annual sales for Kenvue, even with several generic players in the market. Globally, its parent company holds a 15 per cent market share in a $10.4 billion acteminophen category.
While the claims remain fairly unsubstantiated for now, Trump’s choice of messenger has amplified scepticism. Kennedy, appointed health secretary in 2024, has a long track record of controversial claims, including blaming antidepressants for school shootings, suggesting WiFi causes a condition known as “leaky brain,” linking drinking water to transgender identity, and claiming Black Americans have weaker immune systems than white Americans.
He has also long promoted the idea that vaccines cause autism, a claim widely debunked by the scientific community.
Trump has often echoed those positions. On Monday, he floated changes to vaccine schedules, including delayed dosing of measles, mumps, rubella, and varicella shots, and postponing the first dose of the hepatitis B vaccine, again without much substantiated evidence.
Experts warn that when conspiracy theories are legitimised at the presidential podium, public behaviour can shift in harmful ways. As British physicians noted, the Tylenol announcement risks “fearmongering” and deterring pregnant women from accessing safe care.
The market reaction underscores how vulnerable brands can be to political rhetoric. Tylenol, once praised as the gold standard in crisis management, faces its latest test. Global regulators continue to classify paracetamol as safe, but in the glare of a presidential megaphone, scientific consensus risks being drowned out. For Kenvue and other consumer health brands, the challenge will be defending their products without fuelling panic, and preserving public trust in science itself.
