Tylenol, a household name in American medicine with tens of millions of users and a 70-year legacy, stands as a classic brand. In contrast, Kenvue, the company now responsible for it, is merely two years old and largely unrecognized by the public.
A brewing public relations storm engulfs Kenvue as the Trump administration is expected to announce an unproven connection between Tylenol use during pregnancy and autism. This puts the nascent company in an intense spotlight, recalling past crises for the pain reliever. Notably, in the 1980s, Tylenol became a benchmark for corporate crisis management after a product tampering incident resulted in seven deaths and sparked nationwide panic.
Johnson & Johnson successfully navigated that traumatic period, salvaging a product it had manufactured for decades. However, in 2023, the company divested Tylenol and other consumer brands, spinning them off into Kenvue, to focus on its more lucrative medical businesses. Headquartered in Summit, N.J., Kenvue also oversees other beloved and familiar brands such as Band-Aid, Listerine, Neutrogena, and Johnson’s Baby Shampoo.
The renewed scrutiny on Tylenol began earlier this month after The Wall Street Journal reported on the Trump administration’s impending report linking the medication to autism during pregnancy. Kenvue’s stock has since dropped by 16 percent, including a 6 percent decline on Monday.
Melissa Witt, a spokeswoman for Kenvue, stated on Monday, “we believe independent, sound, science clearly shows that taking acetaminophen does not cause autism.” She further expressed, “We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers.”
For years, researchers have investigated a potential connection, but existing studies have not demonstrated that Tylenol use by pregnant women causes autism.
Kenvue has proactively tried to preempt Monday’s announcement and reassure consumers. Earlier this month, Kirk Perry, the company’s interim chief executive, met with Robert F. Kennedy Jr., the nation’s health secretary, to present scientific evidence refuting any link between Tylenol and autism and to emphasize the product’s safety and importance for managing fevers in pregnant women, according to a report from The Journal.
Ms. Witt confirmed to The New York Times that the company engaged in a “scientific exchange with the secretary and members of his staff as it relates to the safety of our products.”
This month, the company also updated the frequently asked questions section of its website, adding language to reassure consumers that they should not be “concerned about acetaminophen and autism.”
Tylenol is the most widely recognized among approximately 600 products containing acetaminophen, an analgesic. A trade group for consumer health care products indicates that almost a quarter of U.S. adults use an acetaminophen-containing medicine weekly.
Despite generic competition, Tylenol still contributes an estimated $1 billion in annual sales to Kenvue, according to financial services firm Morningstar. (Kenvue does not publicly disclose Tylenol’s specific revenue.)
“Any potential threat to the product could have a noticeable impact on the firm’s earnings power,” noted Keonhee Kim, a Morningstar analyst, in a report to investors.
Even before officials amplified the issue, Tylenol had faced lawsuits from families alleging that their children were diagnosed with autism or attention deficit hyperactivity disorder (ADHD) after prenatal Tylenol exposure.
Kenvue, alongside major retailers selling generic versions of the product, was named in the litigation. However, a federal judge dismissed these claims, citing a lack of reliable scientific evidence. The families involved are currently appealing this decision.
Beyond the Tylenol controversy, Kenvue has been grappling with strategic challenges and declining sales. In July, the company removed its chief executive, Thibaut Mongon, replacing him with Kirk Perry, an experienced executive in the consumer goods sector. Recent months have also seen activist investors expressing interest in Kenvue, advocating for its acquisition or the sale of some of its business units.
Acetaminophen was first discovered in the 19th century, but it wasn’t until the late 1940s that its efficacy in reducing pain and fever was demonstrated by researchers.
At that time, studies were beginning to highlight safety risks associated with excessive aspirin use, which was the dominant pain reliever. McNeil Laboratories, a family-owned company in Philadelphia, recognized an opportunity to position acetaminophen as a safer alternative.
In 1955, McNeil launched its inaugural Tylenol product, Elixir Tylenol, a liquid formulation for children. The product was packaged to resemble a cartoon fire engine and marketed to “little hotheads.”
In 1959, Johnson & Johnson acquired McNeil. The following year, Tylenol became available over the counter, without requiring a prescription.
Over the decades, Tylenol has occasionally undergone recalls due to quality control issues. The product has also navigated several debates within the medical community and regulatory proposals concerning its known side effects, such as liver damage when taken in high doses.
In 2013, an investigation by ProPublica revealed that over three decades, Johnson & Johnson’s McNeil unit “repeatedly fought against safety warnings, dosage restrictions and other measures meant to safeguard users of the drug.” The company, however, maintained that it takes product risks seriously and consistently acted to mitigate them.
The most significant threat to the product occurred in 1982 when someone tampered with Extra-Strength Tylenol capsules, lacing them with cyanide. This tragic event led to the deaths of seven people, including a 12-year-old girl, in the Chicago area. No one was ever formally charged with the murders, although one suspect, now deceased, was convicted of extortion for attempting to demand $1 million from Johnson & Johnson in exchange for stopping the killings.
Johnson & Johnson responded swiftly, pulling Tylenol from American shelves and introducing new tamper-resistant packaging, thereby rebuilding public trust. This historic episode was recently dramatized in the true-crime show “Cold Case: The Tylenol Murders,” released on Netflix this year.