Tylenol, a classic American pain reliever, boasts a 70-year history and is used by millions. Yet, the company responsible for it, Kenvue, is a mere two years old and largely unknown to most Americans. However, that anonymity was shattered on Monday when President Trump ignited a public relations nightmare for the nascent firm.
In a surprising move, he offered direct medical advice, asserting an unproven link between Tylenol use during pregnancy and autism. “If you’re pregnant, don’t take Tylenol,” Mr. Trump repeatedly declared at a White House news conference. Following his remarks, Trump administration health officials announced plans to update the drug’s label and caution doctors against its use for routine fevers in pregnant women.
Tylenol has faced severe challenges before. In the 1980s, the brand famously navigated a corporate crisis when product tampering resulted in seven deaths and sparked national panic. Johnson & Johnson, then the manufacturer, successfully rebuilt trust and rescued the product.
However, in 2023, Johnson & Johnson spun off Tylenol and other consumer brands into a new entity, Kenvue, to focus on its more profitable medical businesses. Based in Summit, N.J., Kenvue is also responsible for other beloved household names like Band-Aid, Listerine, Neutrogena, and Johnson’s Baby Shampoo.
Public scrutiny on Tylenol reignited earlier this month when The Wall Street Journal reported the Trump administration’s intentions to release a report tying Tylenol use during pregnancy to autism. This news caused Kenvue’s stock to plunge by 17 percent and drop another 7 percent on Monday.
Before President Trump’s warnings, Melissa Witt, a Kenvue spokeswoman, issued a statement asserting, “we believe independent, sound, science clearly shows that taking acetaminophen does not cause autism.” She further expressed deep concern about the health risks such suggestions pose for expectant mothers. Kenvue did not provide a comment in response to the president’s specific warnings. Despite years of research, studies have yet to establish a causal link between Tylenol use among pregnant women and autism.
Kenvue actively tried to prevent Monday’s announcement and reassure consumers. Kirk Perry, the company’s interim chief executive, met with Robert F. Kennedy Jr., the nation’s health secretary, earlier this month. During their discussion, Perry argued there was no connection between Tylenol and autism and emphasized the drug’s importance as a safe fever reducer for pregnant women, according to an account in The Journal. Ms. Witt confirmed Kenvue’s engagement in a “scientific exchange” with the secretary and his staff regarding product safety. Additionally, this month, the company updated its website’s FAQ section with language aimed at reassuring consumers about acetaminophen and autism concerns.
Acetaminophen, Tylenol’s active ingredient, is found in approximately 600 products. Each week, almost a quarter of U.S. adults use a medicine that contains acetaminophen, as reported by a consumer health care products trade group. Despite generic competition, Tylenol still brings in roughly $1 billion in annual sales for Kenvue, according to Morningstar, a financial services company. (Kenvue does not publicly disclose Tylenol’s specific revenue figures.)
“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 message to investors.
Even before the Trump administration brought the issue to the forefront, Tylenol faced lawsuits from families alleging their children developed autism or attention deficit hyperactivity disorder due to prenatal Tylenol exposure. Kenvue, along with major retailers selling generic versions, was named in this litigation. However, a federal judge dismissed these claims, citing a lack of reliable scientific evidence. The families are currently appealing this decision.
Beyond the Tylenol controversy, Kenvue has been grappling with broader operational challenges, including declining sales. In July, the company replaced its chief executive, Thibaut Mongon, with Kirk Perry, an experienced consumer goods executive. Recent months have also seen increased interest from activist investors, who are pushing for Kenvue to be acquired or to divest some of its business segments.
Acetaminophen itself was discovered in the 19th century, but its pain-relieving and fever-reducing properties weren’t recognized until the late 1940s. At the time, concerns about aspirin’s safety were emerging, prompting McNeil Laboratories, a Philadelphia-based family company, to position acetaminophen as a safer alternative. In 1955, McNeil launched Elixir Tylenol, a children’s liquid medicine, famously packaged to resemble a cartoon fire engine and marketed for “little hotheads.” Johnson & Johnson acquired McNeil in 1959, and Tylenol became available over-the-counter the following year.
Throughout its history, Tylenol has experienced occasional recalls due to quality control issues. The product has also been at the center of medical and regulatory discussions regarding its known side effects, such as liver damage, particularly when taken in high doses. A 2013 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 Tylenol occurred in 1982 when capsules of Extra-Strength Tylenol were tampered with, laced with cyanide, leading to the deaths of seven people in the Chicago area, including a 12-year-old girl. No one was ever charged with the murders, although a now-deceased suspect was convicted of extortion related to a demand for $1 million to halt the killings. Johnson & Johnson responded swiftly by recalling Tylenol nationwide and introducing tamper-resistant packaging, a move that became a classic example of corporate crisis management. This dramatic event was even featured in a true-crime show, “Cold Case: The Tylenol Murders,” released on Netflix this year.