Tylenol, a beloved American pain reliever, boasts a 70-year legacy and millions of users. Yet, the company now responsible for it, Kenvue, is just two years old and largely unfamiliar to the public.
The Trump administration is reportedly set to announce a connection between Tylenol use during pregnancy and autism, a claim currently lacking scientific proof. This development thrusts Kenvue into a major public relations crisis, reminiscent of past challenges Tylenol has overcome. Notably, in the 1980s, the brand famously navigated a corporate crisis after product tampering led to seven deaths and widespread panic, becoming a textbook example of crisis management.
Johnson & Johnson successfully recovered from that traumatic incident, saving the product it had produced for decades. However, in 2023, as part of a strategic shift towards its more profitable medical businesses, the company spun off Tylenol and its other consumer brands into the newly formed Kenvue. Located in Summit, N.J., Kenvue also manages other well-known, household names such as Band-Aid, Listerine, Neutrogena, and Johnson’s Baby Shampoo.
Public scrutiny on Tylenol intensified earlier this month when The Wall Street Journal broke the news of the Trump administration’s upcoming report on the alleged link between prenatal Tylenol use and autism. Following this revelation, Kenvue’s stock experienced a significant drop, falling 16 percent, and an additional 6 percent on Monday alone.
In response, Melissa Witt, a Kenvue spokesperson, issued a statement on Monday asserting, “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.”
Despite years of research into a potential link, studies conducted so far have not established a causal relationship between Tylenol use by pregnant women and autism.
Kenvue has proactively engaged in efforts to prevent Monday’s announcement and to reassure its customer base. Earlier this month, Kirk Perry, the company’s interim chief executive, reportedly met with Robert F. Kennedy Jr., the nation’s health secretary, to present evidence refuting any connection between Tylenol and autism. He emphasized the product’s safety and importance for pregnant women needing fever relief, according to reports in The Journal.
Ms. Witt confirmed to The New York Times that Kenvue had indeed participated in a “scientific exchange” with the secretary and his team regarding the safety of their products.
Furthermore, this month, the company updated the frequently asked questions section of its website, adding clear guidance to consumers that they should not be “concerned about acetaminophen and autism.”
Tylenol stands as the most recognized of approximately 600 products containing acetaminophen, its primary pain-relieving ingredient. A trade group for consumer health care products indicates that almost a quarter of U.S. adults use an acetaminophen-containing medicine weekly.
Even amidst fierce generic competition, Tylenol continues to be a substantial revenue generator for Kenvue, contributing an estimated $1 billion in annual sales, according to financial services firm Morningstar. (Kenvue itself does not disclose Tylenol-specific revenue figures.)
Keonhee Kim, a Morningstar analyst, warned investors in a recent note: “Any potential threat to the product could have a noticeable impact on the firm’s earnings power.”
Prior to the Trump administration’s amplified focus on the issue, Tylenol was already facing lawsuits. Families claimed their children developed autism or attention deficit hyperactivity disorder following Tylenol use during pregnancy.
Kenvue, alongside major retailers offering generic alternatives, was named in these lawsuits. However, a federal judge ultimately dismissed these claims, citing insufficient reliable scientific evidence. The families involved are currently in the process of appealing this decision.
Beyond the Tylenol controversy, Kenvue has been grappling with its overall strategic direction amid declining sales. In July, the company replaced its chief executive, Thibaut Mongon, with Kirk Perry, an experienced leader in the consumer goods sector. Recent months have also seen activist investors express interest, advocating for the company’s acquisition or the divestiture of certain business units.
Acetaminophen, the active ingredient in Tylenol, was first identified in the 19th century, but its ability to alleviate pain and reduce fevers wasn’t recognized by researchers until the late 1940s.
During that era, concerns were emerging about the safety risks associated with excessive aspirin use, which was then the leading pain reliever. McNeil Laboratories, a Philadelphia-based family business, seized this opportunity to market acetaminophen as a safer alternative.
In 1955, McNeil launched its first Tylenol product, Elixir Tylenol, a liquid formulation specifically for children. The company cleverly packaged it to resemble a cartoon fire engine, promoting it as medicine “for little hotheads.”
Johnson & Johnson acquired McNeil in 1959, and the following year, Tylenol became widely available over-the-counter, eliminating the need for a prescription.
Throughout its history, Tylenol has occasionally faced product recalls due to quality control issues. It has also navigated ongoing medical debates and regulatory discussions concerning its known side effects, particularly liver damage when taken in high doses.
The most severe challenge to the product occurred in 1982 when Extra-Strength Tylenol capsules were tampered with, laced with cyanide, leading to the deaths of seven individuals in the Chicago area, including a 12-year-old girl. Although no one was ever charged directly for the deaths, one suspect (now deceased) was convicted of extortion for attempting to secure $1 million from Johnson & Johnson to halt the killings.
Johnson & Johnson responded swiftly and decisively, restoring public confidence by immediately recalling Tylenol from all American shelves and introducing innovative tamper-resistant packaging. This landmark incident even inspired a true-crime show, “Cold Case: The Tylenol Murders,” which premiered on Netflix this year.