The pain reliever Tylenol is a beloved American household name, boasting a 70-year legacy and millions of users. Yet, the company responsible for it, Kenvue, is a mere two years old and remains largely unfamiliar to the public.
A recent statement from the Trump administration on Monday has drawn a controversial parallel between Tylenol use during pregnancy and autism, a link that scientists have yet to confirm. This has plunged Kenvue into a significant public relations challenge, reminiscent of past crises the brand has faced. Decades ago, in the 1980s, Tylenol navigated an infamous tampering incident that tragically resulted in seven deaths, becoming a case study in effective crisis management.
Johnson & Johnson successfully recovered from that harrowing period, preserving a product it had produced for many years. However, in 2023, the company shifted its focus towards its more lucrative medical ventures, spinning off Tylenol and its other consumer brands into a new entity named Kenvue. Headquartered in Summit, N.J., Kenvue is now responsible for numerous cherished and recognizable brands, including Band-Aid, Listerine, Neutrogena, and Johnson’s Baby Shampoo.
Public scrutiny of Tylenol intensified earlier this month following reports of the Trump administration’s intention to publish a report linking prenatal Tylenol use to autism. This news has severely impacted Kenvue’s financial standing, with its stock dropping by 16 percent and a further 6 percent decline on Monday alone.
In response to these developments, Melissa Witt, a Kenvue spokeswoman, released a statement asserting, “We believe independent, sound science clearly shows that taking acetaminophen does not cause autism.” She emphasized the company’s strong disagreement with any opposing views, expressing deep concern for the potential health risks such suggestions could create for expectant mothers.
While researchers have investigated a potential link for several years, current studies have not yet established that Tylenol use during pregnancy directly causes autism.
Kenvue actively worked to prevent Monday’s announcement and alleviate consumer concerns. Interim CEO Kirk Perry reportedly met with Health Secretary Robert F. Kennedy Jr. to argue against any Tylenol-autism link and highlight the medication’s critical role in safely managing fevers for pregnant individuals.
Ms. Witt confirmed that Kenvue had participated in a “scientific exchange” with the Health Secretary and his team concerning the safety of their products.
To further address public anxiety, Kenvue updated its website’s FAQ section this month with reassuring statements, advising consumers not to be “concerned about acetaminophen and autism.”
Tylenol stands as the most recognized brand among over 600 products that contain acetaminophen, a widely used pain reliever. Weekly, almost a quarter of American adults utilize a medication containing this active ingredient, as reported by a prominent consumer health care trade group.
Despite fierce generic competition, Tylenol continues to be a significant revenue driver for Kenvue, with estimated annual sales of around $1 billion, according to financial analysts at Morningstar. (Kenvue itself does not publicly disclose Tylenol-specific revenue figures).
Keonhee Kim, a Morningstar analyst, highlighted the potential financial repercussions in a recent investor note, stating that “any potential threat to the product could have a noticeable impact on the firm’s earnings power.”
Even prior to the Trump administration’s remarks, Tylenol was already facing legal challenges. Families had filed lawsuits asserting that their children were diagnosed with autism or ADHD following Tylenol use during pregnancy.
Kenvue, alongside major retailers selling generic acetaminophen, was named in this litigation. However, a federal judge dismissed these claims, citing insufficient reliable scientific evidence. The families involved are currently appealing this ruling.
Beyond the Tylenol controversy, Kenvue has been grappling with overall strategic challenges and declining sales. In July, the company replaced its chief executive, Thibaut Mongon, with Kirk Perry, an experienced leader in consumer goods. This leadership change coincided with increased interest from activist investors, who are advocating for a potential acquisition or the divestiture of certain business segments.
Acetaminophen, the active ingredient in Tylenol, was initially discovered in the 19th century. However, its efficacy in relieving pain and reducing fevers wasn’t recognized until the late 1940s.
During that era, concerns were emerging regarding the safety of excessive aspirin use, then the dominant pain reliever. McNeil Laboratories, a Philadelphia-based family business, identified a market opening to position acetaminophen as a safer alternative.
In 1955, McNeil launched its inaugural Tylenol product, Elixir Tylenol, a liquid formulation specifically for children. It was cleverly packaged to resemble a cartoon fire engine and marketed with the playful tagline, “for little hotheads.”
Four years later, in 1959, Johnson & Johnson acquired McNeil. By the following year, Tylenol was made available over-the-counter, eliminating the need for a prescription.
Throughout its history, Tylenol has faced occasional recalls due to quality control concerns. The product has also been at the center of medical and regulatory discussions regarding its well-documented side effects, such as liver damage, particularly when taken in high doses.
A 2013 investigation by ProPublica revealed that for over three decades, Johnson & Johnson’s McNeil division consistently resisted increased safety warnings, dosage limits, and other protective measures for Tylenol users. (The company has stated it prioritizes product safety and consistently worked to reduce risks).
The most severe threat to Tylenol’s reputation occurred in 1982 during a tragic incident where Extra-Strength Tylenol capsules were tampered with, laced with cyanide, and caused the deaths of seven individuals in the Chicago area, including a young girl. While no one was ever charged with the murders, a suspect, now deceased, was convicted of extortion for attempting to leverage the crisis against Johnson & Johnson.
In response, Johnson & Johnson swiftly removed Tylenol from all American store shelves and introduced innovative tamper-resistant packaging, effectively rebuilding public trust. This historical event even inspired a recent true-crime series on Netflix, “Cold Case: The Tylenol Murders.”