Tylenol, a household name in American pain relief for over seven decades, is trusted by millions. Yet, the company responsible for this iconic brand, Kenvue, remains largely unfamiliar to the public, having only spun off from Johnson & Johnson two years ago.
However, Kenvue is now facing an unexpected and critical public relations challenge. The Trump administration is reportedly preparing to announce unproven links between Tylenol use during pregnancy and autism. This puts the company directly in the public eye, revisiting a familiar position for the Tylenol brand, which notably navigated a severe crisis in the 1980s following product tampering incidents that led to multiple deaths and widespread panic.
While Johnson & Johnson successfully recovered from the earlier crisis, saving a product they had long produced, the landscape shifted in 2023. Prioritizing its lucrative medical divisions, Johnson & Johnson spun off Tylenol and its other consumer health products into a new independent entity: Kenvue. Headquartered in Summit, N.J., Kenvue manages a portfolio of beloved household names including Band-Aid, Listerine, Neutrogena, and Johnson’s Baby Shampoo.
This latest wave of scrutiny began earlier this month after The Wall Street Journal revealed the Trump administration’s impending report. The news, suggesting a link between prenatal Tylenol use and autism, caused Kenvue’s stock to plunge by 16 percent and another 6 percent on Monday.
In response, Kenvue spokeswoman Melissa Witt stated on Monday that the company firmly believes “independent, sound science clearly shows that taking acetaminophen does not cause autism.” She further emphasized, “We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers.”
For years, researchers have actively investigated a potential link between Tylenol and autism; however, existing studies have not established a causal relationship between acetaminophen use during pregnancy and autism.
Kenvue has been proactively working to prevent this week’s announcement and calm consumer fears. Earlier this month, interim CEO Kirk Perry reportedly met with Health Secretary Robert F. Kennedy Jr., presenting arguments that Tylenol and autism are unrelated, and highlighting the medication’s crucial role in safely managing fevers for pregnant women.
Ms. Witt confirmed to the press that Kenvue had indeed engaged in a “scientific exchange” with the Health Secretary and his team concerning the safety profile of their products.
To further alleviate public anxiety, Kenvue updated its website’s FAQ section this month, explicitly advising consumers not to be “concerned about acetaminophen and autism.”
As a leading analgesic, Tylenol is one of roughly 600 products that contain the active ingredient acetaminophen. Data from a consumer healthcare trade group indicates that almost a quarter of American adults use an acetaminophen-containing medicine weekly.
Despite fierce generic competition, Tylenol remains a significant revenue driver for Kenvue, with financial services firm Morningstar estimating annual sales around $1 billion, though Kenvue itself does not disclose specific Tylenol revenue figures.
Morningstar analyst Keonhee Kim warned investors that “any potential threat to the product could have a noticeable impact on the firm’s earnings power.”
An archival image shows David Clare, then president of Johnson & Johnson, testifying before the Senate in 1986. This was during the infamous Tylenol poisonings, an event that later became a classic case study in corporate crisis management.
Even before the recent escalation by Trump officials, Tylenol was already facing legal challenges. Numerous lawsuits had been filed by families alleging that their children developed autism or ADHD following Tylenol use during pregnancy.
Kenvue, alongside major retailers offering generic acetaminophen products, 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 navigating broader internal challenges, including slumping sales and uncertainty about its strategic direction. In July, CEO Thibaut Mongon was replaced by Kirk Perry, an experienced leader in consumer goods. This leadership change comes amidst growing pressure from activist investors advocating for Kenvue’s acquisition or the divestment of certain business segments.
Acetaminophen, the active ingredient in Tylenol, was first discovered in the 19th century. Yet, its efficacy in reducing pain and fever wasn’t fully recognized until researchers confirmed these properties in 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 opportunity and positioned acetaminophen as a safer alternative.
McNeil launched its first Tylenol product, Elixir Tylenol for children, in 1955. The medicine was playfully packaged to resemble a cartoon fire engine and advertised as “for little hotheads.”
Johnson & Johnson acquired McNeil in 1959, and by the following year, Tylenol was readily available over-the-counter without a prescription.
Throughout its history, Tylenol has faced occasional product recalls due to quality control concerns. It has also been at the center of ongoing medical debates and regulatory discussions surrounding its well-documented side effects, particularly liver damage, when consumed in high doses.
A 2013 ProPublica investigation revealed that over a thirty-year period, Johnson & Johnson’s McNeil division “repeatedly fought against safety warnings, dosage restrictions and other measures meant to safeguard users of the drug.” Johnson & Johnson, however, maintained that it always took product risks seriously and consistently worked to mitigate them.
The most severe challenge to the Tylenol brand occurred in 1982. A perpetrator tampered with Extra-Strength Tylenol capsules, infusing them with cyanide, which tragically resulted in the deaths of seven individuals in the Chicago area, including a young 12-year-old girl. Although no one was ever charged directly for the murders, a suspect (now deceased) was convicted of extortion for attempting to leverage the crisis against Johnson & Johnson for $1 million.
Johnson & Johnson responded decisively, swiftly removing Tylenol from store shelves nationwide and introducing innovative tamper-resistant packaging to restore public confidence. This gripping event later inspired a Netflix true-crime documentary, “Cold Case: The Tylenol Murders,” released recently.