Tylenol Maker Kenvue Faces Renewed Crisis After Trump’s Warning and FDA Action
Thank you for reading this post, don't forget to subscribe!The company that makes Tylenol, Kenvue, is facing a major public relations and legal challenge. This follows a public warning from President Donald Trump and a new directive from the US Food and Drug Administration (FDA) regarding the use of acetaminophen during pregnancy.
The Unproven Link and Mounting Legal Pressure
There is no proven causal link between Tylenol (acetaminophen) and autism in children. While some studies have suggested an association between the two, they have not established causation. Nevertheless, President Trump’s public rebuke—urging people not to take Tylenol—and a new FDA initiative have created significant problems for Kenvue.
The FDA has initiated a process to change the product label on acetaminophen-containing products to state that the ingredient is “associated with a higher risk of autism in children when taken by pregnant women.” The agency has also sent a letter to doctors nationwide about this potential risk.
Plaintiffs’ lawyers say this new warning could give new life to a barrage of lawsuits against Kenvue that were recently dismissed by a federal court. Even if the warning doesn’t explicitly state a causal relationship, a jury could use it as powerful evidence.
Kenvue’s Response and Broader Business Challenges
Kenvue has publicly defended its product, stating, “We stand with the science and believe we will continue to be successful in litigation as claims lack legal merit and scientific support.” The company could sue the federal government to challenge the new warning, but legal experts believe it would be an uphill battle, as courts typically give the FDA broad authority on health-risk matters.
This new crisis comes at a difficult time for Kenvue, which was recently spun off from Johnson & Johnson. The company is already dealing with slowing sales and pressure from activist investors to overhaul its business. Tylenol is Kenvue’s most significant brand, so any damage to its reputation or sales could have a substantial financial impact.
The new warning could also have a wider effect, potentially deterring consumers beyond pregnant women. Medical experts and the wider scientific community are concerned that the government’s message could create confusion, leading expecting mothers to avoid treating fevers—a condition that can be dangerous for both the mother and child if left untreated.
