Following a White House press conference on Sept. 22, during which Donald Trump alleged a link between acetaminophen use during pregnancy and autism, the Informed Consent Network (ICAN) filed a petition with the FDA to add a warning to all drugs that contain acetaminophen. ICAN is a nonprofit organization that aims to provide “every person with the right to informed consent,” according to their website.
Acetaminophen, the active ingredient in Tylenol, is not known to cause autism. Credit: Kenvue
ICAN requested a warning stating that the use of products containing acetaminophen “may increase your child’s risk of neurodevelopmental disorders, including autism spectrum disorder and attention-deficit hyperactivity disorder.”
While some early observational studies found a correlation between acetaminophen, also known as paracetamol, and slightly higher rates of autism during pregnancy and ADHD diagnoses, the largest and most rigorous study to date did not find such a link. That study, which used sibling control analysis and analyzed 2.5 million Swedish births, was published in JAMA in April 2024. The idea that acetaminophen causes autism appears to be a mix-up of correlation and causation. Mothers who take acetaminophen during pregnancy are more likely to have conditions like chronic pain, migraines, fever or infections, and these conditions themselves are genetically linked to autism and ADHD.
Kenvue pushes back
Kenvue, the maker of Tylenol, published a response to the petition on Sunday. The company also sent a comment to the FDA on Friday stating that the requested changes to the label are “unsupported by the scientific evidence and legally and procedurally improper.”
The current warning label on acetaminophen reads “if pregnant or breastfeeding, ask a health professional before use.” Kenvue stated that this warning “is the most conservative and appropriate warning.” In its comment, the company urged the FDA not to accept the label changes.
Kenvue also stated that the proposed label revisions “would be contrary to federal law,” specifically the process outlined in the Federal Food, Drug and Cosmetic Act (FDCA). The act’s primary purpose is to “safeguard” and “protect” consumers from dangerous exposure and the “adulteration” and “misbranding” of products. The FDCA gives the FDA power to regulate foods, drugs, medical devices, cosmetics and tobacco products from the “moment of their introduction into interstate commerce all the way to the moment of their delivery to the ultimate consumer.”
The FDCA also lays out steps for changing label warnings. In order to change a label, the FDA is required to “make reasonable efforts to notify sponsors of the drug”, “issue a proposed administrative order on the FDA’s website and explain the grounds for issuance of the order” and “provide for a public comment period of no less than 45 days.” If the FDA decides to move forward with the proposed label changes, it would have to follow these steps.
Trouble in the courts
Kenvue stock is down almost 29% Tuesday morning, but the Tylenol saga is not the only cause. Last week, 3,000 people in the U.K. filed a joint suit against Johnson & Johnson, which spun off Kenvue in 2023. The suit claims that the company knowingly sold baby powder that was contaminated with a carcinogen. Shares of Kenvue dropped 10% that afternoon.
This is not the first time Johnson & Johnson’s baby powder has come under scrutiny. Earlier this month, Johnson & Johnson was ordered to pay $966 million to the family of a cancer survivor who also claimed the powder contained a carcinogen.
The baby powder line has faced a series of lawsuits since 2013. The company discontinued the talc-based baby powder in 2023 and switched to cornstarch.
Filed Under: Neurological Disease, Obstetrics & gynecology
