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ICAN’s Tylenol (acetaminophen) petition recently made headlines as multiple news agencies covered a response by Tylenol’s maker, Kenvue. The petition, filed last month, asked the FDA to move quickly to amend the warning label on all acetaminophen products to warn women that taking it during pregnancy could possibly cause neurodevelopmental harms to their unborn child.
ICAN supporters will be unsurprised to hear Kenvue opposes our petition. In its response, it claims that “scientific evidence does not support a causal association between acetaminophen use in pregnancy and neurodevelopmental disorders, including ASD and ADHD.” Note its very specific use of the phrase “causal association.” What it doesn’t—and can’t—say is that acetaminophen has been proven safe during pregnancy. Scientists simply don’t know for certain whether it’s safe or not for all women, in all stages of pregnancy. Some compelling evidence points to an associated harm, while other evidence does not.
ICAN doesn’t believe in waiting another decade for the science to be “settled” considering how many babies could potentially be harmed in the meantime. Our public health authorities should be following precautionary and informed consent principles. Mothers must be informed of potential—not just proven—risks. Trust mothers to consult with their doctors—who also must be educated about all potential risks—and to make the decision that is right for themselves and their babies.
There’s still time to submit your comment in support of ICAN’s petition here: https://www.regulations.gov/document/FDA-2025-P-4153-0001/comment. Share your thoughts with the FDA and add to the growing pressure on the agency to start recognizing the important and often-dismissed right of informed consent.
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