WASHINGTON, D.C. – The Consumer Healthcare Products Association (CHPA) today urged the U.S. Food and Drug Administration (FDA) to deny Citizen Petition FDA-2025-P-4153, which seeks to add a new warning on acetaminophen products regarding unproven claims related to autism and ADHD, despite FDA’s own reviews and high-quality human studies which do not support such claims.
“Rhetoric has outrun the research,” said CHPA President & CEO Scott Melville. “OTC Drug labels are relied upon by consumers and heath care practitioners, and they must be based on facts, not unproven assertions. The FDA’s own reviews find no adequate or consistent evidence establishing a causal link between acetaminophen and autism, and it remains the only OTC pain reliever considered appropriate throughout pregnancy when used as directed. A speculative warning would mislead patients and undermine maternal care.”
Key scientific & regulatory facts:
- When used as directed, acetaminophen is the only OTC pain reliever and fever reducer recognized worldwide as appropriate for use throughout an entire pregnancy by leading regulatory authorities and medical organizations:
- Regulatory / global authorities:
- Medical & health professional organizations:
- The most rigorous sibling-controlled studies of acetaminophen from around the world (encompassing more than 2.7 million children) show no increased risk of neurodevelopmental disorders after accounting for familial and genetic confounding; where evaluated, outcomes including autism, ADHD, and intellectual disability were consistently null.
- Over a decade of FDA internal reviews (2014–2025) repeatedly conclude the evidence is insufficient to support a causal association.
- Adding an unproven warning without causal evidence would violate FDA’s OTC standard that labeling be “clear and truthful” and not misleading.
- False and improper labeling would discourage appropriate acetaminophen use and could push pregnant women toward other pain management choices with proven pregnancy risks. It could also lead some women to leave their pain or fever untreated, which itself is another well-established risk factor for adverse pregnancy outcomes.
“Congress established a clear process for OTC label changes, and it’s imperative FDA follow it,” said Scott Furness, Ph.D., CHPA’s Senior Vice President of Regulatory & Scientific Affairs. “For OTC monograph products, label changes are governed by the FD&C Act 505G(b) administrative order process, which cannot be circumvented through a citizen petition. The administrative order process requires public participation and transparency, ensuring that any scientific conclusions undergo rigorous review.”
“The science is equally clear,” continued Dr. Furness, “the most rigorous sibling-controlled studies, covering more than 2.7 million children, show no increased risk once family factors are accounted for. Proposing a warning in the absence of causal evidence is not just premature, but it is inconsistent with how FDA evaluates and communicates drug risks. That is why CHPA urges FDA to deny the petition and maintain current evidence-based labeling while continuing more research and routine, ongoing surveillance of real-world data.”
Click here for CHPA’s full comments and here for CHPA’s Sept. 22 statement following the White House’s announcement on acetaminophen.
