WASHINGTON, D.C. — The Consumer Healthcare Products Association (CHPA) is calling on the U.S. Food and Drug Administration to reject a citizen petition that seeks to add new warnings on acetaminophen labels linking the common pain reliever to autism and ADHD. The group says the proposal is based on unproven claims that conflict with the FDA’s own reviews and decades of scientific evidence.
“Rhetoric has outrun the research,” said Scott Melville, CHPA president and CEO. “OTC drug labels are relied upon by consumers and health 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.”
Longstanding Scientific Consensus
Acetaminophen — sold under brand names such as Tylenol and widely used in both prescription and over-the-counter medications — is one of the most studied pain relievers in the world. CHPA noted that multiple global and medical authorities, including the FDA, European Medicines Agency (EMA), and World Health Organization (WHO), recognize acetaminophen as the only OTC pain and fever reducer suitable for use throughout pregnancy when taken as directed.
U.S. medical organizations such as the American College of Obstetricians and Gynecologists (ACOG), Society for Maternal-Fetal Medicine (SMFM), and the American Academy of Pediatrics (AAP) also continue to endorse its safety profile.
Citing large-scale epidemiological research, CHPA emphasized that the most rigorous sibling-controlled studies — encompassing data from more than 2.7 million children worldwide — have found no increased risk of autism spectrum disorder, ADHD, or intellectual disability once genetic and familial factors are accounted for.
“Over a decade of FDA internal reviews, from 2014 through 2025, repeatedly conclude that evidence is insufficient to support a causal association,” the association said in its statement.
Regulatory and Safety Implications
CHPA warned that adding a warning based on speculative links would violate the FDA’s requirement that OTC labeling be “clear and truthful” and not misleading. Such a move, the group said, could have unintended public health consequences — deterring appropriate acetaminophen use, pushing pregnant women toward less safe alternatives, or leading them to forgo treatment for pain or fever altogether.
Untreated pain and fever during pregnancy are well-documented risk factors for adverse maternal and fetal outcomes, CHPA noted.
“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 and scientific affairs. “For OTC monograph products, label changes are governed by the FD&C Act’s 505G(b) administrative order process, which cannot be circumvented through a citizen petition.”
That process, he added, ensures public participation and transparency, requiring rigorous review of scientific evidence before any labeling change is made.
Maintaining Evidence-Based Labeling
Dr. Furness stressed that proposing a warning absent causal evidence is inconsistent with the FDA’s risk communication standards. “The science is equally clear,” he said. “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 — it is inconsistent with how FDA evaluates and communicates drug risks.”
CHPA’s full comments are available on its website, along with a statement released in September following the White House’s announcement regarding acetaminophen.
The association urged the FDA to deny Citizen Petition FDA-2025-P-4153, maintain current evidence-based labeling for acetaminophen, and continue supporting ongoing research and post-market surveillance to ensure public confidence in one of the most widely used pain relievers worldwide.
