NCL Urges FDA to Reject Misleading Petition on Acetaminophen Labeling

Warns against politicizing drug safety decisions and spreading misinformation to pregnant women 

Media Contact: Lisa McDonald, Vice President of Communications, 202-207-2829 

Washington, DC – The National Consumers League (NCL) has submitted comments urging the U.S. Food and Drug Administration (FDA) to reject a petition from the Informed Consent Action Network (ICAN) that calls for new warnings on over-the-counter acetaminophen products. NCL warns that ICAN’s proposed labeling changes are not supported by credible science and could needlessly alarm pregnant women. 

“Decades of high-quality research show no causal link between acetaminophen use in pregnancy and neurodevelopmental disorders such as autism,” said NCL CEO Sally Greenberg. “The science is clear: acetaminophen remains the safest and most effective option for managing fever or pain during pregnancy. Overstating unproven risks will only confuse and endanger women and their babies.” 

“Inserting politically motivated warnings into drug labeling would erode public trust in the FDA and risk discouraging appropriate treatment for pregnant women, potentially leading to greater harm,” Greenberg added. “Pregnant women deserve clear, evidence-based information to protect their health and their children’s health.”  

NCL notes that medical experts, including the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, and the American Academy of Pediatrics, have all reaffirmed acetaminophen’s safety when used as directed. In addition, FDA’s own notice to physicians issued in September states that “a causal relationship has not been established.” 

NCL’s full comments are available here. 

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About the National Consumers League (NCL)      

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.