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# Kenvue Urges FDA to Reject Acetaminophen Petition
- URL: https://www.fdaweb.com/kenvue-urges-fda-to-reject-acetaminophen-petition/
- Published: 2025-10-20T12:00:00.000Z
- Updated: 2026-09-14T15:24:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160069

Kenvue is urging FDA to deny a recent citizen petition requesting updates to the pregnancy warning on acetaminophen products. The 9/22 petition sought to add labeling linking acetaminophen use during pregnancy to neurodevelopmental disorders, including autism. It also proposed limits on dose, frequency, and duration for both consumer and professional labeling.

In 10/17 [comments](https://www.kenvue.com/kenvue-brands-citizen-petition-response?ref=fdaweb.com) to FDA, Kenvue argued that the requested changes are not supported by scientific evidence. The company cited extensive reviews by FDA, leading professional organizations — including the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, and the World Health Organization — as well as its own ongoing evaluations, all of which have found no causal association between acetaminophen use in pregnancy and neurodevelopmental disorders.

Kenvue emphasized that the current pregnancy warning, which advises patients to consult a healthcare professional before use, is the most conservative and appropriate guidance. “Healthcare professionals are best positioned to weigh individual patient conditions and provide tailored medical advice,” the company stated.

The company also highlighted public health concerns, noting that adding restrictive language could deter pregnant women from treating fevers and pain, potentially creating greater health risks. Kenvue further argued that the proposed labeling revisions would bypass federal regulatory processes and improperly intervene in the practice of medicine.

Kenvue concluded that the petition is scientifically unfounded, contrary to public health interests, and inconsistent with federal law, urging FDA to maintain the current acetaminophen pregnancy guidance.