On October 17, 2025, Kenvue Brands LLC (“Kenvue”) submitted its response to the Citizen Petition filed on September 22, 2025 requesting labeling changes to the pregnancy warning on acetaminophen products and requested that the U.S. Food and Drug Administration (FDA) deny the petition because the labeling changes are not supported by the existing science that shows no proven link between taking acetaminophen and autism.
Proposed consumer-facing label changes include adding claims of an increased risk of acetaminophen use during pregnancy and neurodevelopmental disorders and directs that use be limited in terms of dose, duration and frequency. A second revision is proposed to professional labeling to describe an association between acetaminophen and neurodevelopmental disorders.
Kenvue strongly believes that the existing instruction “if pregnant or breast-feeding, ask a health professional before use” is the most conservative and appropriate warning as a healthcare professional is best able to advise patients on whether taking acetaminophen is appropriate based on their patient’s unique medical condition.
The Bottom Line:
- The labeling request in the Citizen Petition is unsupported by scientific evidence.
- Compelling public health considerations support the existing pregnancy warning.
- Adoption of the proposed labeling revisions would be contrary to federal law.
The labeling request is unsupported by scientific evidence and would represent an unexplained departure from FDA’s longstanding position on acetaminophen during pregnancy.
- Acetaminophen is a common active ingredient in multiple over-the-counter and prescription medications.
- Kenvue has continuously evaluated the science on acetaminophen use in pregnancy and neurodevelopmental disorders, including autism, and has found no causal association.
- For over a decade—and as recently as August 2025—FDA evaluated the scientific evidence and repeatedly concluded the data do not support a causal association. FDA also previously evaluated—and rejected—updating the pregnancy warning.
- Leading professional organizations have independently reviewed the science regarding acetaminophen use in pregnancy and neurodevelopmental disorders and agree causation has not been established—American Academy of Pediatrics, American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine, and World Health Organization.
Compelling public health considerations support the existing pregnancy warning.
- Significant public health considerations, including the known risk of untreated high fevers and lack of safe alternatives, weigh heavily against adding language that may discourage pregnant women from seeking medically appropriate treatment.
- The existing pregnancy warning recognizes that health professionals are in a unique position to address patient conditions, medical histories, and other considerations. Healthcare professionals are best positioned to weigh these variables and provide tailored medical advice.
- Sending pregnant women to their healthcare professional gives them an opportunity to assess whether a patient’s pain is an indication of some other underlying medical condition that may require medical intervention.
Adoption of the proposed labeling revisions would be contrary to federal law.
- The Citizen Petition process should not be used to circumvent the administrative order process set out in the Federal Food, Drug, and Cosmetic Act (“FDCA”).
- The proposed labeling changes should be rejected as they would inappropriately intervene in the practice of medicine.