Citizen Petition from Siri & Glimstad LLP on behalf of Informed Consent Action Network

The Informed Consent Action Network (ICAN) argues that sibling-control analyses in prenatal neurodevelopment research are often unstable and potentially biased, and therefore should not be used to dismiss potential risks from prenatal acetaminophen. They advocate for the FDA to weigh these studies alongside other evidence to justify a precautionary prenatal warning.

The Informed Consent Action Network supports the citizen petition requesting a precautionary warning on prenatal acetaminophen use. They argue that biomarker-based studies provide more reliable evidence of adverse neurodevelopmental outcomes by reducing recall bias and exposure misclassification compared to self-reporting studies.

Americans for Scientific Integrity supports the proposed action by providing supplemental evidence that suggests precautionary risk communication regarding prenatal acetaminophen exposure is appropriate. They argue that recent studies showing structural brain differences and potential risks for ADHD and autism, combined with biological considerations regarding metabolic windows, warrant clearer information for pregnant individuals and clinicians.

The commenter is submitting a preprint research paper and additional references to support the scientific context of the citizen petition. They argue that acetaminophen is a developmental neurotoxin that contributes to autism spectrum disorder (ASD) and advocate for changes in clinical practice, specifically regarding its use during vaccination.

Americans for Scientific Integrity is submitting a supplemental comment to support the Informed Consent Action Network's petition regarding acetaminophen use during pregnancy. They argue that a new peer-reviewed study on rodent neurotoxicity provides evidence of biological plausibility for the petition's request for precautionary labeling.

Americans for Scientific Integrity (AFSI) argues that the FDA should consolidate the review of two separate petitions regarding acetaminophen safety because the metabolic vulnerabilities of fetuses and infants are biologically continuous. They also request that the FDA mandate a precautionary warning on OTC acetaminophen labels for children due to reported associations with asthma, allergies, and eczema.

Kenvue Brands LLC opposes the proposed labeling changes for over-the-counter acetaminophen products, arguing that the scientific evidence linking prenatal use to neurodevelopmental disorders is unreliable and methodologically flawed. The company contends that the requested warnings would be misleading, violate the First Amendment, and contradict the FDA's evidence-driven regulatory framework.

The Society for Developmental and Behavioral Pediatrics opposes the proposed FDA labeling change for over-the-counter acetaminophen. They argue that there is no strong evidence linking appropriate acetaminophen use during pregnancy to an increased risk of autism or ADHD, citing studies that suggest genetics and maternal health are more likely factors.

The Organization for Latino Health Advocacy opposes the proposed label change for acetaminophen during pregnancy. They argue that the product label should remain based on the full body of scientific and medical literature and emphasize that pregnant patients should not have to suffer unnecessary pain.

LNK International, Inc., a generic pharmaceutical manufacturer, opposes the proposed labeling changes for acetaminophen-containing products. They argue that the current warning statement is sufficient, the proposed changes lack scientific evidence, and that implementing them would be burdensome and confusing for consumers and manufacturers.