Comment from Americans for Scientific Integrity
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Summary: 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.
Please see the attached comment submitted in response to Kenvue’s supplemental comment dated December 23, 2025, together with an accompanying exhibit.