Supplemental Comment from anita tibau

Comment on Docket FDA-2025-P-2526-0001 As the petitioner in FDA-2025-P-2526-0001, I submit this supplemental comment to strongly reinforce the urgent need for the FDA to grant the petition in full: immediately ban mercury dental amalgam (or reclassify from Class II to Class III), mandate comprehensive patient disclosures of mercury risks, and require evidence-based safe removal protocols (e.g., IAOMT SMART). Mercury dental amalgam contains ~50% elemental mercury, a potent neurotoxin that releases vapor continuously, posing cumulative risks especially to children, pregnant/nursing individuals, and those with genetic susceptibilities. The FDA's own 2020 recommendations advise avoiding amalgam in high-risk groups due to potential neurodevelopmental, renal, and immunological harms—yet the agency continues to permit its use in most children ≥6 and the general population, relying on ethically and scientifically flawed data including the Casa Pia Children's Amalgam Trial (NIH/NIDCR Grant U01-DE011894). This trial exposed ~507 institutionalized Portuguese children (many wards of the state) to amalgam during neurodevelopment, overlapping the 2002 Casa Pia systemic child sexual abuse scandal (public exposure/convictions during enrollment/follow-up). Consent/assent was compromised by extreme coercion/undue influence in an abusive institutional environment; no independent advocates were appointed for wards as required by 45 CFR 46.409 (Subpart D protections). Primary conclusions (DeRouen et al., JAMA 2006) claimed "no significant adverse effects," but independent re-analyses reveal clear harms overlooked in aggregate data: Dose-dependent renal biomarker changes (GST-α/π, albumin) and glomerular/tubular injury (Woods et al., Environ Res 2008; PMID 18721920). Elevated urinary porphyrins indicating early heme biosynthesis disruption, most pronounced in younger children (Woods et al., J Toxicol Environ Health A 2009; PMID 19557617). Dose-related kidney integrity markers and urinary mercury increases (Geier et al., Hum Exp Toxicol 2012/2013; PMIDs 21803780, 22893351). Neurobehavioral deficits in genetically susceptible subgroups (CPOX4, BDNF Val66Met polymorphisms), especially boys (Woods et al., Neurotoxicology 2014; PMID 25109824). These signals demonstrate foreseeable harms not adequately assessed or disclosed, violating 45 CFR 46.111 (risk minimization) and 46.116 (informed consent). I have submitted a formal complaint to OHRP (February 2026) requesting noncompliance determination, suspension of federal reliance on this data, and remedial coordination—further evidencing the ethical compromise embedded in FDA policy. Continued reliance on Casa Pia contradicts evolving science, FDA's high-risk warnings, and U.S. obligations under the Minamata Convention (ratified 2013; global phase-down). The EU banned amalgam effective 2025–2026; over 30 countries have restricted/banned it. The U.S. lags dangerously, exposing millions (including vulnerable/low-resource groups) to preventable mercury exposure. Granting this petition would: Protect public health by eliminating the largest non-occupational mercury source. Align U.S. policy with international standards and Minamata goals. Mandate disclosures and SMART removal to prevent iatrogenic harm during extraction. Restore trust eroded by decades of inaction on known risks. I urge the FDA to act expeditiously: approve the petition without delay, reject reliance on ethically tainted studies like Casa Pia, and initiate rulemaking for a full ban/reclassification. Public comments supporting this petition (e.g., "I support banning mercury dental amalgam to protect vulnerable populations") further demonstrate broad concern. Thank you for considering this critical matter. I am available for any questions or additional evidence (FOIA records, publications, etc.). Respectfully, Anita Tibau Petitioner, FDA-2025-P-2526-0001