Citizen Petition from Anita Vazquez Tibau

Anita Vazquez Tibau, representing Global Advocate for Mercury-Free Dentistry, supports the reclassification of dental amalgam from Class II to Class III. She argues that current special controls are insufficient to ensure safety, citing new scientific evidence of genotoxicity, neurological risks, and population-level mercury exposure.

Anita Tibau is submitting a formal petition to the Office for Human Research Protections (OHRP) regarding the Casa Pia Children's Amalgam Trial. She argues that the study violated federal regulations and ethical principles, specifically regarding the protection of vulnerable children, and requests a formal determination of noncompliance, suspension of federal reliance on the data, and remedial measures for the participants.

Anita Vazquez Tibau, an individual petitioner, is requesting that the FDA include a notice of a formal OIG investigation in the administrative record. She argues that the FDA's reliance on the Casa Pia Children's Amalgam Trial data is procedurally deficient due to documented mismanagement, regulatory noncompliance, and data integrity issues.