This briefing document summarizes a Citizen Petition submitted to the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) on June 17, 2025. The petition, filed by “Interest of Justice” (Dustin Bryce Rosondich and Xylie Desiree Eshleman), requests the immediate reclassification of all COVID-19 mRNA and adenoviral vector products as “gene therapy products.” The petitioners argue that the current classification as “vaccines” is a misapplication of regulatory standards, leading to statutory violations, international legal contraventions, and insufficient safety oversight.

Based on their mechanism of action, these products unequivocally meet the FDA’s own established definitions of gene therapy. The petition leverages the Accardi doctrine, which mandates that agencies adhere to their own established rules and guidance, and the recent overturning of Chevron deference in Loper Bright v. Raimondo (2024), to argue that the FDA no longer has interpretive shield to justify its current classification. The petition further highlights systemic regulatory failures, including the suppression of safety information, improper use of Emergency Use Authorizations (EUAs), and violations of military and international informed consent requirements. It calls for comprehensive regulatory and administrative actions, including clinical holds, EUA revocations, and long-term safety monitoring.

It includes a number of US Department of Defense (DoD) Statutory Violations.