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Applied Biological Laboratories Inc. was cited for selling unapproved COVID-19 products—"Biovanta Dual Action Throat Spray" and "Biovanta Triple Action Lozenges"—through their websites without FDA authorization, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act. The products were also found to be misbranded under section 502 of the FD&C Act and promoted through social media channels to treat, prevent, mitigate, diagnose, or cure COVID-19. The company's marketing claims and sale of these unapproved drugs constituted prohibited introduction of new drugs into interstate commerce during the COVID-19 public health emergency.