Loading…
Halodine, LLC marketed unapproved new drug products—non-alcohol-based nasal and oral antiseptic products—through its websites and social media platforms with claims that they could mitigate, prevent, treat, diagnose, or cure COVID-19 and other conditions, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act. The products were also found to be misbranded drugs under sections 502(a) and (ee) of the FD&C Act, lacking required FDA approval and proper labeling. The company's distribution of these products into interstate commerce violated sections 301(a) and (d) of the FD&C Act, making their introduction or delivery for introduction prohibited.