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FluxxLab LLC sold unapproved new drugs—specifically Covid-19 Immune Support Tincture and CBDA+CBD Oil Tincture—that were marketed to mitigate, prevent, treat, diagnose, or cure COVID-19, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act. The products were also misbranded under section 502 of the FD&C Act and their sale constituted prohibited introduction of unapproved drugs into interstate commerce under sections 301(a) and (d). The enforcement action was issued during the COVID-19 public health emergency, when the FDA was taking urgent measures to protect consumers from unauthorized COVID-19 treatment claims.