Loading…
Covalon Technologies Inc. was warned for marketing unapproved new drug products—non-alcohol based hand sanitizers—that were claimed to mitigate, prevent, treat, diagnose, or cure COVID-19, in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act. The company sold these products through its website (covaguard.com) and social media channels (Instagram and Facebook) without FDA approval or authorization, and the products were also misbranded under section 502(ee) of the FD&C Act. This enforcement action was issued during the COVID-19 public health emergency, when the FDA prioritized protecting consumers from unauthorized products making disease claims.