FDA WARNING_LETTER - Sanit Technologies, LLC dba Durisan - April 15, 2020

On May 7, 2020, the FDA issued a Warning Letter to Durisan after reviewing its website and social media on April 15, 2020. The agency found that Durisan was offering non-alcohol based hand sanitizer products with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. These products are deemed unapproved new drugs under sections 505(a) and 201(p) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and their introduction into interstate commerce is prohibited by section 301(d). The FDA determined the products are not Generally Recognized As Safe and Effective (GRASE) for their intended uses and lack FDA-approved applications. Furthermore, Durisan's hand sanitizers do not conform to the 1994 Tentative Final Monograph (TFM) for topical antiseptics or its amendments, nor do they meet the conditions for marketing without approval under section 505G(a)(3) of the CARES Act. Specifically, claims of effectiveness against COVID-19 and up to 24 hours of efficacy against pathogens exceed the TFM's scope, creating a false sense of security and endangering public health. The firm was instructed to immediately cease selling these unapproved products and respond within 48 hours to COVID-19-Task-Force-CDER@fda.hhs.gov, detailing corrective actions and preventative measures. Failure to comply could result in legal action, including seizure and injunction, and placement on FDA's public list of firms selling fraudulent COVID-19 products.