FDA WARNING_LETTER - Viraldine, LLC - March 01, 2022

On March 7, 2022, the FDA and FTC issued a Warning Letter to the company operating viraldine.com for selling unapproved and misbranded drug products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. The FDA reviewed the website on December 21, 2021, and March 1, 2022.

The products, including "1.5% POVIDONE IODINE USP ANTISEPTIC NASAL SPRAY," "1% POVIDONE IODINE USP ANTISEPTIC NASAL SPRAY," ".5% POVIDONE IODINE USP ANTISEPTIC NASAL SPRAY," and "1.5% POVIDONE IODINE USP ANTISEPTIC THROAT SPRAY," are considered "new drugs" under section 201(p) of the FD&C Act because they are not generally recognized as safe and effective (GRASE) for their labeled uses. They are marketed in violation of sections 505(a) and 301(d) of the FD&C Act, as no FDA-approved applications are in effect.

The products are also misbranded under section 502(ee) of the FD&C Act because they are nonprescription drugs subject to section 505G but do not comply with its marketing requirements and are not FDA-approved. Specific violations