Varigard, LLC – FDA Warning Letter, Aug 11, 2021

On December 29, 2021, the FDA issued a Warning Letter to Varigard for selling unapproved new drug products related to COVID-19. The FDA reviewed Varigard's websites (varigard.com, shop.varigard.com) and social media (Twitter, Facebook) on August 11, 2021, finding that their alcohol-based topical antiseptic products were marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19 and other serious infections.

These products are deemed "unapproved new drugs" under Section 505(a) of the FD&C Act (21 U.S.C. 355(a)) because they are not generally recognized as safe and effective (GRASE) for their intended uses and lack FDA approval. Furthermore, they are "misbranded drugs" under Sections 502(a) and (ee) (21 U.S.C. 352(a) and (ee)).

Specific violations include claims like "LAB TESTS PROVE VARIGARD TRAPS AND KILLS COVID-19" and "2 Hours of protection per use…Proven to kill actual COVID-19 (SARS-CoV-2)." The products also contain "patented organic polymers" as unlisted active ingredients, which are not permitted in consumer antiseptic hand rubs under the 1994