FDA WARNING_LETTER - Strategia Project Management, Inc. - September 28, 2021

On September 28, 2021, the FDA issued a Warning Letter to microSURE regarding their unapproved new drug products related to COVID-19. The FDA reviewed microSURE's websites (microsure.com, microsure.com/shop) and social media (Twitter, Facebook) and found they offered a non-alcohol-based topical antiseptic product, microSURE Hand Sanitizer, with claims to mitigate, prevent, treat, diagnose, or cure COVID-19 and other serious infections.

The FDA determined this product is an unapproved new drug, violating section 505(a) of the FD&C Act, and a misbranded drug under sections 502(a) and (ee). Claims such as testing against SARS-CoV-2, destroying viruses, and eradicating bacteria and viruses establish its intended use as a drug. The product is considered a "new drug" because it is not generally recognized as safe and effective (GRASE) for its claimed uses. No FDA-approved applications are in effect for this product.

Furthermore, while the product lists benzalkonium chloride as an active ingredient, claims about silica dioxide forming a crystalline layer to eradicate bacteria and viruses indicate silica dioxide is also an active ingredient. Silica dioxide is not a permitted active ingredient for consumer antiseptic hand rub products under the 1994 TFM. The product's claims of effectiveness against SARS-CoV-2