Quadrant Sales & Marketing, Inc. – FDA Warning Letter, May 29, 2020

On May 28, 2020, the FDA issued a Warning Letter to the company operating cleanhandsandmore.com after reviewing their website on April 30, 2020. The FDA found that the website was offering a non-alcohol based hand sanitizer product for sale in the United States with claims that it could mitigate, prevent, treat, diagnose, or cure COVID-19.

The FDA determined that this product is an unapproved new drug, sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The product is considered a drug under section 201(g)(1)(B) and (C) of the FD&C Act due to its intended use for disease diagnosis, cure, mitigation, treatment, or prevention, and/or to affect the body's structure or function. It is also a new drug under section 201(p) because it is not generally recognized as safe and effective (GRASE) for its claimed uses, and no FDA-approved application is in effect.

Specifically, the hand sanitizer, containing benzalkonium chloride, does not conform to the 1994 Tentative Final Monograph (TFM) for OTC topical antiseptics or its amendments. The claims of preventing infection from specific pathogens, including the novel coronavirus, and providing up to