FDA WARNING_LETTER - Kleenhanz, LLC - April 19, 2022

On April 19, 2022, the FDA issued a Warning Letter to Kleenhanz regarding its Kleenhanz® Towelettes topical antiseptic products, sold via www.kleenhanz.com, Amazon.com, and promoted on Twitter. The FDA's April 2022 review found the products were marketed with unapproved claims to mitigate, prevent, treat, diagnose, or cure COVID-19 and other conditions, classifying them as unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. § 355(a), and misbranded drugs under section 502(ee), 21 U.S.C. § 352(ee).

Violations include claims like "Protect yourself against Coronavirus" and effectiveness against various viruses and bacteria (e.g., H1N1, Hepatitis, HIV, MRSA), which exceed the scope of general topical antiseptics. The products are considered "new drugs" because they are not generally recognized as safe and effective (GRASE) for their intended uses. Furthermore, Kleenhanz® Towelettes do not conform to the 1994 Tentative Final Monograph (TFM) or subsequent amendments for OTC topical antiseptics, specifically regarding active ingredients. While the label lists benzalkonium chloride, the website also claims benzethonium