Covalon Technologies Inc. – FDA Warning Letter, Mar 24, 2021

The FDA issued a Warning Letter to Covaguard after reviewing its websites on March 24, 2021, finding the company selling non-alcohol based hand sanitizers with unproven claims related to COVID-19. The FDA determined these products are unapproved new drugs under 21 U.S.C. 355(a) and misbranded drugs under 21 U.S.C. 352(ee), prohibiting their introduction into interstate commerce per 21 U.S.C. 331(a) and (d). The products are classified as "new drugs" because they are not Generally Recognized As Safe and Effective (GRASE) for their intended uses (21 U.S.C. 321(p)), and no FDA-approved applications exist. Furthermore, these consumer topical antiseptics do not conform to the 1994 Tentative Final Monograph (TFM) or its amendments, failing to meet conditions for marketing without approval under section 505G of the FD&C Act. Specifically, labeling claims suggesting COVID-19 prevention and up to 24 hours of efficacy against serious pathogens exceed the TFM's scope and lack supporting clinical data, potentially endangering public health by fostering a false sense of security. Covaguard must immediately cease selling these unapproved products and, within 48 hours, provide an email to the FDA detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply could lead to legal action, including seizure and injunction, and the firm's inclusion on FDA's public list of non-compliant COVID-19 product sellers. Products may also be refused admission into the U.S.