FDA WARNING_LETTER - Prefense LLC - April 06, 2020

On April 23, 2020, the FDA issued a Warning Letter to the company operating www.prefense.com, www.safety-med.com, www.mdsassociates.com, and www.apollosafetyproducts.net, following a review on April 6, 2020. The letter addresses the sale of "Prefense Hand Sanitizers" with unapproved claims related to COVID-19 and other diseases.

The FDA determined that Prefense Hand Sanitizers are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. § 355(a), and their introduction into interstate commerce is prohibited by section 301(d), 21 U.S.C. § 331(d). The products are marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19, which establishes them as drugs under 21 U.S.C. § 321(g)(1)(B) and (C).

These products are considered new drugs because they are not generally recognized as safe and effective (GRASE) for their intended uses. No FDA-approved applications exist for Prefense Hand Sanitizers, and no adequate clinical studies support their GRASE status.

Furthermore, the products do not conform to the 1994 Tentative