Prefense LLC – FDA Warning Letter, Apr 6, 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
ID · 89b28576-e80b-4b2c-a4be-c4b8b534108a
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.