FDA WARNING_LETTER - CofixRx, LLC - January 04, 2022

On April 5, 2022, the FDA issued a Warning Letter to the manufacturer of CofixRX Nasal Spray following a January 4, 2022, review of their website (https://cofixrx.com) and product labeling. The FDA determined that CofixRX Nasal Spray is an unapproved new drug, sold in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a), and a misbranded drug under sections 502(a) and (ee) of the FD&C Act, 21 U.S.C. 352(a) and (ee).

The product is marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19 and other conditions, such as "DESTROYS SARS CoV-2 and other COLD & FLU viruses in 15 seconds" and "offers up to 8 hours of protection." These claims render it a "drug" under section 201(g)(1)(B) and (C) of the FD&C Act. As a "new drug," it is not generally recognized as safe and effective (GRASE) for its intended uses, and no FDA-approved application exists.

Furthermore, CofixRX Nasal Spray does not conform to the conditions for marketing nonprescription drugs without an