# FDA WARNING_LETTER - CofixRx, LLC - January 04, 2022

Source: https://www.keypedia.com/records/warning_letter/cofixrx-llc/2fed8cdf-b429-4581-b3f6-ad5c04ebdf59

> FDA WARNING_LETTER for CofixRx, LLC on January 04, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: CofixRx, LLC
- Inspection Date: 2022-01-04
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Carolyn E. Becker](https://www.keypedia.com/people/carolyn-e-becker/ad2daae5-dda1-4b9c-a69a-775997e7b60b)
- [Adam Fovenesi](https://www.keypedia.com/people/adam-fovenesi/c4696e5f-f15b-41aa-9f8c-4f7c5e8ce585)

Company: https://www.keypedia.com/companies/cofixrx-llc/9211428e-96b7-45c6-86c1-513acf392221

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c