FDA WARNING_LETTER - Salvacion USA Inc. - February 20, 2024

On February 13, 2024, the FDA issued a Warning Letter to Mr. Hwang concerning the distribution of Covixyl Nasal Spray. The FDA reviewed the firm's website (https://covixyl.com/) and social media pages (https://twitter.com/gocovixyl, https://www.facebook.com/covixyl) on October 10, 2023.

The FDA determined that Covixyl Nasal Spray is an unapproved new drug, violating sections 505(a) and 301(d) of the Federal Food, Drug, & Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). The product is classified as a drug under section 201(g)(1)(B) and/or 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(B) and 321(g)(1)(C), due to claims indicating its intended use for disease diagnosis, cure, mitigation, treatment, prevention, or to affect body structure/function.

Examples of violative claims include: "Covixyl® was developed to safely and effectively create a barrier in the nasal passages that helps block airborne viruses, keeping you