WARNING LETTER
Salvacion USA Inc.
MARCS-CMS 672252 —
February 13, 2024
Product:
Drugs
Recipient:
Recipient Name
Ryan S. Hwang
Recipient Title
Director
Salvacion USA Inc.
210 Sylvan Avenue Suite 24
Englewood Cliffs
,
NJ
07632-2503
United States
info@cofixyl.com
Hello@Covixyl.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Secondary Issuing Offices
United States
WARNING LETTER
February 13, 2024
RE: 3017660889
Dear Mr. Hwang:
This letter concerns your firm’s distribution of the drug product Covixyl Nasal Spray.
1
The U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://covixyl.com/ on October 10, 2023. On the same date, we also reviewed your social media websites at https://twitter.com/gocovixyl and https://www.facebook.com/covixyl, directing consumers to your website https://covixyl.com/ to purchase your products. Based on our review, Covixyl Nasal Spray is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food, Drug, & Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). These violations are described in more detail below.
Unapproved New Drug Violations
Your Covixyl Nasal Spray is a drug as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body.
Examples of claims from your website https://covixyl.com/, and your social media websites https://twitter.com/gocovixyl and https://www.facebook.com/covixyl, that provide evidence of the intended use (as defined in 21 CFR 201.128) of the product as a drug include, but may not be limited to, the following:
“Covixyl® was developed to safely and effectively create a barrier in the nasal passages that helps block airborne viruses, keeping you from getting sick.” [from your website https://covixyl.com/]
“Initial testing against
SARS-CoV-2, Rotavirus, H1N1 (Influenza A), and Human Respiratory Syncytial Virus (RSV)
proved the efficacy of ELAH against infection in vitro, showing 99+% reduction across all 4 viruses.” [from your website https://covixyl.com/]
“Laboratory testing and clinical trials have proven the power of Covixyl® to block airborne viruses before they gain entry into the body, for up to 6 hours.” [from your website https://covixyl.com/]
“Covixyl® creates a physical barrier in the nasopharynx which prevents airborne respiratory viruses from attaching to the cell walls, protecting the body from infection for up to six hours per use.” [from your website https://covixyl.com/]
“Protection that Lasts up to 6 Hours” [from your website https://covixyl.com/]
“The Future of Virus Protection is Here” [from your website https://covixyl.com/]
“Covixyl is the future of virus protection and your partner in crime to a healthy, care-free life...
Drug-free
Non-addictive
6 hours of protection
Choose Covixyl and claim your life back!” [from a September 28, 2023 post on your Facebook webpage at https://www.facebook.com/covixyl]
“…Here's to all the teachers who are on the frontlines with sneezing and sniffling kiddos You are the real MVPs
Looking for a better way to stay protected from viruses in the classroom? Covixyl blocks airborne viruses, giving you an extra layer of protection!” [from an October 5, 2023 post on your Facebook webpage at https://www.facebook.com/covixyl]
“…Covixyl is the virus-blocking nasal spray that allows you to live life safely, easily, and freely!” covixyl.com/#order-now” [from an August 3, 2023 post on your X (formerly Twitter) webpage at https://twitter.com/gocovixyl]
“Allow me to (re) introduce myself, my name is CO… We are Covixyl, a nasal spray that blocks airborne viruses before they attack! Spray, Protect, Reconnect and Shop now at Covixyly.com #Tripledemic #flu” [from an October 26, 2022 post on your X (formerly Twitter) webpage at https://twitter.com/gocovixyl]
Your Covixyl Nasal Spray product is not generally recognized as safe and effective (GRASE) for its above referenced uses and, therefore, this product is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for Covixyl Nasal Spray. Accordingly, the introduction or delivery for introduction into interstate commerce of this product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent by email to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance at FDAAdvisory@fda.hhs.gov and include your firm name in the subject line of your email.
Sincerely,
/S/
CAPT Tina Smith
Office Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
______________________
1
Your firm markets this product to contain Ethyl Lauroyl Arginate HCl (ELAH).
Content current as of:
02/20/2024
Regulated Product(s)
Drugs