Fraudulent Coronavirus Disease (COVID-19) Products
Health fraud scams are everywhere and the FDA has been monitoring scams associated with COVID-19 products. To help combat these scams, the U.S. Food and Drug Administration is issuing warning letters to firms for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure coronavirus disease 2019 (COVID-19).They are actively monitoring for any firms marketing products with fraudulent COVID-19 prevention and treatment claims. The FDA is exercising its authority to protect consumers from firms selling unapproved products and making false or misleading claims, including, by pursuing warning letters, seizures, injunctions or criminal prosecutions against products and firms or individuals that violate the law.
Below are some of the recent warning letters the FDA has sent out to companies.
Warning letter issued to: Amcyte Pharma, Inc.
MARCS-CMS 623474 -- JANUARY 03, 2022
Product: Drugs
WARNING LETTER
Date: January 3, 2022
RE: Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://nasitrol.com/ on December 20, 2021. The FDA has observed that your website offers Nasitrol for sale in the United States and that this product is intended to mitigate, prevent, treat, diagnose, or cure COVID-191 in people. Based on our review, this product is an unapproved new drug sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. ? 355(a). Furthermore, this product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. ? 352. The introduction or delivery for introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. ? 331(a) and (d).
Some examples of the claims on your website, https://nasitrol.com/science/, that establish the intended use of your product and misleadingly represents it as safe and/or effective for the treatment or prevention of COVID-19 include:
"In vitro study of Iota carrageenan in SARS-CoV-2 . . . This study performed at the University of Tennessee provides evidence of the inhibitory effect of Iota Carrageenan on the propagation of SARS-CoV-2 in a call [sic] based assay."
"A Nasitrol clinical trial ICU hospital personnel exposed to SARS-CoV-2 . . . An independent, double-blinded, placebo controlled multicenter clinical trial providing evidence of the protective effect of Nasitrol in doctors and nurses highly exposed to SARS-CoV-2 (personnel dedicated to the COVID-19 ICU) during a period of one month."
Warning letter issued to: Varigard, LLC
MARCS-CMS 616757 -- DECEMBER 29, 2021
Product: Drugs
WARNING LETTER
Date: December 29, 2021
RE: Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your websites at the Internet addresses, https://www.varigard.com/ and https://shop.varigard.com/ on August 11, 2021. We also reviewed your social media websites at Internet addresses, https://twitter.com/varigard and https://www.facebook.com/varigard/, where you direct consumers to your website, https://www.varigard.com/ to purchase your products.
The FDA has observed that your websites offer alcohol-based consumer topical antiseptic products1 for sale in the United States and that the products are intended to mitigate, prevent, treat, diagnose, or cure COVID-192 and other serious infections in people. Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Furthermore, these products are misbranded drugs under sections 502(a) and (ee) of the FD&C Act, 21 U.S.C. 352(a) and (ee). The introduction or delivery for introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. 331(a) and (d). These violations are described in more detail below.
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named "severe acute respiratory syndrome coronavirus 2" (SARS-CoV-2). The disease caused by the virus has been named "Coronavirus Disease 2019" (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.3 In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19 that has been extended.4 Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 or other conditions.
Some examples of the claims on your product labels and websites that establish the intended use (as defined in 21 CFR 201.128) of your products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 and other serious infections include, but may not be limited to, the following:
"LAB TESTS PROVE VARIGARD TRAPS AND KILLS COVID-19" [from the product labels for Varigard Hand Sanitizing Lotion]
"Varigard? Formulas Provide the Longest Lasting Personal and Surface Protection Against Deadly Pathogens including COVID-19." [from your website https://www.varigard.com/]
"Varigard...2 Hours of protection per use...Proven to kill actual COVID-19 (SARS-CoV-2)" [from your website https://www.varigard.com/]
"Instead of relying on alcohol alone, our products use patented organic polymers designed to prevent germs from spreading through contact long after application.
For more information about health scams and fraudulent Coronavirus disease (COVID-19) products, please visit the FDA website.
Fraudulent Coronavirus Disease (COVID-19) Products
Health fraud scams are everywhere and the FDA has been monitoring scams associated with COVID-19 products. To help combat these scams, the U.S. Food and Drug Administration is issuing warning letters to firms for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure coronavirus disease 2019 (COVID-19).They are actively monitoring for any firms marketing products with fraudulent COVID-19 prevention and treatment claims.
The FDA is exercising its authority to protect consumers from firms selling unapproved products and making false or misleading claims, including, by pursuing warning letters, seizures, injunctions or criminal prosecutions against products and firms or individuals that violate the law.
Below are some of the recent warning letters the FDA has sent out to companies.
Warning letter issued to: Amcyte Pharma, Inc.
MARCS-CMS 623474 -- JANUARY 03, 2022
Product: Drugs
WARNING LETTER
Date: January 3, 2022
RE: Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://nasitrol.com/ on December 20, 2021. The FDA has observed that your website offers Nasitrol for sale in the United States and that this product is intended to mitigate, prevent, treat, diagnose, or cure COVID-191 in people. Based on our review, this product is an unapproved new drug sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. ? 355(a). Furthermore, this product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. ? 352. The introduction or delivery for introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. ? 331(a) and (d).
Some examples of the claims on your website, https://nasitrol.com/science/, that establish the intended use of your product and misleadingly represents it as safe and/or effective for the treatment or prevention of COVID-19 include:
"In vitro study of Iota carrageenan in SARS-CoV-2 . . . This study performed at the University of Tennessee provides evidence of the inhibitory effect of Iota Carrageenan on the propagation of SARS-CoV-2 in a call [sic] based assay."
"A Nasitrol clinical trial ICU hospital personnel exposed to SARS-CoV-2 . . . An independent, double-blinded, placebo controlled multicenter clinical trial providing evidence of the protective effect of Nasitrol in doctors and nurses highly exposed to SARS-CoV-2 (personnel dedicated to the COVID-19 ICU) during a period of one month."
Warning letter issued to: Varigard, LLC
MARCS-CMS 616757 -- DECEMBER 29, 2021
Product: Drugs
WARNING LETTER
Date: December 29, 2021
RE: Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your websites at the Internet addresses, https://www.varigard.com/ and https://shop.varigard.com/ on August 11, 2021. We also reviewed your social media websites at Internet addresses, https://twitter.com/varigard and https://www.facebook.com/varigard/, where you direct consumers to your website, https://www.varigard.com/ to purchase your products.
The FDA has observed that your websites offer alcohol-based consumer topical antiseptic products1 for sale in the United States and that the products are intended to mitigate, prevent, treat, diagnose, or cure COVID-192 and other serious infections in people. Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Furthermore, these products are misbranded drugs under sections 502(a) and (ee) of the FD&C Act, 21 U.S.C. 352(a) and (ee). The introduction or delivery for introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. 331(a) and (d). These violations are described in more detail below.
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named "severe acute respiratory syndrome coronavirus 2" (SARS-CoV-2). The disease caused by the virus has been named "Coronavirus Disease 2019" (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.3 In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19 that has been extended.4 Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 or other conditions.
Some examples of the claims on your product labels and websites that establish the intended use (as defined in 21 CFR 201.128) of your products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 and other serious infections include, but may not be limited to, the following:
"LAB TESTS PROVE VARIGARD TRAPS AND KILLS COVID-19" [from the product labels for Varigard Hand Sanitizing Lotion]
"Varigard? Formulas Provide the Longest Lasting Personal and Surface Protection Against Deadly Pathogens including COVID-19." [from your website https://www.varigard.com/]
"Varigard...2 Hours of protection per use...Proven to kill actual COVID-19 (SARS-CoV-2)" [from your website https://www.varigard.com/]
"Instead of relying on alcohol alone, our products use patented organic polymers designed to prevent germs from spreading through contact long after application.
For more information about health scams and fraudulent Coronavirus disease (COVID-19) products, please visit the FDA website.