Happi Staff12.31.20
Rowpar Pharmaceuticals, Scottsdale, AZ, has been issued a warning letter following after the FDA and Federal Trade Commission (FTC) reviewed its website on October 22, 2020, and December 7, 2020, respectively as well as on its Facebook and Twitter pages.
The FDA has observed that your website offers CloSYS Oral Spray, CloSYS Non-Irritating Rinse Un-flavored for Ultra Sensitive Mouths, and CloSYS Non-Irritating Rinse Mildly Flavored for Sensitive Mouths products for sale in the US and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 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 section 502 of the FD&C Act, 21 U.S.C. § 352.
Some examples of the claims on your websites that establish the intended use of your products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 included “Lab Tests: CloSYS Oral Rinse Eliminated COVID-19 Virus up to 98.4% in 30 seconds” from an August 31, 2020 post on Facebook and “Lab Test: CloSYS Ultra Sensitive Rinse, CloSYS Sensitive Rinse, & CloSYS Oral Spray Reduced COVID-19 virus up to 98.4% in 30 seconds. … As CloSYS is an excellent antimicrobial for oral care we initiated lab tests to understand if our patented formula might be helpful reducing the viral load of saliva thus potentially lowering the transmission of the COVID-19 virus (not to be confused with the more common less harmful human coronaviruses)” which was made on its website [from your website www.closys.com].
The full list of claims can be found here.
FDA said the company should take immediate action to correct the violations.
The FDA has observed that your website offers CloSYS Oral Spray, CloSYS Non-Irritating Rinse Un-flavored for Ultra Sensitive Mouths, and CloSYS Non-Irritating Rinse Mildly Flavored for Sensitive Mouths products for sale in the US and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 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 section 502 of the FD&C Act, 21 U.S.C. § 352.
Some examples of the claims on your websites that establish the intended use of your products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 included “Lab Tests: CloSYS Oral Rinse Eliminated COVID-19 Virus up to 98.4% in 30 seconds” from an August 31, 2020 post on Facebook and “Lab Test: CloSYS Ultra Sensitive Rinse, CloSYS Sensitive Rinse, & CloSYS Oral Spray Reduced COVID-19 virus up to 98.4% in 30 seconds. … As CloSYS is an excellent antimicrobial for oral care we initiated lab tests to understand if our patented formula might be helpful reducing the viral load of saliva thus potentially lowering the transmission of the COVID-19 virus (not to be confused with the more common less harmful human coronaviruses)” which was made on its website [from your website www.closys.com].
The full list of claims can be found here.
FDA said the company should take immediate action to correct the violations.
