FDA WARNING_LETTER - Rowpar Pharmaceuticals - December 07, 2020

On December 18, 2020, the FDA and FTC issued a Warning Letter to the company operating www.closys.com, www.facebook.com/ClosSYS/, and www.twitter.com/closys. The agencies reviewed these websites on October 22, 2020, and December 7, 2020.

The letter states that CloSYS Oral Spray, CloSYS Non-Irritating RINSE UN-flavored for ULTRA SENSITIVE Mouths, and CloSYS Non-Irritating RINSE Mildly Flavored for SENSITIVE Mouths are offered for sale with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. The FDA determined these products are unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and are misbranded drugs under section 502 (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)).

The letter cites the public health emergency and national emergency declarations related to COVID-19 as context for urgent FDA action. The company is requested to immediately cease selling these unapproved and