FDA WARNING_LETTER - Iotech International, LLC - March 09, 2022

On March 15, 2022, the FDA and FTC issued a Warning Letter to Iotech International for selling "ioRinse" and "ioCleanse Molecular iodine Hand Cleanser" on their website and social media, claiming they mitigate, prevent, treat, diagnose, or cure COVID-19. The FDA determined these products are unapproved new drugs under section 505(a) and misbranded drugs under section 502(ee) of the FD&C Act, violating sections 301(a) and (d).

The products are considered "new drugs" because they are not generally recognized as safe and effective (GRASE) for their intended uses, and no FDA-approved applications exist. They do not conform to OTC drug monographs or section 505G requirements for marketing without approval, as their COVID-19 claims exceed general antiseptic uses. "ioCleanse" also contains molecular iodine, an active ingredient not classified in the 1994 TFM.

Iotech International must immediately cease selling these unapproved and unauthorized COVID-19 products. Within 48 hours, they must email COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective actions and documentation, and email rcleland@ftc.gov certifying cessation of unsubstantiated claims. Failure to comply may result in legal action, including seizure, injunction, civil penalties up to