FDA WARNING_LETTER - Ionogen, LLC - June 23, 2020

On July 7, 2020, the FDA issued a Warning Letter to the company operating ionopure.com after reviewing their website on June 23, 2020. The FDA observed that "Ionopure Skin & Hands" was offered for sale with claims indicating its intent to mitigate, prevent, treat, diagnose, or cure COVID-19.

The FDA determined this product is an unapproved new drug, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and a misbranded drug under section 502 of the FD&C Act (21 U.S.C. § 352). Its introduction into interstate commerce is prohibited by sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)).

The letter emphasizes the public health emergency declared for COVID-19 and the FDA's urgent measures against unapproved products making COVID-19 claims. The company was instructed to immediately cease selling the unapproved and unauthorized product for COVID-19-related uses.

The company must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective actions, steps to prevent recurrence, and supporting documentation.