# FDA WARNING_LETTER - Ionogen, LLC - June 23, 2020

Source: https://www.keypedia.com/records/warning_letter/ionogen-llc/4e700ca2-1c26-4dd6-a694-6de1bda0565a

> FDA WARNING_LETTER for Ionogen, LLC on June 23, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Ionogen, LLC
- Inspection Date: 2020-06-23
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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.

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)

Company: https://www.keypedia.com/companies/ionogen-llc/91f7340d-eb54-4f8d-81a0-c1819eea4150

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c