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

Source: https://www.keypedia.com/records/warning_letter/iotech-international-llc/c779828e-2cfb-43f4-a505-255f5aaf378c

> FDA WARNING_LETTER for Iotech International, LLC on March 09, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Iotech International, LLC
- Inspection Date: 2022-03-09
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

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- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
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Company: https://www.keypedia.com/companies/iotech-international-llc/50cf3626-6c42-4ca8-8065-9b9e8243958b

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