# FDA WARNING_LETTER - Viraldine, LLC - March 01, 2022

Source: https://www.keypedia.com/records/warning_letter/viraldine-llc/16937018-40d1-46fc-9f2a-ade4ca0a3435

> FDA WARNING_LETTER for Viraldine, LLC on March 01, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Viraldine, LLC
- Inspection Date: 2022-03-01
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On March 7, 2022, the FDA and FTC issued a Warning Letter to the company operating viraldine.com for selling unapproved and misbranded drug products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. The FDA reviewed the website on December 21, 2021, and March 1, 2022.

The products, including "1.5% POVIDONE IODINE USP ANTISEPTIC NASAL SPRAY," "1% POVIDONE IODINE USP ANTISEPTIC NASAL SPRAY," ".5% POVIDONE IODINE USP ANTISEPTIC NASAL SPRAY," and "1.5% POVIDONE IODINE USP ANTISEPTIC THROAT SPRAY," are considered "new drugs" under section 201(p) of the FD&C Act because they are not generally recognized as safe and effective (GRASE) for their labeled uses. They are marketed in violation of sections 505(a) and 301(d) of the FD&C Act, as no FDA-approved applications are in effect.

The products are also misbranded under section 502(ee) of the FD&C Act because they are nonprescription drugs subject to section 505G but do not comply with its marketing requirements and are not FDA-approved. Specific violations

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Associate Director](https://www.keypedia.com/people/serena-viswanathan/7d1b292d-1f22-42ff-8452-0bc9673b8326)

Company: https://www.keypedia.com/companies/viraldine-llc/0432ffc6-683b-4513-b4e4-1035aa140e5f

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