# FDA WARNING_LETTER - Ageless Global, LLC - January 19, 2021

Source: https://www.globalkeysolutions.net/records/warning_letter/ageless-global-llc/b7dab831-8cd8-4669-a61e-3482458f7f25

> FDA WARNING_LETTER for Ageless Global, LLC on January 19, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Ageless Global, LLC
- Inspection Date: 2021-01-19
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On March 1, 2021, the FDA and FTC issued a Warning Letter to Ageless Global Lab regarding the sale of unapproved and misbranded products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. The agencies reviewed websites (agelessgloballab.com, cvk365.com, covid19mdhub.com, lionsfuel.com, mdimmunespray.com, mdmouthspray.com) and social media on January 18-19, 2021.

The products "Immunoral," "Immune Plus," "MD Immune Support Spray," and "MD CVK-365 Mouth Spray" are deemed unapproved new drugs under section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) and misbranded under section 502 (21 U.S.C. § 352). The letter cites claims on their websites and social media establishing intended use for COVID-19. Additionally, Immunoral is misbranded due to false claims of HHS approval as an IRB study, citing an expired IRB registration (IORG001078, expired April 14, 2014).

The letter demands immediate cessation of sales of these products. Ageless Global Lab must email COVID-19-Task-

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/ageless-global-llc/bddc2f77-1927-4374-85d8-45a29924df5c

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