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

Record Details

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-

Company: Ageless Global, LLC
Inspection Date: January 19, 2021
Product Type: Drugs
Office: Center for Drug Evaluation and Research
People: Donald D. Ashley (Director)
Serena Viswanathan (Associate Director)

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ID · b7dab831-8cd8-4669-a61e-3482458f7f25

Violation Codes4

21.U.S.C. 355(a)21 U.S.C. 35221 U.S.C. 331(d)21 U.S.C. 331(a)

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