Ageless Global, LLC
4 extracted findings · 1 model-assigned issue type
FDA source excerpt, selected passage
your websites offer the products “Immunoral,” “Immune Plus,” “MD Immune Support Spray,” and “MD CVK-365 Mouth Spray” for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19[1] in people.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
The firm markets four products with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.
Supporting FDA text
Source excerpt · automated text-match checkyour websites offer the products “Immunoral,” “Immune Plus,” “MD Immune Support Spray,” and “MD CVK-365 Mouth Spray” for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19[1] in people.
The products are unapproved new drugs under FD&C Act section 505(a).
Supporting FDA text
Source excerpt · automated text-match checkthese products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a).
The products are misbranded drugs under FD&C Act section 502.
Supporting FDA text
Source excerpt · automated text-match checkthese products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352.
The firm falsely claims HHS approved an IRB study and lists an expired IRB registration.
Supporting FDA text
Source excerpt · automated text-match checkyour firm’s website, product label and/or social media pages falsely suggest that the “Department of Health and Human Services (HHS) approved as an IRB study” using Immunoral. However, we note that the HHS does not approve studies and that the registration for the IRB that you list “IORG001078,” expired on April 14, 2014.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
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Source passage selected by the model
Source passage selected by the model
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Send email to COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours describing corrective steps
- Send email to FTC's Richard Cleland at rcleland@ftc.gov within 48 hours describing actions
- Review websites, product labels, and promotional materials to stop misleading COVID-19 claims