Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1your 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.
Passage 2these 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).
Passage 3these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352.
Passage 4your 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.