FDA warning letter · Drugs

Medical Mikes, Inc.

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

the FDA has observed that your website offers cannabidiol (CBD) products 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 2

Based on our review, these 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 3

Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352.

Passage 4

Boosts Immune System: This 2020 review of existing research concluded that CBD could control immune responses to cytokines, chemokines, and regulatory cell induction, creating a potential use case for Covid treatment by preventing Cytokine Storms–the condition that transforms standard cases into life-threatening scenarios.

Passage 5

Researchers Recommend CBD-Based Clinical Trials for Covid-19 Prevention

Passage 6

Lab Research Says CBDa and CBGa Can Stop Covid-19