FDA warning letter · Drugs

Functional Remedies, LLC D/B/A Synchronicity Hemp Oil

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

your website offers Full-Spectrum Hemp Oil and 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

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

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

Passage 4

Hemp Oil has been shown to possibly reduce viral inflammation, known as a cytokines storm, which can be detrimental and even deadly to a person suffering from a viral infection, such as COVID-19.

Passage 5

Cannabinoids may decrease the number of receptors available to the virus giving your body more of a chance to fight it.