FDA WARNING_LETTER - cbd life holdings llc - November 30, 2014

The FDA issued a Warning Letter to CBD Life Holdings LLC dba Ultra CBD after reviewing their website (ultracbd.com) and product literature in November 2014. The FDA determined that the product "Ultra CBD" is promoted for conditions that cause it to be an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act.

The letter cites therapeutic claims on the website, promotional literature, and Facebook page that establish the product's intent for use in the cure, mitigation, treatment, or prevention of disease. Examples of claims include "Antipsychotic – combats psychosis disorders," "Anti-tumoral – combats tumor and cancer cells," "Treats rheumatoid arthritis," and "CBD Protective Against Ebola Virus." The letter also notes that scientific publications cited commercially on the website, such as "The Inhibitory Effects of Cannabidiol on Systemic Malignant Tumors," serve as evidence of the product's intended drug use.

Since Ultra CBD is not generally recognized as safe and effective for these uses, it is considered a "new drug" requiring prior FDA approval, which it lacks, violating 21 U.S.C. § 355(a) and § 331(d). Furthermore, the product is misbranded under 21 U.S.C. § 352(f)(1) because it is offered for conditions not amenable to self-diagnosis and treatment