FDA WARNING_LETTER - Hemp Oil Care

The FDA issued a Warning Letter to Tigran Lalayan of Hemp Oil Care after reviewing their website, https://www.hempoilcare.com, in November 2014. The FDA determined that several products, including "Cibdex Hemp CBD Complex Drops," "Cibaderm Hemp Salve," and "Dixie Botanicals Dew Drops Hemp Oil Supplement," are promoted with claims that cause them to be unapproved and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

The website made claims such as CBD's documented capabilities as an "antipsychotic," "anti-cancer agent," "anti-diabetic," "analgesic for rheumatoid arthritis," and for treating "pancreatic cancer" and "schizophrenia." These claims establish the products' intended use for the cure, mitigation, treatment, or prevention of disease, classifying them as drugs under section 201(g)(1)(B) of the Act.

Furthermore, these products are considered "new drugs" under section 201(p) because they are not generally recognized as safe and effective for their intended uses and lack FDA approval. Introducing new drugs without prior FDA approval violates section 301(d) and 505(a) of the Act.

Additionally, the products are misbranded under section 502(f)(1) because their labeling lacks adequate directions for use by a layman, as they are intended