FDA WARNING_LETTER - Purecbd.net - February 28, 2015

The FDA issued a Warning Letter to Natural Organic Solutions, specifically addressing Joe Cain, regarding products claiming to contain cannabidiol (CBD) sold on www.purecbd.net and www.etsy.com/shop/PureCBD. The FDA reviewed these websites and accompanying literature in February 2015.

The FDA determined that products like "CBD Hemp Oil Treatment," "Hemp CBD (Cannabidiol) Extract Capsules," "CBD Extract Capsules Anti Anxiety Formula," and "High CBD Healing Salve" are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. This is due to claims suggesting their use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Examples of such claims include treating cancer, MS, resistant bacteria, neuroinflammation, schizophrenia, preventing panic/anxiety attacks, and healing third-degree burns.

These products are also deemed "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their intended uses. Introducing new drugs into interstate commerce without prior FDA approval violates section 505(a) and 301(d) of