FDA WARNING_LETTER - Plant Cures Incorporated

On May 27, 2008, the FDA issued a Warning Letter to Christopher Gussa of Plant Cures Incorporated, also known as The Herbal Healing Place, Desert Dragon Healing Center, and Desert Dragon Herbs. The letter states that a review of the website www.plantcures.com revealed that the products "Bloodroot Extract," "Ojibwa Tea or "Essiac,"" and "C-Cell 4 Destroyer" 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)].

The FDA cited therapeutic claims on the website, including suggestions that Bloodroot could be developed as a cancer drug, claims of Ojibwa Tea curing cancer, and "C-Cell 4 Destroyer" providing defense against cancer. These claims, supplemented by metatags like "cancer" and "Herbal healing cures for . . . cancer," establish the products as drugs intended for disease cure, mitigation, treatment, or prevention.

The products are 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 claimed uses. Marketing these new drugs without prior FDA approval, as required by