FDA WARNING_LETTER - Road to Healing - April 28, 2008

On April 28, 2008, the FDA reviewed Road to Healing's website, roadtohealine.com, and determined that the products "Cat's Claw," "Chlora Plasma," "Melatonin," "Native Herbal Tea Rene Caisse's Original Formula," and "Red Clover Plus" 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 USC 321(g)(1)(B)]. The website's therapeutic claims, including those for cancer, AIDS, arthritis, and other diseases, establish these products as drugs intended for cure, mitigation, treatment, or prevention of disease, violating the Act.

Examples of claims include "Cat's Claw" preventing malignant cells in cancer, "Chlora Plasma" reducing cancer tumors and combating viral infections, "Melatonin" destroying disease-causing substances and treating various cancers, "Native Herbal Tea" treating all forms of cancer, and "Red Clover Plus" fighting cancerous growths and aiding skin inflammations. Personal testimonials also claimed recovery from brain tumors and skin cancer using these products. Meta tags like "anti cancer treatment" further supported these claims.

These products are not generally recognized as safe and effective for their promoted uses, making them "new drugs" under Section 201(p) of the Act [21 USC 321