FDA WARNING_LETTER - Daniel Chapter One Inc

The FDA issued a Warning Letter to Daniel Chapter One Inc. on August 15, 2008, following a review of their websites (www.danielchapterone.com, dc1pages.com, and dc1store.com). The FDA determined that the products "7 Herb™ Formula," "Apple Pectin Plus," and "CoQ10" 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 therapeutic claims, including descriptions of ingredients and testimonials, establish these products as drugs intended for the cure, mitigation, treatment, or prevention of disease. Examples of claims cited include "Burdock Root, used in Ayurvedic and Chinese medicine to treat cancer," "Sheep Sorrel is a traditional folk remedy for cancer," and testimonials describing tumor shrinkage and cancer remission. "Apple Pectin Plus" was claimed to "help reduce the risk of colon, breast and prostate cancer," and "CoQ10" was linked to treating "heart disease, heart failure, hypertension, muscular dystrophy, cancer... diabetes, obesity, periodontal disease."

These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because