BioAnue Laboratories, Inc. – FDA Warning Letter, Feb 29, 2012

The FDA reviewed BioAnue Laboratories, Inc.'s websites (www.tumorx.com, www.cancerx.org, www.hopewelltechnologieslimited.com, and www.vmhe.com) in February 2012 and determined that their "Bovine Cartilage," "TumorX BioEnerGenics Co-Enzyme -Q1O," "TumorX Cardio Clean," "Diabetic Mender," "TumorX Formula CX," and "Stroke Mender" products are promoted as drugs. The therapeutic claims, including implied claims in product names, on the websites and in metatags, establish these products are intended for the cure, mitigation, treatment, or prevention of diseases such as various cancers, HIV/AIDS, heart disease, diabetes, and stroke.

These products are considered "new drugs" under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their promoted uses and lack prior FDA approval as required by section 505(a) [21 U.S.C. § 355(a)]. Furthermore, since the conditions addressed are not amenable to self-diagnosis and treatment, adequate directions for use cannot be provided for a layperson, rendering the products misbranded under section 502