FDA WARNING_LETTER - Nutreglo Products, Inc.

On February 26, 2015, the FDA issued a Warning Letter to Nutreglo Products Inc., specifically addressing Ms. Erma Melvin, following a December 2014 review of their website, http://nutregloproducts.com. The FDA determined that the products Sour Sop (Guanabana) Graviola, Moringa (Oleifera), and Guinea Hen weed (Anamu) petiveria 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 on the website, such as "Anti cancer properties," "kill certain types of Liver, Colon cancer, Ovarian cancer, breast cancer cells," "cure various kinds of diseases," and aiding with "Type 2 Diabetes, High Blood pressure, Arthritis, Asthma, Heart diseases, Breast Cancer," establish the products' intended use in the cure, mitigation, treatment, or prevention of disease.

These products are considered "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. Introducing new drugs into interstate commerce without prior FDA approval violates section 505(a