For Earth, Inc. – FDA Warning Letter, Aug 31, 2011

On August 19, 2011, the FDA issued a Warning Letter to For Earth, Inc., regarding its MiGenetics products (African Origin, Asian Origin, Hispanic Origin, and European Origin). The FDA reviewed the company's website (www.migenetics.com) in August 2011 and determined that the products are promoted for conditions that cause them to be unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)].

The claims on the website, including those for specific ingredients and testimonials, establish that the products are intended for use in the cure, mitigation, treatment, or prevention of disease. Examples of claims cited include zinc for sickle cell anemia, vitamin D for cancer and osteoporosis, amaranth for cancer and heart disease, brown seaweed for obesity and tumors, graviola for cancer, chromium for diabetes and hypertension, selenium for cancer and inflammatory diseases, and various vitamins for heart disease, Alzheimer's, and infections. Testimonials also claimed benefits for heart conditions, cholesterol, asthma, and diabetes.

Since these products are not generally recognized as safe and effective for these uses, they are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p