Natural Guidance, LLC – FDA Warning Letter, Jul 31, 2011

On July 15, 2011, the FDA issued a Warning Letter to Natural Guidance, LLC and Ancient Naturals, LLC, owned by Mr. Mitchell A. Propster, following a review of their websites, www.naturalguidance.com and www.salba.com, in July 2011.

The FDA determined that Salba® brand products are promoted for conditions that classify them as unapproved new drugs under the Federal Food, Drug, and Cosmetic Act (the Act). Therapeutic claims on the websites, such as "Prevents Blood Sugar Imbalance," "management of diabetes," "lowering blood pressure, blood glucose," and testimonials related to diabetes control, arthritis, and depression, establish the products as drugs intended for disease treatment or prevention. Since these products are not generally recognized as safe and effective for these uses, they are considered "new drugs" requiring an approved New Drug Application (NDA) under section 505(a) of the Act. Furthermore, the products are misbranded under section 502(f)(1) of the Act because they lack adequate directions for use for conditions not amenable to self-diagnosis and treatment by laypersons.

Additionally, the Salba products are misbranded under section 403 of the Act due to unauthorized nutrient content claims. Examples include: 1. Using "richest sources of... magnesium, calcium, iron" for Salba Whole Food Bars when the