Mundo Natural Inc – FDA Warning Letter, Apr 22, 2014

On April 22, 2014, the FDA issued a Warning Letter to Mundo Natural Inc. after reviewing their website, www.mundonatural.tv, in March 2014. The FDA determined that the products "Neuro AD," "Stop Diabetes," "Stop High Blood Pressure," "Moringa 7," and "Purpurea Echinacea" 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 "Neuro AD" minimizing depression symptoms, "Stop Diabetes" reducing high blood sugar, "Stop High Blood Pressure" regulating blood pressure, "Purpurea Echinacea" fighting colds and infections, and "Moringa 7" combating insomnia, joint pain, asthma, and diabetes, establish the products' intent for use in the cure, mitigation, treatment, or prevention of disease. The product names "Stop Diabetes" and "Stop High Blood Pressure" are also considered disease claims.

These products are deemed "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 or delivering new drugs