World Nutrition, Inc. – FDA Warning Letter, Oct 27, 2020

The FDA issued a Warning Letter to World Nutrition, Inc. on October 27, 2020, following a September 2020 review of their website, www.worldnutrition.net. The FDA determined that ten products—Vitälzȳm Extra Strength, Vitälzȳm Systemic and Digestive Formula, Vitälzȳm Cardio, Vitälzȳm Digest, Vitälzȳm Xe, Nättovīta™, Ketsumeisei™, Probiotic 10/50 by Vitälzȳm, Flexera™, and PuraCell™—are marketed with claims that establish them as 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)(B)].

The violations stem from numerous claims on the company's website, including product pages, articles, videos, and testimonials, which suggest the products are intended for the cure, mitigation, treatment, or prevention of diseases. Examples include claims to "reduce chronic inflammation," "regulate an over-active or weakened immune system," "remove excess fibrin and plaque," "reduce the levels of C-Reactive Protein," "dissolve existing blood clots," "combat chronic inflammation," "improve fatty liver condition," "lower cholesterol levels," "regulate diarrhea,"