FDA WARNING_LETTER - Iowa Select Herbs, L.L.C. - August 21, 2013

On August 14-21, 2013, an FDA inspection of Iowa Select Herbs, LLC, and a March 2014 review of their website, revealed serious violations of the Federal Food, Drug, and Cosmetic Act. The company's Flax Seed, Holy Basil, Papaya Leaf Extract, and Ginkgo Leaf Extract products are promoted with therapeutic claims (e.g., preventing cancer, treating diabetes, reducing tumor growth, treating Alzheimer's), making them unapproved new drugs under section 201(g)(1)(B) and 201(p)(1) of the Act. These products are also misbranded under section 502(f)(1) because they lack adequate directions for layperson use for conditions not amenable to self-diagnosis.

Furthermore, all dietary supplement products are adulterated under section 402(g)(1) due to numerous Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111). These include failure to establish specifications for components, in-process materials, labels, and packaging (21 CFR 111.70); failure to verify the identity of dietary ingredients (21 CFR 111.75(a)(1)(i)); failure to confirm identity of other components (21 CFR 111.75(a)(2)); failure to collect representative samples (21 CFR 11