Ancient Formulas Marketing Draws FDA Warning

LENEXA, Kan.FDAs Kansas City District office issued a warning letter to Wichita, Kan.-based Ancient Formulas in early February, following an October 2010 inspection of the companys facility by FDA. While FDA noted the company did send an adequate response to certain deviations from the federal dietary supplement cGMPs (current good manufacturing practices) noted in a 483 inspection report, it had concerns regarding the marketing and distribution of certain products.

Specifically, FDA stated the therapeutic claims used in product labels and marketing for several items positions them as unapproved new and misbranded drugs, not dietary supplements. For example, the product names and statements of identity for CHOLESTOLESS, H.P. #1 and H.P. #2 (Hyper-ten-sion), PROST-AID and ARTHRO-CARE suggests the intended uses are to treat disease states such as high cholesterol, hypertension, prostate disorders and arthritis, respectively. Other product labels and marketing materials cited the ability of ingredients in the products to address disease states such as anemia, type II diabetes, urinary tract infections and depression. One product, DYABET, was also called out for containing ingredients not declared on the label (specifically, the capsule ingredients), and the lack of inclusion of a supplement facts panel.