FDA WARNING_LETTER - Ancient Formulas Inc. - October 21, 2010

An FDA inspection of Ancient Formulas Inc. (Wichita, KS) from October 18-21, 2010, revealed significant violations concerning the marketing and distribution of various products. The firm's products, including LEUKO-MAX, DYABET, CHOLESTOLESS, H.P. #1/2, RE. #3, CRAN-URSI PLUS, PROST-AID, EYE-SEE, ARTHRO-CARE, MONOLAURIN, HAPPY WATER, and CURCUMIN-C3, are promoted with therapeutic claims (e.g., treating infections, diabetes, high cholesterol, hypertension, arthritis, cancer prevention). These claims establish the products as unapproved new drugs under sections 201(g)(1) and 201(p) of the Federal Food, Drug, and Cosmetic Act, requiring prior FDA approval per section 505(a). Additionally, the "DYABET" product was found to be a misbranded dietary supplement under section 403 of the Act. Specifically, it contained undeclared ingredients (e.g., capsule gelatin), violating 403(i)(2) and 21 CFR 101.4. Its labeling also failed to comply with nutrition information presentation requirements, specifically not presenting a "Supplement Facts" panel as mandated by 403(q)(5)(F) and 21 CFR 101.36(e)(1). The inspection also identified several deviations from dietary supplement Good Manufacturing Practice (GMP) requirements under 21 CFR Part 111, which the firm addressed in a November 2, 2010 response. The FDA requires prompt corrective action for all violations within 15 working days, with documentation. Failure to comply may lead to enforcement actions, including product seizure and injunction.