FDA WARNING_LETTER - Total Nutrition Inc - April 24, 2017

On August 16, 2017, the FDA issued a Warning Letter to Total Nutrition, Inc. following an inspection from March 6 to April 24, 2017. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their products adulterated. Additionally, several products were identified as unapproved new drugs and/or misbranded drugs due to therapeutic claims on their websites and labels.

Key violations include: 1. **Unapproved New Drugs/Misbranded Drugs:** Products like Aller Ease, Inflam Ease, Airway Clear, Osteo-Gest, Arth-Support, Olive Leaf Extract, Astragalus Root, Elderberry Sambucus, Tart Cherry, Tumeric Curcumin, Napro-Zyn With Tumeric, Bromelain, and Boswellia were marketed with disease treatment/prevention claims, classifying them as unapproved new drugs. Aller Ease and Airway Clear were also misbranded for lacking adequate directions for layperson use. 2. **CGMP Violations:** * Failure to establish and follow written procedures for quality control operations (21 CFR 111.103), including material review, disposition decisions, and approval/rejection of reprocessing. The firm's reliance on "input-based" Certificates of Analysis (COAs) from contract manufacturers was deemed insufficient for product