FDA WARNING_LETTER - New Dawn Nutrition, Inc. - December 30, 2014

The FDA issued a Warning Letter to New Dawn Nutrition, Inc. following inspections from December 16-30, 2014, at their Omaha and Papillion facilities. The inspection revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Adulterated Products (DMBA):** "NDN Ares Battle Ready Pre Workout" and "NDN Ares Black" products were found to contain dimethylbutylamine (DMBA), despite labels declaring 1,3 Dimethylamylamine. DMBA is considered a new dietary ingredient for which no safety notification was submitted, nor is there evidence of its safety or prior marketing as a dietary ingredient before October 15, 1994. Synthetically produced DMBA is also not considered a dietary ingredient under the Act. 2. **Dietary Supplement CGMP Violations:** As an own-label distributor, New Dawn Nutrition is responsible for CGMP compliance. Violations included failure to establish specifications for incoming products (21 CFR 111.70(f)) and finished product packaging/labeling (21 CFR 111.70(g)), lack of written procedures for quality control (21 CFR 111.103), failure to identify quality control personnel (21 CFR 111.12(b)), inadequate lot tracing (21 CFR 111.16