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

Source: https://www.keypedia.com/records/warning_letter/new-dawn-nutrition-inc/608cae0d-d651-4c7a-b8ed-98b958c52aeb

> FDA WARNING_LETTER for New Dawn Nutrition, Inc. on December 30, 2014. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: New Dawn Nutrition, Inc.
- Inspection Date: 2014-12-30
- Product Type: Food
- Office Name: Kansas City District Office
- Summary: 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

## Related Officers

- [Division Director](https://www.keypedia.com/people/cheryl-a-bigham/10eee053-f062-4bcf-8e0f-2cd83f4928bf)

Company: https://www.keypedia.com/companies/new-dawn-nutrition-inc/89cb36c4-ccb3-4c90-a736-e7a6049815ac

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79