What happened
Original notice title
Total Body Nutrition 9/28/17
From the archived source record
During the inspection, our investigators found significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, and Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause the dietary supplements manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that the dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. We provide comments to your response immediately following the violations addressed below. Our analysis of these samples found that they contained 13-dimethylamylamine (DMAA), an unsafe food additive under section 409(a) of the Act [21 U.S.C. § 348(a)]. Therefore, 1,3D Nox Xtrim Green Apple, Adrenal Pump, Shredder, and Tummy Tuck are adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)]. FDA has also determined that your 1,3D Nox Xtrim Green Apple, Tummy Tuck, Adrenal Pump, Omega-3 Fish Oil, and Shredder products are misbranded dietary supplements under Section 403 of the Act [21 U.S.C. 343], in that their labels fail to include required information or contain false or misleading information. Adulterated Dietary Supplements: Unsafe Food Additive During your inspection , Investigators collected samples of the following products: 1,3D Nox Xtrim Green Apple, (b)(4) Adrenal Pump, (b)(4) Shredder, (b)(4) Tummy Tuck, (b)(4) The products were analyzed by the FDA for the presence of DMAA. Any food additive that has not been approved for its intended use in food is deemed to be unsafe and causes the food to be adulterated under section 402(a)(2)(C)(i) of the Act.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 7c63f8500ae0
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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