Total Body Nutrition FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on September 28, 2017
Executive Summary
The FDA issued a warning letter to Total Body Nutrition on September 28, 2017 citing labeling violations. Consumers who have purchased products from this company should exercise caution. The letter was issued by New York District Office.
Detailed Analysis
False Claims and Regulatory Violations
“Digestive System- … improving intestinal health and reducing inflammation assisting those with IBS or Crohn’s Disease.”
Your 1,3D Nox Xtrim Green Apple, Tummy Tuck, and Shredder product labels do not bear the correct text of the FDA disclaimer statement. These product labels also fail to bear a symbol next to each structure/function claim linking the claim to the disclaimer, as required by 21 CFR 101.93(c).
Potential Health Risks
“Heart- … helping reduce the risk of arrhythmias and sudden death by heart attack.”
“Brain – Better brain function though more efficient neurotransmitters leading to … less likelihood of depression and reduced risk of ADHD in children.”
“Immune System and Cancer – A stronger immune system, proven to be beneficial for … lowered risk of breast and prostate cancer.”
Regulatory Context
Your 1,3D Nox Xtrim Green Apple product’s batch production record collected during theinspection lists caffeine as an ingredient, but this ingredient is not declared on the product’s label in accordance with 21 CFR 101.4(g). Additionally, the Master Manufacturing Record (MMR) for 1,3D Nox Xtrim Green Apple, provided in your May 8, 2017 response, lists Malic Acid, Dextrose Anhydrous and M100 Maltrin, but these three ingredients are not declared on the product label. These ingredients were also listed on the Batch Production Record for 1,3D Nox Xtrim Green Apple(b)(4)collected during inspection of your firm from February 3, 2017 to March 31, 2017. Finally, two ingredients listed as N, N Dimethyl HCL and Beta Phenyl Ethylamine HCL on the MMR are listed on the finished product labeling as one
The Supplement Facts panel of your 1,3D Nox Xtrim Green Apple product label declares as dietary ingredients “Arginine AKG,” “Carnosyn,” “Creatine MagnaPower,” “GAKIC,” and “HICA,” but these are not the common or usual names for these dietary ingredients. In the“Other ingredients” section of Supplement Facts, the label also declares “acesulfame K,” which is not the common or usual name for that ingredient.
Your 1,3D Nox Xtrim Green Apple, Tummy Tuck, Adrenal Pump, and Shredder productlabels do not present the “other ingredients” statement outside and immediately below the supplement facts box, in accordance with 21 CFR 101.4(g).
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Total Body Nutrition?
- The FDA issued a warning letter citing labeling violations related to their products or manufacturing practices.
- Are Total Body Nutrition products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have labeling violations that may affect product safety.
- What should I do if I've used Total Body Nutrition products?
- If you have used products from Total Body Nutrition and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.
Source Document
This report is based on an official FDA warning letter. The original document is a public record.
View Original FDA Warning Letter