Posted October 18, 2017

Total Body Nutrition Warned for Banned Stimulant in Supplements

On September 28, 2017, the FDA issued a warning letter to Total Body Nutrition following a facility inspection which found some of the company's products to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.  

These violations include failure to implement quality control operations to ensure the quality of dietary supplements, as required by federal regulations.

Some of the company's products, including 1,3D Nox Xtrim Green Apple, Adrenal Pump, Shredder, and Tummy Tuck, were also found to contain DMAA, a stimulant which is not permitted in dietary supplements.

DMAA is known to narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack. It is often promoted as a stimulant, pre-workout, or weight loss ingredient, and sometimes referred to as 1,3-dimethylamylamine, methylhexanamine, or geranium extract.

Additionally, statements made about the company's Omega-3-Fish Oil and Total Estro (3,3 Diindolymethane) products were found to be drug claims. For example, the label on their Omega-3 Fish Oil supplement states "Heart- ... helping reduce the risk of arrhythmias and sudden death by heart attack," "Immune System and Cancer — A stronger immune system, proven to be beneficial for ... lowered risk of breast and prostate cancer," and "Diabetes — Fish oil enhances insulin secretion from beta cells in the pancreas, regulating blood sugar levels. DHA plays a protective role in diabetic neuropathy in all forms of diabetes." 

(See's Product Review on Fish Oil Supplements.)

See related warnings:

FDA Says DMAA Can't Be Sold as a Supplement -- Warns Sellers

FDA Warns Seller of Probiotic and Omega-3 Supplements for Manufacturing Violations

Seller of B Vitamins, Omega-3s and More Warned for Manufacturing Violations, Drug Claims

Seller of Omega-3, Ginkgo, Vision Supplements & More Warned for Drug Claims

Seller of Joint Health, Omega-3 Supplements & More Warned for Manufacturing Violations, Drug Claims

Maker of Multivitamin and Fish Oil Warned for Manufacturing Violations

To read the full warning, use the link below.