September 30, 2015 — TruVision Health LLC has received a Warning Letter about dangerous ingredients in the weight-loss supplement TruWEIGHT & Energy.
The FDA is concerned about a potent mixture of ingredients that could increase heart-rate, blood pressure, and potentially the risk of cardiovascular events.
One of the ingredients listed on the label is AMP, also known as 1,3-Dimethylbutylamine (DMBA). Earlier this year, the FDA told twelve manufacturers of DMBA-laced supplements that the ingredient is not approved for use in supplements.
The FDA took action after researchers warned that it is a chemical analogue to DMAA, a synthetic stimulant that has been linked to cardiovascular events and other side effects.
Another controversial ingredient in Tru Weight & Energy is Bitter Orange Extract. Although bitter orange (C. aurantium) is allowed in supplements, highly-concentrated extracts (synephrine 30%) are not natural and may have deadly risks. According to the FDA:
“Consumption of products containing a high dosage of bitter orange extract and synephrine could lead to a significant increase in systolic blood pressure, diastolic blood pressure, and heart rate.”
Tru Weight & Energy contains caffeine, which is a stimulant that could exacerbate negative effects of DMBA and synephrine. As evidence of possible risks, the FDA cited a health assessment (PDF) of synephrine and caffeine in weight-loss supplements.
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