TruVision Health recalls products due to possible health risk

EDITOR'S NOTE

TruVision Health LLC has recalled multiple dietary supplement products because they contain the substances hordenine and/or DMHA. Hordenine has been the subject of past FDA warning letters as an alleged unapproved dietary ingredient. FDA has stated that it considers DMHA to be a substance that does not meet the statutory definition of a dietary ingredient and is an unsafe food additive.

Recalled products were packaged as capsules in blister packs and cardboard cartons, or as stick packs in 30 count bags, and distributed throughout the US and several other countries.

TruVision Health LLC is recalling the dietary supplement products listed below because they contain the unapproved dietary ingredients hordenine and/or octodrine/DMHA (1,5-Dimethylhexylamine).

Hordenine is possibly unsafe when taken by mouth and might cause stimulating side effects such as rapid heart rate, high blood pressure, jitteriness, nervousness, nausea, vomiting or insomnia. These adverse events are more likely to occur in sensitive sub-populations of people such as pregnant women and consumers with cardiovascular disease. Currently, hordenine is not an approved dietary ingredient in dietary supplements.

Octodrine or DMHA (1,5-Dimethylhexylamine) appears to be similar to another stimulant called dimethylamylamine (DMAA), which was removed from the market in certain countries due to safety concerns. In animal studies, octodrine has been found to increase heart rate, myocardial contractility, and pain threshold. Since no data exists on its metabolic pathway in humans, the use of octodrine during exercise is potentially dangerous. DMHA is considered to be a substance that does not meet the statutory definition of a dietary ingredient and is an unsafe food additive.

You should stop using the recalled product(s) immediately. Some consumers of these products have reported experiencing chest pain, chills, diarrhea, dizziness/lightheadedness, fatigue, headache, high blood pressure, high heart rate, jitters, nausea, nervousness, rash, stomach pain or upset, sweating and vomiting.