TruVision Health LLC – FDA Warning Letter

On September 21, 2015, the FDA issued a Warning Letter to TruVision Health LLC regarding their product, tru Weight & Energy TM. The letter states that the product is labeled and/or offered for sale as a dietary supplement and appears to declare DMBA (1,3-Dimethylbutylamine) and Bitter Orange Extract (synephrine 30%) as dietary ingredients.

The FDA asserts that DMBA is a "new dietary ingredient" for which a notification is required under section 413(a)(2) of the Act and 21 CFR 190.6. To the best of FDA's knowledge, there is no information demonstrating that DMBA was lawfully marketed as a dietary ingredient in the U.S. before October 15, 1994, nor that it has been present in the food supply as an unchemically altered food. The required notification has not been submitted, rendering the product adulterated under sections 402(f)(1)(B) and 413(a) of the Act. Furthermore, the FDA states there is no evidence establishing DMBA's safety, and synthetically produced DMBA is not considered a dietary ingredient under section 201(ff)(1) of the Act.

Regarding Bitter Orange Extract (synephrine 30%), the FDA states that while bitter orange is a dietary ingredient, the levels of synephrine