FDA WARNING_LETTER - Nutrex Research, Inc. - August 18, 2017

This FDA Warning Letter, dated April 24, 2015, addresses Nutrex Research, Inc.'s product Adipodex, labeled as a dietary supplement. The primary concern is the inclusion of 4-Amino-2-Methylpentane Citrate (DMBA) as a declared dietary ingredient.

The FDA states that DMBA is a "new dietary ingredient" requiring notification under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR 190.6. To the FDA's knowledge, DMBA was not lawfully marketed as a dietary ingredient before October 15, 1994, nor has it been present in the food supply as an unchemically altered food article. Since the required notification was not submitted, Adipodex is deemed adulterated under sections 402(f)(1)(B) and 413(a) of the Act.

Furthermore, the FDA indicates a lack of evidence establishing DMBA's safety when used as a dietary ingredient, leading to further adulteration under the same sections due to inadequate information to assure safety. The letter also notes that synthetically produced DMBA, if used, does not meet the definition of a "dietary ingredient" under section 201(ff)(1) of the Act, as it is not a vitamin, mineral, amino acid,