DMBA is labeled as a dietary ingredient in some products marketed as dietary supplements. However, the FDA is not aware of any information demonstrating that DMBA was lawfully marketed as a dietary ingredient in the United States before October 15, 1994. As a result, for dietary supplements that contain DMBA to be lawfully marketed, one of the following must apply:
- the product containing the dietary ingredient must contain only dietary ingredients that have been present in the food supply as an article used in food in a form in which the food has not been chemically altered, or
- there must be a history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended in the product labeling, will reasonably be expected to be safe; and prior to bringing the products to market, the manufacturer or distributor must notify FDA of the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably expected to be safe.
Because neither of these conditions has been met by those marketing products that contain or are labeled as containing DMBA as a dietary ingredient, the FDA considers these dietary supplements to be adulterated.
DMBA is also known as:
- 2-Amino-4-Methylpentane Citrate
- 4-Amino-2-Methylpentane Citrate
- 4-Amino Methylpentane Citrate
- AMP Citrate
- 4-AMP Citrate