DMBA is declared as a dietary ingredient on the labeling of some dietary supplements. Under existing law, a “new dietary ingredient” is a dietary ingredient that was not marketed in the United States before October 15, 1994. The FDA is not aware of any information demonstrating that DMBA was lawfully marketed as a dietary ingredient in the United States before this date. As a result, DMBA is a new dietary ingredient, and dietary supplements that contain DMBA must, among other requirements, satisfy one of the following:
- DMBA, and all other new dietary ingredients in the product, must 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 DMBA, when used under the conditions recommended or suggested in the product labeling, will reasonably be expected to be safe; and at least 75 days before the product is introduced or delivered for introduction into interstate commerce, the manufacturer or distributor must notify the FDA of the basis on which the manufacturer or distributor has concluded that a dietary supplement containing DMBA will reasonably be expected to be safe.
Because neither of these conditions has been met by those marketing products that contain DMBA as a dietary ingredient, these products are deemed 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
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