DMHA is labeled as a dietary ingredient in some dietary supplements. The FDA is not aware of any information demonstrating that DMHA was lawfully marketed as a dietary ingredient in the United States before October 15, 1994. As a result, if DMHA is a dietary ingredient, we believe it would be a new dietary ingredient and one of the following must apply for dietary supplements that contain DMHA to be lawfully marketed:
- the product contains 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, at least 75 days before being introduced to the market, the manufacturer or distributor must notify the 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 for dietary supplements that contain DMHA, these products would be deemed to be adulterated, assuming DMHA is properly labeled as a dietary ingredient. Alternatively, if DMHA is not a dietary ingredient as declared on the product label, it would be an unsafe food additive when present in dietary supplements, and dietary supplements containing DMHA would be adulterated for containing an unsafe food additive.
DMHA is also known as:
- 2-Heptylamine, 6-methyl-
- 2-Isooctyl amine
FDA Issued Warning Letters:
- Line One Nutrition
- Iron Brothers Supplements
- Eflow Nutrition LLC
- Hi-Tech Pharmaceuticals, Inc.
- IQ Formulations, LLC / DBA Metabolic Nutrition Inc.
- Down To Earth Solutions, LLC
- Forbidden Labz
- Total Body Nutrition Labs, LLC
- Goldstar Performance Products
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