FDA considers DMHA to be a substance that does not meet the statutory definition of a dietary ingredient and is an unsafe food additive. Accordingly, we consider dietary supplements containing DMHA to be adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Our reasoning follows.
Under the FD&C Act, dietary supplements must contain at least one “dietary ingredient.” A “dietary ingredient” is a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any dietary ingredient from the preceding categories. Non-dietary ingredients intended for use in dietary supplements must be used in accordance with a food additive regulation or be generally recognized as safe (GRAS) for their intended use, unless they meet one of the other listed exceptions to the food additive definition. Because DMHA does not qualify as a dietary ingredient, is not an approved food additive, is not GRAS, and does not meet any of the other listed exceptions to the food additive definition, it is an unsafe food additive, and dietary supplements containing DMHA are adulterated under the FD&C Act.
DMHA is also known as:
- 2-Heptylamine, 6-methyl-
- 2-Isooctyl amine
The pre-2020 actions listed below reflect the Agency’s position as of April 2019 when the FDA had concluded that DMHA was either an adulterated “new dietary ingredient” or an unsafe food additive. After further research and consideration, FDA concluded that DMHA is an unsafe food additive, as explained above. The Agency still considers dietary supplements containing DMHA to be adulterated.
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
For More Information:
- Constituent Update (April 2019)
This webpage describes FDA’s views and recent actions with regard to an ingredient used in products marketed as dietary supplements. If you have evidence that calls FDA’s views into question, we invite you to submit it, along with your reasoning, to FDA at ODSP@fda.hhs.gov.
This page is not intended to provide a complete list of all FDA actions and communications with regard to this ingredient and its use in products marketed as dietary supplements.