DMHA in Dietary Supplements

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).

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), 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:

1,5-Dimethylhexylamine
1,5-DMHA
2-amino-5-methylheptane
2-amino-6-methylheptane
2-aminoisoheptane
2-Heptylamine, 6-methyl-
2-Isooctyl amine
2-Metil-6-amino-eptano
6-Amino-2-methylheptane
Amidrine
Octodrine
Vaporpac

FDA Issued Warning Letters:

For More Information:

Constituent Update