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                Dietary Supplement Ingredient Directory

Dietary Supplement Ingredient Directory Home
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          Dietary Supplement Ingredient Directory
          DMHA in Dietary SupplementsDietary Supplement Ingredient Directory DMHA in Dietary Supplements
  
  	
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    PrintFDA 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:

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
	VaporpacThe 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:**

**May 2020**

Nutracap Labs LLC**October 2019**

Revital U International, LLC**September 2019**

Alternative Laboratories**April 2019**

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.**

                                                                                  Content current as of:
      03/06/2023
              
              
Regulated Product(s)
		 Dietary SupplementsDietary Supplement Ingredient Directory
 
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