1,3-Dimethylamylamine

## What It Does 1,3-Dimethylamylamine (DMAA) is categorized as a stimulant. However, based on the provided sources, there is insufficient clinical data to detail its specific physiological effects, benefits, or mechanisms of action in the human body. Instead, DMAA is primarily known for being the subject of one of the most significant legal and regulatory battles in the history of the sports nutrition industry.

## The Science and The Legal Battle The core scientific debate surrounding DMAA was not necessarily about what it does to the human body, but rather where it comes from and how it is classified under the Dietary Supplement Health and Education Act of 1994 (DSHEA).

### The Geranium Argument Hi-Tech Pharmaceuticals and its CEO, Jared Wheat, led a massive legal campaign arguing that DMAA is a naturally occurring constituent of the geranium plant (specifically *Geranium robertianum*). Under DSHEA, if a substance is a constituent of a botanical, it can legally be sold as a dietary supplement. Hi-Tech pointed to studies showing DMAA was found in nature and cited the 'Iovate Patent'—a patent filed in the US and granted in Canada that demonstrated the extraction of 3% DMAA from *Geranium robertianum*.

Hi-Tech argued that DSHEA does not explicitly state that the dietary ingredient sold in a bottle must be physically extracted *from* the botanical itself, implying that synthetically creating a compound that exists in nature should still be compliant with the spirit of the law.

### The FDA's Counter-Argument The FDA and the US Government pushed back heavily. In their formal response filed on January 5, 2018, the FDA argued that interpreting DSHEA in Hi-Tech's manner would mean almost anything could be classified as a dietary ingredient. The FDA argued that the language in DSHEA—words like concentrates, metabolites, extracts, and combinations—all refer to physical processes. Therefore, the FDA concluded that a 'constituent' must refer to a material that can be derived through a physical process from a botanical, not merely synthesized in a lab to mimic a natural compound.

Furthermore, the FDA argued that DMAA is not Generally Recognized As Safe (GRAS), meaning it cannot legally be added to food or supplements.

## What The Research Says (Court Findings) The 'research' in the case of DMAA ultimately came down to judicial review. The timeline of the legal battle is as follows:

* **2012:** Initial FDA seizures of DMAA products occur. * **October 2017:** In an unrelated event, Hi-Tech Pharmaceuticals is raided over Red Yeast Rice, but federal agents confiscate their DMAA inventory during the raid. * **November 22, 2017:** Hi-Tech officially files an 89-page appeal to the United States Court of Appeals for the Eleventh Circuit, arguing DMAA is a botanical constituent and that the FDA overstepped by seizing products without proving them unsafe. * **January 5, 2018:** The FDA files its response, arguing DMAA is not a botanical constituent and is not GRAS. * **January 25, 2018:** Hi-Tech files its final response to the FDA. * **August 16, 2018:** Oral arguments are heard at the Eleventh Circuit Court of Appeals. * **August 30, 2019:** The United States 11th Circuit Court of Appeals upholds the district court ruling against DMAA.

The court's definitive statement was: > "DMAA is not an 'herb or other botanical.' It is not a 'constituent' of an herb or other botanical. And it is not generally recognized by qualified experts, as adequately shown through scientific procedures, to be safe under the conditions of its intended use. The district court properly so ruled. The decision is AFFIRMED."

Following this, Hi-Tech requested an *en banc* review (a hearing before all appellate judges). On **April 17, 2020**, this request was officially denied, effectively ending the legal battle and cementing DMAA's status as an illegal ingredient in dietary supplements.

## Dosing Guide While DMAA is no longer legally permitted in dietary supplements, historical catalog data provides insight into how it was formulated by brands before the ban.

* **Catalog Dose Survey:** Based on a survey of 8 products containing DMAA, the standard dose was universally **50mg** (Range: 50-50mg, Median: 50mg, Mean: 50.0mg). * **Minimum Effective Dose:** Insufficient data. * **Upper Limit:** Insufficient data.

## Forms Compared Insufficient data provided in the sources to compare different forms of DMAA.

## When & How To Take It Insufficient data provided in the sources regarding timing and protocols.

## Stacking Insufficient data provided in the sources regarding synergistic ingredients.

## Who Should Take It According to the FDA and the United States 11th Circuit Court of Appeals, no one should take DMAA, as it is not Generally Recognized As Safe (GRAS) and is not a legal dietary ingredient.

## Who Should NOT Take It Everyone. The ingredient has been seized by the FDA and ruled unsafe for use under the conditions of its intended use in dietary supplements.

## The Bottom Line 1,3-Dimethylamylamine (DMAA) is a stimulant that was once popular in sports nutrition, typically dosed at 50mg. However, it became the center of a massive legal battle between Hi-Tech Pharmaceuticals and the FDA. Despite arguments that DMAA is a natural constituent of the geranium plant, the US Court of Appeals definitively ruled in 2019 (and finalized in 2020) that DMAA is not a botanical, not a constituent of a botanical, and not Generally Recognized As Safe (GRAS). It is legally dead as a dietary supplement ingredient.