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# Hi-Tech Files DMAA Appeal
- URL: https://www.fdaweb.com/hi-tech-files-dmaa-appeal/
- Published: 2017-07-27T12:00:00.000Z
- Updated: 2026-09-14T22:36:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139242

Hi-Tech Pharmaceuticals is asking the 11th Circuit Court of Appeals to reverse a lower court decision that DMAA (1,3-dimethylamylamine) does not qualify as a dietary ingredient. “Hi-Tech believes that the court’s failure to find that DMAA is a constituent of a botanical, which would have led to Hi-Tech winning on summary judgment, constitutes reversible error,” company president **Jared Wheat** says in an e-mail statement to *National Products Insider*. “Hi-Tech is optimistic that we will prevail at the 11th Circuit.”

The online newsletter says that FDA and the Justice Department had no comment. Five years ago, FDA sent Warning Letters to several companies selling DMAA. A 2013 agency document describes DMAA as an amphetamine derivative that does not belong in supplements. FDA says it has no information indicating that DMAA is safe.

Attorneys contacted by the newsletter say it is possible the appeals court would address the broader issues of what qualifies as a botanical under the Dietary Supplement Health and Education Act (DSHEA) and whether a synthetically produced ingredient like DMAA can be sold in supplements.

In a 2016 draft new dietary ingredient guidance, FDA said that a synthetic copy of an herb or other botanical does not meet the definition of a dietary ingredient under a plain reading of the law.

The lower court judge who ruled against Hi-Tech said that in using the term botanical in DSHEA, “Congress intended that there must be at least some history of the substance in question having been extracted in usable quantities from a plant or plant-like organism.”

“There was no evidence that DMAA had not been extracted from plants in commercial quantities,” Wheat told the newsletter. “To the contrary, there is a patent application for just such an extracting process in the record. There is no legislative history or legal support for the court’s novel interpretation of DSHEA’s definition of botanicals, and the government did not even make an argument for any such interpretation.”