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# Judge Faults FDA, Still Rules Against Hi-Tech
- URL: https://www.fdaweb.com/judge-faults-fda-still-rules-against-hi-tech/
- Published: 2017-04-05T12:00:00.000Z
- Updated: 2026-09-14T22:16:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138383

A Georgia federal judge found fault with several FDA arguments but still determined that Hi-Tech Pharmaceuticals’ DMAA (1,3-dimethylamylamine) is not a dietary ingredient. An online blog [post](Despite%20rejecting%20a%20number%20of%20FDA’s%20arguments%20in%20a%20lawsuit,%20a%20federal%20judge%20in%20Atlanta%20on%20Monday%20concluded%20on%20his%20own%20that%20DMAA%20%281,%203-dimethylamylamine%29%20is%20not%20a%20dietary%20ingredient.) says the agency has been trying for years to remove the ingredient from the dietary supplement market. The court’s decision is likely not the last word, given that Hi-Tech had vowed to appeal a loss to the 11th Circuit Court of Appeals.

The court found that FDA’s definition of a botanical was “arbitrary and not entitled to deference.” It said an agency guidance document “merely purports to provide guidance to industry regarding the requirements of providing notice to FDA relating to new dietary ingredients. The publication does not appear to be a scientific paper and there is no indication of who wrote it. In short, the government has failed to provide an adequate basis for its interpretation of congressional intent in using the term ‘botanical’ on the Dietary Supplement Health and Education Act (DSHEA).”

The court also said the agency failed to meet its burden of proof that DMAA is not in geraniums. “It is undisputed that at least three different studies found DMAA in geraniums, and the fact that other studies, which may well have used different methodologies, did not detect DMAA is not determinative,” the decision said.

However, the fact that only trace amounts of DMAA were detected in geraniums led the court to rule in favor of FDA and against Hi-Tech, which has sold tens of millions of dollars’ worth of products containing DMAA. “It is inconceivable that in passing the DSHEA Congress intended for supplement manufacturers to take a chemical that heretofore had only been manufactured in a laboratory and to scour the globe in search of minuscule amounts of that chemical in obscure plants so that they could declare the substance a dietary ingredient under the statute,” the judge wrote. He concluded that DMAA is not a botanical and therefore not a dietary ingredient. It is a food additive that is presumed to be unsafe unless it is generally recognized as safe and effective, he said.

“This court’s conclusion after reading the various expert reports and other documents is that there is no consensus regarding the question of whether the consumption of DMAA is safe,” the judge said. He determined that the Hi-Tech products containing DMAA are adulterated and subject to seizure, and rejected company claims that the government violated the Federal Food, Drug, and Cosmetics Act, DSHEA, the Administrative Procedures Act, or the Constitution’s Fifth Amendment.