> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Hi-Tech Pharma Sues FDA on Action Against Supplements
- URL: https://www.fdaweb.com/hi-tech-pharma-sues-fda-on-action-against-supplements/
- Published: 2019-05-03T12:00:00.000Z
- Updated: 2026-09-15T01:24:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144027

Hi-Tech Pharmaceuticals [says](https://www.marketwatch.com/press-release/hi-tech-pharmaceuticals-sues-the-fda-for-its-campaign-of-intimidation-2019-05-03?ref=fdaweb.com) it has sued FDA in DC federal court claiming that the agency “bypassed standard rule-making procedures in favor of a campaign of intimidation to try to force companies to destroy their products containing 2-Aminoisopheptane, or DMHA.” The complaint states that DMHA has existed in the food supply for many years. “Hi-Tech and the industry have sold millions of bottles of dietary supplement products containing this ingredient without any serious adverse event reports,” it says. Hi-Tech claims that DMHA is a natural constituent of the walnut tree and Kigelia Africana fruit.

Last month, FDA sent Hi-Tech a Warning Letter dealing with four of the company’s dietary supplements containing DMHA. In response, the company said the letter represents agency “bullying” attempts to “quasi ban a product by Warning Letter rather than rulemaking” and “is not the law.” The [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm635811.htm?ref=fdaweb.com) questioned whether DMHA is a new dietary ingredient under provisions of the law and says it is not generally recognized as safe under its conditions of use in the dietary supplements.

Hi-Tech says its lawsuit seeks a court order to stop “FDA's campaign of intimidation” and that “if the agency has scientific evidence which brings the safety of DMHA into question, that it disclose same and engage in the formal rule making process to ban the ingredient.”