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# Hi-Tech Says FDA Warning Letter is ‘Bullying’
- URL: https://www.fdaweb.com/hi-tech-says-fda-warning-letter-is-bullying/
- Published: 2019-04-17T12:00:00.000Z
- Updated: 2026-09-15T01:20:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143893

Hi-Tech Pharmaceuticals, Norcross, GA, says a 4/10 FDA Warning Letter dealing with four of the company’s dietary supplements containing DMHA 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) questions 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. “Failure to immediately cease distribution of your products Ultimate Orange, HydroxyElite, Lipodrene Elite, and Synadrene, and any other products you market that contain DMHA, could result in enforcement action by FDA without further notice,” the letter says.

In its [response](https://www.marketwatch.com/press-release/hi-tech-responds-to-bullying-tactics-issued-by-fda-warning-letter-on-dmha-2019-04-17?ref=fdaweb.com), Hi-Tech says FDA is using the same tactics it employed in its effort to force companies to destroy products containing DMAA. The company sued the agency 11/5/13 over DMAA and is awaiting a ruling on its suit from the 11th Circuit Court of Appeals. The company statement says Hi-Tech “is determined to force FDA to follow the law and stop its ‘bullying tactics.’ If FDA is allowed to run amok and continue to ‘bully’ ingredients that they don’t like off the market, then the dietary supplement industry will cease to be able to give consumers ingredients they desire such as DMAA and DMHA that have excellent safety records and are constituents of botanicals.”