Hi-Tech Responds to "Bullying Tactics" Issued by FDA Warning Letter on DMHA

biospace | April 17, 2019

Hi-Tech Responds to "Bullying Tactics" Issued by FDA Warning Letter on DMHA
Hi-Tech Pharmaceuticals once again states that FDA's attempt to quasi ban a product by warning letter rather than rulemaking is not the law. Hi-Tech is working on a response to the agency but wanted consumers to know Hi-Tech will not just roll over due to an ill informed warning letter. Hi-Tech Pharmaceuticals was forced to sue the FDA November 5th, 2013 in Federal Court because the agency bypassed standard rule-making procedures in favor of a bullying campaign to try to force companies to destroy their products containing DMAA. Now the agency has engaged in the exact same tactics with DMHA it resorted to with DMAA, that is now the center of a 5 year battle between Hi-Tech and FDA that is just waiting a ruling by the 11th Circuit Court of Appeals.2-amino-5-methylheptane, 2-amino-6-methylheptane, 2-heptanamine,5-methyl-, Octodrine is a stimulant compound naturally found in Walnut Bark extract, or the bark from the Juglans Regia tree. It is also found in the fruit in Kigelia africana Extracts and is often considered to exert its influence as a decongestant and bronchodilator. 2-amino-5-methylheptane shares functions such as the support of energy levels, acting as widening of the bronchi for more air flow, and constricting the blood vessels for decreased swelling (better ability to breathe).

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Nilfisk offers a variety of industrial vacuum solutions suited for the pharmaceutical industry, varying from single-phase, three-phase and pneumatic, made of stainless steel or completely painted. Nilfisk industrial vacuum solutions help pharmaceutical manufacturers solve a variety of cleaning challenges including combustible dust, general maintenance, process integration, laboratory and cleanroom contamination control.

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Spotlight

Nilfisk offers a variety of industrial vacuum solutions suited for the pharmaceutical industry, varying from single-phase, three-phase and pneumatic, made of stainless steel or completely painted. Nilfisk industrial vacuum solutions help pharmaceutical manufacturers solve a variety of cleaning challenges including combustible dust, general maintenance, process integration, laboratory and cleanroom contamination control.