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

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Apr 17, 2019, 11:05 ET

NORCROSS, Ga., April 17, 2019 /PRNewswire/ -- 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 11^th 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).

2-amino-5-methylheptane can be used for lifting is its ability to boost energy levels and enhance focus and attention. it can potentially increase the levels of monoamines such as dopamine and noradrenaline and further support motivation and desire to train. It also has the capacity to increase the pain threshold and definitely support more intense workouts and decrease the rate of perceived exertion. 2-amino-5-methylheptane can potentially also be used to help support fat loss by minimizing your desire to snack and possibly straying from your diet due to the role of excellent appetite suppressant.

In the last few decades there has been an exponential growth in the field of Herbal medicine. It is getting popularized in developing and developed countries owing to its natural origin and lesser side effects. One such medicinal plant is Juglana regia (Juglandaceae), which is commonly known as walnut. All parts of plants are important viz. bark, leaves, flowers, seed, oil etc. Traditionally the plant is used as central nervous system stimulant, lipolytic, antihistamic, antiasthmatic, laxative, purgative, whereas the plant possess beneficial effects such as anti-oxidant, antiulcer, immunemodulatory, antidiabetic, hepatoprotective, antiinflammatory, antimicrobial, wound healing, and many other medicinal properties. This activity of the plant possess due to the important phytochemical constituents like flavonoids, saponins, glycosides, alkaloids and steroids.

Walnuts are the oldest tree food known to man, dating back to 7000 B.C. The Romans called walnuts Juglans regia, "Jupiter's royal acorn." Early history indicates that English walnuts came from ancient Persia, where they were reserved for royalty. Thus, the walnut is often known as the "Persian Walnut." Walnuts were traded along the Silk Road route between Asia and the Middle East. Caravans carried walnuts too far off lands and eventually through sea trade, spreading the popularity of the walnut around the world. English merchant marines transported the product for trade to ports around the world and they became known as "English Walnuts." England, in fact, never grew walnuts commercially. The outer shell provided a natural protective layer helping to maintain the quality of the nut. Today the nut trade continues to be a well-established, ordered, and structured business, and the California walnut is well known as the top quality walnut for the world. Walnut (Juglans regia L.) is also the most widespread tree nut in the world. China is the largest producer of walnut in the world. According to the Food and Agriculture Organization (FAO), UN 2013 statistics, Chinese walnut production reached 1655.508 thousand tons in 2011, accounting for 48.42% of the world's total production of walnut, ranking first in the world production of walnut. The FDA authorized a health claim indicating that diets including walnuts can reduce the risk of heart disease.

"Both now and when Congress enacted DSHEA, the common meaning of 'constituent' has been '[o]ne part of something that makes up a whole; an element.' It is a 'component' of something else." Hi-Tech believes FDA is purposely turning a blind eye to this language. Hi-Tech has stated, quoting Black's Law and the American Heritage dictionaries. "Nothing in that language suggests that a substance is not a 'constituent' of a 'botanical' merely because it has not previously been 'extracted' from the plant, or because it is not present in some threshold 'usable' amount." Hi-Tech believes FDA's interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) conflicts with "the ordinary meaning" of the term constituent. "Both now and when Congress enacted DSHEA, the common meaning of 'constituent' has been '[o]ne part of something that makes up a whole; an element.' It is a 'component' of something else," Hi-Tech stated, quoting Black's Law and the American Heritage dictionaries. "Nothing in that language suggests that a substance is not a 'constituent' of a 'botanical' merely because it has not previously been 'extracted' from the plant, or because it is not present in some threshold 'usable' amount."

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 do not 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. Hi-Tech's CEO, Jared Wheat, quotes John Paul Jones and says... "I have not yet begun to fight!" Hi-Tech will of course continue to supply its customers with DMHA-containing products until there is a final, judicial determination.

About Hi-Tech Pharmaceuticals

Hi-Tech Pharmaceuticals (https://www.hitechpharma.com/index.htm) is a leading Sports Nutrition manufacturer. Since 1979, Hi-Tech Pharmaceuticals, Inc. and its sister company, Hi-Tech Nutraceuticals, LLC. have been providing quality custom manufacturing services to the pharmaceutical, dietary supplement and beverage industries. Hi-Tech Pharmaceuticals is a cGMP certified company that operates out of Four (4) US Production facilities and (3) Warehouses, totally over 500,000 sq. ft. The two Georgia based production facilities are both located outside Atlanta in the Norcross and Suwanee Advanced Technology areas. Hi-Tech also has Two (2) facilities located outside State College, Pennsylvania. Hi-Tech holds a Drug Manufacturing License issued by the State of Pennsylvania Food and Drug Branch and is registered as a Food and Drug Establishment with the FDA in Pennsylvania. The company ranks among the top dietary supplement companies and generic pharmaceutical companies in several markets around the world and has among the largest capacity of U.S.-based manufacturers. Hi-Tech Pharmaceuticals has impressive capabilities to supply the global demand of pharmaceuticals. On an annual basis, Hi-Tech Pharmaceuticals can manufacture 35 billion tablets and 10 billion capsules. Hi-Tech Pharmaceuticals can also package 500 million bottles, 250 million blister packs, and 150 million pacquettes.

SOURCE Hi-Tech Pharmaceuticals, Inc.