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DMAA is legal? Hi-Tech Pharmaceuticals vs FDA – next round!

The dispute between Hi-Tech Pharmaceuticals and the Food and Drug Administration (FDA) is almost legendary for people interested in supplementation. The dispute arising from the questioning of the pre-workout – Jack3D – due to the content of DMAA, has moved from the “next routine procedure of excluding the product from market” to the fight for the smallest “legal traps” which is observed by almost all global supplementation companies. Everything however indicates that Hi-Tech has obtained a very powerful argument in this fight.

Legal fun in cat and mouse
Remind yourself of the last situation when you wanted to prove someone that he was wrong. How much did it take you? Hour, day, week, month? Most likely, if the interlocutor was stubborn you waved your hand with a “waste of time” thought. The situation looks quite different however when the disposal of a full warehouse that you want to sell is at stake.

In this situation Hi-Tech is doing its best to prove to the US legal authorities that DMAA can be part of the dietary supplements legally.

Stalemate
Apart from the description of all appeals and institutions around the case, the legal letters of both parties can be summed up more or less like this: “To whom it may concern. You are wrong. Regards Hi Tech / FDA. ” The brutal truth is that the fight against state authorities is a fight with the molochs but nevertheless Hi-Tech do not want to give up.

Arguments
The last argument of Jared Wheat (CEO of HI-Tech Pharmaceuticals) is that DMAA is naturally produced by plants (more precisely “is part of it”), which meets the definition of a DSHEA (Dietetary Supplement Health And Education Act ), and nowhere in the document is there any statement that the ingredient must come from the plant.

They refer to the ‘Iovate patent’ (a Chinese company that owns among others the MuscleTech brand). Behind this patent lies an effective method of extracting Geranium or Pelargonium extracts containing an increased amount of DMAA.

So everything is legal?
Not exactly. Law organs have the advantage of being the one who interprets the law. The court was not inclined to argue about the naturalness of DMAA.

And here we come to the last breakthrough in the whole matter. The court also admitted that DMAA is found naturally in plants and that it can not be a component of dietary supplements.

And here is the opportunity for a favorable appeal of Hi-Tech, because the court’s ruling is excluded with the definition of what can be a DSHEA dietary supplement or its ingredient. We can evey say that the court excluded himself by the above statement.

The fight continues
We will definitely have another appeal from Hi Tech … And impatiently waiting for the next judgment of the court. However, there is a good chance that the matter is coming to an end and fanatics of “strong impressions” in stimulating supplements will regain their favorite substance.

We will try to keep you updated on the next steps in this matter!

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David

David

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