Dmaa banned by the FDA

LeanEngineer

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Yep! i saw this! Definitely time to stock up.
 
zcol94

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I'm gonna wait on a couple more sources before I go out an stock up.... Marc talks alot...
Love that mts whey though
 
NurseGray

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Still waiting to hear from the big dogs.
 
Rollinbeer

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Since when?!?! Well f#?k me to tears time to load up on my jack'd up im almost dry
 
NurseGray

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Seems we are not put to rest yet. Should you stock up on your favorite DMAA products? This might not be a bad idea but this certainly isn't over yet.
 

Sss23

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I thought dmaa died with oxy elite pro original formula and was banned then?? Where have I been
 

ECWHY

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I've never used DMAA, what do you guys recommend I stack up on?

Also for the lazy:

The Defendants in the forfeiture action, undetermined quantities of all articles
of finished and in-process foods, raw ingredients (bulk powders, bulk capsules)
containing DMAA with any lot number, size, or type container, whether labeled or
unlabeled listed in the amended complaint, [Doc. 25 as further amended by Doc. 138],
are hereby CONDEMNED, and FORFEITED to the United States for destruction.


The parties’ various motions to seal documents, [Docs. 99, 105, 111, 112, 114],
and to file excess pages, [Docs. 106, 110, 118], are GRANTED nunc pro tunc.
IT IS SO ORDERED, this 3rd day of April, 2017
But:

Hi-Tech has 28 days to file a Motion to Reconsider,[11] which they most certainly will do.
If their motion fails, they will appeal to the 11th Circuit.
 
NurseGray

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I thought dmaa died with oxy elite pro original formula and was banned then?? Where have I been
Wow your like a year late lol
 
Afi140

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I've never used DMAA, what do you guys recommend I stack up on?

Also for the lazy:



But:

Hi-Tech has 28 days to file a Motion to Reconsider,[11] which they most certainly will do.
If their motion fails, they will appeal to the 11th Circuit.
Mesomorph and/or angel dust extreme.
 
justhere4comm

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WesleyInman

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I've never used DMAA, what do you guys recommend I stack up on?

Also for the lazy:



But:

Hi-Tech has 28 days to file a Motion to Reconsider,[11] which they most certainly will do.
If their motion fails, they will appeal to the 11th Circuit.

I just bought a tub of Wicked and honestly for me its stronger then Mesomorph and Dust Extreme. Though I do like all 3 of the products tbh. You cant lose either way. The dust extreme gummy bear flavor, and mesomorph Rocket pop and tutti frutti are awesome. The wicked Fruit punch flavor tastes pretty crappy imo. I don't like the Beta Alanine in any of them either, but that is just me. I would easily use any of these 3 PWOs myself or with clients.

Another cool product I have currently purchased is called Excelsior. It does not contain dmaa or Beta Alanine, and its still probably the strongest non DMAA product I have found. Def can spike BP still though so watch out.

Mind you I am not affiliated with any of these companies or products, just giving you guys some personal feedback.
 

ECWHY

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Mesomorph and/or angel dust extreme.
Meso seems to be better for the price. Found it for buy 1 get 50% off on a site so was thinking of buying 4. Still kinda price for 25 servings

I just bought a tub of Wicked and honestly for me its stronger then Mesomorph and Dust Extreme. Though I do like all 3 of the products tbh. You cant lose either way. The dust extreme gummy bear flavor, and mesomorph Rocket pop and tutti frutti are awesome. The wicked Fruit punch flavor tastes pretty crappy imo. I don't like the Beta Alanine in any of them either, but that is just me. I would easily use any of these 3 PWOs myself or with clients.

Another cool product I have currently purchased is called Excelsior. It does not contain dmaa or Beta Alanine, and its still probably the strongest non DMAA product I have found. Def can spike BP still though so watch out.

Mind you I am not affiliated with any of these companies or products, just giving you guys some personal feedback.
Yeah, might try Meso to pair with my EC stack pwo. I'd remove my caffeine and take ephedrine + meso.
 
cobri66

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I just bought a tub of Wicked and honestly for me its stronger then Mesomorph and Dust Extreme. Though I do like all 3 of the products tbh. You cant lose either way. The dust extreme gummy bear flavor, and mesomorph Rocket pop and tutti frutti are awesome. The wicked Fruit punch flavor tastes pretty crappy imo. I don't like the Beta Alanine in any of them either, but that is just me. I would easily use any of these 3 PWOs myself or with clients.

Another cool product I have currently purchased is called Excelsior. It does not contain dmaa or Beta Alanine, and its still probably the strongest non DMAA product I have found. Def can spike BP still though so watch out.

Mind you I am not affiliated with any of these companies or products, just giving you guys some personal feedback.
I agree..Wicked is stronger than Meso
 
NurseGray

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If the FDA won MSJ on DMAA not being a dietary supplement then that's kinda the ruling by the big dogs, no?
Big dogs were VT and Jared Wheat. Don't think this is over just yet
 
Woody

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Big dogs were VT and Jared Wheat. Don't think this is over just yet
I'm not extremely familiar with the case. But the depo offerings I've seen and the lack of expert by FDA seems like this will be appealed
 

ECWHY

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How many of you are actually about to stock up? I'm thinking I'll wait until we hear some more
 

alvin1

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Anyone did try superpump version with dmaa? Is it worth it?
 
danielmoo

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Anyone did try superpump version with dmaa? Is it worth it?
Wish I had a sample to send to you. I'll let whoever has tried it give their opinions since I'm obviously a rep. All I'll say from my experiences is that the lower caffeine content (250mg) plus the DMAA amount of 70mg leads to a very, very smooth but strong and sustained energy through the workout. Haven't experienced a crash, not even close.
 
AdelV

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I just bought a tub of Wicked and honestly for me its stronger then Mesomorph and Dust Extreme. Though I do like all 3 of the products tbh. You cant lose either way. The dust extreme gummy bear flavor, and mesomorph Rocket pop and tutti frutti are awesome. The wicked Fruit punch flavor tastes pretty crappy imo. I don't like the Beta Alanine in any of them either, but that is just me. I would easily use any of these 3 PWOs myself or with clients.

Another cool product I have currently purchased is called Excelsior. It does not contain dmaa or Beta Alanine, and its still probably the strongest non DMAA product I have found. Def can spike BP still though so watch out.

Mind you I am not affiliated with any of these companies or products, just giving you guys some personal feedback.
I meant that for you.

Thoughts on that product you mentioned Excel? I heard from others it's like Craze.
 

Br1ck_Sh1thouse

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Anyone did try superpump version with dmaa? Is it worth it?
So I actually tried meso and sp both for the first time 2 weeks ago been alternating to see which I like better, so far it's like 60/40 in favor of sp. Fyi I add beta alanine to it though.

Still need to try wicked and dust extreme....
 

alvin1

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So I actually tried meso and sp both for the first time 2 weeks ago been alternating to see which I like better, so far it's like 60/40 in favor of sp. Fyi I add beta alanine to it though.

Still need to try wicked and dust extreme....
How was the pump on it?
 

Br1ck_Sh1thouse

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How was the pump on it?
For me it was decent, I also take saltpeter in add
addition because I'm keto, IF and lift first thing in the morning so getting a pump is a small feat in its self.
 
WesleyInman

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I meant that for you.

Thoughts on that product you mentioned Excel? I heard from others it's like Craze.
Excelsior is solid. Its very strong. It def spikes my BP pretty high still though, but it has no BA and I am a fan of this product.

I would not say for me it acts like Craze. Craze gave me a nice euphoria and was not as strong. This def gives you a euphoric feeling when you first try it, but it feels diff then Craze, to me at least.

If I had to compare Excelsior to another PWO on the market, I would say M1- by TLM Research. Which is also a good non dmaa product...the M1 does make my nose run everytime I use it.
 
VaughnTrue

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Please see the official HTP response I posted here in the main supp section
 
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[size=+3]Hi-Tech’s CEO, Jared Wheat, said he is “going to continue to fight for DMAA until Hell freezes over, and then fight on the ice.”[/size]



Hi-Tech Pharmaceuticals, Inc. (Hi-Tech) wants to give an update to the industry on how the battle of David vs. Goliath is progressing in the fight for DMAA. In light of the Court’s recent Order, there have been a lot of questions surrounding recent events concerning DMAA that Hi-Tech felt it needed to address.

Preliminarily, a key issue in this case has been the definition of “botanical.” The Court rejected the Government’s narrow definition of “botanical”:


Relevant to this case, dietary ingredients include “an herb or other botanical . . . or a concentrate, metabolite, constituent, extract, or combination of” an herb or other botanical. 21 U.S.C. § 321(ff). Accordingly, the first issue that must be determined under the statutory scheme is whether DMAA is a “botanical” as that word is used in tATLANTA, April 5, 2017he statute. The Government stipulates that it bears the burden of proving that DMAA is not a botanical …

The Government asserts that a botanical is “a plant, alga, or fungus, or a physical part or secretion of a plant, alga, or fungus, such as bark, leaves or fruits.” In support of this assertion, the Government cites to the affidavit of its expert, Cara Welch. In her affidavit, Dr. Welch gives generally the same definition of a botanical and cites to her report. Dr. Welch’s report gives that same definition for botanical and cites to an online FDA publication that gives the same definition in its glossary without citation to anything. The FDA publication merely purports to provide guidance to industry regarding the requirements of providing notice to the FDA relating to new dietary ingredients. The publication does not appear to be a scientific paper and there is no indication of who wrote it. In short, the Government has failed to provide an adequate basis for its interpretation of Congressional intent in using the term “botanical” in § 321(ff). This Court thus finds that the Government’s definition is arbitrary and not entitled to deference under Chevron, U.S.A., Inc. v. Nat. Resources Def. Council, Inc., 467 U.S. 837 (1984).
The Court further acknowledged Hi-Tech’s proffered science demonstrating the presence of DMAA in the geranium plant:

Hi-Tech has presented fairly substantial evidence that trace amounts of DMAA have been found in a species of a geranium plant in the form of three published papers that provided the details of tests detecting DMAA. The Government has asserted three arguments to dispute the presence of DMAA in geraniums, but this Court finds that those arguments are not sufficient to meet the Government’s burden of establishing that DMAA is not in geraniums. This Court is first unimpressed by the Government’s arguments regarding the fact that other studies have failed to find the presence of DMAA in geraniums. In particular, this Court takes judicial notice of a paper, Thomas D. Gauthier, Evidence for the Presence of 1,3-Dimethylamylamine (1,3-DMAA) in Geranium Plant Materials, ANALYTICAL CHEMICAL INSIGHTS, 8: 29-40 (2013) available at https://www.ncbi.nlm.nih.gov/ pmc/articles/PMC3682735/, in which the author surveyed the various studies that either found or did not find DMAA in geranium plants. He concluded that, “[o]verall, these studies show that 1,3-DMAA is found naturally in some, but not all, geranium plants and extracted geranium oils.” The author further opined that the studies that failed to find DMAA used extraction techniques that may not have been suitable for retention of DMAA due to its volatility. It is undisputed that at least three different studies found DMAA in geraniums, and the fact that other studies, which may well have used different methodologies, did not detect DMAA is not determinative.

This Court is likewise unswayed by the Government’s argument that it is impossible for the geranium in question to synthesize DMAA. In its motion for summary judgment, the Government asserts that: “The uncontroverted evidence is clear: Geraniums cannot make DMAA. There is no biological process or biosynthetic pathway by which a geranium plant could do so” …

Finally, in response to the Government’s argument that the geraniums from one of the studies may have been contaminated by fertilizer that contained DMAA, the argument fails to address the fact that other studies did find DMAA …

This Court credits Hi-Tech’s argument that a botanical can be synthesized in a laboratory without losing its status as a botanical under § 321(ff). Indeed, growing popularity of a substance in a certain plant might endanger that plant’s existence if manufacturers were not permitted to synthesize the substance without running afoul of the requirements in the DSHEA, and chemical synthesis is often more economically efficient than extracting a particular compound from a plant.
Despite these favorable findings, the Court wrongly concluded that for a substance to be considered a “botanical” that there must be at least some history of the substance in question having been extracted in usable quantities from a plant or a plant-like organism. According to the Court, “[t]o hold otherwise would be to open the door to bogus claims that, for example, a given chemical had been detected in a fungus found only in a remote Tibetan river valley, and the FDA would be left to refute that claim – to prove a negative – which the instant case demonstrates is not easily done.”

It is Hi-Tech’s position that the Judge’s conclusion constitutes clear error in the following respects:

This is not the scenario of a rare Tibetan plant, but rather common geraniums that have been in the food supply for decades;
There was no evidence that DMAA had not been extracted from plants in commercial quantities. To the contrary, there is a patent application for just such an extracting process in the record; and
There is no legislative history or legal support for the Court’s novel interpretation of DSHEA’s definition of botanicals, and the Government did not even make an argument for any such interpretation.
Hi-Tech believes that the Court’s failure to find that DMAA is a constituent of a botanical, which would have led to Hi-Tech winning on summary judgment, constitutes reversible error. Hi-Tech is optimistic that its motion to reconsider will be successful. If it is not, however, Hi-Tech will appeal to the Eleventh Circuit and take it all the way to the Supreme Court if necessary. This could extend this litigation for several more years. Hi-Tech’s CEO, Jared Wheat, said he is “going to continue to fight for DMAA until Hell freezes over, and then fight on the ice.” Hi-Tech will of course continue to supply its customers with DMAA-containing products until there is a final, judicial determination.






































Also, as with the multiple of people who say HT isn't going to win this case, I'd like to present you with some nice updates to another "unwinnable" case HT just got ruled in its favor! Ron Kramer of Thermolife AKA "TrollLife" had his arginine "patent" revoked, and not only that...he's now held liable to paying Jared/HiTech [size=+5]~$960,000 in lawyer fees.[/size]









[size=+3] Hi Ron! If you see Jared at any more FTC hearings make sure to bring your checkbook please![/size]​
 
danielmoo

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It can’t be bargained with. It can’t be reasoned with. It doesn’t feel pity, or remorse, or fear. And it absolutely will not stop, ever, until you are dead.
 
Jiigzz

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The thing is, this is what I have been saying for ages about ALOT of these new stimulants. They synthesize them first and then try to find evidence to support their existence in nature. The amounts are so minuscule and not widely available, that extracting them is of huge cost, if even truly possible.

I thought Hi Tech were actually doing well on this one, but I even wrote about this in a PP article years ago.
 
MidwestBeast

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Nac

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The thing is, this is what I have been saying for ages about ALOT of these new stimulants. They synthesize them first and then try to find evidence to support their existence in nature. The amounts are so minuscule and not widely available, that extracting them is of huge cost, if even truly possible.

I thought Hi Tech were actually doing well on this one, but I even wrote about this in a PP article years ago.
Maybe you can help me understand this better.

What does the source matter?

If the synthesized compound used in the supp is identical to that found in nature, wheres the issue? Why does it have to be extracted? Surely, it only need be extractable, if even only in theory.
 
HIT4ME

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Doesn't the law state that the ingredient has to have been used as a supplement or part of a normal food supply prior to 1992 or something like that? If so, that negates the judges finding because you can make the case that geraniums fit that bill while some rare herb in Tibet doesn't. So his logic is faulty.
 
VaughnTrue

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Doesn't the law state that the ingredient has to have been used as a supplement or part of a normal food supply prior to 1992 or something like that? If so, that negates the judges finding because you can make the case that geraniums fit that bill while some rare herb in Tibet doesn't. So his logic is faulty.
in theory, if the rare herb from tibet was eaten by an indigenous people, it would be part of the food supply ;)
 

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HIT4ME

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in theory, if the rare herb from tibet was eaten by an indigenous people, it would be part of the food supply ;)
Then it fits the law...The need is to prove it is part of the food supply. If they can prove that a group of people are it, the law is satisfied....

And the judge could have made a case that the supplement company would have to prove that an ingredient is actually found in a plant, and that the plant is part of the food supply. Saying that the FDA would have to prove it wasn't in the herb is stupidity at its finest.
 
Nac

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Anyone been reading N_H's "refutations" of the geranium studies?
 

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