Hi-Tech Appeals to Get its Wrongfully-Confiscated DMAA Back

Are you now refering to the MMA cheater and saying it was the supplements fault?
Or something else?

Then why let people out of prison at all if formerly convicted aren’t innocent until proven quilty?

Updated the top of the post with the motion’s denial.

Hi-Tech will be appealing this motion to the district court, but given the Holidays, they’re not expected to appear before the judge or have a decision until mid-January or so.

So until then, still no DMAA supplements being manufactured, and supplies continue to dwindle.

That’s the short-term play. The long-term play is still the main DMAA lawsuit’s appeal to the 11th circuit, which can be found here.

IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF GEORGIA ATLANTA DIVISION

UNITED STATES OF AMERICA

P LAINTIFF, v. UNDETERMINED QUANTITIES OF . . . 1,3-DIMETHYLAMYLAMINE HCL (DMAA) . . .

D EFENDANTS,

and

HI-TECH PHARMACEUTICALS, INC., AND JARED WHEAT,

Civil Action No. 1:13-cv-03675-WBH-JCF

C LAIMANTS.

MEMORANDUM IN SUPPORT OF THE UNITED STATES’ MOTION FOR SUMMARY JUDGMENT

You guys should include the whole truth when talking about this case. I think you could easily pull the summary judgement document from Pacer discussing Undetermined Quantities of 1,3-Dimethylamylamine HCl (DMAA). It gives every argument that DMAA is not naturally produced by geranium plants, Eli Lilly invented and patented DMAA in the 1940’s and included it as a synthetically produced-product, active ingredient in a drug.There is no known biological process by which a geranium plant could make DMAA. Therefore, DMAA is not a constituent of the geranium plant and is not a dietary ingredient. Hi-Tech’s experts denied even being qualified to speculate about a biosynthetic pathway that geranium turns itself into DMAA and they didn’t take any efforts to determine such a pathway.

You might consider reading this document, if you already have I am curious about how you can still think DMAA comes from geranium?

You guys are all about the truth, hey if you already put this out their my bad, If you have not maybe you should.

Actually, they gave zero reasons. Their argument was that “we don’t know how geraniums are able to make this compound”. Did you even read Judge Hunt’s Summary Judgement (which was in favor of the US Government)??

Here’s a snippet for you:

It’s 2017 and you’re making arguments that were relevant in 2010 but have since been resolved. DMAA IS FOUND IN GERANIUM - TIME TO MOVE ON

And that patent is
a) no longer valid, and
b) no longer enforceable because DMAA has been found in nature!

Now that we KNOW that DMAA has a clear basis in nature (even if in small quantities), the compound itself cannot be patented! So if you tried to revive and enforce that patent, it would easily be invalidated.

I know it’s nearly impossible to keep track of all of the statism going around, but you should consider reading this SCOTUS decision:

This led to this guidance (which for whatever reason is no longer live on USPTO’s site but is archived here):

I know you won’t read it all, so long story short, if you ‘discover’ something that’s part of nature even before it’s known to be part of nature, you did NOT invent it (mother nature / God / whatever forces did), and that compound itself cannot be patented because it’s naturally occurring.

This is why I keep harping on the fact that those crooked scientists tried to cover up DMAA’s basis in nature. 11 times it’s been found, four of which were covered up. At least now I’m starting to understand why.

Either way, time to update your knowledge base and catch up with today’s agreed-upon facts. Citing invalid 80 year old patents is beyond weak.

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dayum Mike sounds all hyped up… take your Anavite this morning eh? :slight_smile:

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Mike, I will read all of this and get back to you. I have no problem admitting if I am wrong, however I know I am not.

The zero reason they were not able to explain how geranium got in there, is because it was put in their, the product was spiked. Look at the players involved in all this, not the most reputable bunch.

Why would Khan and ElSohly and Armstrong all put it in there, especially when the former two were paid by two different groups who clearly had an anti-DMAA bias?

That’s the thing for me. I no longer even cite the USPLabs studies as evidence that it’s a constituent. Toss those out if you want. Khan, ElSohly’s, and Armstrong’s “research” and emails it perfectly fine for us. Maybe Lisi too, that study is suspicious as well.

Read the Daniel Armstrong research situation and storyline again. It’s seriously beyond preposterous.

These studies should all be retracted or at least revised, and along with them, the letters the FDA cited them in to attack USPLabs.

You seriously can’t expect anyone to take you seriously after this statement.

Mike, What about Hi-Tech’s use of anabolic steroids in his five alleged prohormone products? This should certainly bother you, I know it bothers me…

Mike, it is ultimately irrelevant for the purposes of the DSHEA as to whether or not an ingredient proposed for use in a dietary supplements meets the definition of a dietary ingredient if it cannot pass the further safety provisions in DSHEA, which DMAA absolutely cannot in regard to every single safety provision within the language of the law. Unless DMAA has an established track record of safety as a lawfully marketed old dietary ingredient, then it is a new dietary ingredient subject to the notification requirement NDIN - new dietary ingredient notification) that must be submitted by the manufacturer or distributor of each distinctly different DMAA product with clinical evidence of safety 75 days prior to its use in a dietary supplement. If that is not submitted, the product that contains DMAA is NOT an old dietary ingredient as admitted by Mr. Wheat in his appeal brief in which he states it was introduced to dietary supplements in 2005 (old means before 1994) and no NDIN notification has ever been submitted for the use of DMAA in a dietary supplement, which means pre presence of DMAA in any dietary supplement adulterates the product. Moreover, even if an NDIN had been submitted, there has never been any clinical testing performed on DMAA as a standalone ingredient or any DMAA-containing product that incorporated a study design to evaluate safety or for that matter that has even met the FDA’s standard for competent and reliable evidence. Thus, in addition to a new dietary ingredient adulterating a dietary supplement by its presence if no NDIN was submitted, a new dietary ingredient also adulterates a dietary supplement when there is an absence of sufficient clinical safety data (subject to the determination by the FDA) that demonstrates the ingredient will be safe for use in a dietary supplement. Thus, DMAA assuming arguendo it is a dietary ingredient, then it is a new dietary ingredient that adulterates any product that contains it under both adulteration prongs associated with new dietary ingredients. Again, assuming for the sake of argument DMAA is a new dietary ingredient that was the subject of NDIN and there was sufficient safety data presented t the FDA, DMAA would still be illegal and unsafe for use in a dietary supplement per additional safety provisions in DSHEA associated with the approved drug process. Again, keep in mind before even getting to this stage: DMAA is not a dietary ingredient, no NDIN was ever filed based on the argument the DMAA is a new dietary ingredient, and not only is there inadequate safety data to support DMAA as a lawful new dietary ingredient for use in a dietary supplement, but there is a wealth of data that demonstrates that DMAA is unsafe and that products that contain DMAA present a significant number of risks to the health and safety of consumers, including potentially death, especially when used in a product with caffeine and promoted as a pre-workout product, thus superimposing DMAA and caffeine’s synergistic cardiac and nervous system taxing effects on top of the enhanced taxing effects on the body’s cardiovascular and central nervous system that occur from intense exercise. Who besides me can see this as a problem? Trust me plenty have had scary experiences with DMAA products, however they fail to report them.

You need to update your knowledge base concerning what is a legal dietary supplement ingredient and what is not. I gave you a thorough lesson in that above if you care to read it, trust me these are the facts of DSHEA, FDA rules, and the fact that your friend did not submit a new dietary ingredient notification with clinical evidence 75 days prior to its use in ANY products he put DMAA in. That is something you need to consider as its factual. I also am curious of what your take is on Hi-Tech’s use of anabolic steroids in their pro-hormone products? I get we all love to feel like we are getting the most from our supplements, however steroids have long term harmful effects on the body and some people didn’t sign up for that. What ever happened to full disclosure on the label of the product?

Will post an article about this super soon. Have you seen the FDA’s actual lab tests?

Here’s a hint: they didn’t measure actual quantity… and can’t definitively state that they found 1-androstenedione… because it has the same molecular mass as 1-Andro (as well as 1200 other compounds), and even the lab tech calls this out. The tests are weak and not even remotely conclusive.

I was awaiting the Gaspari Anavite test before posting. I’ll get that article going ASAP.

After that crap with Anavite, why would anyone trust them to do lab tests again?? :joy:

Well now that we can agree that DMAA is in geranium, we get back to USPLabs’ original argument that it’s been in the food supply, and thus no NDI is needed.

Even crazier: The FDA has taken down their warning letter against USPLabs that once made the argument "

See for yourself - the warning letter used to be here:
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm302167.htm

Archive:

To the best of FDA’s knowledge, there is no information demonstrating that dimethylamylamine was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for food in a form in which the food has not been chemically altered.

Emphasis mine. Why would they take that warning letter down?! Maybe because it was wrong? I’m honestly just finding this out right now. Now I’m very curious. I emailed Jacob to see if he knows.

Edit: It looks like they also took down the second warning letter that actually referenced those ‘fraud’ studies I loathe, including the preposterous Zhang/Armstrong one:

https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/CFSANFOIAElectronicReadingRoom/ucm350199.htm

https://web.archive.org/web/20171115002334/https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/CFSANFOIAElectronicReadingRoom/ucm350199.htm

Now I’m really wondering what’s up

You’d think if they were trying to build a case against Hi Tech, they wouldn’t be getting rid of everything. Hopefully this means they’re in trouble.

Well ongoing through all of this has been USPLabs’ impending court case, which I hear was backed up to next year. They were indicted for other things though, but maybe they’re getting some behind-the-scenes wins.

Oh wow. Yeah I had no idea USPLabs was still doing stuff. I haven’t heard anything about them in a while.

Mike,

I am done debating with you the DMAA issue as you are so incredibly ignorant about the facts in this case and certainly about the application of the law that it is obviously a waste of time. So moving on, although one final comment about your conspiracy theory about the 2012 USPLabs warning letter and 2013 FDA response to USPLabs not being accessible on the FDA website.

You clearly have no understanding about the publication of documents by the FDA on its website, particularly in regard to its warning letters. At the end of every calendar year, the FDA takes down from its website all warning letters from the calendar year five years before and begins the process of archiving them. When that is done, they post them on their archives database. All 2012 warning letters are gone now and will go back up sometime in early 2018 when they have completed the archiving process. The 2013 response to USPLabs reply to their 2012 warning letter is part of the 2012 warning letter file and thus it is gone for that same reason. You can easily verify this by doing a warning letter historical search for the years 2011, 2012, and 2013 where you will see the all 2011 and 2012 warning letters gone, but you will find the 2011 warning letters in the archives database, and you will find all 2013 and sooner warning letters there. Your ignorance about the subject matter you profess to be qualified to address is what fuels your conspiracy theories.

Back to you later today about your again badly flawed conspiracy theory about how the FDA did not actually find AAS in Jared’s five “prohormone” products.