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

Supplements
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Can confirm, and this will be my next big post. Happy to get it started tomorrow if anyone wishes.

What’s crazy is that the FDA’s lab tech even left footnotes stating that

  1. the requesting agents asked the lab not to quantify the compounds, and
  2. the lab itself stated that the alleged adulterated compounds could not be differentiated from the actual legal ones!!!

In summary - they were told to do a “weak” / non-specific test. Hmmmmmm I wonder why is that?

And then we’ll publish some lab tests on those lots that specifically look for the alleged adulterants, and guess what - they’re not actually found.

Admittedly, those more specific tests were paid for by Hi-Tech, so I’d be happy to hunt the alleged lots down from a retailer and test them myself at yet another lab I trust if needed, but I think this part of the indictment will get tossed without my interference.

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Every day I pray for them FDA is a bunch of shit The products without DMAA are not worth a dollar I hope that short time my fat burn will return

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I’m not privy to the documents surrounding the case other than the original indictment.

But if the facts as you state them here are true, you certainly have a defensible position.

As with all scientific cases though, it’ll be a struggle for both you and the prosecution to clarify your cases whether to a judge or jury. And as you’re also well aware, courts have a prosecution bias on the exact sort of science based case you’re up against.

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I’m curious what sort of DMAA-only safety data you have on <100mg being ‘safer than vitamin C’. I haven’t personally seen a DMAA-only study be posted, but it’s hard to imagine a decent population size study turning up no adverse effects at all. Obviously the stuff is safe, but it also almost certainly poses most of the same obvious side effect profiles as other mild stimulants, and if you’re alleging otherwise that’s an uphill allegation.

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It should not be all that complicated as you will see after Mike posts the lab results. I agree 100% with you on courts having prosecution bias, but under this scenario it will come down to a Daubert hearing prior to trial where the governments testing will not stand.The Daubert Standard used by a trial judge to make a preliminary assessment of whether an expert’s scientific testimony is based on reasoning or methodology that is scientifically valid and can properly be applied to the facts at issue. Under this standard, the factors that may be considered in determining whether the methodology is valid are: (1) whether the theory or technique in question can be and has been tested; (2) whether it has been subjected to peer review and publication; (3) its known or potential error rate; (4) the existence and maintenance of standards controlling its operation; and (5) whether it has attracted widespread acceptance within a relevant scientific community. See Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). You simply can not use a general test that can not distinguish certain compounds, isomers, etc. and it be considered valid scientific methodology.

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I hope Hi-Tech wins this. Kudos for them fighting for us!

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Yeah at this point, I’m less worried about the legal status of DMAA, but more concerned about stopping the FDA from using these dirty tactics.

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You said it man. Here’s my issue.

If I hadn’t spent literally days last fall going through the lawsuit documents and depositions, there would be far fewer people who saw the rigged research studies and FDA collusion. Only a handful of people who read USPLabs’ two huge, unsearchable response PDFs would have understood the anomalies inside.

All you would have seen are a bunch of abstracts on nih.gov that don’t tell you the full truth.

The other side would have been limited to Hi-Tech issuing press releases, some social media posts that disappear and never show up in the search engines, and maybe some forum discussions on AM that also get buried. Everything else would be the talking points from ‘industry trade’ websites that are afraid to take risks or do the deep dive.

Now I am happy to take some of that information burden on, because it’s something I’m obviously passionate about - with our without anyone’s sponsorship.

My question is, where else has nonsense like this gone down where there wasn’t a motivated blogger with a web presence who was willing to spend tons of time looking for the truth? What else have we been misled about?

And trust me, I’m not tooting my own horn here. It’s not about that. I know I’m not going to stop the FDA from using dirty tactics. I just want people to know how disgusting those studies the FDA cited when taking the hatchet to USPLabs truly were.

So I’m just wondering what else is happening where there isn’t a Jared Wheat or a PricePlow to go and take these risks in exposing these fiascos. What else are we being lied to about? What about those who cannot afford to fight back in court?

In short, this situation has really shown me how the sausage is made, and the process stinks. It is sad that my first instinct is to believe the opposite of what they tell me (the food pyramid being one such example). It is shameful how this whole thing has gone down, and now the FDA seems to have doubled down on irrational.

I’m not anti-government. In this thread, I even suggest ways for the government to actually fix things up - a pro-government stance. I want 21 CFR 111 enforced.

But if my tax money pays for something that’s not a matter of national security, I want it to be 100% full access and open source, down to every last email. Otherwise I want no part of it. It shouldn’t take a millionaire businessman with an army of lawyers and an interested blogger/entrepreneur to expose something like this.

This is no longer a government of the people and for the people, and it hasn’t been for a very long time.

/rant.

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That’s always a concern for me. It’s like when you buy a used car off of someone and something breaks a couple days later. You’re left wondering what else wasn’t taken care of. You see the someone pull something shady like this, suddenly you don’t know what else they’ve snuck by you.

Thank god for that PricePlow Mike guy! :wink:

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Update - November 29th is a big day! Wheat and his lawyers ordered to appear before the judge to conduct a hearing over their motion to get their DMAA back:

Full docket text for document 49:

ORDER as to Jared Wheat re [45] MOTION to Modify Conditions of Release filed by Jared Wheat, Hi-Tech Pharmaceuticals, Inc. The Court will conduct an evidentiary hearing and hear arguments of counsel on Wednesday, November 29, 2017, at 2:00 PM in Courtroom 1879, Richard B. Russell U.S. Courthouse, 75 Ted Turner Drive SW, Atl., GA 30303. Defendant Wheat’s appearance is mandatory. Signed by Magistrate Judge Alan J. Baverman on 11/21/2017. (AJB)

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hot damn that IS big news!

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I work for a large government agency that regulates a commercial industry not related to the FDA. However, I’ve been in many high-level meetings to discuss how to proceed against an entity, and I imagine that there are quite a few macro similarities among regulatory agencies and how they decide to proceed in certain situations. Based on my experience, there is one well-placed person (possibly two) at the FDA that is pushing the DMAA case against Hi-Tech. And for the FDA to continue to push this even after a judge has declined to fully support the the agency is telling.

This latest move to make DMAA part of a bond package is beyond unprofessional. If the FDA wanted to continue to pursue DMAA, then it should have kept it as a separate parallel action. But to combine it as part of another action not related to DMAA is hard to believe. I’m sure the FDA sees itself as protecting the consumers. But making the DMAA issue part of the bond arrangement in this case is utterly unprofessional, and smacks of the FDA engaging in a retaliatory pissing match.

There’s someone at the FDA with an ax to grind or who got too emotionally involved in the DMAA case and has weaponized the agency. Similar discussions on enforcement action at my agency that I’ve been a part of have been professional and have respected judicial authority. To see the FDA engage in this type of behavior is unbelievable.

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Wow, thank you for sticking your neck out and making this comment.

What’s your experience with judges in this matter? They now have to appear before him, but I get concerned about judges skewing bias towards government.

This would seem to be the truth.

Oftentimes, we hear screams that “Big Pharma wants it gone!” or similar, but I don’t think this really invades on their territory at all.

As a compound found in nature, it cannot itself be patented, but I don’t see DMAA killing other drug sales like you’d have happen if things like cannabis or psilocybin were on a free market.

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Wew, even knowing that mushrooms are as safe as they are, I can’t see that happening for a few decades. It’s a pretty stigmatized substance.

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Well obviously there are some sides that can happen (namely a bad trip), but there is so much evidence that a single acute dose can dramatically lessen symptoms of PTSD that it’s just sad it’s so stigmatized.

Here’s a hint: single-dose cures aren’t good for business. Pharma likes their patients in constant need (statins, “antidepressants”, HIV drugs, pain, insulin…)

Here’s a recent one from this year:

http://www.tandfonline.com/doi/full/10.1080/02791072.2017.1320734

“Resetting” a depressed brain, getting people to quit alcohol and cigarettes more easily, etc etc. All bad for their business.

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I usually have trouble convincing people medicine is business for some reason. But if you look at the pharmaceutical industry as a business instead of a massive group of Good Samaritans, lots of things make a lot more sense.

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A post was split to a new topic: Planned Obsolescence: A Customer Forever

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Not the first time I’ve seen someone try to weaponize/hijack a Gov’t agency to win for “their cause”(most likely someone is paying them). Seen it happen with USGS, FEMA, NOAA, EPA, USADA

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My experience is that the judges usually side with the government. But my experience is based on my agency doing diligent research, following the law, and not playing dirty tricks like the FDA did here. I haven’t spent much time in court, but I have initiated enforcement action and participated in many other meetings to discuss whether and how the agency should take enforcement actions. It’s these meetings that I believe are similar from agency to agency. The participants are normally upper level managers and attorneys, and the discussions are shaped by the personalities in the room.

And yes, the motivation is almost certainly some person at the FDA on a crusade and not a “Big Pharma” conspiracy. It’s possible that it’s a lead attorney who’s reputation and status within the FDA hinges on getting DMAA banned or winning a judgment against Hi-Tech. It’s also possible that it’s someone who has a broad sense of consumer protection, and sees himself/herself as society’s protector (people go to work for regulatory agencies for different reasons).

Whoever is pushing this most likely has the blessing of someone high up in order to justify the expense of all the resources that the FDA has pitted against Hi-Tech. These things cost money and pull manpower from other endeavors. The FDA appears to be “all in” against DMAA, but these legal shenanigans that they’re doing here would be considered unethical at my agency.

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Isn’t there a big court appearance today? crosses fingers for hi-tech victory

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Update November 29, 2017: The FDA has played a nice chess piece, filing a “Bill of Particulars” stating what was truly confiscated under the rule that Hi-Tech Pharma was using to get their improperly-seized DMAA back – and under that rule, it was just the financial accounts! The FDA had filed a response to Hi-Tech’s emergency motion to release seized assets, and gave Hi-Tech $424,000 back.

This invalidated the Motion to Return Property that Hi-Tech filed, so the judge DENIED their request to return improperly seized assets, but without prejudice. This means Hi-Tech will need to re-file for their DMAA using another tool outside of 41(g), which is no longer valid for the seized supplements.

In the FDA’s response to Hi-Tech’s motion to release seized assets, they again did not mention DMAA a single time, so it seems as though this was a good stall tactic, but the improperly-seized DMAA has still not been addressed, and is still up in the air.

This may go on for a while…