DOJ to announce actions against dietary supplements makers

[De__eB]

Me too, but the more and more I read about this, the less and less I want anything to do with usplabs. Don't get me wrong, I am not a saint, but I try to be as honest as possible and try to treat others as I want to be treated. I try to surround myself with other like minded folks.

Any usplabs reps want to chime in?

If you actually think for even a single instant that a USPLabs rep is going to be posting here any time soon after that indictment

 

[BeardedBreast]

They're probably going to be radio silent for awhile.

No doubt. If they had any knowledge and were in charge of sample and review product distribution, that could involve them in the case.

 

[bighulksmash]

I had a weird phone call yesterday from texas.

 

[Woody]

I had a weird phone call yesterday from texas.

Did we have to give our phone number for the beta test? I cannot recall

 

[mw1]

Me too, but the more and more I read about this, the less and less I want anything to do with usplabs. Don't get me wrong, I am not a saint, but I try to be as honest as possible and try to treat others as I want to be treated. I try to surround myself with other like minded folks.

Any usplabs reps want to chime in?

Seeing that several were actually arrested yesterday I doubt they are able to comment

 

[datsthat]

Seeing that several were actually arrested yesterday I sout the are able to comment

Wow

 

[carmaf]

PES.

I would assume this incident would clear that up once and for all more than anything. If USP = PES, then PES would also be getting indicted, no?

 

[datsthat]

I would assume this incident would clear that up once and for all more than anything. If USP = PES, then PES would also be getting indicted, no?

I would think there is some truth in your statement

 

[BigGame84]

So what was tainted? Just Oxyelite Pro? Or other Supps?

 

[ma70]

So what was tainted? Just Oxyelite Pro? Or other Supps?

Jacked and OxyElite Pro so far.

 

[datsthat]

Would this case essentially kill high tech's lawsuit against fda claiming that DMAA is found naturally?

 

[BigGame84]

Jacked and OxyElite Pro so far.

But those have been discontinued now for years. I'm more interested if there's any Supps they currently offer that are tainted.

 

[ma70]

But those have been discontinued now for years. I'm more interested if there's any Supps they currently offer that are tainted.

Well yeah, that's what I'm waiting for too. I've only tried SuperCissus/PowerFULL and the first helped my joints, and the other helped me sleep (both as expected). Can't really tell if anything else is tainted.

 

[VaughnTrue]

Would this case essentially kill high tech's lawsuit against fda claiming that DMAA is found naturally?

No.

Just like vitamin C is found naturally in oranges, yet we use synthetic vitamin C in ALL supplements(trust me, no one is extracting vit C from any natural source).

Our position is that 1,3 is naturally occurring and in the food supply, which allows it to be DSHEA similar to the other naturally occurring compounds.

 

[cubsfan815]

Hmmm, I have 2 bottles of Ultimate-T, not sure if I'll try them.

 

[datsthat]

This sucks. I am so disappointed with usplabs. I had great results with ultimate T. I now can't help but wonder if my results were due to actually ingredients on label.

I (used to) proudly wore barbell t shirts. I enjoyed their protein and bcca.

 

[Tiocfaidh]

Jacked and OxyElite Pro so far.

forgive me if i missed it, but what were they spiked with? all i can see is that they used synthetic versions. well, whats the difference ignoring the legal semantics?

 

[De__eB]

No.

Just like vitamin C is found naturally in oranges, yet we use synthetic vitamin C in ALL supplements(trust me, no one is extracting vit C from any natural source).

Our position is that 1,3 is naturally occurring and in the food supply, which allows it to be DSHEA similar to the other naturally occurring compounds.

That specific argument is fallacious and stands no chance in court, but it works great as a talking point on forums because it's an easy to understand comparison.

In the end...

Synthetic vitamin C is Pre-DSHEA

Synthetic DMAA is not.

Nobody at the FDA is trying to say that synthetic ingredients can not be dietary supplements.

What they are saying is that a synthetic ingredient that is not pre-DSHEA requires an NDI regardless of whether it is found in nature or not, because the included ingredient itself is not a direct non chemically altered extract.

There are other points that might work in Hi-Tech's favor on DMAA, but the Vitamin C comparison is not.

 

[VaughnTrue]

That specific argument is fallacious and stands no chance in court, but it works great as a talking point on forums because it's an easy to understand comparison.

In the end...

Synthetic vitamin C is Pre-DSHEA

Synthetic DMAA is not.

Nobody at the FDA is trying to say that synthetic ingredients can not be dietary supplements.

What they are saying is that a synthetic ingredient that is not pre-DSHEA requires an NDI regardless of whether it is found in nature or not, because the included ingredient itself is not a direct non chemically altered extract.

There are other points that might work in Hi-Tech's favor on DMAA, but the Vitamin C comparison is not.

I tried to respond his question as it stood, not post 1,000 pages of court documents showing our exact defense on the matter.

I appreciate your insight like always however

 

[BigGame84]

Hmmm, I have 2 bottles of Ultimate-T, not sure if I'll try them.

Why not? To my knowledge, other than the discontinued products (Oxy and Jacked) nothing else has been tainted.

 

[De__eB]

I tried to respond his question as it stood, not post 1,000 pages of court documents showing our exact defense on the matter.

I appreciate your insight like always however

But, everyone who has an interest in the industry should be extremely interested in every bit of minutiae regarding Hi-Techs interactions with the FDA/DOJ as it is going to be a very precedent-pushing case for future non-criminal FDA enforcement activities.

 

[Tiocfaidh]

Why not? To my knowledge, other than the discontinued products (Oxy and Jacked) nothing else has been tainted.

i still can't find what they were tainted with.

 

[The_Old_Guy]

Read the indictment. There are 11 counts. It says that (among other things) that there was no Cynanchum Aurticulatum (here-by called CA) extract in there at all, and that it was just powdered CA root. It says that they knew CA had liver toxicity issues (probably from seizing their entire email server/provider) but figured since they were lying about the extract, that there wasn't enough root to hurt anyone. That's the main one as far as public safety goes. I think there was also one about them trying to 'backdoor' sell all the product that was out there during the Ageline/Liver stuff in Hawaii.

Edit: Yup - .34 & .35 Page 11

 

[cubsfan815]

Why not? To my knowledge, other than the discontinued products (Oxy and Jacked) nothing else has been tainted.

Not about tainted. More the lying on COAs, knowing about liver issues and not disposing product, etc.

 

[VaughnTrue]

But, everyone who has an interest in the industry should be extremely interested in every bit of minutiae regarding Hi-Techs interactions with the FDA/DOJ as it is going to be a very precedent-pushing case for future non-criminal FDA enforcement activities.

Couldn't agree more.


What happens next with Hi-Tech and the FDA/DOJ will shape this industry from here on out. The supplement lover in me is beyond excited, while the supplement industry employee in me is saying "well hot damn...what other industry can my specific skill set land me into?" LOL

 

[BigGame84]

Not that I've tried any of their products but why do I get the sense Hi-Tech is shady.

 

[Tiocfaidh]

Read the indictment. There are 11 counts. It says that (among other things) that there was no Cynanchum Aurticulatum (here-by called CA) extract in there at all, and that it was just powdered CA root. It says that they knew CA had liver toxicity issues (probably from seizing their entire email server/provider) but figured since they were lying about the extract, that there wasn't enough root to hurt anyone. That's the main one as far as public safety goes. I think there was also one about them trying to 'backdoor' sell all the product that was out there during the Ageline/Liver stuff in Hawaii.

Edit: Yup - .34 & .35 Page 11

thought it said there was so little of the ingredient, it couldn't cause issues. i thought the whole ageline liver toxicity was bogus?

 

[De__eB]

i still can't find what they were tainted with.

They weren't "tainted" in the sense you are using.

I'll briefly summarize the allegations.

(all allegedly)

-USPLabs along with SK Labs conspired (two or more parties working together to commit a crime) to commit fraud by requesting that their supplier create a fake COA for their synthetic DMAA, claiming it to be a natural extract. Fraudulently labeled imports are a big no-no.

-They then conspired to commit further fraud by then manufacturing and promoting fraudulently labeled supplements claiming that their ingredient was a natural extract and not the synthetic ingredient it actually is. This is mail fraud and wire fraud, both very broadly defined crimes that are applicable to basically any interstate commerce indictment.

-They committed further import fraud by requesting numerous synthetic ingredients to experiment with, and requesting that their supplier again fake labels for these ingredients claiming them to be green coffee extract.

-They again fraudulently marketed products as containing Aegle Marmelos extract when they actually contained synthetic aegeline.

-They could not get an extract of cynanthum auriculatum that they wanted, so they ordered pulverized roots instead, again fraudulently mislabeled and marketed.

-They were aware of the potential hepatotoxicity of cynanthum auriculatum, but believed that they were using little enough to not cause issues.

-When it came out that they were indeed using enough to cause liver issues in users, they played smoke and mirrors with the FDA, and tried to push as much of their inventory out the door as they could before it could be seized, putting further live(r)s at risk.

-Associated with all of this, they laundered money (Basically broadly defined crime for moving money out of a criminal enterprise) through various shell businesses and into the personal investment accounts of the principles at USPLabs.

 

[VaughnTrue]

Not that I've tried any of their products but why do I get the sense Hi-Tech is shady.

sorry you feel that way.


The truth of the matter is that Hi-Tech has been under intense FDA scrutiny for MANY years, and despite that, Hi-Tech continually passes FDA audits, and even has the gumption to attack the FDA when we will we're being wronged by them (in this instance, 1,3 dimethyl). There is not another manufacturer/company who has to deal with more intense overlook from big brother, and continually fights to have compounds remain legal in this industry.

 

[muscleupcrohn]

Couldn't agree more.


What happens next with Hi-Tech and the FDA/DOJ will shape this industry from here on out. The supplement lover in me is beyond excited, while the supplement industry employee in me is saying "well hot damn...what other industry can my specific skill set land me into?" LOL

I'll be keeping an eye on this for sure. One one hand, no one wants shady companies having the ability to do illegal things with relative impunity, but I also don't part of me is also a bit worried about potential governmental regulation/involvement to the point of banning safe and effective ingredients and/or driving the cost of supplements up significantly. But perhaps busting some of the big dogs, and showing that the people in charge of these companies doing illegal activities can get in some serious trouble, will scare other companies into being more compliant, or at least make them think twice before they act.

I have a feeling that there are a lot of supplement that list an "extract" on a label when the ingredient is actually synthetically derived. I've noticed the newer DMAA supplements not listing "extract" on the supplement facts. Quite obviously, lying to consumers about the source of an ingredient is unacceptable.

 

[Tiocfaidh]

They weren't "tainted" in the sense you are using.

I'll briefly summarize the allegations.

(all allegedly)

-USPLabs along with SK Labs conspired (two or more parties working together to commit a crime) to commit fraud by requesting that their supplier create a fake COA for their synthetic DMAA, claiming it to be a natural extract. Fraudulently labeled imports are a big no-no.

-They then conspired to commit further fraud by then manufacturing and promoting fraudulently labeled supplements claiming that their ingredient was a natural extract and not the synthetic ingredient it actually is. This is mail fraud and wire fraud, both very broadly defined crimes that are applicable to basically any interstate commerce indictment.

-They committed further import fraud by requesting numerous synthetic ingredients to experiment with, and requesting that their supplier again fake labels for these ingredients claiming them to be green coffee extract.

-They again fraudulently marketed products as containing Aegle Marmelos extract when they actually contained synthetic aegeline.

-They could not get an extract of cynanthum auriculatum that they wanted, so they ordered pulverized roots instead, again fraudulently mislabeled and marketed.

-They were aware of the potential hepatotoxicity of cynanthum auriculatum, but believed that they were using little enough to not cause issues.

-When it came out that they were indeed using enough to cause liver issues in users, they played smoke and mirrors with the FDA, and tried to push as much of their inventory out the door as they could before it could be seized, putting further live(r)s at risk.

-Associated with all of this, they laundered money (Basically broadly defined crime for moving money out of a criminal enterprise) through various shell businesses and into the personal investment accounts of the principles at USPLabs.

so in a nutshell, most of the charges were about using synthetic versions and lying about it on import docs. and once you lie about issues, then any money made can be categorized as money laundering and wire fraud since it was made from a criminal act, even though you weren't actively trying to hide anything or commit wire fraud.

and i thought the liver issues were from ageline and the conclusion was that was bs.

comparing this to craze, it seems ds did worse?

 

[De__eB]

sorry you feel that way.


The truth of the matter is that Hi-Tech has been under intense FDA scrutiny for MANY years, and despite that, Hi-Tech continually passes FDA audits, and even has the gumption to attack the FDA when we will we're being wronged by them (in this instance, 1,3 dimethyl). There is not another manufacturer/company who has to deal with more intense overlook from big brother, and continually fights to have compounds remain legal in this industry.

Given Jared's past, are you actually surprised at the FDA scrutiny? Is anybody surprised?

 

[BigGame84]

I think this new Cyclosome delivery Hi-Tech is offering is a complete marketing scam. Of course, I'm sure the placebo will be strong with this one when the early logs come out. Just my opinion.

 

[De__eB]

so in a nutshell, most of the charges were about using synthetic versions and lying about it on import docs. and once you lie about issues, then any money made can be categorized as money laundering and wire fraud since it was made from a criminal act, even though you weren't actively trying to hide anything or commit wire fraud.

and i thought the liver issues were from ageline and the conclusion was that was bs.

comparing this to craze, it seems ds did worse?

If you read the indictment, the liver issues were likely from cynanthum auriculatum and USPLabs knowingly sold the product anyway because they 'thought they weren't including enough to cause issues'

This goes back to the whole 'using ingredients with no human safety data based on a few people testing them in-house' issue that comes up over and over again.

--

There's a reason Matt Cahill's federal indictment was sealed and never saw judicial action.

That reason is not hard to figure out.

I'll bet most people could figure it out first guess.

 

[VaughnTrue]

Given Jared's past, are you actually surprised at the FDA scrutiny? Is anybody surprised?

No, I am not surprised by it, but I do appreciate the fact that despite the scrutiny, we continue to pass with flying colors each and every time.

I think this new Cyclosome delivery Hi-Tech is offering is a complete marketing scam. Of course, I'm sure the placebo will be strong with this one when the early logs come out. Just my opinion.

Understandable position. However, keep in mind these are products we've been producing for some time. Now, we are modifying them to include this delivery system, yet not increasing the price to the end user. This means we get less profit. Why would we do that unless we were convinced the new formulations would provide superior results?

The technology being used for the Cyclosome delivery system was bought directly from the pharmaceutical industry. If we are using it as a "sham", then I guess the countless prescription drugs that utilize the same technology do as well...

 

[Tiocfaidh]

If you read the indictment, the liver issues were likely from cynanthum auriculatum and USPLabs knowingly sold the product anyway because they 'thought they weren't including enough to cause issues'

This goes back to the whole 'using ingredients with no human safety data based on a few people testing them in-house' issue that comes up over and over again.

--

There's a reason Matt Cahill's federal indictment was sealed and never saw judicial action.

That reason is not hard to figure out.

I'll bet most people could figure it out first guess.

in other words, they were taken down for doing what everyone else does. :lol:

as for ds, it would be just a guess but the company still sells products. you would think they would be shutdown permanently.

 

[ma70]

This is some crazy stuff. Thanks de_eb for making it clear whats going on.

 

[De__eB]

in other words, they were taken down for doing what everyone else does. :lol:

as for ds, it would be just a guess but the company still sells products. you would think they would be shutdown permanently.

I think a lot of companies are just being swindled by suppliers and are too naive/ignorant to know it.

Here we have USPLabs/SK actively telling their supplier 'fake this COA for us'

 

[jp_x_type]

well for sure i will not be buying any usp labs products ever again. not because of the liver issues which probably werent down to the product itself, but for the other things usp labs did, and the false claims on what was actually in their products. i have a feeling that as much as usplabs rose quickly to the top of the supplement industry with their massive sales, this inquiry will kill them just as quickly...

 

[BigGame84]

Well I like their Aminolift and the t-shirts are nice lol

 

[conkertheking]

The only part of this that seriously concerns me is where they're including "anything that changes the function of the body" in their definition of "drug". Strikes me that this could be interpreted as being able to ban the OTC sale of pretty much anything which does anything.

 

[jp_x_type]

Seriously, oxyelite pro was some good **** that got a lot of people jacked right up, it was something you could feel and i liked it, but if a company mislabels a product knowingly (jacked in this case) and does other things under the table 'just cos everyone else does' then they have lost my trust. No trust, no buy

Wont miss their uber complicated ingredients lists though lol

 

[jp_x_type]

Seriously, oxyelite pro was some good **** that got a lot of people jacked right up, it was something you could feel and i liked it, but if a company mislabels a product knowingly (jacked in this case) and does other things under the table 'just cos everyone else does' then they have lost my trust. No trust, no buy

Wont miss their uber complicated ingredients lists though lol

 

[jp_x_type]

The only part of this that seriously concerns me is where they're including "anything that changes the function of the body" in their definition of "drug". Strikes me that this could be interpreted as being able to ban the OTC sale of pretty much anything which does anything.

Theyll just force them to place the same old disclaimer more prominently on the bottle me thinks

 

[Adizzle1]

It is being said that they are going to go after another 100 companies however the way I am reading sounds like they have enforced agaisnt 100 companies in the last year, since Nov. 2014, not that there is another 100 companies to receive civil/criminal enforcement.

 

[ma70]

I got two tubs of Modern Creatine and 2 bottles of Ultimate-T for free. Hmmm, wondering whether to use them or not.

 

[cubsfan815]

well for sure i will not be buying any usp labs products ever again. not because of the liver issues which probably werent down to the product itself, but for the other things usp labs did, and the false claims on what was actually in their products. i have a feeling that as much as usplabs rose quickly to the top of the supplement industry with their massive sales, this inquiry will kill them just as quickly...

Why are so many people down playing the liver issue? How does that not concern you? They knew it could cause issues, used it anyways. Then when people got sick they allegedly provided false press releases and tried to sell off remaining inventory.

If all that is true, those seized assets will be going right back to pay future lawsuits lol.

 

[De__eB]

well for sure i will not be buying any usp labs products ever again. not because of the liver issues which probably werent down to the product itself, but for the other things usp labs did, and the false claims on what was actually in their products. i have a feeling that as much as usplabs rose quickly to the top of the supplement industry with their massive sales, this inquiry will kill them just as quickly...

Did you even read the indictment?

They were absolutely down to the product itself.

 

[LLN]

I remember that in their old tubs of OxyElite Pro, they used to brag about being pioneers in the fight against amino spiking and fillers. Leading the industry in ethics indeed...

Wouldn't be surprised if they were fooling us with their protein as well.

 

[BigGame84]

I remember when the first logs of Versa-1 were crazy. Either it was placebo or it was spiked with a prohormone.