Unanswered DMAA Supplements BANNED: FDA Wins 11th Circuit Appeal

The Solution

The Solution

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DMAA is not an “herb or other botanical.” It is not a “constituent” of an herb or other botanical. And it is not generally recognized by qualified experts, as adequately shown through scientific procedures, to be safe under the conditions of its intended use. The district court properly so ruled. The decision is AFFIRMED.
 
jrock645 said:
Doesnt hurt my feelings. That stuff makes me feel awful
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I really like it for the final event at a powerlifting or strongman contest, where you are exhausted and already going to feel like you got hit by a bus after. That extra push can drive you through your pain/exhaustion and it doesn’t matter if you crash once it’s over.

I don’t expect the government to sympathize though
 
Hyde said:
I really like it for the final event at a powerlifting or strongman contest, where you are exhausted and already going to feel like you got hit by a bus after. That extra push can drive you through your pain/exhaustion and it doesn’t matter if you crash once it’s over.

I don’t expect the government to sympathize though
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The crash from that stuff made me feel like im dying. Yeah, my workouts were nuts on it but i couldnt deal with not being able to function and struggling to breath for hours after. No thanks.
 
jrock645 said:
The crash from that stuff made me feel like im dying. Yeah, my workouts were nuts on it but i couldnt deal with not being able to function and struggling to breath for hours after. No thanks.
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INteresting how everyone responds to it. Myself, I dont crash hard from stimulants.
 
jrock645 said:
The crash from that stuff made me feel like im dying. Yeah, my workouts were nuts on it but i couldnt deal with not being able to function and struggling to breath for hours after. No thanks.
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Yeah not something I use in training unless it would basically make or break the session. And I’m not talking about hypertrophy work ever, I mean strength. Vasoconstrictors are a bad idea if you’re trying to get swoll in general.
 
Aleksandar37 said:
Derived from and existing naturally in a plant are two different things. The FDA claims that it doesn't exist naturally in a plant. Does anybody have proof that it does?
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Had always been claimed to be an extract of geranium. I think this is one where chinese coa’s were faked. Id be curious to know more detail behind how eli lilly discovered it or invented it.
 
The Solution said:
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DMAA is not an “herb or other botanical.” It is not a “constituent” of an herb or other botanical. And it is not generally recognized by qualified experts, as adequately shown through scientific procedures, to be safe under the conditions of its intended use. The district court properly so ruled. The decision is AFFIRMED.
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It's not quite over yet.

"Circuit Judge Adalberto Jordan dissented, in part, from the majority’s opinion. “As I read the statute and the record, the FDA was not entitled to summary judgment,” Jordan wrote. “I would remand for a trial on whether DMAA is a ‘constituent’ of geraniums.”

Jared Wheat, owner of Hi-Tech Pharmaceuticals, said Jordan’s interpretation was correct, and he said the company would seek an en banc rehearing. If granted, a full panel of about a dozen judges would hear the case.

An FDA spokeswoman did not immediately respond late Friday to a request for comment."
 
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Aleksandar37 said:
Derived from and existing naturally in a plant are two different things. The FDA claims that it doesn't exist naturally in a plant. Does anybody have proof that it does?
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Well yeah.

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Analysis and Confirmation of 1,3-DMAA and 1,4-DMAA in Geranium Plants Using High Performance Liquid Chromatography with Tandem Mass Spectrometry at ng/g Concentrations

"The reported concentrations of 1,3-DMAA ranged from 68 to 496 ng/g and 1,4-DMAA ranged from 13 to 162 ng/g. "

"Finally, the diastereomer ratios of the 1,3-DMAA in geranium plants from Changzhou are similar to those of the synthetic standards. This indicates that 1,3-DMAA could be a natural product extract, fulfilling a requirement of the Dietary Supplement Health and Education Act."

"The results reported here provide evidence that 1,3-DMAA naturally occurs in geranium plants .."
 
stimtron said:
Well yeah.

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Analysis and Confirmation of 1,3-DMAA and 1,4-DMAA in Geranium Plants Using High Performance Liquid Chromatography with Tandem Mass Spectrometry at ng/g Concentrations

"The reported concentrations of 1,3-DMAA ranged from 68 to 496 ng/g and 1,4-DMAA ranged from 13 to 162 ng/g. "

"Finally, the diastereomer ratios of the 1,3-DMAA in geranium plants from Changzhou are similar to those of the synthetic standards. This indicates that 1,3-DMAA could be a natural product extract, fulfilling a requirement of the Dietary Supplement Health and Education Act."

"The results reported here provide evidence that 1,3-DMAA naturally occurs in geranium plants .."
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Interesting. Based on that paper and this one (Invalid Link Removed ) it looks like it depends on which region you get your Geranium from. Does anybody have the FDA responding to either of these studies? At the end of the day it'll still be available, just not as a dietary supplement. That is unless they make it a controlled substance, which it does have the potential to be ( Invalid Link Removed )
 
Aleksandar37 said:
Interesting. Based on that paper and this one (Invalid Link Removed ) it looks like it depends on which region you get your Geranium from. Does anybody have the FDA responding to either of these studies? At the end of the day it'll still be available, just not as a dietary supplement. That is unless they make it a controlled substance, which it does have the potential to be ( Invalid Link Removed )
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Some labs testing methods are not reliable just look at any of the drug kits they test when they pull people over. So many of those arrested because flour or oregano tests as cocaine or thc. But they are approved and used because it's within the govs standards. The FDA has its own set of standards but they are hardly the final word. I don't see the FDA caring about any tests outside it's own labs. Even though this lab was in Texas.
 
stimtron said:
Some labs testing methods are not reliable just look at any of the drug kits they test when they pull people over. So many of those arrested because flour or oregano tests as cocaine or thc. But they are approved and used because it's within the govs standards. The FDA has its own set of standards but they are hardly the final word. I don't see the FDA caring about any tests outside it's own labs. Even though this lab was in Texas.
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If you're going to call out the FDA on not caring about science, let's use science and not unrelated correlations between lab studies and field equipment used by non-experts. The testing method is fine, but the point of the paper you posted is that it depends on what you sample (ie, not all Geranium plants are created equal). And it looks like one of the judges dissented though, so the there is still a possibility.

These results need to be reproducible though as one paper is never gospel. I'm curious to know if the results were brought to the FDA'a attention and if the FDA ran their own tests on that specific strain of Geranium plant. I'm not seeing anything yet on if they did or didn't.
 
Aleksandar37 said:
If you're going to call out the FDA on not caring about science, let's use science and not unrelated correlations between lab studies and field equipment used by non-experts. The testing method is fine, but the point of the paper you posted is that it depends on what you sample (ie, not all Geranium plants are created equal). And it looks like one of the judges dissented though, so the there is still a possibility.

These results need to be reproducible though as one paper is never gospel. I'm curious to know if the results were brought to the FDA'a attention and if the FDA ran their own tests on that specific strain of Geranium plant. I'm not seeing anything yet on if they did or didn't.
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Not caring about the latest science. If you read the studies on DMAA the methods used were different. But yes there's also regional factors.

They are not required to test regional samples to make a determine it's not present. This is part of the issue at hand and why Hi-Tech is fighting it.

In general any research by done by the FDA or it's network is not considered valid. It's why most drugs or research in other countries is meaningless to them.
 
Aleksandar37 said:
That's them doing their job as competent analytical scientists. What's the issue?
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Are you unaware of the politics and scandals at the FDA? Not sure why you think every FDA scientist is competent or even moral. I guess you think they are beyond human beings and infallible.

The issue is if a lab disagrees with them like in this case and the FDA never bothers to confirm whether or not they are in the right or wrong.

So in this case they will likely ignore the paper despite it being a plant falling within the DSHEA.

There's a reason why the FDA gets taken to court they are not always right or fair.
 
I want hi tech to win so that dmaa can be added to products in a gmp facility, so we know what we are actually getting. Everyone and their mama is putting dmaa on the labels of their temporary pre workouts.
 
stimtron said:
Are you unaware of the politics and scandals at the FDA?

The issue is if a lab disagrees with them like in this case and the FDA never bothers to confirm whether or not they are in the right or wrong.

So in this case they will likely ignore the paper despite it being a plant falling within the DSHEA.

There's a reason why the FDA gets taken to court they are not always right or fair.
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I work constantly with the FDA and have since 1999 and they haven't always been great experiences. Again, you're calling out the FDA for ignoring science, but you're not citing anything actually factual to support that. This is all facebook-worthy, the FDA is out to get you, boogeyman BS. The paper you cited is from 2013 and the work was performed by a company called Environ who was hired by USP Labs to do it. I'm not at all doubting that the work is accurate, but let's stop pretending that there's not the chance of bias.

I'm asking if anybody knows if the FDA was made aware of the fact that DMAA may occur in some specific strains of Geranium and if they did or did not test that out themselves. I haven't been able to find anything yet, but if you don't know yourself, then the generic argument of the FDA is evil isn't actually helping.
 
Aleksandar37 said:
I work constantly with the FDA and have since 1999 and they haven't always been great experiences. Again, you're calling out the FDA for ignoring science, but you're not citing anything actually factual to support that. This is all facebook-worthy, the FDA is out to get you, boogeyman BS. The paper you cited is from 2013 and the work was performed by a company called Environ who was hired by USP Labs to do it. I'm not at all doubting that the work is accurate, but let's stop pretending that there's not the chance of bias.

I'm asking if anybody knows if the FDA was made aware of the fact that DMAA may occur in some specific strains of Geranium and if they did or did not test that out themselves. I haven't been able to find anything yet, but if you don't know yourself, then the generic argument of the FDA is evil isn't actually helping.
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Actually, my mistake. The paper you cited was from 2012, but was also funded by USP Labs.
 
Hows this for factual- if you think approving OxyContin to be used by 12 year olds but deny medical cannabis having any therapeutic benefit for them, you've bumped your damn noggin
 
Aleksandar37 said:
I work constantly with the FDA and have since 1999 and they haven't always been great experiences. Again, you're calling out the FDA for ignoring science, but you're not citing anything actually factual to support that. This is all facebook-worthy, the FDA is out to get you, boogeyman BS. The paper you cited is from 2013 and the work was performed by a company called Environ who was hired by USP Labs to do it. I'm not at all doubting that the work is accurate, but let's stop pretending that there's not the chance of bias.

I'm asking if anybody knows if the FDA was made aware of the fact that DMAA may occur in some specific strains of Geranium and if they did or did not test that out themselves. I haven't been able to find anything yet, but if you don't know yourself, then the generic argument of the FDA is evil isn't actually helping.
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Not citing? I cited the study which shows it's in the plant which the FDA has ignored by claiming otherwise.

Are you really suggesting the FDA is incapable of doing a 1 second pubmed search? If they are unaware of the study it shows how thorough their process is for research. Not very.
 
TheVenom said:
Hows this for factual- if you think approving OxyContin to be used by 12 year olds but deny medical cannabis having any therapeutic benefit for them, you've bumped your damn noggin
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What's the context? Or are we just giving pot to healthy 12 year olds?
 
Aleksandar37 said:
Actually, my mistake. The paper you cited was from 2012, but was also funded by USP Labs.
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Yes and nearly all drugs approved by the FDA are funded by the drug companies. Did you not know that? It has no bearing on the results of the paper in this case.

"
Funding
The authors would like to acknowledge and thank USP Labs, LLC for funding portions of this work. Authors confirm that USP Labs, LLC had no influence over the content of this paper and contributing research.


"Disclosures and Ethics
As a requirement of publication author(s) have provided to the publisher signed confirmation of compliance with legal and ethical obligations including but not limited to the following: authorship and contributorship, conflicts of interest, privacy and confidentiality and (where applicable) protection of human and animal research subjects. The authors have read and confirmed their agreement with the ICMJE authorship and conflict of interest criteria. The authors have also confirmed that this article is unique and not under consideration or published in any other publication, and that they have permission from rights holders to reproduce any copyrighted material. Any disclosures are made in this section. The external blind peer reviewers report no conflicts of interest."
 
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stimtron said:
Yes and nearly all drugs approved by the FDA are funded by the drug companies. Did you not know that?
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Clinical trials are funded by pharma companies. Drug approval isn't based on a single analytical paper. Supplement companies have a far lower bar to get over to get on a shelf.
 
Aleksandar37 said:
What's the context? Or are we just giving pot to healthy 12 year olds?
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That's dodging the point. If you did it on purpose, there's no discussing it with you. If you did it accidentally, youre too want to.
 
TheVenom said:
That's dodging the point. If you did it on purpose, there's no discussing it with you. If you did it accidentally, youre too want to.
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I'm not dodging anything. If you want to have a discussion about facts, then present facts. If you want to claim that this incidence of an FDA ruling is wrong because of a general distrust of the FDA based on an imaginary example, then I'll leave you and Karen to discuss essential oils.
 
stimtron said:
Yes and nearly all drugs approved by the FDA are funded by the drug companies. Did you not know that? It has no bearing on the results of the paper in this case.

"
Funding
The authors would like to acknowledge and thank USP Labs, LLC for funding portions of this work. Authors confirm that USP Labs, LLC had no influence over the content of this paper and contributing research.


"Disclosures and Ethics
As a requirement of publication author(s) have provided to the publisher signed confirmation of compliance with legal and ethical obligations including but not limited to the following: authorship and contributorship, conflicts of interest, privacy and confidentiality and (where applicable) protection of human and animal research subjects. The authors have read and confirmed their agreement with the ICMJE authorship and conflict of interest criteria. The authors have also confirmed that this article is unique and not under consideration or published in any other publication, and that they have permission from rights holders to reproduce any copyrighted material. Any disclosures are made in this section. The external blind peer reviewers report no conflicts of interest."
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Have you published before? This is generic end matter found in most articles. Again, you're comparing clinical trials to a single analytical paper. Peer reviewers are typically blinded, even if the editor isn't.
 
Aleksandar37 said:
I'm not dodging anything. If you want to have a discussion about facts, then present facts. If you want to claim that this incidence of an FDA ruling is wrong because of a general distrust of the FDA based on an imaginary example, then I'll leave you and Karen to discuss essential oils.
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I'm drugged to the gills, my good man.
Trust has nothing to do with it being a genuinely bad call for them to approve OC for kids. There's nothing imaginary about that. But you seem more worried about defending them than I am about discrediting an entity that nobody trusts anyway.
 
TheVenom said:
I'm drugged to the gills, my good man.
Trust has nothing to do with it being a genuinely bad call for them to approve OC for kids. There's nothing imaginary about that. But you seem more worried about defending them than I am about discrediting an entity that nobody trusts anyway.
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I'm asking what context are you saying that a 12 year old would benefit from marijuana where an opioid like oxycontin would be relevant? I asked for clarification of your vague example and rather than answer the question of context, you're accusing me of dodging the point and defending the FDA.
 
Aleksandar37 said:
I'm asking what context are you saying that a 12 year old would benefit from marijuana where an opioid like oxycontin would be relevant? I asked for clarification of your vague example and rather than answer the question of context, you're accusing me of dodging the point and defending the FDA.
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Dude OC only has one use..
 
TheVenom said:
Dude OC only has one use..
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And you're saying "12 year olds" with no context so you can make it sound horrible with zero context. A 12 year old with a sprained ankle is different than a 12 year old with terminal, metastatic pancreatic cancer, dude.
 
Aleksandar37 said:
And you're saying "12 year olds" with no context so you can make it sound horrible with zero context. A 12 year old with a sprained ankle is different than a 12 year old with terminal, metastatic pancreatic cancer, dude.
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Yes they are suffering but that's the price of not putting enough into researching a cure less so than thinking it's a good idea to give these kids newer highly potent addictive pills. There are many safer less toxic pain meds they are and can be using.
 
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stimtron said:
Yes they are suffering but that's the price of not putting enough into researching a cure less so than thinking it's a good idea to give these kids newer highly potent addictive pills. There are many safer less toxic pain meds they are and can be using.
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Pull up your yoga pants, grab your pumpkin spice latte, and join the other essential oil moms over in the corner because you have zero idea what the hell you're talking about and just regurgitate the same big pharma tropes seen everywhere online. Kids and adults should not be getting opioids outside of special circumstances and I have said repeatedly on this board that I'd be in favor of turning back use to only cancer pain and a few other terminal and palliative care scenarios. To say that opioids have no place ever is wrong and simply stupid. If you have a 12 year old with terminal cancer and it's metastasizing throughout their body and they're looking at a couple of weeks tops, you go ahead and ask for the cannabis treatment which won't do a thing because you're worried about long term addiction in somebody who will never see 13.
 
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