Mahmoud ElSohly & Ikhlas Khan’s $2.3 Million FDA Tax Waste: “Methylhexanamine is not detectable in Pelargonium or Geranium species and their essential oils: A multi-centre investigation”

This is part four of a six page series researching whether DMAA (1,3 dimethylamylamine) is a natural constituent of geranium flowers. All six parts are linked from our main DMAA Geranium page.

Given the rancid stench emanating from the previous two disastrous studies discussed on this blog (1. Mahmoud ElSohly and Ikhlas Khan’s USADA-funded cover-up and 2. Daniel Armstrong and Ying Zhang’s Texas-Sized Scandal), and the fact that the Li and Fleming did find DMAA in geraniums, USPLabs still had a leg to stand on in defense of the natural basis of DMAA.

So, per the Hi-Tech Pharmaceuticals Legal Team, the researchers reached out to Dr. Daniel Fabricant of the FDA and “proposed to Dr. Fabricant a strategy for a new, multi-center DMAA study to refute the findings of Li’s work”.[10]

By this point, if you’ve been following this series of articles, you won’t be surprised to discover what happened with this one: the researchers claimed DMAA was “not detectable”, but court documents reveal otherwise… yet never published it anywhere.

And we have the emails to prove it.

August 2014 – Mahmoud ElSohly and Ikhlas Khan’s “Multi-Center Study” – “Methylhexanamine is not detectable in Pelargonium or geranium species and their essential oils: A multi-center investigation”[36,37]

Ikhlas Khan DMAA Multi Center Study - An FDA Tax Waste

How can the title say DMAA was “not detectable” when… it was detected!?!?!

In emails that have been sealed from the public for some suspicious reason, Daniel Fabricant approved the ‘strategy’, and the Multi-Center investigation here began.

This study would utilize several geranium plants from several areas of Asia, including those where Ping had found his, and would test them all in multiple laboratories to get a definitive answer.

As you can imagine from the title of the paper, the researchers claimed that DMAA could not be found in any of the geranium samples nor their oils — they even said so in the title of the paper…

…But as you can probably guess by now, that’s simply not the truth.

MAA was found in China, but not reported

Hi-Tech Pharma’s court documents allege that “One of the four laboratories working on the Multi-Center Study reported to Drs. Khan and ElSohly in April 2013 that it had indeed detected DMAA in several geranium samples from China”[10] but “The positive DMAA test results did not make their way into the article”.

The evidence is in the emails:[38]

Note: The trick to reading the below evidence is to start at the “End of Email Thread” in the middle of the image, and work your way up through time. Then you can see the Attached Unpublished data that backs up the DMAA finding.

DMAA Found in Geranium in Ikhlas Khan's Multi-Center Study

Start at the point where it says “End of email thread” and read up. Then you can read the attached, unpublished data that backs up the DMAA finding.

So what happened here? Our interpretation is this:

  1. One of the head researchers (Mahmoud ElSohly) requested everyone’s data, since he had a presentation coming up.
  2. One of the researchers in China (at the Shanghai Institute of Materia Medica) sent his data. It turns out that he did in fact find minute levels of DMAA in geranium plant material.
  3. The other head researcher confirmed that he had indeed found 2ng. He then asked for further confirmation — how do you know this is a valid 2ng measurement?
  4. The researcher responded that he measured 2ng of known raw DMAA mixed in solution, and got a 2ng reading. He then added that known 2ng DMAA to the plant material which had originally measured as 2ng DMAA, took another reading, and voila, got nearly 4ng material (the peaks were double the original amount, as expected).

This confirms that not only was there some amount of DMAA in the plant material, but also that the measurement device was clearly capable of measuring such numbers.

Unfortunately, these positive findings were never once mentioned in the published paper.

Just like with the other studies, it gets crazier.

The deposition with Ikhlas Khan,[14] the researcher involved in the emails, is a wild read. It can be assumed that English is his second language, so there will be some misunderstandings, but the back-and-forth between Khan and Hi-Tech’s lawyer is full of non-answers, circular reasoning, and possibly even perjury according to Jared Wheat (although that can’t be confirmed).

Take for instance, when he was asked about the findings and why they were never in the published paper and when they confirmed that it could not be found:[14 – Page 144]

Iklas Khan: One study required several paper, full publication. This is summarizing the finding of four labs in one paper. So generally, in scientific community you provide the supplement data and do not make it very heavy publication with all the details. So yes, details are not available but it should be made available in supplemental data.
Hi-Tech Lawyer: Uh-huh. And in — in the conclusion to your report is: “27 different samples of the Pelargonium plant material and oils from a  variety of sources were analyzed by four different laboratories. None of the laboratories found any MHA in any of the samples at the detection levels of the methods used. These results support previous reports that MHA found in dietary supplements is not of natural origin.” Correct?
Iklas Khan: Yes.
Hi-Tech Lawyer: Correct. But yet we have an MRM in Exhibit 9 that shows the detection of DMAA in plant material; correct?
Iklas Khan: No, we did not find.
Hi-Tech Lawyer: Isn’t that what this Exhibit 9 says? Isn’t that what the MRM says? That MHA was detected?
Iklas Khan: This is confirmation. This is in April. In May, he asked you to — to look at your data back. You read the email with it saying — not saying that you — to hide the results. He is saying confirm, because you are finding something, so you better confirm it. And that’s a confirmation.
Hi-Tech Lawyer: I — tell me in this email where you see any effort to do additional research to confirm.
Iklas Khan: How do you confirm without doing additional research?
Hi-Tech Lawyer: That’s what I’m asking you.
Iklas Khan: That — that’s what I’m saying. They should — data should be there.
Hi-Tech Lawyer: Well, if you can find the data, we’d love to see it.
Iklas Khan: Yes.

So in the above exchange during that deposition (which is recorded by a court reporter and subject to felony-level laws like perjury), Hi-Tech’s lawyer is questioning the researcher about the data showing DMAA being found in geranium in China. The researcher claims that you must confirm it. But when asked whether or not there was really an effort to confirm it, he will not give a straight answer.

If you’re going to purposefully hide valid information from us, can you at least do it on your own dime?

This happens in several parts of this twisted and convoluted deposition. Hi-Tech’s lawyers cannot figure out how the evidence shows that DMAA was found but not published in the paper, all while there is no public nor discovery-based evidence showing any actual attempts to actually confirm or “unconfirm” those findings!

Unsurprisingly, in their motion for summary judgment, the US Federal Government (FDA) chose not to use this witness testimony as part of their arguments after these emails were discovered.

They failed to get geraniums from the Chinese region found to contain DMAA

Further, we would love to see those sealed “strategy” emails, because we have to ask whether this study was predetermined to fail, given that the researchers never obtained geranium samples from the Chinese provinces where DMAA had been repeatedly found.

We return to Khan’s deposition to discuss this one, starting on page 119:[14]

Hi-Tech Lawyer: Okay. And the samples that you got from China, what region of China did they come from?
Iklas Khan: This sample was collected by the same person who collected the sample for the studies for Fleming and Li, and they come from Yunnan (phonetic) province.
Hi-Tech Lawyer: And the samples that Dr. Fleming, Dr. Li both tested and confirmed had DMAA in it, what region of China did those samples come from?
Iklas Khan: They found DMAA in dia — in the — in diastereomeric form, sample they analyzed, so I hope it does not imply that they found naturally Having said that —
Iklas Khan: But the samples were, if I recollect, they were Yunnan (phonetic), Guizhou (phonetic), and Changzhou (phonetic) region, which are almost three — close to 2,000 kilometer apart from each other.
Hi-Tech Lawyer: So you didn’t collect any samples for your study from the Changzhou region; correct?
Iklas Khan: No, because we asked the person in China — for us to analyze the sample, we have to contact somebody where we can get the sample from, and that person was the one that provided from the Yunnan province sample, so we assumed that he is going to provide the similar region sample.
Hi-Tech Lawyer: You assumed. What did you do to confirm that?
Iklas Khan: Because that’s what the Yunnan sample that came from provided by the same person.
Hi-Tech Lawyer: But you didn’t get a sample from the Changzhou region; correct?
Iklas Khan: Yes, we did not got the sample from Changzhou.
Hi-Tech Lawyer: Okay. And — and you didn’t run the sample from the Yunnan region against the sample from — against a sample from the Changzhou region; correct?
Iklas Khan: We asked the person in China to provide us the Pelargonium samples. If he would have provided from 10 different places, we would have taken 10. We did not tell them to provide only from Yunnan.
Hi-Tech Lawyer: Okay. But you didn’t also ask him to provide you one from Changzhou either, did you?
Iklas Khan: There is no reason for us to because we are not trying to repeat somebody’s study.

[emphasis ours]

This back and forth goes on for a while, with the same results – they didn’t get a sample from the Changzhou region, an area where DMAA had been repeatedly found in geraniums by the above studies, nor did they try to get one from that area.

They simply “blame” the botanist and move on, without even attempting to replicate the other studies’ findings. Which, by the way, was a primary purpose of this study!!

Level of detection tinkering

And once again, we get the same tinkering of levels of detection as we did with their first study. Even if your equipment can successfully measure 2ng and 4ng amounts — admittedly minuscule numbers — apparently you can simply set your “level of detection” at an arbitrary number above it and never mention it again.

The name of this study warrants retraction

Further, just like Khan and ElSohly’s other study, this one is egregiously named. DMAA was clearly not “not detectable”, given that one center of the study did indeed detect it.

DMAA Found in Geranium in Khan's Multi-Center Study - Preview

“Not detectable” says the title? Not so fast…

If you want to say that it’s “hardly detectable”, then that would be fine. But “not detectable” is quite a binary statement – and the wrong one to boot.

Given that this title is simply incorrect, we once again request that the FDA and Ikhlas Khan and Mahmoud ElSohly retract this paper.

Ikhlas Khan’s Preposterous Deposition

More ridiculousness from Khan’s deposition:[14]

Hi-Tech Lawyer: Where in the paper does it discuss the fact that there was a detection that was subsequently eliminated?  Nowhere; correct? Nowhere in this paper does it discuss there was a possible detection that was eliminated?
Iklas Khan: This is — is work in progress.
Hi-Tech Lawyer: This is a published paper.

How does an experienced researcher call a published paper a “work in progress”? Our government trusts this for actual decision-making?

We could go on forever with this deposition, as it’s filled with non-answers, belligerent arguments (such as Khan stating “If you found these emails, I’m sure you should have all the data too”), and quite ‘conveniently-timed’ spouts of unintelligible English that derail the conversation.

It’s simultaneously fascinating and concerning that the FDA based its warning letters off of this study, alongside the others that also detected DMAA in geraniums. If you’re seriously interested in this case, this Khan deposition is off the wall.

Large amounts weren’t found, but they were detected nonetheless

Anyway, the point is that DMAA was found yet not published as such, and the workaround was simply to raise levels of detection or claim the data was not validated (but show no evidence of attempt at invalidation).

And even without that said, the title of the paper is still incorrect and misleading.

Are you an American taxpayer? Then you paid for this calamity

Best part of this study? It was paid for by the American Taxpayer, as the FDA provided at least 2.3 MILLION DOLLARS to get this study done[14,39] — and we cannot even see all of the data nor research behind it.

What ever happened to this being the “most transparent administration in history”??[40] If you’re going to purposefully hide valid information from us, can you at least do it on your own dime?

Objections to this study

The FDA - Food and Drug Administration

Like it or not, DMAA is found in geraniums, even if in extremely small amounts. Now what is the US Government hiding in Daniel Fabricant’s emails, and why?

Once again, court documents show that DMAA was indeed detected in the geranium samples – even if at miniscule doses – but they were never published nor reported in supplemental data, and the title itself dicatotes otherwise. Further, there has been no proof provided that those positive findings could be invalidated (or that there was even an attempt to invalidate them), which lends to the further lack of credibility of those involved.

Worse, American taxpayers footed the bill for this calamity, and it took Hi-Tech Pharmaceuticals spending over a million dollars in legal fees for us to see how the sausage was really made.

Due to the political nature of this study’s funding, its incorrect title, the suspiciously manicured wording, and incomplete dataset, this published study should not be considered when determining whether or not DMAA can be found in nature.

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References

The following is a list of references from all sources cited in this entire series of articles:

  1. Ping Z, Jun Q, Qing L; “A study on the chemical constituents of geranium oil” (with corrections); Guizhou Inst Technol 25(1):82-85; 1996;  https://blog.priceplow.com/wp-content/uploads/hi-tech-vs-fda-20161230-wenik-exhibit-53-ping-study-translated.pdf
  2. Ping Z, Jun Q, Qing L; “A study on the chemical constituents of geranium oil” (with original parts); Guizhou Inst Technol 25(1):82-85; 1996; https://blog.priceplow.com/wp-content/uploads/ping-chemical-constituents-of-geranium-oil-1996-original-parts.pdf
  3. USPLabs; “First Response Letter to Warning Letter No. 285519”; May 15, 2012; https://blog.priceplow.com/wp-content/uploads/usplabs-fda-warning-letter-response-1-20120515.pdf
  4. Hi-Tech Pharmaceuticals; Exhibit 6: Email from Robert Moore to Amy Eichner; November 29, 2010; https://blog.priceplow.com/wp-content/uploads/hi-tech-vs-fda-20161230-wenik-exhibit-06-robert-moore-fda-email-geranium-dmaa.pdf
  5. Thomas, Jennifer A; “Response Letter to USP Labs LLC Concerning DMAA”; Division of Enforcement, Office of Compliance, Center for Food Safety and Applied Nutrition, Food and Drug Administration; April 18, 2013; https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/CFSANFOIAElectronicReadingRoom/ucm350199.htm
  6. Li, J.S., M. Chen, and Z.C. Li. “Identification and Quantification of Dimethylamylamine in Geranium by Liquid Chromatography Tandem Mass Spectrometry.” Analytical Chemistry Insights 7 (2012): 47–58; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3422085/
  7. Fleming, Heather L., Patricia L. Ranaivo, and Paul S. Simone. “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.” Analytical Chemistry Insights 7 (2012): 59–78; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3512447/
  8. Roosevelt, Michael W; “Warning Letter to USPLabs”; Office of Compliance, Center for Food Safety and Applied Nutrition, Food and Drug Administration; April 24, 2012; https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm302167.htm
  9. Mahmoud A. ElSohly, Waseem Gul, Kareem M. ElSohly, Timothy P. Murphy, Aroona Weerasooriya, Amar G. Chittiboyina, Bharathi Avula, Ikhlas Khan, Amy Eichner, Larry D Bowers; “Pelargonium Oil and Methyl Hexaneamine (MHA): Analytical Approaches Supporting the Absence of MHA in Authenticated Pelargonium graveolens Plant Material and Oil”; J Anal Toxicol (2012) 36 (7): 457-471; June 25, 2012; https://academic.oup.com/jat/article/36/7/457/828772/Pelargonium-Oil-and-Methyl-Hexaneamine-MHA (PDF available at https://blog.priceplow.com/wp-content/uploads/study-where-dmaa-was-detected-in-the-ppb-range-but-not-published-with-that-information-20120625.pdf)
  10. Hi-Tech Pharmaceuticals; “Statement of Undisputed Material Facts”; Hi-Tech Pharmaceuticals vs. FDA; December 30, 2016; https://blog.priceplow.com/wp-content/uploads/hi-tech-vs-fda-20161230-hi-tech-pharma-statement-of-undisputed-material-facts.pdf
  11. Hi-Tech Pharmaceuticals; Exhibit 8: Email Correspondence Between Amy Eichner (USADA – US Anti Doping Agency), Dan Fabricant (FDA), ; April 13, 2011; https://blog.priceplow.com/wp-content/uploads/hi-tech-vs-fda-20161230-wenik-exhibit-08-amy-eichner-dan-fabricant-robert-moore-email.pdf
  12. Hi-Tech Pharmaceuticals; Exhibit 12: Consulting Contract Between Mahmoud ElSohly (Phytochemical Services Incorporated) and Amy Eichner (USADA – US Anti Doping Agency); April 22, 2011; https://blog.priceplow.com/wp-content/uploads/hi-tech-vs-fda-20161230-wenik-exhibit-12-amy-eichner-elsohly-email-consulting-contract.pdf
  13. Hi-Tech Pharmaceuticals; Exhibit 4: Deposition of Amy Eichner (USADA – US Anti Doping Agency); December 14, 2016; https://blog.priceplow.com/wp-content/uploads/hi-tech-vs-fda-20161230-wenik-exhibit-04-amy-eichner-deposition.pdf
  14. Hi-Tech Pharmaceuticals; Exhibit 11: Deposition of Ikhlas Khan; October 26, 2016; https://blog.priceplow.com/wp-content/uploads/hi-tech-vs-fda-20161230-wenik-exhibit-11-ikhlas-khan-deposition-20161026.pdf
  15. Hi-Tech Pharmaceuticals; Exhibit 9; Email Correspondence between Amy Eichner (USADA – US Anti Doping Agency) and Dan Levy (NSF); December 1, 2010; https://blog.priceplow.com/wp-content/uploads/hi-tech-vs-fda-20161230-wenik-exhibit-09-amy-eichner-dan_levy-NSF-email-20101201.pdf
  16. Hi-Tech Pharmaceuticals; Exhibit 13; Email Correspondence between Mahmood ElSohly, Amy Eichner (USADA – US Anti Doping Agency), Larry Bowers (USADA), Ikhlas Khan, and Waseem Gul; May 27, 2011; https://blog.priceplow.com/wp-content/uploads/hi-tech-vs-fda-20161230-wenik-exhibit-13-mahmood-elsohly-finds-dmaa-in-geranium-emails-20110527.pdf
  17. Hi-Tech Pharmaceuticals; Exhibit 14; Email Correspondence between Mahmood ElSohly, Amy Eichner (USADA – US Anti Doping Agency), Larry Bowers (USADA), Ikhlas Khan, and Waseem Gul; https://blog.priceplow.com/wp-content/uploads/hi-tech-vs-fda-20161230-wenik-exhibit-14-mahmood-el-sohly-change-dmaa-detection-limits-20110601.pdf
  18. Gauthier, Thomas D. “Evidence for the Presence of 1,3-Dimethylamylamine (1,3-DMAA) in Geranium Plant Materials.” Analytical Chemistry Insights 8 (2013): 29–40; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3682735/
  19. Ying Zhang, Ross M. Woods, Zachary S. Breitbach, Daniel W. Armstrong; “1,3-Dimethylamylamine (DMAA) in supplements and geranium products: natural or synthetic?”; Drug Testing and Analysis; Volume 4, Issue 12, pages 986–990; December 2012; http://onlinelibrary.wiley.com/doi/10.1002/dta.1368/abstract (full-text available at next citation)
  20. Hi-Tech Pharmaceuticals; Exhibit 18; Ying Zhang, Ross M. Woods, Zachary S. Breitbach, Daniel W. Armstrong; “1,3-Dimethylamylamine (DMAA) in supplements and geranium products: natural or synthetic?” – Published version with Markup; Drug Testing and Analysis; Volume 4, Issue 12, pages 986–990; December 2012; https://blog.priceplow.com/wp-content/uploads/hi-tech-vs-fda-20161230-wenik-exhibit-18-daniel_armstrong_study-published-version-marked.pdf
  21. Hi-Tech Pharmaceuticals; Exhibit 17; Ying Zhang, Ross M. Woods, Zachary S. Breitbach, Daniel W. Armstrong; “1,3-Dimethylamylamine (DMAA) in supplements and geranium products: natural or synthetic?” – UNPUBLISHED version; https://blog.priceplow.com/wp-content/uploads/hi-tech-vs-fda-20161230-wenik-exhibit-17-daniel_armstrong_study-unpublished-version-unmarked.pdf
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  27. Hi-Tech Pharmaceuticals; Exhibit 16; Communications between Elaine Watson (NutraIngredients-USA), Lori Bestervelt (NSF), Amy Eichner (USADA), and Mahmoud ElSohly Regarding Embargoed Armstrong Study; May 22-23, 2012; https://blog.priceplow.com/wp-content/uploads/hi-tech-vs-fda-20161230-wenik-exhibit-16-embargoed-armstrong-study-shared-to-researchers-20120523.pdf
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  29. Watson, Elaine; “USPLabs promises new data that ‘definitively’ proves presence of DMAA in geranium”; NutraIngredients-USA; July 16, 2012;  http://www.nutraingredients-usa.com/Research/USPLabs-promises-new-data-that-definitively-proves-presence-of-DMAA-in-geranium
  30. USPLabs; “Second Response Letter to Warning Letter No. 285519”; September 28, 2012; http://dmaaresearch.com/docs/FDA%20Warning%20Letter%20DMAA%20September%2028%202012%202nd%20Response.pdf (archived at https://blog.priceplow.com/wp-content/uploads/usplabs-fda-warning-letter-response-2-20120928.pdf)
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  32. PricePlow Blog; “$8 Million Worth of Jack3d and OxyELITE Pro… Down the Drain”; July 17, 2013;  https://blog.priceplow.com/jack3d-oxyelite-pro-destroyed
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  36. Mahmoud A. ElSohly, Waseem Gul, Candice Tolbert, Kareem M. ElSohly, Timothy P. Murphy, Bharathi Avula, Amar G. Chittiboyina, Mei Wang, Ikhlas A. Khan, Min Yang, Dean Guo, Wei-Dong Zhang, Juan Su; “Methylhexanamine is not detectable in Pelargonium or Geranium species and their essential oils: A multi-centre investigation”; Drug Testing and Analysis; Volume 7, Issue 7; July 2015; Pages 645–654; http://onlinelibrary.wiley.com/doi/10.1002/dta.1726/abstract
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  45. Angelo Lisi, N. Hasick, R. Kazlauskas, C. Goebel; “Studies of methylhexaneamine in supplements and geranium oil”; Drug Testing and Analysis; Volume 3, Issue 11-12; November-December 2011 ; Pages 873–876; http://onlinelibrary.wiley.com/doi/10.1002/dta.392/abstract (full-text available at https://www.docdroid.net and https://www.webcitation.org/6sFt9cZbM)
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