The Final Countdown in Hi-Tech Pharmaceuticals Fight for DMAA

ATLANTA, June 14, 2018 /PRNewswire/ -- Jared Wheat, CEO of Hi-Tech Pharmaceuticals, released the following statement in response to inquiries on the status of DMAA:  Hi-Tech Pharmaceuticals sued the FDA November 5th, 2013 in Federal Court-Case 1:13-cv-01747, claiming the agency bypassed standard rule-making procedures in favor of a bullying campaign to try to force companies to destroy their products containing 1,3 dimethylamylamine, or DMAA.  "DMAA has existed in the food supply for many years," the complaint states. "Hi-Tech has sold over a million bottles of dietary supplement products containing this ingredient without any adverse event reports." A key issue in this case is whether the substance 1,3-Dimethylamylamine HCL ("DMAA") is a naturally occurring constituent of the geranium plant.

Hi-Tech has presented two experts' about DMAA having been found in geranium. In August of 2012, an article was published in Analytical Chemistry Insights by Charlie Li, which found that DMAA was in geraniums. J.S. Li, M. Chen, and Z.C. Li, Identification and Quantification of Dimethylamylamine in Geranium by Liquid Chromatography Tandem Mass Spectrometry, Analytical Chemistry Insights 2012:7 47-58.  It also presented Dr. Paul Simone who published Analysis and Confirmation of 1,3-DMAA and 1,4-DMAA in Geranium Plants Using High Performance Liquid Chromatography with Tandem Mass Spectrometry... Hi-Tech has also presented expert testimony of the safety of DMAA by Dr.Mitchell Elkind, Dr. Marvin Heuer, and Dr. Matthew Lee.

The Court wrongly concluded that for a substance to be considered a "botanical" that there must be at least some history of the substance in question having been extracted in usable quantities from a plant or a plant-like organism. According to the Court, "[t]o hold otherwise would be to open the door to bogus claims that, for example, a given chemical had been detected in a fungus found only in a remote Tibetan river valley, and the FDA would be left to refute that claim – to prove a negative – which the instant case demonstrates is not easily done."

It is Hi-Tech's position that the Judge's conclusion constitutes clear error in the following respects:

1. This is not the scenario of a rare Tibetan plant, but rather common geraniums that have been in the food supply for decades;
2. There was no evidence that DMAA had not been extracted from plants in commercial quantities.  To the contrary, there is a patent application for just such an extracting process in the record; and
3. There is no legislative history or legal support for the Court's novel interpretation of DSHEA's definition of botanicals, and the Government did not even make an argument for any such interpretation. 

The Government's Antics Discovered During Litigation: The saga of the Government's war against DMAA begins sometime in 2010. Somewhere in that time frame, Amy Eichner, an official of the United States Anti-Doping Agency ("USADA"), with virtually no training or expertise in chemistry became convinced that DMAA presented a health risk to athletes. Eichner took her concerns to the Food and Drug Administration ("FDA"). on October 13, 2010. Dr. Robert J. Moore, an FDA supervisor in the Division of Dietary Supplements, advised Eichner that DMAA "is found in many plants," that plants are dietary ingredients under DSHEA, and that DMAA "appears to be a dietary ingredient under [DSHEA] because it is a constituent of another dietary ingredient (i.e., a plant)." Wenik Decl., Ex. 8, October 2010 through April 2011 email correspondence between Amy Eichner, Robert Moore, and Daniel Fabricant regarding the presence of DMAA in geranium. Later that same day, Dr. Moore advised Eichner that DMAA could be found in geranium oil which had "a fairly long history of food use as an essential oil" and also provided her the cite to a 1996 scientific study by Ping that had detected DMAA in geranium oil.

Things did not go as Eichner had planned. On May 27, 2011, she told Drs. Khan and ElSohly that she had heard a rumor that other researchers had detected DMAA in geranium oil and she was concerned how this might affect their efforts to lobby FDA regarding DMAA. Dr. ElSohly responded by informing Eichner that he and his colleagues had developed a very sensitive method to detect DMAA and that they had indeed found low levels of DMAA in the geranium samples that Eichner had supplied to them. Undaunted, Eichner and her colleague at the USADA, Larry Bowers, agreed with Drs. ElSohly and Khan that the issue could be avoided by simply raising the detection limit in the published article so that a finding that no DMAA was detected could be reported. It also appears that Eichner had a hand in having other test results that showed DMAA to be contained in geraniums suppressed from public view. A team at the University of Texas, including Ying Zhang and Daniel Armstrong, was also looking at the question of whether DMAA was in geraniums in the spring of 2012. Somehow Eichner gained access to an unpublished version of Zhang and Armstrong's results and she forwarded it to Drs. Khan and ElSohly. The version of the Zhang/Armstrong article of 2012 that Eichner reviewed reported the detection of DMAA in significant amounts in two of eight geranium samples. However, once in the hands of Drs. Khan and ElSohly, the published version reported no detection of DMAA. Dr. Khan's was deposed on October 26, 2016. During the deposition, it became clear that Dr. Khan's opinions were based upon facts and data that the Government failed to produce to Hi-Tech in discovery. As Dr. Khan admitted during his deposition, during the course of the Multi-Center Study, testing conducted by the Shanghai Institute revealed that DMAA was detected in some of the samples tested.

The Government's persecution of DMAA and Hi-Tech is outside the pale of the basic premise of ethics. The government prosecutors have gone to great lengths to hide the fact that the declarations and reports of Dr. Khan. The government prosecutors spent months trying to prevent Hi-Tech from gaining this damning information to use during its case and the deposition of Dr. Khan. Instead of doing what a prosecutor is in office to do, which is seek the truth--- government lawyers have obstructed Hi-Tech and its lawyers at every turn to protect its chief witness. Hi-Tech finds it hard to understand the actions by those who have sworn to uphold our laws and [t]he government, which are clearly treading in very shallow water here.

The government's investigation and prosecution of Hi-Tech has been permeated by the systematic concealment of significant exculpatory evidence which would have independently corroborated Hi-Tech's defense and its experts testimony, and seriously damaged the testimony and credibility of the government's key witness. The recent stunning revelations of the prosecutors withholding evidence finally makes sense why they obstructed Hi-Tech at every turn when it has tried to get records from the University of Mississippi. The government's lawyers allowed false declarations and reports from Dr. Khan to be introduced into evidence although he knew they were inaccurate. "This is not about mistakes," countered Jared Wheat, CEO of Hi-Tech Pharmaceuticals. "This is not about negligence. This is not about incompetence. This is about intentional wrongdoing."

Hi-Tech believes that the Court's failure to find that DMAA is a constituent of a botanical, which would have led to Hi-Tech winning on summary judgment, constitutes reversible error. Hi-Tech's  appeal to the Eleventh Circuit will be heard the week of August 14th.  Hi-Tech expect to prevail at the 11th Circuit and be offering DMAA to its consumers again in short order.

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SOURCE Hi-Tech Pharmaceuticals, Inc.