ATLANTA, April 18, 2017 /PRNewswire/ — Hi-Tech Pharmaceuticals, Inc. (Hi-Tech) wants to give an update to the industry on how the battle for the ability to keep DMAA legal and available to our consumers is progressing.

The Court’s holding was erroneous should be vacated for two reasons. First, there is no requirement under DSHEA––in the statute, the legislative history, or the case law––that a substance only qualifies as dietary ingredient if it can be extracted in «usable quantities.» In fact, DSHEA clearly states that the «constituents» of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical.

Importantly, the Government agreed with this interpretation of DSHEA. Simply put, the Court’s conclusion otherwise impermissibly interjected its policy opinions in place of statutory interpretation. The Court’s conclusion is thus reversible legal error and must be reconsidered.

Second, the Court entered summary judgment resolving a factual issue–– whether DMAA can be extracted from geraniums in «usable quantities»––based on an incomplete record. The case law is clear: sua sponte entry of summary judgment on a factual issue that was not fully developed, which no party advocated, and which the losing party neither had been properly noticed nor provided an opportunity to present evidence regarding, is inappropriate as well as reversible error. Moreover, this finding ignored certain evidence in the record, which Claimants are entitled to supplement, regarding the ability to extract DMAA from geraniums in «usable quantities.» The Court committed an error by relying on this incomplete factual record to grant summary judgment. The April 3 Order should be vacated on this basis as well and the judgment and order should be vacated.

Furthermore, the Court rejected the Government’s three main critiques of scientific papers failing to detect DMAA, explaining: (1) the papers cited by the Government that did not detect DMAA «may not have been suitable for [detection] of DMAA due to its volatility;» (2) Dr. Paula Brown’s testimony regarding the ability of geraniums to produce DMAA was not «unequivocal» and did not provide anything «close to uncontroverted evidence that geraniums cannot make DMAA;» and (3) the Government’s claims that DMAA detected in geraniums was the result of contamination «fail[ed] to address the fact that other studies did find DMAA.»Id. at 5-6. As such, the Court was «unswayed by the Government’s argument that it is impossible for the geranium in question to synthesize DMAA,» and concluded that «the question as presented by the parties is whether DMAA has been detected in geraniums, not how the geraniums happened to put the chemical there. . . this Court would be inclined to find that the Government has failed to meet its burden of establishing that DMAA has been found in geraniums.» Id. at 6-7. We believe that because this was the dispositive issue in this case, that should have been the end of the Court’s analysis and summary judgment should have been entered in favor of Hi-Tech.

The Court’s ensuing analysis, however, suffered from a key legal error. Absent any briefing on the point from either Claimants or the Government, the Court concluded that «in using the term botanical, Congress intended 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 . . . .» Id. at 9 (emphasis added). The Court cited no reference within DSHEA, its legislative history, or the case law to support this novel position. Moreover, this interpretation ignores the fact that Congress clearly could have, but did not, include a requirement that a substance qualifies as «a concentrate, metabolite, constituent, extract, or combination» of a dietary ingredient only if it can be extracted in «usable quantities.» By engrafting this novel «usable quantity» requirement onto 21 U.S.C. Section 321(ff)(1), the Court has impermissibly encroached on the policy making prerogative of Congress. Simply put, there is no requirement that any such extract or constituent be present in anything above «trace» quantities.

Notably, the Government in its briefing did not even advocate the position reached by the Court. See Gov’t Motion for Summary Judgment, Doc. No. 107-1,at 1 («The issue in this case is whether [DMAA] is a ‘dietary ingredient’ . . . . To decide this issue, this Court needs to resolve [whether] DMAA is naturally produced by geranium plants[.]»). The Government––similar to Claimants––took the position that the presence of DMAA in geraniums, even in trace amounts, would render it a dietary ingredient under DSHEA. In fact, the Government’s Answer acknowledged that the mere fact that the DMAA used in Claimants’ products is synthetic has no bearing on whether DMAA qualifies as a dietary ingredient so long as it is a constituent of the geranium plant. Answer of United States, Doc. No. 52, ¶ 14; see also Ex. 35, Welch Dep. at 27:7-27:23 (the Government’s regulatory expert, Dr. Cara Welch, testified that synthetic ingredients can be dietary ingredients under DSHEA). Moreover, the Court accepted the parties’ position that synthetically produced DMAA could qualify as a botanical under DSHEA. See April 3 Order at 8.

The April 3 Order simply ignores the import of the final subsection of this key part of DSHEA. Rather than focus on the definition of «constituent,» which is the relevant definition, the Court instead focused on the definition of «botanical,» concluding that «[i]n normal usage, a botanical is a plant, a part of a plant, or a substance that is derived from a plant for a medicinal, cosmetic, or other purpose.» April 3 Order at 8. Hi-Tech take no umbrage with the Court’s definition of botanical. What is missing, however, is an analysis of what a constituent of a botanical is under DSHEA. As noted above, Congress explicitly included «constituents» of botanicals as dietary ingredients under DSHEA and did not set any quantitative limit as to what qualifies as such. See 21 U.S.C. Section 321(ff)(1)(F). Based on this irrefutable definition of «constituent,» DMAA qualifies as a dietary ingredient, even if it is only present at «trace» levels in geraniums. The Court’s reading of DSHEA simply reads the word constituent out of the statute in order to further the Court’s opinion about what it thinks Congress conceivably or «inconceivabl[y]» meant when it drafted DSHEA.

Lastly, aside from DMAA, there are numerous other constituents of organic substances that naturally occur in minute quantities which are made synthetically for dietary supplements. For example, both Resveratrol, an ingredient in grapes (and in wine) and CoQ10, which is an antioxidant that is synthesized in the body and is found in foods such as beef, chicken, fish, peanuts, and strawberries, can be commercially synthesized and are routinely included in dietary supplements. Both of these substances have long been recognized as dietary ingredients under DSHEA. Yet, Resveratrol is found only in very small amounts in red wines, which have a Resveratrol content (per 5-oz glass) of 0.03-1.07 mg, which is approximately the same levels DMAA is found in the plant.

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 is optimistic that its motion to reconsider will be successful and this will be the end of the litigation and the fight over DMAA will be concluded. If it is not, however, Hi-Tech will appeal to the Eleventh Circuit and take it all the way to the Supreme Court if necessary. This could extend this litigation for several more years. Hi-Tech’s CEO, Jared Wheat, quotes John Paul Jones and says… «I have not yet begun to fight!» Hi-Tech will of course continue to supply its customers with DMAA-containing products until there is a final, judicial determination.

 

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SOURCE Hi-Tech Pharmaceuticals, Inc.