Hi-Tech Pharmaceuticals, Citing 'a Witch Hunt,' Responds To Government Allegations

News provided by

Jun 13, 2018, 08:15 ET

NORCROSS, Ga., June 13, 2018 /PRNewswire/ -- Hi-Tech Pharmaceuticals responds to the Government "Witch hunt" against it and its efforts to stop it from selling lawful dietary supplements. The Government in its zeal to stop Hi-Tech from selling DMAA, DHEA and other lawful dietary supplements circumvented telling the grand jury the truth about Hi-Tech's dietary testosterone boosters and prohormone products. The Government's current and absurd position in its indictment omits the fact that only trace amounts of the substances may have been found in Hi-Tech products, thereby misleading the grand jury and the public as to the facts upon which the indictment was brought against Hi-Tech. For instance, the evidence indicates that upon learning only trace amounts of the substances were detected, the government exhibited a willful blindness to these circumstances, and then compounded this reckless conduct by affirmatively instructing the FDA laboratory not to quantify those substances. The recently produced laboratory documents produced reveal the Government's dogged determination to indict Hi-Tech no matter what laboratory testing of Hi-Tech's products revealed – or did not reveal. Indeed, the recent production reveals that the Government tested each of the five products in November of 2016 by two different methods (single and double mass spectrometry) and did not detect controlled substances in any of the products. The government case agent specifically did not want confirmation of just how low the trace levels of these substances were, as evidenced by a telephone call he had with the FDA lab the day before the last and most sensitive round of testing was performed. In this call, the FDA chemist asked him if he wanted quantification testing performed if only trace amounts of scheduled substances were detected, and he said, "no." Simply put, this is not the conduct of a government charge with a good faith belief that a crime actually occurred.

The Government initial testing as stated above showed no steroids were found in Hi-Tech's products, nonetheless they decided to repeat testing the following month using different and/or increasingly sensitive methods. This time, the test results for the products came back with one of the three following results: (1) no controlled substances detected (again); (2) a questionable identification of a controlled substance; or (3) only a trace amount of a controlled substance. Again, not what the Government was looking for from a company it had decided to indict regardless of the facts. So, the Government tested the products yet again in January of 2017 using various methods, this time including triple mass spectrometry, an even more sensitive method. On this last attempt, tests on each of the products detected a trace amount of a controlled substance – even with the Androdiol and Superdrol products, for which all five prior tests resulted in no finding of a controlled substance. Thus, the various testing methods employed did not all agree on whether a controlled substance was present in any of the products. Notably, only trace levels could be detected by even the most sensitive of methods, and the levels of these substances could be present in amounts as low as 10 billionths of a gram. These trace amounts are so low that the Schedule III substances would not be "biologically active" upon oral administration, or would not have any favorable or harmful effect on the body to include injury to the health of the person consuming the substance.

What the government also failed to inform the grand jury was that the "prohormone" advertised as being in Hi-Tech's products, dehydroepiandrosterone ("DHEA"), is expressly exempted from the definition of "anabolic steroid" by statute. 21 U.S.C. § 802(41)(A) & (C). As to the nature of the products being sold, the fact that only trace amounts of the Schedule III substances were detected (if at all) is critical to whether a company broke the law because the detection of trace amounts of such substances does not indicate that a crime has taken place. First, the law does not concern itself with all technical violations of the Food, Drug, and Cosmetic Act ("FDCA"). As recognized by the Food and Drug Administration ("FDA"), "it is not possible to produce food or food ingredients that are entirely free from contamination by foreign substances or impurities." Poisonous or Deleterious Substances, Food and Drug Admin., 42 Fed. Reg. 190 (Sept. 30, 1977); see also United States v. Articles … Provimi, 425 F.Supp. 228, 229 (D.N.J. 1977) ("Whether an article in interstate commerce is a food or a drug, the court is well aware that no named substance, whatever it may be, can be 'absolutely pure.'") Thus, the long-recognized "de minimis" doctrine in food and drug law mitigates against unjustifiably harsh consequences of an overly literal interpretation of FDA regulations. In United States v. 900 Cases Peaches, 390 F.Supp. 1006, 1010 the Court stated that strict enforcement "would set a standard which 'would ban all processed food from interstate commerce'"). Additionally, the fact that only trace amounts of the substances may have been detected demonstrates not only that Hi-Tech lacked the requisite intent to commit the felonies, but also that no crime was actually committed in this case under 21 U.S.C. §§ 331, 343, and 841.

For instance, in United States v. Chin Chong, 990 F.Supp.2d 320, 322–23 (E.D.N.Y. 2014), the Government argued that "the knowing importation of a single molecule of a controlled substance constitutes a felony offense, emphasizing that the plain language of [the controlled substances import/export statute] contains no minimum-quantity requirement." In response, the Court noted that: Credible studies indicate that as much as 90% of the paper currency in the United States is contaminated with a "detectable amount" of cocaine. These studies are known not just to the courts, law enforcement, and forensic chemists, but to members of the general public. Would a knowledgeable judge with a contaminated $10 bill carried in his wallet on return to the United States from a judicial conference in London be committing a serious drug crime? The government's wooden interpretation of [the controlled substances import/export statute] would dictate that any individual who enters the United States with a modest amount of United States currency has committed a felony drug offense, assuming the traveler is familiar with the contents of her wallet and these well-known facts on contamination referred to above. In this case, if the government had provided the grand jury with the fact that only trace amounts of controlled substances were detected in Hi-Tech's products, the Government would be taking the similarly untenable position that even a trace amount of such a substance is sufficient to charge a company with a crime – a position that would also provide for charges to be filed against every bank, every hemp and poppy seed producer, and likely every processed food manufacturer in the country.

In actuality, neither the law nor the Government (outside of this case) are deaf to the reality that trace amounts of controlled substances are all around us. For example: The Department of Health and Human Services ("HHS") acknowledges that codeine and morphine are present in poppy seeds in an amount sufficient to cause a urine specimen to test positive for those opioids. As explained by HHS, "[e]ating a normal dietary amount of poppy seeds" can lead to a "substantial" concentration of morphine in the urine. Dept. of Health and Human Serv., Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs, at 5-6 and 5-8 (2017). If selling poppy seeds was illegal then every coffee shop and bakery would be closed down and their owners would be put in jail. That clearly is not the law. Additionally, various state legislatures have taken steps to ensure the legality of "industrial hemp" from the plant cannabis sativa, defining the term to include parts and varieties of the plant containing a specified amount of the controlled substance tetrahydrocannabinol ("THC"). See, e.g., W. Va. Code § 19-12E-3(2); Ind. Code § 15-15-13-6; M.G.L.A. 128 § 116; see also 7 U.S.C. § 5940.

The newly disclosed evidence shows the government purposefully withheld critical information from the grand jury and augmented this deception by including misleading information about the ingredients in Hi-Tech's products. More specifically, the evidence shows that well before the government presented their case to the grand jury they knew that the laboratory tests performed on Hi-Tech's products allegedly detected only trace amounts of controlled substances and that they intentionally deprived the grand jury of this information.

About Hi-Tech Pharmaceuticals

Hi-Tech Pharmaceuticals (https://www.hitechpharma.com) is a leading Sports Nutrition manufacturer. Hi-Tech Pharmaceuticals is a cGMP certified company that operates out of Four (4) US Production facilities and (2) Warehouses, totally over 600,000 sq. ft. Hi-Tech Pharmaceuticals has impressive capabilities to supply the global demand of sports supplements, vitamins, and pharmaceuticals. On an annual basis, Hi-Tech Pharmaceuticals can manufacture 35 billion tablets and 10 billion capsules. Hi-Tech Pharmaceuticals can also package 500 million bottles, 250 million blister packs, and 150 million pacquettes.

SOURCE Hi-Tech Pharmaceuticals, Inc.