 |
 |
 |
 |
 |
 |
 |
 |
Press ReleaseHi-Tech Pharmaceuticals, Inc. to File Preliminary Injunction Against FDA Seizure of Dietary Supplements Containing Ephedrine AlkaloidsNORCROSS, Ga., Feb. 27, 2006 -- On February 24, 2006, the Food and Drug Administration (FDA) and U.S. Marshal's Office seized approximately $3,000,000 of ephedra-containing dietary supplements from Hi-Tech Pharmaceuticals, Inc., located in Norcross, Georgia. The FDA also filed a Complaint for Forfeiture against Lipodrene(R) and Stimerex-ES(R) dietary supplements that are manufactured, marketed, and distributed by Hi-Tech Pharmaceuticals, Inc. This action was in response to a lawsuit filed by Hi-Tech Pharmaceuticals, Inc. on August 10, 2005 - 1:05-CV-2083.It is the position of Hi-Tech Pharmaceuticals, Inc. that this action is the result of a series of unsuccessful attempts by several FDA regional offices to prevent Hi-Tech Pharmaceuticals, Inc. from legitimately selling the company's ephedra-based Lipodrene(R) and Stimerex-ES(R) dietary supplements to health food retailers. Initially, on August 3, 2005, the FDA requested that Hi-Tech Pharmaceuticals. Inc. cease and desist sales of these ephedra-containing dietary supplements. The FDA, however, refused to provide Hi-Tech Pharmaceuticals, Inc. with any written documentation from the national office of the FDA, stating that selling Lipodrene(R) or Stimerex-ES(R) dietary supplements was illegal. The FDA also chose not to exercise its right to seize any dietary supplement introduced into interstate commerce in violation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) or the Food Drug and Cosmetic Act (FD&C). Because of the failure on the part of the FDA to justify any legal basis for its request that Hi-Tech Pharmaceuticals, Inc. not sell its Lipodrene(R) or Stimerex-ES(R) dietary supplements, Hi-Tech Pharmaceuticals, Inc. informed the FDA that the manufacture and sale of Hi-Tech Pharmaceuticals, Inc. ephedra-containing dietary supplements would continue within the framework of the law. On February 21, 2006, Hi-Tech Pharmaceuticals, Inc. responded to the FDA's motion to dismiss the lawsuit previously filed by Hi-Tech Pharmaceuticals, Inc., presently pending in the United States District Court of the Northern District of Georgia, before the Honorable Judge Ernest Tidwell. The FDA alleged that since the FDA had taken no action against Hi-Tech Pharmaceuticals, Inc., the lawsuit was without merit. Hi-Tech Pharmaceuticals responded that the government was "venue shopping." On the very next day, on February 22, 2006, The FDA initiated action through the Office of the United States Attorney that resulted, on February 24, 2006, in the previously herein described civil seizure and arrest of Lipodrene" and Stimerex-ES" dietary supplements. No other civil or criminal action was filed against Hi-Tech Pharmaceuticals, Inc. The case, Hi-Tech Pharmaceuticals, Inc. v. Lester M. Crawford, et al., No. 1:05-CV-2083 (Northern District of Georgia), filed on August 10, 2005, will now likely be before the Court within a few days due to this recent seizure by the FDA in Georgia. It is the position of Hi-Tech Pharmaceuticals, Inc. that the basis for its filing of this case is to prevent continued arbitrary and capricious behavior on the part of the FDA, in complete contravention to the federal court decision in April 2005 in which the Honorable Judge Tena Campbell reversed the FDA's ban on ephedra. It is also the position of Hi-Tech Pharmaceuticals, Inc. that although this action may, on the surface, appear to be a blow to the rights of consumers to continue to obtain the benefits of Lipodrene(R) and Stimerex-ES(R), the reality is that Hi-Tech Pharmaceuticals finds this action a necessary step for Hi-Tech Pharmaceuticals, Inc. to have immediate standing before the Court. Hi-Tech Pharmaceuticals, Inc. is determined to ensure that this type of FDA misconduct, both directly and also through its "pawn" regulatory agencies at the state and local level, does not happen again with its ephedra-containing dietary supplements. Accordingly, Hi-Tech Pharmaceuticals, Inc. will be filing a Preliminary Injunction motion on February 27, 2006. It is noteworthy that the FDA took no action against Hi-Tech Pharmaceuticals, Inc. in regard to the manufacture and sale of its Lipodrene(R) and Stimerex-ES(R) dietary supplements over the past ten months since the April 2005 Federal Court decision in Utah, even though during this time period the FDA routinely conducted inspections at Hi-Tech Pharmaceuticals, Inc. in Norcross, Georgia. Hi-Tech Pharmaceuticals will continue to sell, manufacture, and distribute Lipodrene(R) and Stimerex-ES(R), and many other dietary supplements containing ephedrine alkaloids. Hi-Tech Pharmaceuticals, Inc. is advising retailers of dietary supplements that legal counsel for Hi-Tech Pharmaceuticals has clearly interpreted that the Honorable Judge Tena Campbell's ruling in Utah, in April 2005, made the following determinations: 1) The 2004 Final Rule issued by the Food and Drug Administration ("FDA"), which declared dietary supplements containing ephedrine alkaloids illegal, has been ruled invalid. This means dietary supplements containing ephedra are currently legal again. 2) The matter has been remanded back to the FDA for further rule-making consistent with the Court's opinion. Hi-Tech Pharmaceuticals, Inc. has always maintained that dietary supplements containing ephedrine alkaloids are safe and effective when used according to label instructions. The labels for Lipodrene(R) and Stimerex-ES(R) state that the products contain 25mg ephedrine group alkaloids per tablet, with a recommendation of two tablets daily, not to exceed four tablets within a 24-hour period (100mg per day). This recommendation is within the FDA's safety parameters for the consumption of ephedrine. It is the position of Hi-Tech Pharmaceuticals, Inc. that this April 2005 ruling is significant for the entire dietary supplement industry. The Court's Order makes it clear that the FDA must comply with the current law, as explicitly written in DSHEA. If the inappropriate standard that the FDA had applied in regard to ephedra-containing dietary supplements (supplements are defined as "food" under DSHEA) had been upheld, other foods, such as potato chips, could potentially have been banned. Hi-Tech Pharmaceuticals, Inc. states that this recent action by the FDA, with complete disregard for the Utah Federal Court's ruling to the contrary, is an attempt to intimidate a small, dietary supplement company from legally selling beneficial dietary supplements containing ephedrine alkaloids, and that this action is an excellent example of how the FDA often engages in practices contrary to the public interest. Hi-Tech Pharmaceuticals, Inc. states that it shall remain steadfast in its position, and that the company will continue to fight this David vs. Goliath battle. Hi-Tech Pharmaceuticals, Inc. stands behind the safety and efficacy of its products, and looks forward to its day in court. Media or Consumer Inquiries: Steve Smith 770-797-9959 |
 Subscribe and receive targeted press release announcements. Choose from several categories. Sign up today!  Media Searches Reference Tools Journalism Sites Public Relations PR Bookstore Organizations/Assns. Careers |