Natural Products Insider

SEP-OCT 2017

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6 INSIDER September/October 2017 In the News In July, Hi-Tech Pharmaceuticals Inc. fi led a notice of appeal with the U.S. Court of Appeals for the 11th Circuit in Atlanta, continuing a years-long quarrel with the federal government over the legality of an ingredient in sports supplements. In April, a federal judge ruled that DMAA— also known as 1,3-dimethylamylamine—did not qualify as a dietary ingredient and that Hi-Tech's products containing the substance were adulterated. Hi-Tech, a Norcross, Georgia-based manufacturer of dietary supplements, and its president, Jared Wheat, are seeking a review of the lower court's April 3 order and judgment, and a more recent order denying their motion for reconsideration. Ricardo Carvajal, a director with the law fi rm Hyman, Phelps & McNamara P.C., said Hi-Tech has a right to appeal the district court's decision to the 11th Circuit. Unlike petitions for certiorari that are fi led with the U.S. Supreme Court, the circuit courts don't have discretion on whether to review a case, he explained. "Hi-Tech believes that the court's failure to fi nd that DMAA is a constituent of a botanical, which would have led to Hi-Tech winning on summary judgment, constitutes reversible error," Wheat said in an emailed statement. "Hi-Tech is optimistic that we will prevail at the 11th Circuit." The U.S. Department of Justice, which is representing FDA in the lawsuit, declined to comment. FDA also had no comment. Five years ago, FDA issued warning letters to several companies selling DMAA, including USP Labs LLC, a fi rm that is now the target of a felony criminal prosecution. In a 2013 online document, FDA described DMAA as an amphetamine derivative that doesn't belong in supplements, and the agency said it had no information to show the ingredient was safe. Hi-Tech has insisted over the years that its ingredient is legal to sell in supplements, and that it is unaware of any scientifi c or medical literature that calls into question DMAA's safety. Marc Ullman, a lawyer in New York who advises dietary supplement companies on FDA regulations, said the case is a signifi cant one concerning such issues as the defi nition of a dietary ingredient under the Dietary Supplement Health and Education Act of 1994 (DSHEA) and whether a synthetic copy of a natural substance found in a botanical qualifi es as a dietary ingredient. While the specifi c issues on appeal haven't been identifi ed, Ullman conceded, "Obviously, an appellate circuit court decision is of great signifi cance." The case isn't just about the legality of DMAA. It's conceivable the 11th Circuit would address the broader issues of what qualifi es as a botanical under DSHEA and whether a synthetically produced ingredient like DMAA can be sold in supplements. Prison Sentence In other news related to DMAA, a judge has sentenced the president of a dietary supplement company to serve 18 months in prison for introducing misbranded food into interstate commerce. Derek Vest of Gentech Pharmaceutical authorized the inclusion of DMAA in various supplements, but he failed to disclose the presence of DMAA on the product labeling, according to the U.S. Attorney's Offi ce for the Middle District of Florida. David Goldberg, an attorney representing Vest, and Lexium International, formerly known as Gentech, did not respond to requests for comment. In March, the 52-year-old Vest accepted a plea deal following a federal grand jury investigation into his company's manufacturing, marketing and sales of dietary supplements containing unlabeled DMAA. Formed in 2010, "Gentech developed and sold supplement products for cognitive function, weight loss and sleep aid," according to a 2016 fi ling with federal regulators by Lexium. Gentech later changed its name to Lexium, and Vest sold his interest in Lexium in 2015, the fi ling noted. The conduct targeted by federal prosecutors covered April 2013 to November 2014, while Vest oversaw the manufacture, marketing and sale of purported dietary supplements as president of Gentech. During the above period, Vest's company sold more than 2 million misbranded tablets that were shipped to consumers, the U.S. Attorney's Offi ce said. Vest must forfeit US$2.5 million as part of his plea deal and the sentence imposed by the court. Daniel Williams, a spokesman for the U.S. Attorney's Offi ce in Tampa, Florida, declined a request to interview the prosecutor in the case, Yolande Viacava, regarding Vest's sentence. However, he said the offense to which Vest pleaded guilty carried a maximum statutory penalty of three years in prison, and the government recommended a sentence at the low end of the advisory guideline range. "Ultimately, it was the court that determined the sentence that was suffi cient, but not greater than necessary, and imposed a sentence of 18 months imprisonment," Williams said in an emailed statement. Ullman, of counsel to Rivkin Radler LLP, said the prosecution against Vest "should serve as a reminder that violations of the Federal Food, Drug and Cosmetic Act are all potentially criminal offenses. "While FDA is often very slow in bringing prosecutions like this, companies need to realize that this is a public health law and that ignoring FDA warnings can come with very severe consequences," the regulatory lawyer said in an emailed statement. Hi-Tech Files Appeal in DMAA Fight With FDA by Josh Long Ignoring FDA warnings can come with very severe consequences. — Marc Ullman, of counsel, Rivkin Radler LLP

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