A judge sentenced the president of a dietary supplement company to serve 18 months in prison for introducing misbranded food into interstate commerce, the U.S. Justice Department announced this week. <\/p>\n
Derek Vest of Gentech Pharmaceutical authorized the use of an amphetamine derivative, DMAA (1,3-Dimethylamine), in various supplements, but he failed to disclose the presence of DMAA on the product labeling for the tablets, according to a July 18 press release from the U.S. Attorneys Office for the Middle District of Florida. <\/p>\n
David Goldberg, an attorney representing Vest, and Lexium International, formerly known as Gentech, did not immediately respond to requests for comment. <\/p>\n
FDA for years has maintained DMAA is an illegal ingredient in dietary supplements, and a federal judge sided in April with the public health agency in an unrelated case that is likely to be reviewed by a federal appeals court in Atlanta. <\/p>\n
In March, the 52-year-old Vest of Fort Myers, Florida accepted a plea deal following a federal grand jury investigation into his companys manufacturing, marketing and sales of dietary supplements containing unlabeled DMAA. <\/p>\n
Formed in 2010, Gentech developed and sold supplement products for cognitive function, weight loss and sleep aid,\" according to a 2016 filing with federal regulators by Lexium. Gentech later changed its name to Lexium, and Vest sold his interest in Lexium in 2015, the filing noted. <\/p>\n
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. <\/p>\n
During the above period, Vests company sold more than 2 million misbranded tablets that were shipped to consumers, the U.S. Attorneys Office said. Vest must forfeit US$2.5 million as part of his plea deal and the sentence imposed by the court. <\/p>\n
Daniel Williams, a spokesman for the U.S. Attorneys Office in Tampa, Florida, declined a request to interview the prosecutor in the case, Yolande Viacava, regarding Vests 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. <\/p>\n
Ultimately, it was the court that determined the sentence that was sufficient, but not greater than necessary, and imposed a sentence of 18 months imprisonment,\" Williams said in an emailed statement. <\/p>\n
Marc Ullman, a lawyer in New York whoadvises dietary supplement companies on FDA regulations,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. <\/p>\n
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,\" said Ullman, Of Counsel to Rivkin Radler LLP, in an emailed statement. <\/p>\n
In an unrelated case, a federal judge in April rejected a dietary supplement manufacturers argument that DMAA qualifies as a dietary ingredient. Jared Wheat, the owner of Hi-Tech Pharmaceuticals Inc., which has sold supplements containing DMAA for several years, has vowed to file an appeal. <\/p>\n
Our position on DMAA has been constant,\" Steven Tave, director of FDAs Office of Dietary Supplement Programs (ODSP), told INSIDER in a phone interview earlier this year. Its an illegal ingredient. It shouldnt be in dietary supplements. <\/p>\n
Tave suggested other companies selling DMAA are on FDAs radar for enforcement action. <\/p>\n
When we see it, we take action,\" he said, but action isnt necessarily instantaneous, so whether its a warning letter, whether its judicial action, just because you havent seen something happen doesnt mean that were not working on it.\" <\/p>\n<\/p>\n
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Executive Sold DMAA Supplements, Sentenced to Prison - Natural Products INSIDER (blog)<\/a><\/p>\n","protected":false},"excerpt":{"rendered":" A judge sentenced the president of a dietary supplement company to serve 18 months in prison for introducing misbranded food into interstate commerce, the U.S. Continue reading