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A Utah man pleaded not guilty Tuesday to charges he used a Viagra-like drug to spike erectile dysfunction supplements promoted as "100 percent natural" and that carried such names as "Stiff Nights," "Size Matters" and "Natural Wow."
Kelly Dean Harvey, 48, of West Jordan, faces 31 charges for allegedly violating federal laws that control the use and labeling of drugs, as well as for alleged money laundering and mail and wire fraud. In a separate case, Harvey also has pleaded not guilty to nine charges for allegedly violating federal law while importing ephedrine, a substance used in some supplements to promote body fat reduction.
Assistant U.S. District Attorney Mark Hirata also said in court Tuesday that Harvey is facing an additional investigation outside of Utah but didn't reveal its focus or whether more charges are expected.
According to the federal grand jury indictment, Harvey and his Murray-based company initially called TSN Labs Inc. and later renamed Novacare LLC imported a product containing sulfoaildenafil from China for use in "dietary supplements" marketed under various names.
Sulfoaildenafil citrate is the active ingredient in Viagra, a prescription drug approved by the Food and Drug Administration to treat erectile dysfunction. Its maker, Pfizer Inc., warns on labels that Viagra can cause heart attacks or strokes if used in conjunction with heart medications or blood thinners.
The indictment says Harvey failed to list all of the ingredients in the supplements containing sulfoaildenafil as required by federal law. Along with two others, he is charged with conspiracy to "fraudulently manufacture, distribute, and market in interstate commerce a drug as a "dietary supplement" to evade and avoid appropriate government regulation by the FDA and for financial gain.
The indictment identifies one unnamed coconspirator as a resident of Grand Rapids, Mich., who owned Impulsaria LLC and IC Marketing. The other is said to be a resident of China who also owns a home in Wesley Chapel, Fla., and who operated Regent Pharmaceuticals Group Inc.
The indictment alleges that between November 2006 and May 2010, Harvey and the coconspirators imported 39 orders of Ophioglossum Thermale (OT) from Shandong, China-based Rizhao Sunan Trading Co. Ltd. in exchange for $931,000.
Harvey had two U.S. labs test of OT that showed the presence of an analogue called sulfoaildenafil. The use of sulfoaildenafil would have subjected TSN and Novacare's supplements to regulation but Harvey did notify the FDA, the indictment says.
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