Tuesday witnessed a federal grand jury in Utah indict a man with an onslaught of charges pertaining to the safety, effectiveness and labeling of over the counter drug products. According to the indictment, Kelly Dean Harvey of West Jordan faces charges of violating several laws that were intended to regulate safe drug practices. Subsequently, Harvey recently pleaded not guilty to allegedly saturating erectile dysfunction supplements with a Viagra-like drug. Allegations brought against Harvey also included money laundering and mail and wire fraud.
Initially known as TSN Labs Inc., Harvey’s Murray-based company was renamed Novacare LLC for undisclosed reasons. According to company practices, Novacare LLC imported a product containing sulfoaildenafil from China on a regular basis. After acquiring sulfoaildenafil from China, Harvey’s company would then market it as a dietary supplement under various names.
Sulfoaildenafil is the active ingredient in a number of dietary supplements that are intended to assist in the treatment of erectile dysfunction. Made popular because it is the active ingredient in Pfizer’s Viagra, sulfoaildenafil has been approved by the U.S. Food and Drug Administration (FDA). However, Pfizer has issued increased warnings that Viagra can cause heart attacks or strokes if used in conjunction with heart medications or blood thinners.
While the use of sulfoaildenafil is legal, removing it from the drugs label violates federal law. According to the indictment leveled against Harvey, his company neglected to label their products with sulfoaildenafil. Doing so may place patients at an increased risk of severe blood clots that are not indicated on the labeling.
According to an FDA Recall Firm Press Release, Novacare LLC had received a recall notice in 2010 for the same violation. The press release acknowledges that Novacare LLC was informed by representatives of the FDA and that the products appear to contain sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction. “Sulfoaildenafil” is not declared on the product labels. The undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
After Novacare failed to comply with strict FD regulations, the agency followed up with enforcement actions in December of 2010. In a letter to Novacare LLC, the FDA confirmed that laboratory analyses of numerous dietary supplements contained sulfoaildenafil, an analogue of sildenafil. Included in the letter were specific directions to correct the violations mentioned.
However, the recent indictment confirms that Harvey and his company have continued to market products without the proper labeling practices. Neglecting to do so may have places many patients at risk of adverse health events. Harvey had 2 U.S. labs test for 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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