SALT LAKE CITY — A Utah man faces federal charges of conspiracy, wire fraud and money laundering for his role in manufacturing and selling Viagra-like erectile dysfunction supplements that were marketed as “100 percent natural.”
The products contained drugs that have been linked to serious health problems and should have been regulated by the Food and Drug Administration, according to a 31-count indictment unsealed recently in U.S. District Court in Salt Lake City.
Kelly Dean Harvey, 48, West Jordan, is charged with importing a raw ingredient from China and selling it through his Murray-based TSN Labs Inc., later called Novacare LLC, as “Stiff Nights,” “Size Matters,” “Natural Wow” and “OMG.”
Harvey’s attorney denied the allegations, saying that no one has ever reported health problems.
“Mr. Harvey has cooperated from the beginning with the FDA’s investigation despite his belief that it was handled unprofessionally and contrary to the FDA’s own investigatory regulations,” his attorney, Jamie Zenger, an assistant federal defender, said in an email Tuesday.
The indictment charges that Harvey was paid more than $2 million for erectile dysfunction products from April 2007 to June 2010.
The FDA began warning consumers in 2009 that such products may contain substances that can cause health problems. It specifically warned consumers about “Stiff Nights.” Harvey was aware of these alerts but conspired to misbrand the drug to avoid federal regulation, the indictment alleged.
Charges against Harvey include one count of conspiracy, 12 counts of wire fraud, nine counts of mail fraud and nine counts of money laundering.
If convicted, the U.S. Attorney’s Office also has asked for forfeiture of two lots owned by Harvey in Cottonwood Heights, Utah, two vehicles and $3.3 million.
Court documents allege that between November 2006 and May 2010, Harvey wired approximately $931,000 to China for a raw ingredient called ophioglossum thermale, or OT.
Harvey had two U.S. labs test the ingredient in 2007. Though the active ingredients used in Viagra, Levitra and Cialis were not present, it did have sulfoaildenafil, a compound similar to the active ingredient in Viagra, the indictment alleged. He told the labs not to report the results of the tests, court documents said.
The use of sulfoaildenafil would have subjected Harvey’s products to FDA regulation.
The FDA has said the active ingredient, when combined with prescription drugs such as nitrates, including nitroglycerian, may cause dangerously low blood pressure. Drug labeling on Pfizer’s Viagra warns people taking heart or blood-thinning medications that they could suffer heart attack or stroke if they use the product.
The website that marketed “Stiff Nights” claimed it was different from Viagra because it was a nutritional supplement, not a drug.
“Since the formula uses only all natural ingredients, it seems logical that you reduce the risks of certain side effects associated with Viagra,” it stated, according to the indictment.
The website’s disclaimer is that “no formal study has been done on this.”
An FDA inspection at TSN Labs in March 2010 obtained samples of three raw ingredients used to manufacture “Stiff Nights.”
Tests showed the sample tested positive for sulfoaildenafil.
According to court documents, Harvey acknowledged the FDA visits to a business partner in China, and asked if the person knew anyone in China that could make their product and ship directly to U.S. clients.
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