September 27, 2011
SALT LAKE CITYKelly Dean Harvey was indicted by a federal grand jury for selling unapproved drugs that were marketed at a natural sexual health supplement. Harvey was charged with introducing misbranded drugs into interstate commerce, wire fraud, mail fraud and money laundering after selling Stiff Nights" and other products that contained Ophioglossum Thermale (OT), an analogue of sildenafil citrate, the active ingredient in the FDA-approved drug Viagra.
In total, Harvey was charged with one count of conspiracy, 12 counts of wire fraud, nine counts of mail fraud, five counts of concealment of money laundering and four counts of money laundering.
According to court documents, Harvey knowingly conspired to fraudulently manufacture, distribute and market a drug as a "dietary supplement" to evade and avoid appropriate government regulation by FDA and for financial gain.
The documents state Harvey obtained OT from an unindicted co-conspirator who imported the ingredient as a raw ingredient from China to manufacture products targeted for men seeking to enhance their sexual experiences or address erectile dysfunction (ED). Harvey placed and received about 39 orders (each order ranging from 1 kg to 75 kg) from around November 2006 to around May 2010 . For this, he wired approximately $931,000 to a Chinese account. From April 2007 to May 2010, Harvey allegedly made more than $2 million for ED products.
The court documents said Harvey sent his products to two U.S. labs to test the OT products to determine the presence of a drug, including sildenafil citrate, or any synthetic active drug ingredient. Although the lab results did not confirm the presence of sildenafil citrate (Viagra), vardenafil (Levitra) or tadalafil (Cialis), they confirmed the presence of a compound with characteristics similar to sildenafil or what appeared to be a sildenafil drug analogue.
If FDA found out about these tests, the agency would have classified the product as a drug. However, the court documents say Harvey controlled the limited dissemination of the lab results, including to the exclusion of FDA.
The grand jury also alleged Harvey and his two co-conspirators learned their consumers experienced varying degrees of headaches, a common side effect when using ED drugs, yet the court documents said they continued to sell the products.
In March 2010, FDA inspected NovaCare, which had been previoulsy named TSN Labs and had been engaged by Harvery to produce dietary supplements. During the inspection, FDA inspectors obtained samples of three raw ingredients used in the manufacturing of Stiff Nights, including a 50 gram sample of OT. FDA tests of the OT sample were positive for sulfoaildenafil. In response, NovaCare issued a product recall. NovaCare was not named in any of the court documents against Harvey and is not a party to the government's actions.
The court papers also noted Defendant Harvey and his two co-conspirators discussed two consumer alerts from FDA. One that warned alert warned consumers that Stiff Nights, a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal." The other alert noted an FDA-led Internet survey found that "more than one-third of purchased 'dietary supplements' claiming to spur sexual enhancement or treat ED contained undisclosed prescription drug ingredients or similar substances."
Harvey also used OT to manufacture other drugs that were marketed as dietary supplement, according to the court documents, with names such as Aziffa, Size Matters, Erex, Mojo, Hard Drive, Straight Up, MONSTER EXCYTE, Natural WOW! Ultra Perform for MEN, Natural WOW! Ultra Perform for WOMEN, OMG, ProLatis, Verect, Xaitrix, Zilex (with golden spear), Eyeful, RedMagic and Zotrex.
Additionally, the court document said Harvey promoted Zotrex at Zotrex.net, OrderYoursToday.com and TSN2000.com as a "dietary supplement" that contained "natural compounds that work similarly to prescription ED drugs without the negative side effects." Although Harvey listed "ophioglossum polyphylious" (a fictitious name and non-existent ingredient) on the Zotrex brand label, it omitted OT, sulfoaildenafil or what appeared to be a sildenafil drug analogue from its list of ingredients.
In response to news articles about the indictment, John D. Burns, group chief financial officer, NovaCare, said Harvey's alleged actions, if accurate, were actions of an individual without complicity of the company or any of its employees or owners. Harvey, a manager and part owner of NovaCare, was placed on administrative leave from and relieved of official responsibilities by the board of directors on April 12, 2011, the day the company first became aware of the possibility of potentially illegal actions having been committed. The board has since relieved him of all responsibilities with the company.
"NovaCare LLC does not condone illegal acts by any of its employees in their official or unofficial roles within or outside of the company, Burns said. "We value our status as an FDA-approved provider and a cGMP (current good manufacturing practice) producer of quality nutraceuticals and supplements. The company has cooperated fully with the FDA in this investigation, to include a voluntary recall of the underlying products. Further, the company stopped producing the products in question the day it was advised of the issues.
Sildenafil citrate, among other things, opens capillaries, which increases blood flow and heart rate. Pfizer labeling of Viagra warns that people on heart medications (such as Plavix) or blood-thinning medications (such as Coumadin) could suffer a heart attack or stroke if they used sildenafil citrate. Pfizer, as the distributor of Viagra, advises practitioners not to prescribe Viagra to any patients with heart conditions, warning that the effects ofViagra could cause blood pressure to drop to an unsafe or life-threatening level.
Under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321, the term "drug" to include articles that were intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man were intended to affect the structure or any function of the body of man. Under the FDC Act, a drug is deemed to be misbranded if, among other circumstances: its labeling is false or misleading in any particular, 21 U.S.c. § 352(a); or the label does not bear the established name and quantity of each active ingredient, 21 U.S.C. § 352(e)(1)(A).
Viagra is a drug that was approved by FDA to treat erectile dysfunction and is manufactured by Pfizer Inc.
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