Kelly 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.