LOS ANGELES – A Southern California man was sentenced Monday to 100 months in federal prison for illegally importing from China and selling $11 million worth of pharmaceutical-grade erectile dysfunction drugs that were falsely marketed as herbal remedies for men, some of whom suffered permanent injuries after consuming them.
The U.S. Attorney’s Office announced Monday that John Seil Lee, 41, was sentenced by United States District Judge Percy Anderson, who ordered him remanded into federal custody. Judge Anderson – who also ordered Lee to pay more than $552,000 in restitution to his victims, including men who were injured by Lee’s misbranded pills – remarked in court on Lee’s “callousness” and how Lee’s “scheme has literally ruined lives.”
“It’s obvious to me,” Judge Anderson said, “that this defendant has little or no respect for the law or the harm he caused numerous victims.”
On February 27, Lee pleaded guilty to three felony counts of conspiracy, importing contraband into the United States, and filing a false tax return.
Lee’s companies – KHK International Trade Enterprise, Inc., and SHH World Trading Enterprises, Inc. – each were sentenced today to five years’ probation. KHK was fined $100,000 and SHH was ordered to pay its victims $115,484 in restitution. Lee’s companies each pleaded guilty in February to two felony counts of introducing misbranded drugs into interstate commerce.
From 2011 through early 2017, Lee illegally imported shipments of powder Tadalafil – a prescription drug used to treat erectile dysfunction and sold under the brand name Cialis – from suppliers in China. Lee then manufactured the powder Tadalafil into at least 5.5 million pills that he sold to distributors across the United States. In order to boost sales, Lee made the pills with up to 14 times the level of Tadalafil contained in Cialis.
Lee sold at least $11 million worth of pills across the United States – under names such as “X Again,” “X Monster” and “Royal Master” – with labels that did not disclose the presence of Tadalafil and falsely stated that no prescription was necessary, according to court documents. Lee also continued selling the pills despite FDA announcements that the pills were tainted because they contained undeclared Tadalafil. In order to evade federal regulators, Lee relabeled the tainted pills in response to FDA announcements about their safety, the information states. For example, in August 2016, after the FDA announced that SHH’s “One More Knight” pills contained undisclosed Tadalafil, Lee rebranded the same pills as “Own the Knight” and continued selling them.
After Lee closed SHH following the execution of federal search warrants in February 2017, he helped his friend Jin Su Park set up RNG Global Management and Trading Group to operate as a copycat business, according to Park’s plea agreement and statements made in court today. Park took 14,000 of Lee’s pills, rebranded them as “EEZZY UP PLATINUM,” and sold them to Lee’s former distributors across the country. EEZZY UP’s packaging also failed to disclose that the pills contained Tadalafil.
The FDA’s approval of Cialis is limited to the use under the supervision of a licensed professional. Due to toxicity and other potentially harmful effects – including life-threatening drops in blood pressure, loss of vision, loss of hearing and prolonged, painful erections that can result in permanent injury – drugs similar to Cialis are not safe for use except under the supervision of a medical practitioner.
In addition to the convictions of Lee, KHK, and SHH, federal prosecutors have obtained 13 guilty pleas from individuals and companies who conspired with Lee to distribute his misbranded erectile dysfunction drugs. These defendants are scheduled to be sentenced by Judge Anderson over the next several months.
The investigation into these cases was conducted by U.S. Immigration and Customs Enforcement’s Homeland Security Investigations, the Food and Drug Administration’s Office of Criminal Investigations and IRS Criminal Investigation.
The cases are being prosecuted by Assistant United States Attorney Matthew W. O’Brien of the Environmental and Community Safety Crimes Section.
Hidden active pharmaceutical ingredients have been identified in products promoted not only for sexual enhancement, but also for bodybuilding, pain relief and weight loss. The FDA has issued hundreds of public warnings and recall announcements related to these types of fraudulent products. The FDA’s Tainted Products database can help consumers identify some of these potentially harmful products. Even if a product is not included in the list, consumers should be cautious about using certain products, especially those promoted for sexual enhancement, weight loss, bodybuilding and pain relief.