LOS ANGELES – Four companies and three individuals have agreed to plead guilty to federal criminal charges related to the illegal importation and sale of $11 million worth of pharmaceutical-grade erectile dysfunction drugs that were falsely marketed as herbal remedies for men.

            Federal prosecutors today filed two new cases against distributors of the misbranded drugs.

In one of the cases filed today in United States District Court, Jin Su Park, 40, of Hacienda Heights, agreed to plead guilty to one felony count of importing contraband into the United States and one felony count of introducing misbranded drugs into interstate commerce. Park's company, RNG Global Management and Trading Group, Inc., based in Rowland Heights, agreed to plead guilty to two felony counts of introducing misbranded drugs into interstate commerce.

In another case filed today, Lancaster Distributors, Inc., a Salem, Oregon-based company, and one of its employees, Matthew Burroughs, 42, of Salem, each agreed to plead guilty to one misdemeanor count of conspiracy to introduce misbranded drugs into interstate commerce.

Last month, Park's friend and former colleague, John Seil Lee, 40, of Walnut, agreed to plead guilty to a seven-count information that charged him with felony counts of conspiracy, importing contraband into the United States, filing a false tax return, and introducing misbranded drugs into interstate commerce. Lee's companies – KHK International Trade Enterprise, Inc., and SHH World Trading Enterprises, Inc. – also agreed to plead guilty to the charges.

According to the documents filed in Lee's case, 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, court papers state.

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, his friend Park set up RNG Global to operate as a copycat business, according to Park's plea agreement. 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.

In its plea agreement, Lancaster admitted that it purchased from Lee at least 153,000 male sexual enhancement pills containing Tadalafil for approximately $362,000. Burroughs admitted to purchasing the mislabeled drugs on behalf of Lancaster.

The arraignments for Lee, KHK, and SHH have been scheduled for February 19. Once he pleads guilty, Lee will face a statutory maximum sentence of 20 years for the smuggling count, five years for the conspiracy count, and three years for the tax count. 

The arraignments for Park, RNG Global, Burroughs, and Lancaster have been scheduled for March 18. Park faces a statutory maximum sentence of 20 years for the smuggling count and three years for the distribution count. Burroughs faces a statutory maximum sentence of one year in prison.

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.

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.