Three people and four companies have pending plea agreements in federal court on charges related to the illegal importation and sale of $11 million worth of herbal remedies that contained an undisclosed active pharmaceutical ingredient (API), according to NBC4 Los Angeles – KNBC. The three individuals, in this case, are John Seil Lee of Walnut, Jin Su Park of Hacienda Heights, and Matthew Burroughs of Salem, Oregon. Park and Lee operated companies that manufactured the pills while Burroughs worked for a company that purchased and distributed the pills across the United States.

According to a court document, John Seil Lee operated four companies between 2011 and 2017 that each manufactured and distributed supposed herbal pills that all contained undisclosed tadalafil. Lee established KHK International Trade Enterprise, Inc. (KHK) in Diamond Bar, California, in March 2014, but shut the company down after the U.S. Food and Drug Administration (FDA) listed one of the company’s pills as a tainted product on their website in December 2015. Lee opened SHH World Trading Enterprises, Inc. (SHH) in January 2016 to replace KHK. Just like KHK, SHH marketed and distributed pill containing undisclosed tadalafil. In June 2017, the FDA listed several of SHH’s brands as tainted products on their website. Over the years, prosecutors estimated that Lee purchased enough bulk tadalafil from suppliers in China to produce at least 5,500,000 pills. There is a plea deal for Lee submitted in court, but at this time that record is under seal.

In Park’s plea agreement, he admitted to being a longtime friend of Lee who began to assist at his friend’s pill business no later than in 2015. In February 2017, a search warrant executed by the Department of Homeland Security Investigations (HSI) and the FDA at SHH immediately shut down the business. In the aftermath, Park took approximately 14,000 pills that had already been manufactured and stored them at this home. Additionally, he kept a thumb drive that contained information on Lee’s business including “customer lists, pricing information, and smuggling contacts in China.” Park set up his own company, RNG Global Management and Trading Group Inc. (RNG) to be a copycat of Lee’s pill business.

Park repackaged the pills he took from Lee’s closed business in February 2017 as “EEZZY UP PLATINUM.” The wording on the packaging was nearly identical to Lee’s. After reaching out to some of Lee’s former customers, Park’s pills were sold in stores in Florida, Delaware, and Texas. In September 2017, Park began negotiations with one of Lee’s Chinese suppliers to purchase five kilograms of dapoxetine and five kilograms of Rhodiola rosea, ingredients that would be used to make pills. These negotiations included finding the best way for Park to pay for the items without alerting law enforcement. Eventually, the package containing the dapoxetine was shipped to a post office box controlled by Park in Michigan via a Korean intermediary.

Park never had the opportunity to forward the package to himself in California because of an interview conducted by HSI and FDA agents in May 2018. At that meeting Park agreed to have the package containing the dapoxetine forwarded to an HSI agent in Los Angeles. Shortly after that, Park started to purge his office of evidence, taking five trips to a recycling center. Twelve cases of EEZZY UP PLATINUM pills and his office computer were in this haul. Although a search of the recycling center turned up the packaging, the pills themselves and the computer were never found.

The final individual with a plea agreement tied to these fake pills is Matthew Burroughs. Burroughs worked for Lancaster Distributors in Oregon, and between January 2013 and February 2017, Burroughs purchased at least 153,000 pills from Lee. Burroughs was aware the herbal pills contained undisclosed tadalafil. The plea agreement stated that a typical Cialis prescription contains 25-85 milligrams of tadalafil, and the pills Lee sold to Burroughs included up to 350-500 milligrams of the API. Every time the FDA pulled one of Lee or Park’s pills, Burroughs agreed to whatever substitute they suggested.

In a press release announcing the plea deals, the FDA Office of Criminal Investigations (FDA-OCI) reiterated the face that tadalafil must only be taken under the supervision of a licensed professional. Potential complications from ingesting this medicine include life-threatening drops in blood pressure, loss of vision, and loss of hearing. U.S. Immigration and Customs Enforcement’s Homeland Security Investigations, FDA-OCI, and Internal Revenue Service Criminal Investigations all worked these cases. Assistant U.S. Attorney Matthew W. O’Brien of the Environmental and Community Safety Crimes Section is prosecuting these cases for the U.S. Department of Justice.

Undisclosed active pharmaceutical ingredients have been found in pills marketed for sexual enhancement, bodybuilding, pain relief, and weight loss. Hundreds of public warnings and recall announcements can be found on the FDA’s Tainted Products database.