A Walnut man was sentenced Monday to eight years and four months in federal prison for illegally importing 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.
John Seil Lee, 41, was sentenced by U.S. District Judge Percy Anderson, who ordered him immediately taken into federal custody.
Anderson -- who also ordered Lee to pay more than $552,000 in restitution to men who were injured by the misbranded pills -- remarked on Lee's "callousness" and how his scheme "has literally ruined lives."
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"It's obvious to me that this defendant has little or no respect for the law or the harm he caused numerous victims," Anderson said from the bench.
Lee pleaded guilty in February to three felony counts of conspiracy, as well as importing contraband into the United States and filing a false tax return, according to the U.S. Attorney's Office.
Lee's companies -- KHK International Trade Enterprise and SHH World Trading Enterprises -- each were sentenced to five years' probation. KHK was fined $100,000 and SHH was ordered to pay victims $115,484 in restitution. Guilty pleas were entered in February on behalf of Lee's companies to two felony counts of introducing misbranded drugs into interstate commerce, federal prosecutors said.
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 U.S. Food and Drug Administration 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, prosecutors said.
In August 2016, for example, 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, according to the U.S. government.
Tadalafil under the name of Cialis is used to treat impotence and symptoms of an enlarged prostate. Another brand of tadalafil is Adcirca, which is used to treat pulmonary arterial hypertension.
In addition to the convictions of Lee, KHK and SHH, federal prosecutors obtained 13 guilty pleas from individuals and companies who conspired with Lee to distribute his misbranded erectile dysfunction drugs. Those defendants are scheduled to be sentenced by Anderson over the next several months.
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.