Wednesday, April 21, 2010

Misbranded Drugs

Federal Prisoner Serving Time for Health Care Fraud Charged with Distributing Misbranded Drugs That Were Labeled as ‘All-Natural’ Sexual Enhancement


April 21, 2010 - SANTA ANA, CA—An Orange County man who is currently serving a 10-year federal prison sentence for health care fraud has been charged with distributing misbranded drugs called “Vitalex” that were marketed as “all-natural” versions of sexual enhancement drugs such as Viagra.

Phu Tan Luong, also known as Peter Luong, 55, formerly of Huntington Beach, and his daughter, Helene Ngoc Bich Luong, 26, who formerly resided at a family home in Huntington Beach that has been seized by the government, were charged in a criminal information filed last week in United States District Court.

The criminal information, which was filed last Thursday, alleges that Luong and his daughter used a company called Vitapro, Inc. to deliver into interstate commerce misbranded drugs called Vitalex for men and Vitalex for women. The drugs were advertised and labeled as “herbal sexual enhancement supplements” and “all-natural” versions of Viagra, Cialis, or Levitra. However, these “supplements” actually contained an unregulated drug—an Acetildenafil-analog—which is similar to those found in brand-name erectile dysfunction drugs and which pose a serious health risk (see: http://www.ncbi.nlm.nih.gov/pubmed/16982533). The Luongs allegedly obtained the components of Vitalex from China and shipped the drugs from Orange County throughout the United States and to other countries.

Five years ago, Phu Tan Luong was convicted of 35 counts of health care fraud and five counts of money laundering in connection with a medical supply company he owned called United Medical Supply that submitted fraudulent claims to Medicare for enteral nutrition, motorized wheelchairs, and hospital beds that were not medically necessary and, in many cases, never delivered. Luong was sentenced to 10 years in federal prison for his role in the scheme that caused Medicare to suffer approximately $14 million in losses. Using money generated by the United Medical Supply scheme, Phu Tan Luong started Vitapro, and, with the help of his daughter, continued to run the business after he started his prison sentence in late 2006.

The U.S. Food and Drug Administration executed a search warrant in April 2008 and seized a large amount of the Vitalex products and packaging from the Vitapro business and Luong family residence. While the FDA shut down the Vitapro business, Vitalex products continue to be sold over the Internet.

“The FDA-Office of Criminal Investigations is fully committed to investigating and supporting the prosecution of those who may endanger the public’s health and safety by manufacturing and selling unsafe products to be used on an unsuspecting public,” said Thomas Emerick, Special Agent in Charge, FDA-Office of Criminal Investigations, Los Angeles Field Office.

The Luongs are each charged with one count of delivery for introduction into interstate commerce of a misbranded drug, a misdemeanor offense that carries a statutory maximum sentence of one year in federal prison.

Helene Luong is believed to be in Canada. Phu Tan Luong, who is currently in a federal prison facility in Pecos, Texas, is expected to be returned to Southern California for an arraignment on June 7.

The case was jointly investigated by the U.S. Food and Drug Administration, the Federal Bureau of Investigation, and U.S. Immigration and Customs Enforcement.

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