FDA's Office of Criminal Investigations assists in prosecuting the maker of "all-natural" sexual enhancement drugs, an action in line with its strategy to seek more misdemeanor charges against violative food and drug firms.

Food and drug attorneys say the charges brought by the U.S. Attorney for the Central District of California against Phu Tan "Peter" Luong and Helene Luong are unsurprising and represent the latest manifestation of FDA backing up words with action.

The fact that Peter Luong already is serving a 10-year prison sentence for health care fraud did not deter OCI from pursuing him for manufacturing and marketing Vitalex "herbal sexual enhancement supplements" that contained active drug ingredients for erectile dysfunction, according to an April 20 release.

Both Luongs, who ran Vitapro Inc., are charged with one count of delivery of a misbranded drug for introduction into interstate commerce.

The U.S. Attorney claims the Luongs continued selling Vitalex products after FDA executed a search warrant and seizure in April 2008.

"Maybe in another era, at another time, somebody would've said, 'Well, this guy's already in prison, it doesn't make sense to bring a misdemeanor prosecution case against him,'" said Mark Brown, a partner with King & Spalding in Washington.

"It's clear ... that there's going to be more criminal enforcement and more misdemeanor prosecutions based on violations" of the Food, Drug and Cosmetic Act, Brown added (see ¹ Also see "FDA Targets Executives With Powerful Misdemeanor Strategy" - Pink Sheet, 26 April, 2010.).

Under the misdemeanor charges, the Luongs each face up to one year in federal prison. Helene Luong is believed to be in Canada, according to the U.S. Attorney's office.

The usefulness and the increased use of misdemeanor prosecution do not mean OCI will rule out felony charges, however. Brown said with sufficient evidence of intent, FDA could have pursued a felony case against the Luongs.

Enforcement Message Should Be Clear

Over the past year, FDA sent a message to many stakeholders in regulated industries that it will not hesitate to engage in enforcement activity - from warning letters to seizures to criminal investigations - against firms flouting the law.

"I think anyone that ignores a warning letter at this point really is putting themselves in harm's way," said former federal prosecutor Robert Nicholson, of Fort Lauderdale, Fla.-based Nicholson Law Group.

Many supplement industry stakeholders welcome criminal prosecutions against firms marketing so-called dietary supplements adulterated with Rx ingredients. Bringing criminal charges against companies that intentionally sell adulterated supplements would be a significant deterrent, stakeholders say.

Critics of the industry and of FDA's current enforcement also push for criminal prosecutions in cases concerning adulterated nutritional products, although they do not differentiate between actual supplements and those marketed in violation of food and drug laws (² Also see "USADA Builds Team To Change Supplement Law, Cites "Lax" Regulations" - Pink Sheet, 7 December, 2009.).

Products marketed for weight loss, sexual enhancement or strength training are most commonly cited by FDA as being unapproved drugs because they are adulterated with Rx ingredients. Principal Deputy Commissioner Josh Sharfstein says FDA's top supplement industry priorities include removing "spiked" supplements from the market (³ Also see "Sharfstein Says Spiked Products Top FDA Supplement Enforcement Goals" - Pink Sheet, 26 October, 2009.).

- Dan Schiff ( ⁴ d.schiff@elsevier.com )

FDA Plays Misdemeanor Card In Adulterated Supplement Prosecution

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