FDA’s Criminal Enforcement Priorities Protecting Public Health

By: John Roth

Although perhaps not widely known, FDA’s Office of Criminal Investigations (OCI) is an integral part of FDA’s mission to protect the public’s health.  FDA’s team of top-flight federal agents – who have the same type of arrest authority as other federal law enforcement agents – gives the FDA unique fact-finding tools and provides for strong, industry-wide deterrence. Their work is different from, but enhances, the regulatory work typically conducted by inspectors and investigators that makes up the bulk of FDA’s field operations.

OCI focuses its efforts on threats to the public health in four areas: we investigate criminals who can’t be reached by the rest of FDA, particularly in the area of counterfeit and unapproved medical products; we move against public health problems when our ordinary regulatory tools aren’t the best option; we seek criminal penalties against conduct in which the harm to the public is so grievous that a criminal response is appropriate; and we investigate lying to the FDA and other behavior that deprives the FDA of its ability to regulate. We have a variety of tools at our disposal to accomplish our mission, including felony charges under the Federal Food, Drug, and Cosmetic Act, misdemeanor prosecutions of responsible corporate officers, and prosecutions for fraud, money laundering and obstruction of justice.

It’s a big job.  FDA regulation affects more than 20 cents of every consumer dollar spent on products in the U.S. And the fact is, some conduct by individuals and entities is beyond the reach of FDA’s typical administrative and civil enforcement tools. This conduct includes rogue internet pharmacies, purveyors in grey and black market unapproved medicines, and counterfeiters, both in the United States and overseas. Individuals intent on defrauding an unsuspecting public are often part of a larger organized criminal enterprise and don’t respond to the normal FDA regulatory process. They are engaged in a crime, and as a result the FDA treats it as a crime, and that’s where OCI steps in. 

The case of Shengyang Zhou is a good example. In January 2010, the FDA became aware of counterfeit versions of the popular weight loss drug Alli being distributed in the United States, and warned consumers about its dangers. The counterfeit product had entered the legitimate supply chain lacking the active ingredient contained in the genuine Alli and, especially alarming, contained undeclared amounts of the drug sibutramine, which is no longer sold in the United States because of concerns over its association with increased heart attacks and strokes. OCI agents had initiated a criminal investigation after intercepting unapproved dietary supplements laced with sibutramine and phenolphthalein that had been shipped from China to an individual in Colorado. This seizure ultimately led to OCI agents developing an undercover operation against a Chinese counterfeiter, Shengyang “Tom” Zhou. Posing as buyers, OCI Special Agents met with Zhou in Bangkok and negotiated a sale of counterfeit drugs to be shipped to the United States. During the undercover operation, Zhou bragged that he had a factory in southwest China that could make thousands of boxes of weight-loss products per day. Zhou was ultimately arrested, pled guilty, and was sentenced to 87 months’ imprisonment.  Evidence presented at Zhou’s sentencing included a physician who had unsuspectingly taken the counterfeit Alli and suffered a stroke.

Admittedly, not all our work is this interesting and dramatic. But this is a good example of the truly remarkable skills – from technological and scientific, to the intangible personal skills of working undercover overseas – that our agents bring to the task. In a future blog, I’ll explain our work when ordinary regulation is insufficient and when we move against people who lie to the FDA, which prevents the Agency from doing its regulatory job. Some may not be as colorful as the example above – but all will show the key role of OCI in furthering the FDA mission in protecting the public health. 

John Roth is the Director of FDA’s Office of Criminal Investigations



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