Inspections, Compliance, Enforcement, and Criminal Investigations

Criminal Investigations Case Activity

Examples of the types of criminal investigations OCI investigates.

Cyber Crime

  • Google, Inc.: OCI initiates an investigation from information supplied by a suspect in another case who used Google’s services to advertise his illegal online pharmacies. Undercover OCI agents then pose as operators of “Canadian” online pharmacies and pay Google for listing their illegal sites in Google’s AdWords platform, demonstrating that the company does not care if the products are being sold illegally. After showing Google the evidence, the company agrees to a civil settlement, acknowledging that it had helped “Canadian” online pharmacies target ads for their illegal organizations through AdWords.   Google forfeits $500 million and agrees to follow a number of compliance and reporting measures to make sure similar conduct would not happen in the future.
  • Pakistan National Pleads Guilty in Multi-National Cybercrime Investigation:  A dual citizen of Pakistan and the United Kingdom creates, maintains and controls more than 1,500 websites that promote the sale of drugs claiming to cure and treat hundreds of diseases, including cerebral palsy, mental retardation, Parkinson’s disease, Alzheimer’s disease, and emphysema. The websites include falsified cure rates, false clinical research and fabricated testimonials.  They generate more than $12 million in sales. The drugs supposedly come from Europe, Australia, and New Zealand, but are in fact from Pakistan.

    The man behind the scheme is arrested when he flies into the U.S. on a business trip. He pleads guilty to wire fraud.
  • OCI Seizes More Than 4,400 Websites:  As part of Interpol's yearly Operation Pangea, OCI agents obtain seizure warrants for more than 4,400 websites illegally selling counterfeit or misbranded drugs that purport to be brand-name pharmaceuticals. Many of these websites are part of an online network of pharmaceutical sites which claim to be legitimate online pharmacies operating in Canada, while others claim affiliation with major U.S. pharmacy retailers. Drugs purchased from these sites are not from Canada, nor are they brand-name or FDA approved, but come from sites in India and Singapore.
    The FDA's Office of Criminal Investigations Cybercrime Investigations Unit banner is now displayed on all 4,402 seized websites to alert consumers that the sites were identified as engaging in this illegal activity.

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Prescription Drugs

  • Ozay Pharmaceuticals: A Turkish drug wholesaler is sentenced to 27 months in prison for smuggling counterfeit, misbranded and adulterated cancer treatment drugs into the U.S.  Tests show that some of the drugs from Turkey have no active drug ingredients.  FDA issues several public safety alerts about the illegal cancer treatments circulating in the country. The investigation leads to eight related prosecutions.
  • Cumberland Distribution, Inc. Two Texas residents plead guilty to participating in a prescription drug diversion (theft) scheme that results in profits of more than $14 million. The two residents bought prescription drugs that had been stolen from legitimate suppliers and resold the stolen goods to authorized pharmacies, assuring their buyers that the drugs came from approved sources.  
  • Gallant Pharma: A dual citizen of Canada and Barbados and co-founder of Gallant Pharma International Inc., is sentenced to three years in prison and payment of $3.4 million in forfeiture and restitution to victims. For at least three years, the Canadian-Barbadian citizen sells in the U.S. more than $12.4 million in non-FDA-approved chemotherapy drugs and injectable cosmetic drugs and devices. Nine additional co-defendants also plead guilty.
  • New England Compounding Center (NECC): The owner of the New England Compounding Center is convicted of racketeering, mail fraud, and selling misbranded drugs. The drugs lead to a nationwide fungal meningitis outbreak, leaving more than 700 patients in 20 states with a fungal infection after receiving injections of a prescription injectable drug manufactured by NECC. Of those patients, 64 died. The outbreak was the largest public health crisis ever caused by a pharmaceutical product. The case is currently under appeal.
  • Project Greenlife: A man operates an online business selling “Miracle Mineral Supplement” – touted as curing cancer and AIDS, plus numerous other diseases and illnesses, including the common cold. But it is a mixture of water and sodium chlorite, an industrial chemical used as a pesticide and for wastewater treatment which can cause potentially fatal side effects if swallowed.
    The man is sentenced to more than four years in federal prison. Three other conspirators earlier plead guilty to introducing misbranded drugs into interstate commerce. 
  • Male Enhancement Products from China: A foreign national is convicted of illegally importing and selling online misbranded male enhancement drugs from China, disguised as “all-natural” and “herbal” dietary supplements when they are shipped to the U.S. The man and his brother import the products, which contain the drug ingredients found in the FDA-approved drugs Viagra and Cialis, both of which require a prescription from a doctor. The man currently awaits sentencing.

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Foods, Dietary Supplements

  • Peanut Corporation of AmericaTwo former officials of the Peanut Corporation of America (PCA) are sentenced to prison for their roles in a conspiracy to defraud their customers by shipping salmonella-positive peanut products. They also confess to falsifying microbiological test results. The tainted peanut butter leads to an outbreak with more than 700 cases of salmonella poisoning in 46 states and nine deaths.   PCA’s former president receives a sentence of 28 years in prison, the largest criminal sentence ever given in a food safety case.
  • 5-Hour Energy Drink: A federal jury convicts eight defendants for attempting to increase profits by selling mislabeled and counterfeit 5-Hour Energy drinks. The defendants remove the legitimate labels from more than 350,000 bottles of 5-Hour Energy and replace them with false labels. Eventually they begin to produce counterfeit energy drinks. They sell the product for less than the standard market price.   This case represents one of the largest domestic food counterfeiting cases prosecuted by the U.S. Department of Justice.  The owner was sentenced to 86 months in Federal prison; his wife was sentenced to 26 months' prison.
  • Raw Deal, Inc: The owner of a company that makes and markets dietary supplements tells his employees to add “fillers,” including cocoa replacer and rice flours, to the company’s products and to certify that some of the company’s products are kosher or organic, even though they are not. During an earlier FDA inspection, he instructs employees to alter documents and not to let the FDA inspectors see “fillers” being added to customers’ orders.

    For selling diluted and adulterated dietary ingredients and supplements, he is sentenced to 40 months in prison.

  • Jensen Farms: Two cantaloupe farm owners plead guilty to charges of shipping their cantaloupe knowing that it is contaminated by a poisonous bacteria, Listeria monocytogenes (L. mono). The cantaloupes go to 28 states, resulting in at least 147 hospitalizations and 33 deaths. One woman, pregnant at the time of her outbreak-related illness, has a miscarriage.

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Medical Devices

  • Candy Color Lenses: The owner and operator of the Candy Color Lenses website masterminds an international scheme to import counterfeit and misbranded contact lenses from Asia and sell them online without a prescription to tens of thousands of U.S. customers. Many customers complain about the quality of the contact lenses; the owner admits that some of the lenses were contaminated with a potentially dangerous bacteria.    He is sentenced to 46 months in prison and forfeits $1.2. million in proceeds.
  • Apollo Endosurgery: A medical device salesman pleads guilty to wire fraud for selling expired LAP-BAND adjustable gastric banding systems to physicians. The salesman and his cohorts change serial numbers and expiration dates on expired medical devices, then create false labels with fake serial numbers and expiration dates, and finally sell these misbranded and adulterated devices to local physicians. The criminals are awaiting sentencing.
  • Westmoreland: A Maryland woman pleads guilty to injecting non-medical grade silicone, which is used in caulking and the manufacture of heat-resistant tiles, into clients’ buttocks and other body parts to enhance their appearance. She gives the silicone injections to thousands of customers in her home and in hotel rooms, charging $250-500 per session. Serious harm, including death, can occur as a result of having this procedure. The woman currently awaits sentencing. 

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Tobacco

  • Counterfeit Cigarettes: OCI agents work with colleagues from the Bureau of Alcohol, Tobacco and Firearms to conduct an undercover purchase of counterfeit cigarettes from China, enough cigarettes to fill a 20-foot cargo container. Shortly after, an undercover OCI agent meets with the source of the counterfeit cigarettes, who is then arrested for smuggling counterfeit tobacco products. He later pleads guilty and is serving 16 months in federal prison.
  • Counterfeit Newport Cigarettes: An undercover OCI agent meets overseas with a suspect to arrange purchase of counterfeit cigarettes. OCI then wires more than $130,000 to Dubai for the undercover purchase of 1,030 cases of counterfeit Newport cigarettes, with an estimated street value of $5.6 million. The counterfeit cigarettes are seized when they reach the U.S. port of entry. The suspect is sentenced to serve 16 months in prison, for trafficking in counterfeit cigarettes. 

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Veterinary Drugs

  • Counterfeit Labels for Illegal Veterinary Drugs: The CEO of a printing and packaging company pleads guilty to making and shipping counterfeit labels for veterinary drugs – Frontline, Frontline Plus and Rimadyl, among others – to the drug producers, who are located in other states. The CEO awaits sentencing.
  • Contaminated Cattle Feed: A Canadian corporation that manufactures and brokers the sale of cattle feed is fined $80,000 for importing contaminated cattle feed into the U.S. The feed contained more than double the amount of an antibiotic that is regularly used in animal feed; the purchaser was not aware of this 200 percent increase in the feed that had been ordered.

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Page Last Updated: 06/26/2017
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