FDA, International Authorities Shutter Thousands of Illegal Online Drug Stores

Regulatory NewsRegulatory News
| 09 June 2016 | By Michael Mezher 

The US Food and Drug Administration (FDA) and other international regulators and law enforcement on Thursday announced the results of a series of actions to combat illegal and counterfeit medicines.

For its part, FDA says it requested the closure of 4,402 websites that illegally marketed or sold drugs or other chemical products to US consumers, and issued 53 warning letters to website operators "for offering unapproved and misbranded prescription drug products."

FDA's actions were part of the Interpol-led Operation Pangea IX, a coordinated "week of action" that ran from 31 May to 7 June against counterfeit and illegal medicines, involving regulatory authorities, customs agencies and law enforcement from more than 100 countries.

"Operation Pangea IX demonstrates the FDA's continuing commitment to stand united with our international partners to protect consumers in the United States and throughout the world from criminals who put profit above the health and safety of consumers," said George Karavestos, director of FDA's Office of Criminal Investigations.

Additionally, FDA says it conducted "extensive inspections" at international mail facilities (IMFs) in cooperation with Customs and Border Protection, which resulted in the detention of nearly 800 parcels, which the agency says it will destroy if they are found to be in violation of the law.

"Preliminary findings from drug products screened at the IMFs show that US consumers had purchased certain unapproved drug products from abroad to treat depression, narcolepsy, high cholesterol, glaucoma, and asthma, among other diseases," FDA said.

Authorities in other countries also found illegal healthcare products, including drugs to treat life-threatening diseases. According to Interpol, "Myanmar authorities seized illicit anti-cancer medication and in Singapore, anabolic steroids, sleeping pills, pregnancy test kits and drugs for infertility and weight loss were recovered."

In 2015, Pangea VIII involved agencies from 115 countries and was responsible for 156 arrests, the seizure of 20.7 million illegal drugs and supplements, and the closure of more than 2,400 websites globally.

This year, Pangea XI involved agencies from 103 countries and yielded 393 arrests, the seizure of 12.2 million counterfeit drugs and 270,000 medical devices, and resulted in the closure of 4,932 websites globally.

FDA claims responsibility for the bulk of the shuttered websites, saying it sent "formal complaints" requesting the closure of 4,402 websites.

Of those sites, FDA says 110 promoted the chemical 2,4-Dinitrophenol (DNP) as a weight loss drug. According to FDA, "DNP is most often used as a dye, wood preserver, and herbicide and has never been approved … for use as a drug."

From 2013 to 2014, FDA carried out an investigation into online sales of DNP after a Rhode Island resident died as a result of taking the chemical. Last month, FDA and the Department of Justice announced that one of the online sellers the deceased man had bought DNP from plead guilty to "introducing an unapproved drug into interstate commerce."





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