FDA cracks down on illegal internet sales of prescription medicines in Operation Pangea IX

FDA takes action against more than 4,000 websites

The US Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, has taken action against 4,402 websites that illegally sell potentially dangerous, unapproved prescription medicines.

This crackdown was part of Operation Pangea IX, the Ninth Annual International Internet Week of Action (IIWA), a global cooperative effort, led by Interpol, to combat the unlawful sale and distribution of illegal and potentially counterfeit medical products through the internet.

'Preventing illegal internet sales of dangerous unapproved drugs is critical to protecting consumers’ health,' said George Karavetsos, Director of the FDA’s Office of Criminal Investigations.

'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.'

The goal of Operation Pangea IX was to identify the makers and distributors of illegal prescription drugs and to remove these products from the supply chain.

Preventing illegal internet sales of dangerous unapproved drugs is critical to protecting consumers’ health

The FDA’s Office of Criminal Investigations, Office of Regulatory Affairs, and Centre for Drug Evaluation and Research participated in the enforcement action, which ran from 31 May to 7 June.

The action included the FDA carrying out extensive inspections at International Mail Facilities (IMFs) in coordination with US Customs and Border Protection. Formal complaints were sent to domain registrars requesting the suspension of the 4,402 websites.

More than 100 websites that sell the chemical 2,4-Dinitrophenol (DNP) as a weight-loss product were identified. DNP is most often used as a dye, wood preserver, and herbicide and has never been approved by the FDA for use as a drug.

A recent FDA task force investigation into the distribution of DNP resulted in a guilty plea on 9 May from Adam Alden of Bakersfield, California, for introducing an unapproved drug into interstate commerce. A Rhode Island customer who purchased DNP via the internet from Alden, among other sources, died in October 2013 as a result of DNP ingestion.

During the IIWA, the FDA, in addition to requesting the suspension of more than 4,000 websites, issued warning letters to the operators of 53 websites illegally offering unapproved and misbranded prescription drugs.

FDA inspectors, in collaboration with other federal agencies, screened and seized illegal drug products received through IMFs in San Francisco, Chicago, and New York. These screenings resulted in the detention of 797 parcels which, if found in violation of the Federal Food, Drug, and Cosmetic Act, will be refused entry into the country and destroyed.

Preliminary findings showed that US consumers had purchased unapproved drug products from abroad to treat depression, narcolepsy, high cholesterol, glaucoma, and asthma, among other diseases.

The FDA advises consumers to be cautious when buying prescription drugs online. For tips on how to identify an illegal pharmacy website and advice on how to find a safe online pharmacy go to BeSafeRx: Know Your Online Pharmacy.

In addition to health risks, illegal online pharmacies pose other risks to consumers, including credit card fraud, identity theft and computer viruses. The FDA encourages consumers to report suspected criminal activity at www.fda.gov/oci.