FDA targets unlawful internet sales of illegal prescription medicines during international operation Pangea IX

FDA has requested the suspension of 4,402 websites and has issued warning letters to the operators of 53 websites illegally offering unapproved and misbranded prescription drug products for sale to US consumers.

“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 drug products and to remove these products from the supply chain.

The FDA’s Office of Criminal Investigations, Office of Regulatory Affairs, and Center for Drug Evaluation and Research participated in the enforcement action, which ran from 31 May to 7 June 2016. The FDA conducted extensive inspections at International Mail Facilities (IMFs) in co-ordination with US Customs and Border Protection, and sent formal complaints to domain registrars requesting the suspension of the 4,402 websites. Included are 110 websites that sell the chemical 2,4-Dinitrophenol (DNP) as a weight-loss product. 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 9 May 2016 guilty plea 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 4,402 websites, issued warning letters to the operators of 53 websites illegally offering unapproved and misbranded prescription drug products for sale to US consumers. 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 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. Consumers should 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.

The IIWA is a collaborative effort between the FDA, the US Department of Homeland Security, National Intellectual Property Rights Coordination Center, INTERPOL, the World Customs Organization, the Permanent Forum of International Pharmaceutical Crime, Heads of Medicines Agencies Working Group of Enforcement Officers, the pharmaceutical industry and national health and law enforcement agencies from 115 participating countries.