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FDA Part of International Action Against Internet Sales of Unapproved Drugs and Medical Devices

Jun 19, 2015

In a news release issued on Thursday, the Food and Drug Administration (FDA) said it had sent warning letters and seized potentially dangerous, unapproved medicines and medical devices from more than one thousand websites worldwide.

FDA inspectors and other federal agents screened and seized illegal drugs and medical devices received through international mail facilities in Chicago, Miami and New York, according to the FDA statement.

The FDA sent warning letters to operators of nearly 400 websites and to nine firms distributing unapproved medical devices online. Some of the prescription were purported to be generic versions of FDA-approved drugs such as Nolvadex, Meridia, Valium, Truvada and Advair Diskus. The illegal devices included colon care products and dermal fillers. In addition to the health risks posed by the products, the FDA news release warned that customers who bought the products were also at risk for credit card fraud, identity theft, and computer viruses.

The crackdown occurred as part of the Eighth 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 on the Internet. The enforcement action ran from June 9 to June 16, 2015. The IIWA is a collaborative effort between the FDA, the U.S. 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 health and law enforcement agencies from 111 participating countries.

As part of this year's effort, the FDA sent Warning Letters to the operators of nearly 400 websites that offer unapproved or misbranded prescription medicines to U.S. patients and to nine firms distributing unapproved or uncleared medical devices online. As a result of these screenings, 814 parcels were detained and referred to appropriate FDA offices for follow up. Parcels found in violation of the Federal Food, Drug and Cosmetic Act will be refused entry into the country.

George Karavetsos, director of the FDA's Office of Criminal Investigations, said, "Our efforts to protect the health of American patients by preventing the online sale of potentially dangerous illegal medical products will not cease," according the agency's news release. Karavetsos said the FDA is "not only pleased to be a part of this strong international enforcement effort, but resolved to do everything we can to ensure that the global problem of illegal Internet drug and device sales is deterred as a result."

Preliminary findings from drug products screened at the mail facilities show that certain drug products from abroad, such as antidepressants, hormone replacement therapies, sleep aids, and drugs to treat erectile dysfunction, high cholesterol and seizures were en route to U.S. consumers.

The FDA provides consumers with information to identify illegal pharmacy websites and advice on how to find a safe online pharmacy through BeSafeRx: Know Your Online Pharmacy.

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