FDA Takes Action Against Illegal Online Pharmacies

More than 4400 websites that illegally sell potentially dangerous and unapproved drugs were targeted in an operation by the FDA, law enforcement, and international agencies.

Operation Pangea IX, which is led by INTERPOL, aimed to curb the sale and distribution of counterfeit or illegal drugs online and take those products out of the supply chain.

“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, in a press release. “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 FDA’s Office of Criminal Investigations, Office of Regulatory Affairs, and Center for Drug Evaluation and Research took action against illegal pharmacy websites between May 31, 2016, and June 7, 2016. The investigators sent complaints to domain registrars and asked that 4402 websites be suspended, the FDA stated in a press release.

More than 100 of the sites sold the chemical 2,4-Dinitrophenol (DNP) as a weight-loss product. The chemical is often used as a dye, wood preserver, and herbicide, but it has never been approved by the FDA as a drug.

In October 2013, a customer bought a DNP-containing product online from a man named Adam Alden. The customer died from the DNP ingestion, and Alden pleaded guilty in May 2016 for introducing an unapproved drug into interstate commerce, the FDA noted.

In addition to the requests to have the websites shut down, the FDA sent warning letters to the operators of 53 websites that offered drugs online illegally.

The FDA also inspected international mail facilities in San Francisco, Chicago, and New York and detained nearly 900 packages. If these parcels are found to violate the Federal Food, Drug, and Cosmetic Act, they will be destroyed.

The FDA maintained that the screenings of these parcels at the mail facilities suggested that US patients were buying unapproved drugs from overseas to treat conditions like depression, narcolepsy, high cholesterol, glaucoma, and asthma. The agency warned consumers about buying prescription drugs online and suggested going to the FDA’s resource, BeSafeRx: Know Your Online Pharmacy, to help figure out how to find a safe online pharmacy.

In addition to the problems posed by taking unapproved or dangerous drugs, the FDA also cautioned that illegal online pharmacies may also commit credit card fraud or identity theft. Patients may also be more vulnerable to computer viruses.

One year ago, the FDA carried out Operation Pangea VII, which took action against 1040 websites selling unapproved drugs and medical devices. During last year’s screening of international mail, the FDA detained 814 objects. Some of the most common drugs found during the operation were generic versions of Valium, Truvada, and Meridia.

Around 96% of online pharmacies are noncompliant with federal and state laws or National Association of Boards of Pharmacy (NABP) safety and pharmacy practice standards, according to the NABP.

Pharmacists in brick-and-mortar stores can help raise awareness among their patients about the dangers of using online pharmacies.