The US Food and Drug Administration (FDA) and authorities from 115 countries are cracking down on the unlawful sale and distribution of illegal prescription medicines and medical devices on the Internet, including injectables.
As part of International Operation Pangea VIII, the FDA and its international partners sent warning letters to nearly 400 websites offering unapproved or misbranded prescription medicines to US patients and to nine firms distributing unapproved or uncleared medical devices online.
Some of the products targeted during Operation Pangea VIII include illegal dermal fillers such as “Interfall Hydrogel polyacrylamide dermal filler,” “Dermafil Hyaluronic acid dermal filler,” and “Teosyal Hyaluronic acid dermal filler.”
“Patient safety may be compromised—which causes alarm among ‘considerers’—and slows market penetration for aesthetic treatments.” —Wendy Lewis
In total, Operation Pangea VIII took action against 1,050 websites that illegally sell potentially dangerous, unapproved prescription medicines and medical devices to consumers. These actions include the issuance of regulatory warnings to the operators of offending websites and seizure of illegal medicines and medical devices worldwide. They screened and seized illegal drug products and medical devices received through International Mail Facilities in Chicago, Miami, and New York. These screenings resulted in 814 parcels being 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.
The proliferation of black market products is a threat to doctors, patients, and manufacturers in the aesthetic space, says Wendy Lewis, president of Wendy Lewis & Co Ltd, Global Aesthetics Consultancy. “The expense of policing counterfeit and illegally sold products and prosecuting offenders impacts everyone,” she says.
Don’t be tempted, Lewis says. “If someone tries to sell you something that is exactly the same as the name brand product, think twice. Consumers are getting wiser to a ‘bait and switch’ sales pitch,” she says. “Patient safety may be compromised—which causes alarm among ‘considerers’—and slows market penetration for aesthetic treatments.”
Yes, there is a risk of potentially serious complications using counterfeit devices or products, but these devices are also unreliable and prone to failure. “Who will service you? Where will the company be in 3 years? 5 years? 10 years?” Lewis asks.
In addition to health risks, illegal online pharmacies and illegal online medical device retailers 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.