In 2016 alone, over 1,400 practitioners were warned by the FDA that their supplier was selling unapproved so-called “Botox.” With more than 2,400 professionals warned in the past 5 years, the expansion of use for this medication provides new markets for counterfeiters selling fake and misbranded drugs.
Botulinum neurotoxin, or Botox as it is known, started as a treatment for wrinkles. According to a new report in Time Magazine however, Botox is used to treat dozens of ailments. Time reports that “more than half of its revenue comes from its therapeutic uses for conditions as varied as chronic migraines and back pain to excessive sweating and twitching eyelids.”
Unfortunately for U.S. patients, drug counterfeiters have been exploiting both the expanding market and clinician greed by offering highly discounted versions of non-FDA approved cosmetic injectables from unlicensed sources via Internet sales and blast faxes. Between 2005 and 2013, 46 people were investigated for the purchase or sale of counterfeit/misbranded cosmetic injectable drugs, and over 1,000 U.S. medical practices have been warned by the FDA about buying from fake Botox suppliers.
Since 2013, the FDA has sent out warning letters to a laundry list of medical practices that have purchased counterfeit or unapproved Botox with which to treat patients.
In 2015, the FDA alerted health professionals that counterfeit versions of Botox had been found in the United States.
Also in 2015, the Department of Justice (DOJ) reported two Canadian citizens were sentenced for selling counterfeit Botox in the U.S. The defendants imported their fake Botox from Turkey and sold it to clinics and medical offices all over the United States.
In 2016, The DOJ reported that Neurology Associates of Greenville was sentenced to probation and paid $300,000 fine for purchasing imported and non-FDA approved Botox for treating their patients.
In November 2016, the DOJ reported a nurse who had appeared on the television show Real Housewives of Orange County pleaded guilty to buying misbranded, non-FDA approved Botox from a foreign supplier.
Also in 2016, over 1400 U.S. medical practices received warning letters from the FDA that their unlicensed medication supplier, TC Medical, had been distributing counterfeit Botox. In 2015, TC Medical pleaded guilty to orchestrating a multi-year conspiracy to smuggle misbranded prescription products into the United States.