The US Food and Drug Administration has issued a warning to website operators for the illegal sales of the opioid Tramadol. According to the letters sent to operators, some of the drugs were mislabeled, while others were not approved for sale in the United States. All of the websites are illicit and selling opioids without prescriptions.
FDA Cracking Down 0n Tramadol
While it may seem to be a minor way censure to have an FDA letter sent to a website, it’s the first action the agency typically takes. The FDA’s letter also clearly states that they are taking action, which means the letter is the first step.
The FDA’s primary job is to make sure that our foods and drugs stay safe. They do not have the authority to arrest website operators. However, they often bring the DEA and other law enforcement into cases that involve illegal narcotics.
Once this letter is sent, the FDA can move to shut down the website owner. This usually means a government lawsuit and seizure of the website by the agency. The FDA can also subpoena documents, financial records, and other evidence of illegally profiting.
Types of Website Infractions
Each website the FDA wrote a letter to was illegally promoting Tramadol. Tramadol is an opioid-like medication that is strictly controlled in the United States. It’s considered to be addictive and also carries a black box warning. Several warnings must be printed with every legal prescription of Tramadol.
Black box warnings are vital because they include information regarding the dangers of a drug. For example, Tramadol can’t be taken alongside SSRI antidepressants because of a life-threatening condition called serotonin syndrome. While the syndrome is rare, it is hazardous, and doctors prefer not to mix the drugs. For one pharmacy, the drug was also made by an unapproved, overseas manufacturer. Unapproved drugs from overseas often have quality control issues.
On another website, named “Best Steroid (Redacted), the Tramadol was manufactured by a company overseas. The website did not require a prescription, and therefore is operating illegally.
“Those who illegally sell opioids online put consumers at risk and undermine the significant strides we have made to combat the opioid crisis,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We remain committed to using all available tools to stop the illegal sale of opioids online to help protect consumers from these potentially dangerous products.”