FDA and DEA Jointly Warn Illegal Online Opioid Networks

Regulatory NewsRegulatory News | 30 September 2019 |  By 

In a first for the US Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA), the agencies came together to warn four online networks operating 10 websites that illegally market unapproved and misbranded versions of opioids.

FDA notes that the illegal online pharmacies may put people at risk because there is no guarantee that the medicines are safe and because several of these websites sell opioids online without a prescription.

In the warning letters, dated 6 September, the agencies cited companies for selling unapproved versions of tramadol, marketed as “Top-Tram” or “Tramadol (Ultram) 100 mg” or “Tramadol 200mg Tablets,” and another opioid known as tapentadol, among others.

In addition, the online networks violated the Controlled Substances Act (CSA) by failing to register their online pharmacies with the DEA despite knowingly or intentionally advertising the sale of controlled substances, including opioids.

“While the FDA partners regularly with the DEA, this is the first time we have issued joint warning letters with them,” acting FDA Commissioner Ned Sharpless wrote. “This action further strengthens the warning to the operators of these websites. We remain committed to using all available regulatory and enforcement tools to stop the illicit flow of opioids online.”

FDA, meanwhile, also noted that it has been active in combating the illegal online sales of opioids, with similar warning letters issued in May and August 2018 and in March 2019.

Warning Letters


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