FDA, DEA crack down on illegal online opioid dealers

  • Food and Drug Administration, Drug Enforcement Administration

  • von Kelli Whitlock Burton
  • Clinical Essentials
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Takeaway

  • A joint warning letter from the FDA and the Drug Enforcement Administration (DEA) ordered 4 online networks that operate a total of 10 websites to stop selling illegal unapproved and misbranded versions of opioid medications such as tramadol to American consumers.

Why this matters

  • Illegal online pharmacies market and sell prescription medications and opioids without prescriptions, including opioids that are unapproved, counterfeit, contaminated, expired, or otherwise unsafe.

Key issues

  • The networks receiving warning letters include Divyata, Euphoria Healthcare Pvt Ltd., JCM Dropship, and Meds4U.
  • These networks have not registered their online pharmacies with the FDA, violating the Controlled Substances Act.
  • Unapproved tramadol available online does not include the FDA boxed warning with information about serious and life-threatening adverse effects.
  • This is the first joint warning letter issued by the FDA and DEA, but the FDA issued similar warning letters in June 2018, August 2018, and April of this year to networks that collectively produce more than 70 websites.