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DEA, FDA Issue Joint Warning Letters to Online Opioid Sellers

— October 8, 2019

Two federal agencies join forces to stop online opioid sales.

The U.S. Food and Drug Administration (FDA) and the U.S. Drug Enforcement Administration (DEA) have sent out warning letters to four online networks responsible for the operation of ten websites concerning “illegally marketing unapproved and misbranded versions of opioid medicines.”  The warnings urged site owners to immediately stop distributing opioids to American consumers.

“As the FDA works to forcefully tackle the opioid crisis on all fronts, we cannot allow rogue online pharmacies to continue to fuel the crisis by illegally offering opioids for sale and circumventing the important safeguards that have been put in place for opioids to help protect the public health,” said Acting FDA Commissioner Ned Sharpless, M.D. “Today’s effort is also noteworthy because while the FDA partners regularly with the DEA, this is the first time we have issued joint warning letters with them.  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.”

Consumers who buy prescription medicines, including opioids, from illegal online pharmacies may be getting counterfeit, contaminated, or even expired and useless medications in the mail, according to these agencies.  What’s more, several sites offer opioids without a prescription and the FDA is concerned this will only fuel the crisis.  The sites that received letters were apparently selling “misbranded and unapproved new drugs in violation of the Federal Food, Drug, and Cosmetic Act,” an investigation into the matter discovered.  “In addition to health risks, illegal online pharmacies can pose other risks to consumers, including credit card fraud, identity theft and computer viruses,” the agencies warned.

The networks addressed violated the Controlled Substances Act (CSA) by failing to register their online pharmacies with the DEA, which is required for the sale of any prescription medication which to be legally distributed and dispensed online.

“Issuing these warning letters is not only an effort to deter the availability of dangerous illegal opioids, but it is also a testament to the close cooperation between DEA and FDA,” said Acting DEA Administrator Uttam Dhillon. “We will continue to attack organizations that facilitate the sale of dangerous drugs, putting profit over public safety.”

The companies, given fifteen days to respond, were selling tramadol (among other opioids), which typically comes with a disclaimer on the box that life-threatening risks associated with this pain medication include addiction, abuse, misuse, life-threatening respiratory depression and neonatal opioid withdrawal syndrome.  If it is taken with other nervous system depressants, including alcohol, use could result in coma or even death.

The FDA hosted its second annual Online Opioid Summit earlier this year, which addressed the issue of online opioid selling.  The DEA also participated.  The agency discussed the dangers and initiatives to be taken to combat the crisis.

If the sellers do not comply and remove any remaining inventory from their sites, the FDA and DEA are entitled to take legal action.  The U.S. Department of Justice’s Narcotic and Dangerous Drug Section attorneys assigned to the DEA’s Special Operations Division and Policy Unit also assisted in crafting the letters sent to the websites.


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