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September 10, 2020

The U.S. Food and Drug Administration has issued warning letters to 17 website operators for illegally selling unapproved and misbranded opioids online in violation of the Federal Food, Drug, and Cosmetic Act. Misbranded opioids include those offered for sale without a prescription, as well as opioids that lack adequate directions for use.

The opioids offered for sale include products such as tramadol and oxycodone.  These are prescription drugs that have significant risks of addiction, abuse and misuse, which can lead to overdose and death, and should only be used under the supervision of a licensed health care provider. These warning letters are a continuation of the FDA’s commitment to take action against the illegal sale of opioids over the internet.

“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.”

The warning letters were issued to:

In addition to the significant risks of addiction, abuse and misuse, opioids can cause life-threatening respiratory depression (breathing problems), which can lead to overdose and death, and withdrawal symptoms in newborn babies. When taken with other central nervous system depressants, including alcohol, the use of opioids may result in coma or death.

Opioid addiction is a serious public health issue in the United States, and the sale of unapproved and misbranded opioids may pose heightened dangers to consumers who purchase those products over the internet. Unlike drugs approved by the FDA, there has been no FDA evaluation of whether unapproved products are safe and effective for their intended use, or whether they have dangerous side effects or other safety concerns.

Consumers who buy prescription drugs, including opioids, from illegal online pharmacies may put their health at risk because the products, while being marketed as authentic, may be counterfeit, contaminated, expired or otherwise unsafe. Additionally, several of these websites offer opioids online without a prescription, posing significant risks to consumers. Illegal online pharmacies can also pose other risks to consumers, including credit card fraud, identity theft and computer viruses.

The FDA is committed to addressing the national crisis of opioid addiction on all fronts, with a significant focus on decreasing exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those involved in the illegal importation and sale of unapproved and misbranded opioids.

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