The FDA sent warning letters to nine online networks, which operate 53 websites, to halt illegal marketing of unapproved versions of opioid medications, including oxycodone and tramadol, the agency announced June 5.
Companies that do not correct the violations in the warning letters could be subject to enforcement action, including product seizure or injunction. The FDA requested responses from the companies within 10 working days. The agency directed these organizations to list the specific actions being taken to address its concerns.
"The FDA is taking additional steps to protect U.S. consumers from illicit opioids by targeting the websites that illegally market them and other illicit drugs," said FDA Commissioner Scott Gottlieb, MD.
"The internet is virtually awash in illegal narcotics, and we're going to be taking new steps to work with legitimate internet firms to voluntarily crack down on these sales," the commissioner said.
To address these issues, the FDA is hosting an online opioid summit June 27 with internet companies to develop strategies to fight the crisis.
"At the same time, we'll be taking action against firms whose websites deliberately break the law," Dr. Gottlieb said.
Opioids purchased through these websites could be counterfeit and may contain other dangerous substances, Dr. Gottlieb said.
"The new warning letters are part of a comprehensive campaign to target illegal sales of unapproved opioids," he said. "We'll be following these actions with additional steps in coming months to crack down on the flow of illegal, unapproved opioids sold online and shipped through the mail."