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  1. FDA In Brief

FDA In Brief: FDA Continues Efforts to Curb Illegal Availability of Unapproved Opioids Online

February 1, 2021

Media Inquiries

  Lauren-Jei McCarthy

The following quote is attributed to Donald D. Ashley, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research:

“Websites that illegally offer opioids for sale pose serious risks to the American public and 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.

“As the result of a successful 120-day pilot program launched last year with the FDA, the National Telecommunications and Information Administration and domain name registries, nearly 30 websites illegally offering opioids for sale became inaccessible to the public.

“The pilot program has proven to be an effective tool in maximizing the impact of FDA’s efforts to limit the illegal sale of unapproved opioids online and we are pleased to announce we will continue this collaboration to help prevent illegal online opioid sales.”

Additional Information:

  • Today, U.S. Food and Drug Administration is sharing an important update on the pilot program with the National Telecommunications and Information Administration (NTIA) and three domain name registries to help reduce the availability of unapproved opioids illegally offered for sale online.
  • Under the pilot, the FDA notified registries that participated in the pilot – Public Interest Registry, Registry Services (formerly Neustar) and Verisign – when the agency sent a warning letter to a website operator and the website operator did not respond adequately within the required timeframe. The registries reviewed the FDA’s notifications and assessed whether to take further voluntary action, including possible domain name suspensions or blocks.
  • The illegal sale of opioids online is a major public health concern and a top priority for the FDA. Domain name registries are a critical part of the solution to the illegal sale of opioids online since they play a role in the registration of domain names.
  • The FDA remains committed to addressing the national opioid crisis on all fronts, with a continued 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 taking action against those who contribute to the illegal sale and importation of unapproved opioids.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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