Biden-⁠Harris Administration Designates Fentanyl Combined with Xylazine as an Emerging Threat to the United States

Xylazine’s growing role in overdose deaths nationwide prompts Administration to make this designation for the first time in U.S. history

ATLANTA, GA – Today, Dr. Rahul Gupta, Director of the White House Office of National Drug Control Policy (ONDCP), has officially designated fentanyl adulterated or associated with xylazine as an emerging threat to the United States. Xylazine is a non-opioid tranquilizer approved by the Food and Drug Administration (FDA) for veterinary use but not human use. This designation comes after careful review of the impact of xylazine on the opioid crisis, including its growing role in overdose deaths in every region of the United States.

“As a physician, I am deeply troubled about the devastating impact of the fentanyl-xylazine combination, and as President Biden’s drug policy advisor, I am immensely concerned about what this threat means for the Nation,” said Dr. Gupta. “That’s why the Biden-Harris Administration is using this designation authority for the first time since it passed Congress in 2018. By declaring xylazine combined with fentanyl as an emerging threat, we are being proactive in our approach to save lives and creating new tools for public health and public safety officials and communities across the Nation. To parents, loved ones, community leaders, and those affected by xylazine use: I want you to know that help is on the way.”

ONDCP is required to monitor novel and evolving patterns of substance use, establish criteria for determining when a substance or combination of substances should be designated an emerging threat, and declare emerging threats when the Director deems appropriate based on the criteria. These criteria were published earlier this year, and focus on geographic presence of an emerging threat, as well as impact measured by metrics such as overdoses in the course of a year.

Director Gupta is making this designation because xylazine combined with fentanyl is being sold illicitly and is associated with significant and rapidly worsening negative health consequences, including fatal overdoses and severe morbidity.

The Drug Enforcement Administration (DEA) reports that:

• Between 2020 and 2021, forensic laboratory identifications of xylazine rose in all four U.S. census regions, most notably in the south (193%) and the west (112%).
• Xylazine-positive overdose deaths increased by 1,127% in the south, 750% in the west, more than 500% in the Midwest, and more than 100% in the northeast.

These levels of geographic distribution and rapid increase in negative health outcomes meet the Emerging Threats Criteria used by ONDCP to judge when the novel use of a substance should be considered as an emerging threat to the nation. While national overdose death numbers have flattened or decreased for seven straight months, xylazine is complicating efforts to reverse opioid overdoses with Naloxone and threatens progress being made to save lives and address the opioid crisis.

Following today’s public declaration, the Administration will take steps to publish a whole-of-government response that includes evidence-based prevention, treatment, and supply reduction.

ONDCP is convening an interagency working group to inform the development of the national response plan. The response will include work on xylazine testing, treatment and supportive care protocols, comprehensive data systems (including information on drug sourcing and supply), strategies to reduce illicit supply of xylazine, and rapid research (such as work on the interactions between xylazine and fentanyl).

President Biden has made combatting the opioid crisis a key part of his Unity Agenda for America and has taken several actions to reduce both the supply of fentanyl and negative health outcomes associated with illicit fentanyl and other illicit substances. Fentanyl was dangerous before and it is even more dangerous now due to its combination with xylazine. Addressing the fentanyl crisis also requires addressing the drugs—in particular xylazine—with which fentanyl is being combined. Saving lives is the Administration’s North Star and drives the President’s drug policy.

Read about the Biden-⁠Harris Administration’s efforts to crack down on illicit fentanyl supply chains HERE.

Read the Biden-Harris Administration’s National Drug Control Strategy HERE.

Read about the Emerging Threat Committee’s last meeting regarding xylazine HERE.