Tranq-Laced Fentanyl Named as "Emerging Threat to US" by Biden Administration

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"This is the first time in our nation's history that a substance is being designated as an emerging threat by any administration," Gupta said.

In an unprecedented move, the US government issued a grave new warning about a cocktail of illegal street drugs made of fentanyl and xylazine that's fueling another wave of American overdose deaths.

"I'm deeply concerned about what this threat means for the nation," said Dr. Rahul Gupta, head of the White House Office of National Drug Control Policy. Xylazine, known on the street as Tranq, was first linked to drug deaths in the Northeast but has since spread rapidly in Southern and Western states.

Speaking with reporters ahead of the public announcement, Gupta said the Biden administration will formally notify Congress about the public health threat and will then roll out a plan to combat the crisis over the next 90 days.

"This is the first time in our nation's history that a substance is being designated as an emerging threat by any administration," Gupta said.

Gupta has been on the front lines of the opioid-fentanyl epidemic for decades as drug overdoses surged above 100,000 deaths a year. He said the threat that this latest mix of drugs could make things even worse is alarming.

Already, the latest drug data from 2020-2021 shows a stunning increase in fatal overdoses linked to Xylazine, with deaths in the South surging more than 1,000%. Public health experts say frequent Xylazine users also suffer terrible wounds when they inject the drug. "People are often ending up having to have amputations of their limbs, or having deep ulcers, infections or sepsis," Gupta said.

"I think it's a tremendous public health risk," said Dr. Stephanie Ann Deutsch, a pediatrician who treats kids exposed to drugs at the Nemours Children's Hospital in Delaware. Deutsch published a paper in December warning other pediatricians about her experience struggling to treat young children sickened by Fentanyl and Xylazine. "The children didn't respond to the traditional antidotes and in general were quite critically ill."

In the coming months, the Biden administration's response is expected to include more testing to identify where Xylazine is prevalent in the street drug supply. Gupta also called for increased funding for research to find medical treatments for people affected. He said it's also likely the government will consider further regulations for xylazine, which is used legally by veterinarians as an animal tranquilizer.

Increased Penalties

Gupta said it may also make sense for Congress to increase criminal penalties, as police try to crack down on dealers and gangs adulterating street drugs with xylazine. Maritza Perez Medina with the Drug Policy Alliance said she worries that growing fears about Xylazine and other synthetic drugs will lead to more arrests rather than better treatment.

"We're really targeting people who could benefit from health services," Perez Medina told NPR. "That's my overall concern with the direction the federal government is taking, specifically Congress with criminalizing these emergent substances." Synthetic drugs including fentanyl, methamphetamines and now xylazine have become a political flashpoint as drug deaths rise.

With the Biden administration pivoting to battle the Xylazine-Fentanyl cocktail, experts say they expect to see more deadly synthetic drugs making their way onto American streets.

Xylazine Scheduling

In March, bipartisan legislation – the Combating Illicit Xylazine Act – was introduced in the House and Senate. It describes illicit xylazine as an “urgent threat to public health and safety” and calls for it to be a Schedule III drug under the Controlled Substances Act, a category on the five-level system for substances with moderate to low potential for physical or psychological dependence. Xylazine would be one level below opioids like fentanyl.

“Our bipartisan bill would take important steps to combat the abuse of xylazine by giving law enforcement more authority to crack down on the illicit distribution of this drug, including by putting stiffer penalties on criminals who are spreading this drug to our communities,” Sen. Maggie Hassan, D-N.H., said in a statement in March. The bill would also require manufacturers to send reports on production and distribution to the DEA so the agency can ensure that the product is not being diverted to the black market.

Cracking Down on Fentanyl Supply Chains

At a time when the global illicit fentanyl supply chain has changed how illicit substances are produced and trafficked, the Biden-Harris Administration is announcing a strengthened whole-of-government approach to save lives by disrupting the trafficking of illicit fentanyl and its precursors into American communities. This approach builds on the President’s National Drug Control Strategy and helps deliver on his State of the Union call to beat the opioid and overdose epidemic by cracking down on the production, sale, and trafficking of illicit fentanyl to help save lives, protect the public health, and improve the public safety of our communities.

Less than a decade ago, the supply of illicit drugs was dominated by plant-based drugs, such as heroin and cocaine, or illicit synthetic stimulants, like methamphetamine. These drugs were produced in crude labs, packaged, and then moved into the United States through an illicit production and distribution process managed by established hierarchical drug trafficking organizations.

Today, the drugs most responsible for killing Americans are illicit synthetic opioids like fentanyl and its analogs, which are easier to produce and transport and also significantly more lethal. The nature of these drugs, and their ease of access and potency, present a national security, public safety, and public health threat. While the old trafficking structures still exist, the producers and traffickers of these illicit synthetic drugs now regularly exploit lawful global commercial distribution networks to sustain and enhance their illicit business.

Over the last two years, the Biden-Harris Administration has prioritized a whole-of-government evidence-based strategy to address untreated addiction, prevent drug deaths, and dismantle drug trafficking production and supply chains. In close collaboration with State, Territorial, Local, and Tribal partners, this Administration has expanded access to prevention, harm reduction where not prohibited by law, treatment, and recovery services; emphasized private sector collaboration; invested significant amounts of funding for law enforcement efforts to combat illicit fentanyl trafficking; and enabled historic seizures of illicit fentanyl on the border. These actions have contributed to a steady decrease or flattening in overdose deaths for seven straight months of reporting.

To build on the trend of decreasing overdose deaths, the Administration is cracking down on illicit fentanyl supply chains by:

• Leading a coordinated global effort with international partners to disrupt the illicit synthetic drug trade. Building on the Biden-Harris Administration’s work to successfully schedule nearly a dozen precursor chemicals with global partners through the United Nations Commission on Narcotic Drugs, the United States is building a global coalition to accelerate efforts against illicit synthetic drugs and employing bilateral and multilateral approaches to prevent illicit drug manufacturing, detect emerging drug threats, disrupt trafficking, address illicit finance, and respond to public safety and public health impacts. This global coalition will develop solutions, drive national actions, and create synergies and leverage among like-minded countries who agree that countering illicit synthetic drugs must be a global policy priority.

• Strengthening coordination and information-sharing among U.S. intelligence and domestic law enforcement agencies. It is essential to improve coordination and information/intelligence sharing across the Federal government and with State, Territorial, Local, and Tribal partners to strengthen our ongoing investigative and analytical efforts to target drug traffickers and dismantle their networks. The Biden-Harris Administration will improve tracking of pill presses and their spare parts, including die molds, used to transform powder fentanyl into pills, in collaboration with state and local law enforcement; strengthen Federal law enforcement coordination to increase seizures of bulk cash being smuggled at the Southwest Border; and better track and target the origins, shipments, and destinations of precursors and equipment used to produce illicit fentanyl and its analogs, including by enhancing collaboration across the Federal government’s targeting, screening, and analysis programs.

• Accelerating work with the private sector globally. Illicit drug traffickers often use legitimate commercial enterprises to access significant capital resources, collaborate with raw material suppliers across international borders, use technology to fund and conduct business and innovate production and distribution strategies to expand their markets. To disrupt these criminals’ access to capital and materials, the Biden-Harris Administration is launching a whole-of-government effort, in partnership with the private sector, to strengthen cooperation with international and domestic express consignment carriers to interdict more illicit substances and production materials; educate companies on safeguarding against the sale and distribution of dual-use chemicals and equipment that could be used to produce illicit fentanyl; and intensify global engagement with private chemical industries.

• Further protect the U.S. financial system from use and abuse by drug traffickers. Drug traffickers, who are primarily driven by profits, require significant funds to operate their illicit supply chains. The Biden-Harris Administration will expand its efforts to disrupt the illicit financial activities that fund these criminals by increasing accountability measures, including financial sanctions, on key targets to obstruct drug traffickers’ access to the U.S. financial system and illicit financial flows. We will also strengthen collaboration with international partners on illicit finance and anti-money laundering efforts related to drug trafficking.

• Continue to call on Congress to close legal loopholes for illicit synthetic drugs. Traffickers are continually altering the chemical structure of fentanyl to evade regulation and prosecution under the Analogue Act, sometimes with tragic results.

Congress temporarily closed this loophole by making all fentanyl-related substances Schedule I. However, this measure expires on December 31, 2024. The Administration continues to call on Congress to permanently schedule all illicitly produced fentanyl-related substances into Schedule I and to take other complementary actions to enhance public health and public safety.

Enforcement Efforts

These actions build on the progress made by the Biden-Harris Administration to reduce the supply of illicit drugs:

• The Department of Justice-led Organized Crime Drug Enforcement Task Forces coordinated 427 joint investigations involving fentanyl in Fiscal Year (FY) 2022, leading to 3,961 defendants, 3,337 convictions, and 130 fentanyl network disruptions or dismantlements.

• The Department of Homeland Security’s (DHS) Operation Blue Lotus, a new and robust surge operation, launched on March 13th to target illicit fentanyl. Led by U.S. Customs and Border Protection (CBP) and U.S. Immigration and Customs Enforcement’s (ICE) Homeland Security Investigations (HSI), and working with federal, state, tribal and local partners, DHS is investing additional personnel, technology, and other resources along the southwest border to detect and seize illicit fentanyl at and between ports of entry.

Fentanyl Seizures

In its first week, Operation Blue Lotus stopped more than 900 pounds of illicit fentanyl from coming into the United States.

• The DEA seized over 57.5 million fentanyl-laced, fake prescription pills and 13,740 pounds of fentanyl powder in the calendar year 2022.

• CBP seized 14,700 pounds of fentanyl in FY 2022, which is an approximate 31 percent increase from the amount seized in FY 2021 (11,201 pounds).

• HSI seized more than 21,000 pounds of fentanyl in FY 2022 by targeting the supply chains responsible for foreign-origin shipments of fentanyl and their precursor chemicals.

• The U.S. Postal Inspection Service (USPIS) seized approximately 150% more fentanyl in FY 2022 than the prior year. The majority of these seizures were mailed domestically from the Southwest Border region of the United States. USPIS has created a Southwest Border Initiative to stop the influx of illicit synthetic opioids smuggled across the U.S.-Mexico border and then placed in the domestic mail system to be distributed within the United States.

• The White House Office of National Drug Control Policy (ONDCP)’s High-Intensity Drug Trafficking Areas program reported seizures of more than 26,000 pounds of fentanyl in the last year.

Increased Sanctions

The Department of the Treasury’s Office of Foreign Assets Control has designated nearly 100 individuals and entities for their role in the illicit drug trade, including trafficking fentanyl and precursor chemicals, pursuant to Executive Order 14059 “Imposing Sanctions on Foreign Persons Involved in the Global Illicit Drug Trade,” signed by President Biden in December 2021.

This E.O. builds on two decades of deliberate and impactful sanctions imposed pursuant to the Foreign Narcotics Kingpin Designation Act. These designations included individuals and entities tied to major trafficking organizations such as the Sinaloa and Jalisco New Generation cartels, along with their key global enablers and facilitators.

The Department of State has rallied the global community at the UN Commission on Narcotic Drugs to place international controls on 14 key fentanyl analogs and precursors since 2016, leading efforts around the world to stop the spread of illicit synthetic opioids through more consistent controls by foreign governments.

Public Health Initiatives

In addition to these actions to reduce the supply of drugs, the Administration is accelerating public health initiatives to save lives, for example by:

• Equitably expanding availability and access to opioid overdose reversal products, including the first nonprescription drug approval of naloxone, and delivering more life-saving naloxone to communities hit hard by fentanyl.

• Launching a national campaign to educate young people on the dangers of fentanyl and how naloxone can save their lives.

• Working to close the addiction treatment gap by working with medical professionals to make prescribing proven treatments for opioid use disorder part of routine health care delivery, and ensuring that manufacturers, wholesalers, and pharmacies are making medications available to everyone with a prescription. This also includes providing addiction treatment while individuals are in jails and prisons, and continuing their treatment in their communities, which has been proven to decrease overdose deaths, reduce crime, and increase employment during reentry.

• To support this Administration’s Strategy and to address illicit fentanyl, President Biden has called on Congress to make a historic investment of $46.1 billion for National Drug Control Program agencies, overseen by the White House ONDCP. The FY24 budget request represents a $5 billion increase from the FY22 request and a $2.3 billion increase over the FY23 enacted level. The FY24 budget includes more funding for efforts to reduce the supply of illicit drugs like fentanyl and stop drug trafficking. It also includes greater funding to support the expansion of prevention, treatment, harm reduction, and recovery support services.
  
  

Mexico's Response

The Undersecretary for Prevention and Health Promotion, Hugo López-Gatell Ramírez, assured that fentanyl is an "imported problem" for Mexico, noting that the product arrives from the United States and other parts of the world.

During the press conference of President Andrés Manuel López Obrador on Tuesday, López-Gatell said that fentanyl "is produced from precursors that are not manufactured in Mexico, they are manufactured in other places" such as the United States, which, he explained, has "routes" to the country.

He pointed out that the Government of Mexico does not want the same crisis as in the United States to happen, “we want to have intense anticipation in prevention. Today, it is not a big public health problem, we want to cooperate with the United States, which has a huge problem of addiction to fentanyl, production of fentanyl, and importation of fentanyl."

“The fentanyl epidemic is an imported epidemic. Since the 1950s, after the World War, the United States began to have very free use of opioid drugs in the medical treatment of pain and that contributed to the generation of addiction dependency,” added the Undersecretary.

Sources White House, La Silla Rota, CNN, Riodoce, NPR