The FDA issued an import alert Tuesday to clamp down on the illegal importation of xylazine, an animal tranquilizer showing up more and more in illicit drugs.
“This action aims to prevent the drug from entering the U.S. market for illicit purposes, while maintaining availability for its legitimate uses in animals,” the agency said in a press release.
Veterinarians legitimately use drug products containing xylazine to sedate large animals such as horses and deer, but it is not safe for use in people and may cause serious and life-threatening side effects, the FDA noted. However, “it has been identified as a contaminant found in combination with opioids such as illicit fentanyl, and in combination with other illicit products that contain stimulants such as methamphetamine and cocaine. People who use illicit drugs may not be aware of the presence of xylazine.”
Under the import alert, “xylazine offered for import is subject to heightened FDA scrutiny, and FDA staff may detain the shipment if it appears to be in violation of the law,” the press release stated. “As part of their entry review, FDA staff will consider specific evidence offered by importers that the incoming product is properly labeled, not adulterated, and for legitimate veterinary use.”
“The FDA remains concerned about the increasing prevalence of xylazine mixed with illicit drugs, and this action is one part of broader efforts the agency is undertaking to address this issue,” FDA Commissioner Robert Califf, MD, said in the release. “We will continue to use all tools at our disposal and partner with the Drug Enforcement Administration and other federal, state, local agencies and stakeholders as appropriate to stem these illicit activities and protect public health.”
The American College of Emergency Physicians (ACEP) praised the FDA’s action. “Patients in the emergency department for a fentanyl or heroin-related emergency may have xylazine in their system without knowing it, which makes detection and treatment a challenge for healthcare professionals,” an ACEP spokesperson wrote in an email to MedPage Today. “ACEP applauds the FDA for taking important steps to help limit misuse and prevent emergencies from occurring. We look forward to seeing additional actions that protect patients and enhance treatment and access to care for overdoses and related emergencies.”
While FDA is taking this action, other government officials, including members of Congress and the Drug Enforcement Administration (DEA), are considering making xylazine a controlled substance. In a statement, the American Veterinary Medical Association said that it is “closely engaged with the relevant congressional offices and committees” that are discussing scheduling xylazine, noting that it understands that the DEA “has begun its internal process to schedule the drug.”
One source previously told MedPage Today that the DEA has conducted an 8-Factor Analysis for xylazine, which is an assessment of the drug’s abuse potential that is a required step in the scheduling process.
Additionally, the DEA has said that the “two-part process” to schedule a substance has been in the works since October 2021, according to Fox News. The agency told the news outlet that the process involves sending data to HHS and requesting a scheduling recommendation.
The DEA sent HHS “supplemental information” in September 2022 to “accelerate” the scheduling process, and DEA is “still waiting on HHS to provide a scheduling recommendation,” the article noted. The DEA did not return several requests for comment from MedPage Today.
Andrew Kolodny, MD, an expert in opioid policy and addiction medicine at Brandeis University in Massachusetts, said in a phone interview that the FDA’s action Tuesday “wouldn’t be necessary” if they had scheduled xylazine, “which is what they would do if they were going to follow federal law.” He noted that although he hadn’t seen the DEA’s 8-Factor Analysis, “my understanding is … xylazine is a drug with significant abuse potential, and if it is, it should be scheduled.”
The import alert likely won’t do much good, he added, because “I’m aware of very clear evidence that the xylazine in the illicit drug supply is coming from American distributors; I’ve seen photos [of their products] on the street in Philadelphia. I’m not aware of any evidence that the xylazine winding up on the streets of the U.S. is coming from abroad. If this action by the FDA is based on evidence and data, I think they should share that with the public and the press.”
The fact that the FDA has issued this alert, Kolodny said, “suggests to me they’re not planning to issue a scheduling recommendation any time soon, and that’s troubling.”
Joyce Frieden oversees MedPage Today’s Washington coverage, including stories about Congress, the White House, the Supreme Court, healthcare trade associations, and federal agencies. She has 35 years of experience covering health policy. Follow