FDA to Limit Illicit Import of Xylazine

On February 28, the FDA reported that it would limit the illegal import of xylazine-active pharmaceutical ingredients to minimize public health issues involving illegal usage.

Xylazine, a non-opioid veterinary drug used in animals for sedation, anesthesia, or muscle relaxation, has been illegally manufactured and used, resulting in overdose deaths. The FDA’s new action intends to prevent the drug from being imported into the U.S. market for illicit causes while still allowing imports for necessary animal usage. Veterinarians legally and lawfully utilize drugs containing xylazine to sedate larger animals.

It is, however, harmful in humans and can bring severe side effects, such as severely weakened blood pressure, heart rate, and more. Aside from internal side effects, those who inject drugs with xylazine may also face serious skin wounds that are easily infected, sometimes even causing amputation. Xylazine has been found as a contaminant combined with opioids such as illicit fentanyl or stimulates including methamphetamine and cocaine.

Some individuals using these illicit drugs may not even realize the presence of xylazine in their drugs. "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," says FDA Commissioner Robert M. Califf, M.D.

The FDA took such action to ensure imports of drugs with xylazine are only used for good veterinary use, such as for manufacturers creating FDA-approved xylazine or authorized finished products coming into the U.S. Within the import alert, xylazine coming into the country will be highly inspected. FDA staff may even hold onto any shipment if it has signs of violating the law. The staff will look at specified evidence by importers to ensure all imported products are correctly labeled and for legitimate veterinary usage.

"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," says Califf.

Xylazine-related actions are being examined by the FDA and its Office of Criminal Investigations in conjunction with federal, state, and local associates. In addition, they are working with stakeholders involved in animal health to confirm that medications containing xylazine are available to veterinarians for only necessary use. The FDA will continue to deliver updates regarding the issue.

Director of the FDA’s Center for Veterinary Medicine Tracey Forfa, J.D. concludes: "We recognize the public health effects of xylazine tainting these illicit drugs and are continuing to ensure that legitimate product is restricted to veterinary use only."