By: Tracey Forfa, J.D., Director of FDA’s Center for Veterinary Medicine

You may have read or heard reports lately about xylazine, a chemical now being found in the human illicit drug supply. I’d like to catch up with you about this chemical and what the FDA’s Center for Veterinary Medicine is doing to address the situation.

What is xylazine and why is it a public health concern?

In 1972, the FDA approved a sedative called xylazine hydrochloride for use in animals. The drug remains essential for veterinarians who work with horses and other large animals, like cattle and deer. A small amount of the FDA-approved drug helps calm scared, aggressive, or injured animals, providing pain relief and allowing veterinarians to safely examine them in close quarters and treat their injuries. 

Now, the chemical xylazine is increasingly being found in the illicit drug supply, mixed with other drugs like fentanyl and heroin. Many users of illicit drugs may not even realize xylazine is in their supply, combined with fentanyl or other opioids. The horrible effects of fentanyl mixed with xylazine have created a major public health challenge for people who use drugs and the public health professionals that treat them. These include the potential increased risk of overdose as well as chronic wounds in users that can lead to infection and limb amputations. In recognition of the public concern, the White House Office of National Drug Control Policy (ONDCP) has released a National Response Plan to proactively address this dangerous threat head-on.

What is CVM doing to stop illicit xylazine from getting into the U.S.?

CVM is working in partnership with other offices across the FDA and Department of Health and Human Services as part of a whole-of-government response to this critical and growing issue. In February, in coordination with FDA’s Office of Regulatory Affairs, we took action to help ensure that any xylazine entering the U.S. through legitimate importation pathways is, in fact, headed to valid animal drug manufacturing or research facilities. 

So far, we’ve found four shipments of unapproved xylazine via our import pathways and placed alerts to watch for incoming shipments from three firms. The majority of xylazine hydrochloride shipments through our import processes are headed for the veterinary marketplace or to authorized research facilities.

But what we’ve stopped at the border doesn’t begin to account for the quantity contributing to this growing public health threat. Instead, as noted by the Drug Enforcement Administration in their October 2022 report, The Growing Threat of Xylazine and its Mixture with Other Drugs, buyers can obtain illicit xylazine cheaply online from any number of websites. According to DEA, “[a] kilogram of xylazine powder can be purchased online from Chinese suppliers with common prices ranging from $6-$20 U.S. dollars per kilogram.” 

We’ve noticed from some photos shared by public health professionals on the front lines that illicit products can be packaged and labeled to look like approved drugs. We’ve worked with our colleagues in U.S. Customs and Border Protection to help them identify packaging and labeling FDA-approved products. But illicit xylazine may not be entering the U.S. through normal trade channels or may be declared to CBP as something other than xylazine, to avoid being identified by FDA and CBP’s field staff.

CVM, as well as the agency, is continuing to work with our colleagues in the U.S. Customs and Border Protection and others to mitigate this issue from all sides, in alignment with our public health and law enforcement partners in federal, state and local governments.