Loyola University Chicago School of Law, JD 2024
The FDA has taken action to stop the unlawful importation of a drug called xylazine by announcing on February 28 that they have issued an Import Alert for drug products or ingredients that have xylazine active products within them. Xylazine is a drug used in the veterinary field and is contained in drugs that sedate animals such as horses and deer (animal tranquilizers). It has increasingly been found within drugs in the illegal drug trade and has been linked to overdose deaths all over the country including California and Pennsylvania. The FDA’s action is part of its initiative to protect public health and stop the presence of xylazine in the nation’s illicit drugs.
What is the problem with xylazine?
Xylazine is a non-opioid active ingredient that is used in an animal tranquilizer that the FDA originally approved in 1972. It has been approved to be used on many different animal species (including horses and dogs) to help calm and handle the animals, perform surgeries, be used as a local anesthetic, and relieve pain. Xylazine is not approved by the FDA for human use, and it is not human use due to its life-threatening side effects. The FDA has listed that it can cause severe skin wounds and dead tissue, cause depressed breathing, and raise blood pressure, heart rate, and body temperature to skyrocket.
Public health officials, law enforcement personnel, and policymakers who are already grappling with an opioid crisis that claims thousands of lives each month are now deeply concerned about a drug known as “tranq,” which has become prevalent on the streets. Xylazine, the active ingredient in the drug, has had a particularly severe impact in Philadelphia, where it has been found in a large number of street opioid samples and was detected in 31 percent of unintentional fatal overdoses involving fentanyl or heroin as of 2019. The Drug Enforcement Administration reports that people in Puerto Rico began consuming the animal tranquilizer in the 2000s.
The FDA’s decision to impose an import alert on xylazine has been praised by the DEA, which has vowed to combat the “devastating tide of drug poisonings” plaguing the nation. Mixing xylazine with other illicit drugs, particularly fentanyl, has had catastrophic consequences for communities across the country, according to DEA Administrator Anne Milgram.
According to the FDA, doctors have had to amputate limbs due to infections caused by “skin wounds and patches of dead and rotting tissue” resulting from xylazine use. Wound care nurse Jason Bienert, who works with the addiction recovery group Voices of Hope Maryland, says he treats between 13 and 30 patients each week with xylazine sores in Cecil County near the Delaware border. Bienert described the wounds as having fully rotted skin with purple edges that are blistered and noted that people continue to inject drugs into these edges, exacerbating the wounds. His first patient had to have her hand amputated due to the wounds. Further, since xylazine is not an opioid, it is still unclear whether the overdoses are reversible by naloxone, a medicine known to reverse opioid overdoses.
What is the FDA doing?
The FDA issued an import alert on February 28, 2023. By issuing an import alert, the FDA gives the authorities the power to halt the transportation of both the final medication and its constituents. The recent action taken by the FDA aims to ensure that drugs containing xylazine that are imported into the United States are intended for legitimate veterinary purposes. This includes active pharmaceutical ingredients being transported to FDA-approved manufacturing facilities for processing, compounding of animal drugs at state-licensed compounding pharmacies or by licensed veterinarians, and approved finished products being imported into the U.S.
Under the import alert, the FDA will scrutinize xylazine shipments offered for import more closely, and its staff may detain the shipment if it appears to be in violation of the law. When reviewing incoming products, FDA staff will evaluate specific evidence provided by importers to confirm that the product is properly labeled, not adulterated, and intended for legitimate veterinary use.
Tracey Forfa, J.D., the director of the FDA’s Center for Veterinary Medicine, emphasized the agency’s commitment to restricting xylazine to legitimate veterinary use only, acknowledging the public health impact of the drug’s presence in illicit drugs. The FDA’s criminal investigations office is collaborating with federal, state, and local agencies to investigate any illicit activities related to xylazine that may be criminally prosecuted. The regulation of illegal imports of xylazine is a work in progress for the FDA, but the import alert is a step forward in protecting the lives of U.S. citizens.