The federal Controlled Substances Act (CSA), 18 U.S.C. § 801 et seq., establishes five schedules of chemicals and materials, setting restrictions on their manufacturing, distribution, sale, and possession. Schedule I contains the most highly restricted drugs. The Drug Enforcement Administration (DEA), part of the U.S. Department of Justice (DOJ), has the authority to add drugs to the schedules, remove them, or reschedule them. In August 2016, the DEA published a notice of intent to add two chemicals, the active components of a plant known as kratom, to Schedule I. 81 Fed. Reg. 59929 (Aug. 31, 2016). The DEA claimed that banning kratom “is necessary to avoid an imminent hazard to the public safety.” Id. The notice prompted a massive public response about the purported benefits of kratom. The DEA withdrew its notice of intent about six weeks later and requested additional feedback. 81 Fed. Reg. 70652 (Oct. 13, 2016).
Schedule I controlled substances, according to the CSA, have a “high potential for abuse,” lack a “currently accepted medical use,” and have no “accepted safety” standards for use “under medical supervision.” 21 U.S.C. § 812(b)(1). The CSA includes various opioids and opiate derivatives, including heroin, under Schedule I, as well as MDMA, marijuana, LSD, peyote, and psilocybin. Id. at § 812(c)(I). The DOJ, through the Attorney General, has the authority to add drugs to any of the schedules upon a finding that they have “a potential for abuse” and fit the CSA’s scheduling criteria. Id. at § 811(a). The DOJ has delegated this procedure to the DEA. 21 C.F.R. § 1308.01 et seq.
Kratom is native to Southeast Asia. It is reportedly used in pain management and to treat opiate withdrawal, although the Food and Drug Administration (FDA) has not approved it for any medical use. Since it has similar effects to opioids, it is also used recreationally. According to the Centers for Disease Control and Prevention (CDC), kratom use has been associated with various negative effects. Kratom proponents claim that it is a beneficial alternative to opioid drugs. Six states—Alabama, Arkansas, Indiana, Tennessee, Vermont, and Wisconsin—have banned kratom, along with one county in Florida. The FDA has issued an import alert regarding the plant, and the federal government has seized multiple shipments of dietary supplements containing kratom at U.S. ports.