DEA withdraws kratom ban, opens public comment period

Agency will make final determination on scheduling kratom after December 1, 2016

In late August, DEA announced its intention to make kratom a Schedule I drug to avoid what it called “an imminent hazard to public safety.” But after a public outcry and enormous pressure from lawmakers, in October the agency took the unprecedented move of withdrawing its plans to ban kratom, according to a notice posted in the Federal Register.

Instead, DEA is opening a public comment period ending December 1, 2016, before making a final determination, along with formal input from FDA, about scheduling kratom.

Kratom, a medicinal plant containing mitragynine and 7-hydroxymitragynine, has been marketed as a safe and legal alternative to controlled substances to alleviate pain.

DEA initially proposed the Schedule I classification because, according to the agency, kratom has a “high potential for abuse, has no currently accepted medical use in treatment in the United States, and has a lack of accepted safety for use under medical supervision.”

In addition, DEA stated, the identity, purity levels, and quantity of kratom’s substances are uncertain and inconsistent, thereby posing significant adverse health risks to users. The agency said that law enforcement nationwide had seized more kratom in the first half of 2016 than any previous year, and that this accounted for millions of dosages intended for the recreational market. Kratom has been seized in various forms, including powder, plant, capsules, tablets, liquids, gum/resin, and drug patch.

In recent weeks, prominent Members of Congress, including Sen. Orrin Hatch (R-UT) and Sen. Cory Booker (D-NJ), sent letters to DEA criticizing the kratom ban and calling on the agency to provide a public comment period, stating the need for “adequate time for experts to weigh in.”

A Schedule I designation would have resulted in an immediate shutdown of all scientific studies on kratom’s role in opioid treatment.