The regulatory fight
In 2016, the Drug Enforcement Administration announced its intentions to classify mitragynine and 7-Hydroxymitragynine, the active ingredients in kratom, as a schedule I drug in order to “avoid an imminent hazard to public safety” after two cases of kratom exposure were reported to the American Association for Poison Control Centers, according to a statement released by the DEA.
In November 2017, Scott Gottlieb, MD, commissioner of the Food and Drug Administration, issued a public health advisory reporting that kratom-related calls to U.S. poison control centers soared 10-fold during 2010-2015. It also said that 36 people have died after using products containing kratom. In light of those developments and with the absence of evidence showing that the substance is safe, the agency is taking action, he wrote.
“To fulfill our public health obligations, we have identified kratom products on two import alerts and we are working to actively prevent shipments of kratom from entering the U.S.,” Dr. Gottlieb wrote. “Kratom is already a controlled substance in 16 countries, including 2 of its native countries of origin, Thailand and Malaysia, as well as Australia, Sweden, and Germany. Kratom is also banned in several states, specifically Alabama, Arkansas, Indiana, Tennessee, and Wisconsin, and several others have pending legislation to ban it.”
In December 2017, a group comprising 17 members of Congress responded wrote a letter to Dr. Gottlieb imploring the Trump administration to recognize the merits of the substance and to drop its intention to make it more difficult to procure.