A letter from the U.S. Department of Health & Human Services (“HHS”) rescinding the agency’s prior recommendation to classify kratom as a controlled substance has been revealed to the public, but not until two-and-a-half years after the letter was initially submitted to the U.S. Drug Enforcement Agency (“DEA”).
Kratom advocates, including groups such as the American Kratom Association (“AKA”), contend the failure to make timely and appropriate disclosure of the recission letter to DEA has essentially created a “de-facto” ban on kratom.
In 2016, the DEA tried to ban the chemical in kratom but they reversed course after strong criticism from kratom users and members of Congress. In 2017 HHS submitted a letter to the DEA recommending certain chemicals found in kratom be classified as Schedule I substances. The cannabis industry is, of course, quite familiar with what this classification means. In short, the substance has a “high potential for abuse” for which there is “no currently accepted medical use.”
BUT, at 2018 when the HHS sent another letter to the DEA, only this time, the letter rescinded the prior recommendation to ban the substances in kratom. In the subsequent letter, HHS expressly recommended that the substances in kratom not be controlled, either temporarily or permanently, until scientific research can sufficiently support such an action.
Brett P. Giroir, a medical doctor and acting Assistant Secretary for Health & Human Services and Senior Advisor for Opioid Policy at the time, sent the second letter to the DEA. Giroir specifically advised that based on his review of previous and new scientific data, as well as concerns for the unintended public health consequences of scheduling kratom, he concluded that while the chemicals in kratom have many properties of an opioid, scheduling these chemicals in light of the underdeveloped state of the science would be premature.
Giroir went on to cite studies as examples of the lack of clear evidence supporting the recommended scheduling, such as one study finding that THE CHEMICAL IN KRATOM ACTUALLY REDUCED MORPHINE INTAKE INSTEAD OF SHOWING ABUSE POTENTIAL. He contended that new data like this suggests that kratom’s chemicals do not satisfy the statutory requisites for Schedule 1 substances, irrespective of broader considerations of public health. Accordingly, he advised the DEA that available evidence does not support the chemicals in kratom being scheduled.
This more precise emphasis on kratom regulation is actually more appropriate if the FDA has a focus on how kratom is processed, kratom packaging, kratom contamination and/or kratom sales. Kratom importers as we all know are mostly from Indonesia, the government in Indonesia has also focused on research from kratom since the end of 2020, so we can relax for a moment about the legal status of kratom.
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