11/01/2022 Meeting Minutes - Laserfiche WebLink

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predecessor. the Acting Assistant Secrctar - for I Iealth, forwarded to you his recommendation that mitragynine and 7-hydroxyrnitragynine he pemtanently controlled in Schedule I of the CS;A_ The recommendation included a scientific and medical evaluation prepared by the FDA of the eight factors determinative of control under the CSA. 'Phe FDA evaluation also recommended in favor of the three findings that are required for DBA to place a substance in Schedule I_ I have reviewed the Acting Assistant Secretary's earlier recommendation as [cell as previous and nett scientific data. In light (if this revicw, comhined with concerns for unintended public health consequences, I now conclude that [['title mitragynine and 7-hydroxymitragynine have many' properties of an opioid, scheduling these chemicals at this time in light of the underdeveloped state of the science would be premature. For example, one recently published peer reviewed animal study indicated that mitragynine does not have abuse potential and actually reduced morphine intake. As such, these new data suggest that mitragynine does not satisfy the first o the three statutory requisites for Schedule I. irrespective of broader considerations of public health. While a single study is rarely dispositive, it strongly suggests that further evaluation is warrented. Although there remains cause for concern for 7-hydroxymitragynine and potentially mirragynhhe, the level of scientific data and analysis presented by the FDA and available in the literature do not meet the criteria for inclusion of kratom or its chemical components in Schedule I of the CSA at this time. There is still debate among reputable scientists over whether kratom by itself is associated with fatal overdoses. Further analysis and public input regarding Aratom and its chemical components are needed before any scheduling should be undertaken. It is important that we have additional information to justify scheduling, such as:' • A scientific assessment of how many Americans utilize kratom, and an understanding of the geographic and demographic distribution of these users (Factors 4, 5); • A scientific assessment of the actual scale and degree of dependence and/or addiction of Americans utilizing kratom (Factors 1, 5, 7); • A scientific determination based on data whether kratom actually serves as a gateway drug that promotes fuller use of more dangerous opioids (Factors 1, 4, 5); • A valid prediction of how many kratom users will suffer adverse consequences if kratom is no longer available, including: in Intractable pains psychological distress, risk for suicide; o Transition to proven deadly opioids such as prescription opioids, heroin, or fentanyl; and is Transition to other potent or harmful drugs (Factor 6); • A scientifically valid assessment of causality in the current few deaths in which kratom was co-ut lized with known lethal drugs such as fentanyl (Factors 1, 2, 3, 5 & 6). Furthermore, there is a significant risk of immediate adverse public health consequences for potentially millions of users if kratom or its components are included in Schedule 1, such as: I ani also concerned about the Impact of scheduling knerom on our ability to conduct research, especially eervey reseuch and our aorren by Inability tc routinely test for k,ntorn In those brought into an emergency room as a revut of a possible overdose.