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• Suffering with intractable pain; <br />• Krarom users switching to highly lethal opioids, including potent and deadly prescription <br />opioids, hemin, and/or fentanyl, risking thousands of deaths from overdoses and <br />infectious diseases associated with IV drug use; <br />• Inhibition of patients discussing kratom use with their primary care physicians leading to <br />more harm, and enhancement of stigma thereby decreasing desire for treatment, because <br />of individual users now being guilty of a crime by virtue of their possession or use of <br />kratom <br />• The stifling effect of classification in Schedule I on critical research needed on the <br />complex and potentially useful chemistry of components of kratom. <br />'Therefore, 1 conclude at the current time, available evidence does not support mitragyni ne and 7- <br />hydroxymitragynine being controlled in Schedule I of the Controlled Substances Act this <br />assessment Supersedes the previous recommendation letter from Acting .Assistant Secretar} <br />Wright dated October 17, 3017. In the meantime, it is recognized that kratonr may potcvialk <br />have harmful effects, especialh in specific circumstances and/or when used with potent <br />prescription or illicit drugs. <br />Finalla, it is cntirel} possible that netdant and evidence could Support scheduling of chemicals <br />in kratom at some future time. A},rtoni ma, have harmful effects, particularly , hen used kith <br />other drugs. As such, I cneourage continued enforcement by the FDA against unproven claims <br />by lantom mamtfacturers. I also support enhanced public awaicness that lnntom contains <br />molecules that may potentially he dangerous. I also plan to work expeditiously with eol,cagucs <br />throughout the U.S. government to Seek transparent public and Scicnti tic input, and «t collect <br />data on the critical public health considerations outlined above- <br />Should you have auy questions regarding this recommendation, please contact m}' office at (N') <br />690.7694. <br />Sincerelc fours, <br />Brett P_ Ounir, fvl D_ <br />ADM, CB. Public I lealth Service <br />Assistant Secretary bor I Icalth <br />Scnior Advisor for opioid Po!icv <br />