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DEPARTMENT 00 HEI PlI & IICIII AA SERCICES Of 1,11 I 011,5 ;retay A -nL Ito OL U20i AUG 1 6 2018 the I Ionorable tIttant Dinllon Acting Administrator Drug Enforcement Administration II.S. Department )I JUSticc 8'01 Morrissette Drive Springfield, A"A 221 �? Dear Mr. Dhillon Pursuant to the Controlled Substances Act (CSA), 21 LT S.0 @ 81 I, I am rescinding our prior recommendation dated October 17, 2011, that the suhstances mitragynine and -- hydroxvmitragPnine he perntancn0y controlled in Schedule 1 or the CSA. HHS is instead recommending that mitmgynine and 7-hydroxymitragynine not be controlled at this time, either temporarily orpermanently, until scientific research can sufficiently support such an action. Mitragynine, and 7-OH-mitragynine are two of the constituents of the plant Milragyna speciosa (M. speciosa), commonly referred to as kratom. This decision is based on many factors, in part on new data, and in part on the relative lack of evidence, combined with an unknown and potentially substantial risk to public health if these chemicals were scheduled at this time. Further research, which I am proposing be undertaken, should provide additional data to better inform any subsequent scheduling decision. Procedural Hilton On August 31, 2016, the Drug Enforcement Administration (DLA) isnuud a Nou.cot Intent III temporarily schedule the chemicalk mitragvnine and 7-hvdroxNrni iagvnine into Schedule I pursuant to the tempo in, scheduling provision..' of the CSA, 21 1 S,( � 811(h) Sce SI Fed - Reg. 59,929 (:Aug. 31, IOIli)_ In response to the Notice of Intent, the DFA received uumernus comments from the public on mitragvnine and' -h edroxvmiu'agrnine, including comments offering Their opinions cgarcling the Pharmacological eLCTI of t11111 4LIh3tanee5. 10 allmc amsider nI0u of these connnents. as hell us others received on or hefore Decmuber 1.1_0IF_ the DHA issued n Withdratcal of Not cc of Intent and Solicitafion ofComments int Octnher 3I. 2016, On October I 2n 17. the then- \ct:ii" A—MLI'll Secretin- tnr I Iealth of MIS hcrote to then- Ading Adminislrulor of the DFA u, indicate that HIIS las reconunending that the suhstances mi traevnitle and 7-0ii-mitragvnine he pcintenemk vntrolled in Schedule I of the Controlled