Regulatory Watchdog Calls On DEA To Halt Kratom Ban, Calls On OMB InterventionBy Brandon Turbeville The CRE points out that the DEAs policy on kratom is in conflict with the policy of a number of other federal agencies and, thus, the legality of kratom falls under the jurisdiction of the Office of Management and Budget whose job it is to settle inter-agency conflicts of policy. The letter reads: The Office of Information and Regulatory Affairs (OIRA) has been described as the cockpit of the regulatory state. It is an organization that has a statutory mandate to manage and oversee the flow of regulatory actions taken by federal agencies. In the discharge of these duties OIRA is often involved in one-on-one discussions with agency personnel to resolve potential conflicts with OMB personnel. However, in this instance, the DEA action to ban kratom, the conflict is considerably wider in scope. In this instance there is a sharp disagreement among a number of federal agencies. Consequently if there were ever a time for an OMB intervention this is it. The CREs letter also calls into question the shaky science used by the DEA in order to push its ban when it states: The DEAs August 31, 2016 Federal Register notice placing Mitragynine and 7-Hydroxymitragynine into Schedule I5 highlights the out of context observation that the consumption of kratom individually,or in conjunction with alcohol or other drugs, is of serious concern as it can lead to severe adverse effects and death. The FR notice, however, left out the crucial supporting data that is necessary to understand the information provided by DEA and to it place in a policy context. Earlier this year, the peer-reviewed neuroscience journal Brain Research Bulletin published a survey of the literature on traditional and non-traditional uses of Mitragynin which found that, While several cases of toxicity and death have emerged in the West, such reports have been non-existent in South East Asia where kratom has had a longer history of use. We highlight the possible reasons for this as discussed in the literature. More importantly, it should be borne in mind that the individual clinical casereports emerging from the West that link kratom use to adverse reactions or fatalities frequently pertained to kratom used together with other substances. Therefore, there is a danger of these reports being used to strengthen the case for legal sanction against kratom. This would be unfortunate since the experiences from South East Asia suggest considerable potential for therapeutic use among people who use drugs. Thus, one federal agencylaw enforcement agencyDEA, is in the process of making the possession of kratom a felony at the same time that a journal edited by the Principal Investigator of another federal agency, the National Institute of Child Health Human Development, published an article which concluded that more scientific clinical human studies are necessary to determine [kratoms] potential therapeutic value. Citing research conducted by the USDA, NIH, University of Massachusetts Medical School, and the University of Mississippi, the CRE shows that the DEA has arbitrarily banned kratom and that the DEAs own claims are either disproven or contradicted by the findings of organizations who have actually conducted research on the substance. The CRE writes, The kratom footprint grows even further. The research was so well conducted and received by the scientific community that the aforementioned institutions applied for a patent. How much more additional evidence is needed to demonstrate that the DEA has acted arbitrarily in issuing a ban on kratom? In short, without going through a notice-and-comment process, DEA is obviating another agencys research that was conducted with appropriated funds. With its action, DEA is also obviating the progress and promise of kratom research to boosting the American bio-sciences industry. In short the arbitrary cancellation of kratom by DEA without any public input suggests that OMB must reassert itself with respect to the regulatory actions of the agency. In addition where have been the officials the Office of Legal Counsel in the Department of Justice whose job is to review regulatory actions taken by the components of the agency before they are submitted to OMB? CRE also states that the DEAs actions violate the US-Canada Regulatory Cooperation Council (RCC) Agreement since the U.S. regulatory system coordinates closely with that of Canada. As the FDA recently stated that the Canadian food safety system is comparable to that of the U.S. and since Canada lists kratom as a Natural Health Product, the DEAs actions not only put it in conflict with the RCC but also with the FDA. The CRE also states that the DEAs decision violates the Information Quality Act since it did not designate the Schedule 1 classification of kratom as a HISA (Highly Influential Scientific Assessment). CRE states, The OMB Peer Review Guidelines, which govern the Information Quality responsibility of all federal agencies, define a Highly Influential Scientific Assessment ( HISA) as follows: A scientific assessment is considered highly influential if the agency or the OIRA Administrator determines that the dissemination could have a potential impact of more than $500 million in any one year on either the public or private sector or that the dissemination is novel, controversial, or precedent-setting, or has significant interagency interest. The aforementioned information most certainly demonstrates that the Schedule I listing is controversial and has significant interagency interest. Consequently DEA is required by law to conduct a HISA. Either DEA or OMB can designate a scientific study as a HISA. CRE also points out that the alleged hazards of kratom are not imminent according to the standards set by the Controlled Substances Act. CRE writes, The Controlled Substances Act states ( 21 U.S.C. 811(h)(1) that the Attorney General may act without adherence to established administrative processes If the Attorney General finds that the scheduling of a substance in Schedule I on a temporary basis is necessary to avoid an imminent hazard to the public safety. With respect to established administrative processes the statute states: Rules of the Attorney General under this subsection shall be made on the record after opportunity for a hearing.. Kratom has been in use for decades, if not centuries. What compelling documentation does the DEA, a law enforcement agency, have in its possession that would support a finding of an imminent hazard? DEA did present arguments in the Federal Register in which they claim kratom poses a threat to public health, but none so convincing that it is an imminent threat to public health. The public, including a wide range of experts, should have been given the opportunity to comment on DEAs findings. The DEA chose to bypass the preferred listing process in the Controlled Substances Act, which allows for public comment, by claiming that kratom is an imminent hazard. By taking this action without providing sufficient detail of the factual predicate justifying its determination that kratom is somehow an imminent hazard, the DEA inappropriately revoked any rights of the public to comment on the agencys findings. With all of this in mind, the CRE has issued its recommendations for the DEA, none of which would actually prevent the DEA from moving forward on its plans but which would at least give the American people some breathing room in terms of how long they have to address, fight, and resist the primitive agencys tactics. The CRE recommends the following: 1. Extend the effective date for placing kratom into schedule I until July, 1, 2017. Please see this Action Alert to see what you can do to help keep Kratom legal. Photo source, modified including ThorPorre (Own work) [CC BY 3.0], via Wikimedia Commons, via NB This article (Regulatory Watchdog Calls On DEA To Halt Kratom Ban, Calls On OMB Intervention) can be republished under a Creative Commons license with attribution to Brandon Turbeville, source and Natural Blaze.com. Brandon Turbeville article archive here is an author out of Florence, South Carolina. He is the author of six books, Codex Alimentarius The End of Health Freedom, 7 Real Conspiracies,Five Sense Solutions and Dispatches From a Dissident, volume 1 and volume 2, The Road to Damascus: The Anglo-American Assault on Syria, and The Difference it Makes: 36 Reasons Why Hillary Clinton Should Never Be President. Turbeville has published over 600 articles dealing on a wide variety of subjects including health, economics, government corruption, and civil liberties. Brandon Turbevilles podcast Truth on The Tracks can be found every Monday night 9 pm EST at UCYTV. He is available for radio and TV interviews. Please contact activistpost (at) gmail.com. This is my comment I just made to CRE. September 17, 2016 at 2:15 pm I have herniated discs and spinal stenosis and was back on Hydrocodone last year after not taking it for several years. I hated what they did to me and even though effective I couldnt wait till the effects wore off. I found out about Kratom a few mos. ago and it is keeping me very comfortable with NO side effects. It is a miracle all natural leaf. The Medical Mafia just does not want us taking care of our personal issues naturally. They want us on their very toxic and highly addictive substances with chances to OD on them which many do. Many people I have shared Kratom with say it helped their pain also and they consider it a miracle too. This truly is about money and tyranny! The DEA wants to be the main snake in he bog! 