PETITION BY THE AMERICAN KRATOM ASSOCIATION TO REVIEW AND CORRECT THE FDA’S PUBLIC HEALTH ADVISORY ON KRATOM
November 15, 2017 — The American Kratom Association (AKA), represents more than 3 million adult consumers of the botanical kratom in the United States. The AKA hereby files this Formal Dispute Resolution (FDR) petition with the FDA and the U.S. Department of Health and Human Services challenging the soundness of the decision of the FDA to issue the November 14, 2017 public health advisory on kratom . The AKA asserts that these final decisions by the FDA create an unusual situation requiring an immediate review in the public interest.
REQUEST FOR CORRECTION OF INFORMATION PUBLICLY DISSEMINATED BY CDER AND FDA COMMISSIONER SCOTT GOTTLEIB RELATING TO THE SAFETY OF KRATOM, A BOTANICAL HERB.
The public health advisory issued by the FDA and parroted in the Commissioner’s Statement contains numerous unsubstantiated and inaccurate statements that do not meet the standards of quality required by P.L. 106-554 and Office of Management and Budget (OMB) government-wide requirements for ensuring the quality of information they disseminate to the public, and therefore must be rescinded immediately.
Specifically, FDA claims the following in its November 14 public health advisory as reiterated in Commissioner Gottlieb’s Statement :
Kratom has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction and in some cases deaths;
FDA is aware of reports of 36 deaths associated with the use of kratom-containing products;
The use of kratom is also associated with serious side effects like seizures, liver damage, and withdrawal symptoms;
FDA has evidence to show there are significant safety issue associated with its [kratom] use.
Each of these claims has been incontrovertibly refuted by an 8-Factor Analysis (8-FA) that was completed by Jack Henningfield, Ph.D., who is one of the world’s leading experts on addiction, and the behavioral, cognitive, and central nervous system effects of drugs, and that was delivered to the Drug Enforcement Administration (DEA) and the FDA on November 29, 2016 in direct response to the DEA’s Federal Register notice seeking public comments to be submitted to the FDA regarding kratom.
For years, the FDA has willfully published scientifically inaccurate information on the health effects of consuming kratom, directly influencing regulatory actions by the DEA, states, and various local government entities. AKA believes the FDA health advisory on kratom will lead to more state and local bans, all based on discredited, incomplete, and mischaracterized scientific claims made the FDA and CDER.
Dr. Henningfield’s analysis concluded as follows:
Placement of kratom in the CSA is not warranted from a public health perspective and is more likely to cause public health problems that do not presently exist.
Kratom consumption has not emerged as a public health or medical problem for adults or children despite more than two decades of rapidly increasing consumption by millions of Americans served by approximately 10,000 vendors. Specifically, among the 3-4 publicly documented deaths that have ever been suspected to possibly have involved the consumption of kratom, none have been shown to merit designation as a kratom overdose death and all have involved either other substances or physical or mental health conditions that may have been the primary causes of, or significant contributors to, the death. Remarkably, no deaths, serious adverse effects, or emergency department exposures have been reported in children. It is important to understand that this conclusion does not mean that such events have never or will never occur, but the signal for a public health problem associated with kratom marketing and consumption is very weak.
Kratom consumption appears to be primarily motivated by its perceived effects that enhance well-being, occupational performance, and social interactions, as well as serving as a natural “home remedy” that is preferred by millions of Americans to conventional medicines.
The foregoing is consistent with the pharmacology of kratom and more specifically its alkaloids (MG and 7-OH-MG), which produce mixed pharmacological effects that are generally mild and caffeine stimulant-like at lower dosages. Consumption does not typically interfere with work or social activities and commitments, and in fact kratom is widely reported in the US, as in Southeast Asia, to contribute to work productivity, quality of life, and social relationships.
Although the primary alkaloids of kratom, MG and 7-OH-MG, may demonstrate some characteristics considered for controlled substance scheduling, as do many other products including caffeine, nicotine, some antihistamines, and alcohol, despite decades of wide-spread consumption, there does not appear to be a public health risk that would warrant their scheduling.
MG and kratom have very low toxicity, and thus a favorable safety profile. There have been few reports of serious adverse events or deaths associated with kratom and for most, the contribution of kratom is not clear. For example, in Sweden in about 2008-2009, a blend of herbals including kratom along with the opioid analgesic O-desmethyltramadol, and possibly co-administration of other drug substances was associated with nine deaths. Tramadol (including O-desmethyltramadol), in contrast to kratom, has been documented to carry a risk of severe respiratory depression and overdose death. To date, in the US, there have been no confirmed reports of death that can be considered “causatively” due to kratom overdose. How many, if any deaths, are “probably” classified as kratom poisoning deaths is not clear. This is consistent with the far larger and longer Southeast Asian experience of very few serious adverse events. In both the US and Southeast Asia, the low toxicity of kratom is in striking contrast to the experience with opioids.
There appear to be remarkably low risk of serious adverse effects from kratom consumption as compared to opioids and other common drugs of abuse. Further, there is little evidence that kratom products are used by routes other than oral beverage or food consumption. In contrast, opioids and many other drugs of abuse are frequently used by high impact routes such as nasal insufflation, smoking, and injecting. Graduation from oral consumption to such other routes is common for opioids and other substances of abuse but not for kratom.
Consumption of kratom products appears to provide positive benefits such as relief of pain and fatigue without the adverse consequences produced by other products that are used for similar purposes as reported in the appended testimonials and over a century or more of documented consumption in Southeast Asia. For example, liver disease caused deaths associated with the use of acetaminophen is a serious problem in the US, and there are problems of serious GI side effects and cardiovascular problems associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDS). At the far extreme, there is the inherent risk of overdose and serious addiction associated with the use of opioids. For those who manage various ailments with kratom instead of such products, the benefit to risk ratio appears favorable.
Critically important, there are now four U.S. surveys, including some funded with grants from NIDA, along with thousands of signed testimonials cited in the comments submitted to the DEA during the public comment period that ended on December 1, 2016, that collectively document significant fears among kratom consumers that the government will wrongfully ban kratom. Contrary to the FDA’s public advisory, the survey results demonstrate that any such kratom ban would force many of these consumers to the illicit contraband market to find alternative pain management therapies, and that would pose a far higher safety risk to the public than the current marketplace where kratom is available.
The FDA Office of Dietary Supplements has also received one or more New Dietary Ingredient applications including scientific study data documenting the safety and the very low addiction profile of kratom and affirming the relative safety of kratom’s continued use. This data should help inform the FDA about the safety of kratom, but the Agency is clearly unwilling to factor in this safety data in their assessments of the safety of kratom for consumer use.
In this context, the AKA commissioned a survey of kratom consumers that was recently completed and the preliminary results confirm two earlier cited surveys that many consumers would turn to prescription drugs if kratom were no longer available. The survey results document a perverse and unintended consequence resulting from the FDA’s public health advisory on kratom where the threat to public health, adverse events, and deaths would occur because of any kratom ban.
Specifically, the survey concluded that Ii kratom were no longer legally available, more than one-quarter of survey respondents said they would try to get it even if it were illegal. About one-in-five survey respondents said they would start using “something else” and approximately two-thirds of these respondents said that “something else” would be “prescription drugs,” and about one-third would consider using “illicit or illegal drugs.”
It is inconceivable that the FDA would favor a policy that would foreseeably force a patient who have been weaned off of opioid addition back to dangerously addictive and potentially deadly opioid prescription medications. These facts clearly support the AKA’s position that the FDA’s public health advisory creates an unusual situation requiring an immediate review in the public interest and requiring the FDA to explain and support its alleged evidence supporting its positions on kratom.
In addition to the above survey evidence, the published research of prominent scientists at Columbia University, Johns Hopkins University, the University of Mississippi School of Pharmacy, University of Florida College of Pharmacy, and Rutgers’ Robert Woods Johnson Medical School stand in stark contrast to the poorly articulated FDA staff recommendations on the hazards of kratom use.
The public interest continues to be harmed by the FDA’s willful dissemination of misinformation on kratom to inform the opinions and actions of a variety of other public entities, including the U.S. Congress, state legislators, and a myriad of local government counties, cities and towns. In fact, the FDA cites the fact that kratom has been “banned in several states, specifically Alabama, Arkansas, Indiana, Tennessee and Wisconsin and several others have pending legislation to ban it.” But, the FDA fails to acknowledge that these bans are a direct result of a long-standing anti-kratom misinformation campaign promulgated by the FDA, and the DEA at the behest of the Agency, and the current bans merely document the necessity of the correction of the inaccurate information set forth in the November 14 public health advisory on kratom.
Without a proper review and correction and affirmative withdrawal of the inaccurate information on kratom set forth in the public health advisory, it is guaranteed that the FDA misinformation will lead to additional state and local bans based on the false, discredited scientific claims made by the FDA and DEA.
AKA files this Request for Review and Correction pursuant to the Information Quality Act amendments to the Paperwork Reduction Act, 44 U.S.C. § 3516 Statutory and Historical Notes, P.L. 106-554 (“Information Quality Act”), as implemented through the Office of Management and Budget’s “Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies,” 67 Fed. Reg. 8452 (Feb. 22, 2002) (“OMB Guidelines”), and the “HHS Information Quality Guidelines.”
The Information Quality Act, enacted as an amendment to the Paperwork Reduction Act, 44 U.S.C. § 3501, requires administrative agencies to devise guidelines to ensure the “quality, objectivity, utility, and integrity of information” they disseminate and to “[e]stablish administrative mechanisms allowing affected persons to seek and obtain correction of information maintained and disseminated by the agency that does not comply with the guidelines.”
When the agency is responsible for disseminating “influential” scientific or statistical information, the FDA has heightened responsibilities under the Act to ensure that such disseminated information is reproducible and accurate. The Act contemplates that that all information is accurate given the critical nature of the decisions that will be made by the public about the safety of kratom. “Influential information” is that which is “expected to have a genuinely clear and substantial impact at the national level, or on major public and private policy decisions as they relate to federal justice issues.” To determine that there is a clear and substantial impact, the agency must “have greater certainty than would be the case for many ordinary factual determinations that the impact is occurring or will occur.”
AKA REQUEST FOR REMEDIAL ACTION TO CORRECT THE MISINFORMATION ABOUT KRATOM:
AKA requests Commissioner Gottlieb authorize a review of the FDA’s Public Health Advisory on kratom and authorize a Public Meeting to allow for stakeholders to correct misstatements and factual errors on the science regarding the safety and addiction potential of kratom.
AKA requests the appointment of a Special FDA Advisory Committee of independent experts to review the accuracy, integrity of the data, and the conclusions of the purported “comprehensive scientific and medical evaluation of two compounds found in kratom” referenced by Commissioner Gottlieb prior to any public dissemination or formal actions taken by the FDA based on this analysis.
In the event Commissioner Gottlieb denies the AKA’s request for review, the AKA requests the Acting Assistant Secretary for Health initiate such review and Public Meeting.The AKA respectfully requests these actions because of the adverse impact that inaccurate FDA statements have had in interfering with the freedoms of consumers who have an absolute right to make informed choices on their personal regimen for their health and well-being.
The substantial gap between the publicly available evidence showing the safety of kratom, and the secretive and unsubstantiated conclusions of the FDA staff are, on their face, irreconcilable and arbitrary. This transparent bias raises serious and legitimate questions about the validity of the data relied upon by FDA staff and provided to Commissioner Gottlieb.
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