City Administrator Head:
The Edwardsville City Council will soon be considering a proposed ordinance to ban kratom in the City. I write as the Senior Fellow on Public Policy for the American Kratom Association (AKA), speaking on behalf of the more than 15 million Americans who safely use pure and unadulterated kratom, to ask your consideration of an appropriate regulatory scheme for kratom rather than a blanket ban.
The AKA shares the concern of the City Council, the various committees, and the Police Chief about unregulated kratom products being sold in Edwardsville. However, the information observed in news reports about the discussions on kratom show those discussions rely in large part on inaccurate information disseminated by the FDA that has since been rejected by other federal agencies, and today kratom remains legal in all but six states — states who acted on the FDA recommendations between 2012 and 2016. Since then, more than 14 states have considered and then rejected proposed bans, including the State of Maryland that just in the past few weeks replaced a proposed ban with an age restriction and is considering recommendations for a more rationale regulatory scheme.
In addition, San Diego County last week declined to enact a ban on kratom, and now will look at other options provided under what we call the Kratom Consumer Protection Act (KCPA) that regulates kratom and bans adulterated and dangerous kratom products. Earlier this year Naperville, IL rejected a proposed ban. For your information, the KCPA legislation was filed in the Illinois Legislature — both House and Senate — that will be considered this year.
Used responsibly, kratom is safe for consumers and the reports of adverse events and “kratom associated deaths” are all properly attributed to adulterated kratom products by unscrupulous vendors who spike pure kratom with dangerous substances to give consumers a “high” that is not present in pure kratom.
The AKA recommends a regulatory scheme that would, if adopted by Edwardsville City, require any kratom vendor to register with the City and provide a listing of each kratom product they offer for sale, along with a certification provided the manufacturer from an independent certified laboratory that the kratom product is pure kratom with no dangerous adulterants; is labeled with all ingredients; and is restricted for sale to anyone under the age of 21.
Kratom is not an opioid; it does not suppress the respiratory system as classic opioids do — and that is why opioid overdoses occur; and kratom is not dangerously addictive — it has the same dependency profile as caffeine (kratom is a tree from the coffee plant family).
The science has led to a dramatic turnaround in the attitudes of public policy officials who are now rejecting the FDA’s disinformation campaign on kratom, and four states have passed a responsible regulatory scheme to protect consumers from adulterated kratom products. Utah, Georgia, Arizona, and Nevada enacted versions of the Kratom Consumer Protection Act (KCPA). Similar proposals are now being considered by 21 states in the current legislative session, and three of the six states who banned kratom between 2012 and 2016 are now actively reconsidering those bans.
The Drug Enforcement Administration (DEA) is tasked with scheduling of any dangerous substances to protect the public, and the DEA has rejected one FDA scheduling recommendation in 2016, and have refused to act on a second scheduling recommendation submitted by the FDA in October 2017, more than two years ago.
If the FDA claims were true about the dangers of kratom, the DEA would have acted quickly to protect the safety of the public.
Instead, the DEA has taken a more cautious approach, like the National Institutes of Drug Abuse (NIDA) and the U.S. Congress — who oppose the ban and call for more research.
We would ask you to review the documents contained in the files found in the following link that the AKA believes will provide the context for a decision by San Diego County to enact a version of the Kratom Consumer Protection Act:
https://www.dropbox.com/sh/10e0ncq14pw7w0b/AACqll8u3WKIcKSfHa4aCVU4a?dl=0
Here is a description of the documents in the Dropbox folder:
This document lays out the chronology of events leading up to the current public policy discussion on kratom, and documents both the science and public policy arguments for kratom to remain accessible to consumers under a reasonable regulatory framework.Document 2: Peer reviewed and published article: The abuse potential of kratom according the 8 factors of the controlled substances act: implications for regulation and research
Dr. Henningfield and his colleagues outline the importance of regulation and the need for research that will be impeded if bans are enacted on consumer access to kratom.Document 3: Case Study on 9 Deaths in Sweden FDA Claims are Associated with Kratom
This case study documents that the 9 kratom associated deaths frequently referenced by the FDA were actually caused by an adulterant, O-desmethyltramadol.
Document 4: Babin Report on FDA reported “kratom associated” deaths
This analysis demonstrates these deaths were actually from polydrug use or the use of adulterated kratom products spiked with dangerous substances.
Document 5: Peer reviewed and published article: Suspected Adulteration of Commercial Kratom Products with 7-Hydroxymitragynine
This article documents that kratom products sold to consumer often contain synthetically elevated levels of 7-hydroxymitragynine that renders the kratom product dangerous.
Document 6: Babin Report outlining the FDA’s failure to document the safety risks of kratom for scheduling
This report outlines the deficiencies in the FDA’s petition to schedule kratom and how it fails to meet the criteria for scheduling by the Drug Enforcement Administration (DEA).
Documents 7 & 8: Letters sent from independent scientists sent on kratom to the White House and DEA on February 8, 2018, and a letter to Congressional leaders on June 21, 2018
These letters contest the FDA’s analysis of the dangers of kratom, and emphasizes that a ban will lead to more deaths.
Document 9: A Reply to CDC Report o Unintentional Drug Overdose Deaths with Kratom Detected
This commentary provides perspective to the CDC report and clarifies that kratom was not the cause of any of the deaths and promotes an appropriate regulatory scheme for kratom as the best public policy option.
Document 10: Peer Reviewed published article on the abuse potential and scheduling of kratom proposed by the FDA
This article outlines the scientific case for not scheduling kratom.
Document 11: Kruegel study on the pharmacology of kratom
This study explains the differences between kratom’s pharmacologic activity and those of classic opioids and how they are significantly different.
Document 12: Swogger & Walsh study on kratom use and mental health
This study reports on how kratom’s mental health effects – and withdrawal are mild relative to opioids.
Document 13: NIDA website update after they concluded a review of the FDA claimed 44 deaths associated with kratom
The NIDA review correctly concludes the deaths were attributable to polydrug use and adulterated kratom, with only one unexplained death the FDA claims is associated with only the use of kratom.
Document 14: NIDA International Kratom Symposia slides, 2018
These slides were presented at the NIDA conference showing the evidence-based report on the use in Southeast Asia where no overdose deaths have been reported.
Document 15: Kratom letter from the ASPET Council to the DEA
This letter emphasized the conclusions of the ASPET Council that kratom is a useful tool for weaning from opioid addiction, and that the addiction liability is substantially lower than for opioids.
Document 16: Coe, et al., study on kratom being used as a substitute for opioids
This study of kratom users analyzes the benefits perceived by kratom consumers and specifically with their experience in using kratom as a substitute for opioids to manage pain.
Document 17: Hemby, et al., published article: Abuse liability and therapeutic potential of the Mitragyna speciosa (kratom) alkaloids mitragynine ad 7-hydroxymitragynine
This paper reports on the first animal study on kratom and its potential addiction liability and concludes that the alkaloid mitragynine does not have abuse potential, and actually reduced the cravings in the test animals for the reference drug morphine. This study was funded by NIDA.
Document 18: Yue, et al., published report: Abuse liability of mitragynine assessed with self-administration procedure in rats
This paper documents there is a limited abuse liability of mitragynine and its potential for use to specifically reduce opioid use.
Document 19: Henningfield, et al., published article: Risk of death associated with kratom use compared to opioids
This paper assesses the relative risks of use of kratom compared to opioids and concludes that the risk of overdose death is > 1000 times greater for opioids than for kratom.
Document 20: The AKA GMP Standards for voluntary participation by reputable kratom vendors
These standards require kratom vendors to certify compliance with an independent third party auditor that they are compliant with GMP practices in the production of kratom products.
Document 21: The KCPA Model language for states
The KCPA model language offers the framework to protect consumers from adulterated kratom products, dangerously formulated products, mislabeled kratom, and restricting the sale to minors.
We urge you to delay any final decision on an ordinance to ban kratom, and the American Kratom Association would welcome the opportunity to meet with you to provide additional information. The AKA believes strongly that public policy should be driven by science, and if you allow for that then regulation of kratom is the best public policy option.
Respectfully submitted,
Mac
