Capitol Hill Kratom Briefing

 

Kratom Trade Association’s Michael Werner joined experts from American Kratom AssociationBotanical Education AllianceDrug Policy Alliance, Plants People Health, and A Leaf Of Faith on Capitol Hill to clear up misinformation and make sure that policymakers know the facts about Kratom.

The views, opinions, and scientific conclusions expressed by the panel members who participated in the Congressional Briefings on kratom are their own views, and no one should interpret their comments as endorsements of the positions of any of the advocacy organizations who hosted this event.

 

WATCH THE FULL VIDEO

October 9th, 2018

 

(Jack Henningfield from Pinney Associates speaking)

 

Unfortunately, Kratom is sometimes mistakenly thought of as a highly addictive opioid and cause of death around the country, warranting classification as a Schedule I controlled substance. These are just some of the dangerous misconceptions our scientists and lobbyists combatted as they spoke to rooms full of Congressional staff.

“We can balance consumer safety with access to this natural botanical product consumed by millions of Americans without government overreach,” said Michael Werner, a federal regulatory policy and legislative advisor for KTA. “Working with legislators, KTA seeks to find common-sense compromises based on science in the face of misinformation to protect people’s right to consume Kratom and manage their own well-being.”

 

(Michael Werner, KTA Policy Advisor)

Memorandum

The following documents can be downloaded together or individually

A substantial body of emerging science and research are validating both the basic safety of the natural plant for consumer use and documenting the fact the concerns about kratom are actually derivative of adulteration and contamination of kratom products, or deaths actually caused by polydrug use or unrelated health or social conditions of the decedents that do not support any regulatory action against kratom.

The National Institute on Drug Abuse (NIDA) confirmed this safety profile for kratom in its September 20, 2018 update to the DrugFacts publication as follows:

 

Can a person overdose on kratom? 

In 2017, the Food and Drug Administration (FDA) began issuing a series of warnings about kratom and now identifies at least 44 deaths related to its use, with at least one case being investigated as possible use of pure kratom. Most kratom associated deaths appear to have resulted from adulterated products (other drugs mixed in with the kratom) or taking kratom along with other potent substances, including illicit drugs, opioids, benzodiazepines, alcohol, gabapentin, and over-the-counter medications, such as cough syrup. Also, there have been some reports of kratom packaged as dietary supplements or dietary ingredients that were laced with other compounds that caused deaths.

The following documents can be downloaded individually or with the link to the right.  Download All

Document 1Patterns of Kratom use and health impact in the US – results from an online survey; Grundmann; Drug and Alcohol Dependence, 2017.

There are nearly 5 million kratom users in the United States, and surveys show that kratom is primarily used by a middle-aged (31 – 50 years), middle income ($35,000 and above) population for purposes of self-treating pain (68%) and emotional or mental conditions (66%). Consumers report that kratom had only mild negative effects.

Document 2Abuse Liability and therapeutic potential of the Mitragyna speciosa (kratom) alkaloids mitragynine and 7-hydroxymitragynine, Addiction Biology; Hemby, McIntosh, Leon, Cutler & McCurdy, published on June 27, 2018.

Research confirms that MG, the main kratom alkaloid, does not have abuse or addiction potential and actually reduces morphine intake – a desired characteristic for any candidate pharmacotherapies for opiate addiction and withdrawal. The potential bad-actor 7-OH alkaloid constitutes only 2% of the alkaloid content of the kratom plant and has no significant pharmacological effect on consumers.

This is an important study that addresses the addictive potential of kratom using the most well-accepted and relied upon animal model. It shows that the major naturally occurring constituent responsible for the health-related effects of kratom, mitragynine, is of very low abuse potential. A second substance, 7-hydroxymitragyine, that naturally occurs at such low levels in kratom that it might be of minimal health consequence, has higher abuse potential.

This has at least two regulatory implications: (1) the finding does not support FDA’s claim that kratom is a narcotic-like opioid, and (2) in regulating kratom products, FDA could set standards to ensure that no kratom product contain levels of 7-hydroxymitraginine exceeding those that are commonly present in kratom leaves and products. The study also showed that mitragynine treatment reduced morphine self-administration, an effect consistent with the self-reported use of kratom to reduce opioid craving and use, and consistent with the conclusion that mitragynine is the predominant active constituent in kratom.

Document 3: Addiction: Society for the Study of Addiction, Letter to the Editor, The Therapeutic potential of kratom, June 28, 2018, Oliver Grundmann, Paula Brown, Jack Henningfield, Marc Swogger, Zach Walsh.

Document 4Synthetic and Receptor Signaling Explorations of the Mitragyna Alkaloids: Mitragynine as an Atypical Molecular Framework for Opioid Receptor Modulators, Journal of the American Chemical Society, Kruegel, Gassaway, Kapoor, Varadi, Majumdar, Filizola, Javitch, and Sames, December 2016.

Document 5The medicinal chemistry and neuropharmacology of kratom: A preliminary discussion of a promising medicinal plant and analysis of its potential for abuse, Kruegel, Grundmann, Neuropharmacology, 2017.

Despite assertions by the FDA, research confirms that kratom and its alkaloids are not functionally identical to opioids, and their mechanisms of action are distinctly different.

Document 6Unintentional Fatal Intoxications with Mitragynine and O-Desmethyltramadol from the Herbal Blend Krypton; Kronstrand, Roman, Thelander, and Eriksson, Journal of Analytical Toxicology, Vol. 35, May 2011.
The nine Sweden deaths actually were the result of the contamination and adulteration of the powdered kratom product with a toxic dose of O-desmethyltramadol, a chemical formulation of the opioid Tramadol.

Document 7Henningfield 8-Factor Analysis addressing the requirements for scheduling under the CSA, submitted to the DEA in November 2016.

Document 8The abuse potential of kratom according to the 8 factors of the controlled substances act: implications for regulation and research, Psychopharmacology, 23 December 2017

Kratom does not cause deaths and does not have the same effects of classic opioids on the respiratory system that would support any scheduling of kratom.

The FDA death reports do not document any death exclusively caused by kratom.

Document 9: Raw data file issued by the FDA on November 14, 2017.

Document 10: Raw data file issued by the FDA on February 14, 2017.

Document 11The FDA Kratom Death Data: Exaggerated Claims, Discredited Research, and Distorted Data Fail to Meet the Evidentiary Standard for Placing Kratom as a Schedule I Controlled Substance, March 2018, Jane Babin, Ph.D., Esq., University of San Diego School of Law, J.D., Purdue University, Ph.D., Molecular Biology.
Any deaths alleged to be associated to the use of kratom merely document the possible use of kratom products at the time of the occurrence of a death caused by other specific factors, i.e., where the cause of death is related to a gunshot wound; a suicide related to mental health issues; physical injuries that caused ancillary medial issues resulting in a fatality; use of an illegal drug; polydrug use of prescription and/or illegal drugs as toxic dose levels; and deaths that are related to other unrelated medical conditions that have no relationship to kratom use, i.e., a death from deep vein thrombosis.

Of the 44 claimed deaths, the FDA identifies only a single death as being kratom-related involving an individual who “had no known historical or toxicologic evidence of opioid use, except for kratom.” The FDA refuses to release any additional information on the death other than the subject’s age and ethnicity and provides no information on how kratom was determined to have contributed to the death.

Document 12Kratom use and mental health: A systematic review; Swogger, and Walsh; Drug and Alcohol Dependence, 2018.

Document 13CPDD/NIDA International Kratom Symposium Summary Slides, June 9, 2018.
Kratom use produces a similar addiction profile to caffeine, and its effects are mild in contrast to the psychosocial and physiological effects relative to that of opioids.

Document 14:  FDA Docket FDA-2018-N-0987 comments submitted by Jack E. Henningfield, VP of Research and Policy at PinneyAssociates, and Adjunct Professor of Behavioral Sciences at The Johns Hopkins University School of Medicine, May 18, 2018.

Document 15: CPDD 2018, Poster on Kratom and its Mitragynines in the Opioid Crisis: A Path to or Away from Opioids, Henningfield, Raffa, Garcia-Romeu, Doshi.
A ban on kratom actually increases the public safety risk as patients using kratom are force to (1) used NSAID medications that have serious documented adverse health risks; (2) use dangerously addictive and potentially deadly opioids; or (3) seek kratom on the black market where adulteration, contamination, and dangerously formulated kratom products have been identified.

Additional research and documents of interest:

Document 16:  Science Letter to Leader McConnell, Minority Leader Schumer, Speaker Ryan, Minority Leader Pelosi, requesting the DEA return the FDA scheduling recommendation for further review and study, June 21, 2018.

Document 17: NCSL State Legislatures Magazine, April 2018, Kratom Concerns.

Document 18: Science Letter to Kellyanne Conway, Counselor to the President, and Robert W. Patterson, Acting Administrator of the Drug Enforcement Administration, February 8, 2018.

Document 19: American Society for Pharmacology and Experimental Therapeutics (ASPET) letter (representing 5,000 members) letter to Acting Administrator Robert W. Patterson of the DEA, arguing that placing kratom on Schedule I would “effectively eliminate an important avenue of research that has the potential to ameliorate the effects of the ongoing opioid crisis and possible lead to more effective treatments of pain.”

Document 20: DEA 2016 Docket, “Schedules of Controlled Substances: Temporary Placement of Mitragynine and 7-Hydroxymitragynine into Schedule I; Withdrawal” @ https://www.regulations.gov/docket?D=DEA-2016-0015

Document 21: FDA 2018 Docket, “Patient-Focused Drug Development on Opioid Use Disorder; Public Meeting; Request for Comments” @ https://www.regulations.gov/docket?D=DEA-2016-0015

Document 22: FDA Fails to Follow the Science on Kratom, August 2018, Jane Babin, Ph.D., Esq.