October 19, 2020
The AKA is proud to announce the formal agenda for the 2020 Kratom Leadership Summit to be held in Tampa Florida on November 11th thru 13th.
This is an amazing opportunities to participate in hearing and discussing the current status of many initiatives in the kratom scentific and advocacy arenas.
There are options to attend in person as well as virtually.
October 13th 2020
Four years ago today is a day I will never forget.
October 7th, 2020
The American Kratom Association is proud to announce that the "Protect Kratom because Kratom Saves Lives" National Ad Campaign is live!
Our new website www.ProtectKratom.org is now live and is designed to help kratom consumers contact their elected officials.
The AKA has launched a national advertising campaign across news channels and online sources. These are fantastic examples of how powerful American kratom consumers are when they share their stories. Please watch and share:
https://vimeo.com/showcase/kratomsaveslives
September 21st, 2020
New Study Adds to Evidence of Low Abuse Potential of Kratom
Research Directly Contradicts FDA’s Position that Kratom is a Morphine-Like Opioid
For a PDF copy of this release please click here
Washington D.C. – A new study by leading kratom researchers from the National Institute on Drug Abuse (NIDA)-funded kratom research program of the University of Florida found low abuse potential of mitragynine and 7-hydroxymitrgynine in a classic animal model. This research adds to the body of evidence that directly contradicts the FDA’s claim that kratom is a morphine-like opioid.
The American Kratom Association (AKA) applauds this important new research that adds to the evidence that the FDA is wrong on its conclusions on kratom. “Kratom needs to be responsibly regulated to prevent dangerously adulterated counterfeit kratom products,” commented Mac Haddow, Senior Fellow on Public Policy for the AKA. “The FDA has sufficient statutory authority to protect consumers, and this research proves once again the FDA has been wrong on characterizing kratom as having the same effects as classic opioids. The FDA must begin protecting consumers from adulterated kratom products rather than using adulterated products as the justification for a total ban just to expand their regulatory authority.”
The study concluding that kratom’s primary alkaloids did not produce rewarding brain effects was published in the peer-reviewed journal, Drug and Alcohol Dependence by Dr. Behnood-Rod and colleagues.[i] This animal study employed the well-established intracranial self-stimulation procedure (ICSS)[ii] that has been used for decades to document the rewarding effect of drug in male and female rats.
The authors conclusions included the following:
In contrast to mitragynine and 7-hydroxymitragynine, they found, as shown in other studies “that the 10 mg/kg dose of morphine is rewarding”, clearly differentiating these constituents from morphine.
This study is an important complement to other recent studies employing the drug self-administration procedure which show that mitragynine is of very low abuse potential.[iii] [iv] This is important because mitragynine is the alkaloid that is common to most marketed kratom products in the US and globally and is believed to be the primary naturally occurring kratom constituent the provides the effects[v] [vi] that consumers report is the basis for their consuming kratom products.
The study also complements two other studies that employed well-established models for comparing substances to morphine with respect to physical dependence and withdrawal. Those studies found very low levels of withdrawal[vii] [viii] produced by mitragynine exposure as compared to morphine. This is consistent with surveys and field studies[ix] [x] [xi] suggesting that even in heavy long term users of kratom who might experience withdrawal from kratom when they stop using it, the effects are generally far less intense and more readily self-manageable than those produced by abstinence from morphine and other classic addicting opioids. In fact, these studies and other evidence also indicate that many people report using kratom to self-manage opioid addiction, craving, and withdrawal though this is not recognized as an approved safe and effective use by health authorities.[xii] [xiii]
Dr. Jack Henningfield, an internationally recognized expert in the assessment and regulation of substances with a potential for abuse and addiction who was not involved in the study, stated, “This new study provides important additional scientific evidence that kratom does not warrant regulation as morphine-like opioid (i.e., “narcotic”). Nor should kratom be described as opioid-like with respect to its abuse potential or addictiveness or safety profile based on this study and other research”[xiv] [xv] [xvi] Dr. Henningfield[xvii] has researched and contributed to the regulatory approaches for many substances and new drugs through his studies with the National Institute on Drug Abuse, Johns Hopkins University, and other research institutions, and provides consulting support through PinneyAssociates on drug regulation as well as kratom science, including advising to the American Kratom Association.
Dr. Henningfield further commented: “Abuse potential assessment and substance regulation is strongest when based on a broad range of types of laboratory studies and real world evidence to understand the pharmacological effects, safety and public health risks and benefits, as recommended in FDA’s 2017 guidance: Assessment of the Abuse Potential of Drugs.[xviii] This was the approach by my colleagues and I in our analyses[xix] of kratom’s abuse potential and our regulatory recommendations. It is exciting to see kratom research efforts increasing and using a broad range of techniques such as the animal self-administration, ICSS, and withdrawal models, and studies of potential therapeutic effects, as well as surveys of real world use and effects in the US and other countries such as by Malaysia’s Center for Drug Research.”[xx]
Relevance of COVID-19 and the Opioid Epidemic
Dr. Henningfield added: “The COVID-19 pandemic on top of the opioid overdose epidemic adds to the urgency of regulatory approaches to preserve access to kratom by consumers but with product standards to address safety concerns. Kratom was the lifeline away from opioids for many people before the COVID pandemic because for many people formal treatment programs and FDA approved treatment approaches were not accessible, effective or acceptable. The COVID pandemic has been associated with increased opioid overdose deaths and impaired access to formal addiction treatment programs.”[xxi]
Utah State Senator Curt Bramble, the primary sponsor of the first state legislation to provide for responsible regulation to prevent adulterated kratom products, agreed: “Now is not the time to reduce access to kratom. Now is the time for other states and ideally the Federal government to follow the lead of Utah and other states such as Arizona, Georgia, and Nevada: Begin to regulate kratom to ensure access to kratom products that meet high standards for purity, packaging, labeling and marketing, and are not adulterated with other substances including artificially elevated alkaloid levels.”
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[i] https://www.sciencedirect.com/science/article/abs/pii/S0376871620304002
[ii] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4081730/
[iii] https://pubmed.ncbi.nlm.nih.gov/29949228/
[iv] https://pubmed.ncbi.nlm.nih.gov/30039246/
[v] https://www.sciencedirect.com/science/article/pii/S0955395919301252
[vi] https://onlinelibrary.wiley.com/doi/full/10.1111/add.14371
[vii] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7221179/
[viii] https://pubmed.ncbi.nlm.nih.gov/31832720/
[ix] https://www.sciencedirect.com/science/article/pii/S0955395919301252
[x] https://pubmed.ncbi.nlm.nih.gov/28521200/
[xi] https://www.sciencedirect.com/science/article/abs/pii/S0376871620300144
[xii] https://pubmed.ncbi.nlm.nih.gov/29949213/
[xiii] https://www.drugabuse.gov/publications/drugfacts/kratom
[xiv] https://www.sciencedirect.com/science/article/abs/pii/S0376871620304002
[xv] https://pubmed.ncbi.nlm.nih.gov/28830758/
[xvi] https://pubmed.ncbi.nlm.nih.gov/31647958/
[xvii] https://www.pinneyassociates.com/our-people/
[xviii] https://www.fda.gov/media/116739/download
[xix] https://pubmed.ncbi.nlm.nih.gov/29273821/
[xx] https://www.drugabuse.gov/international/abstracts/kratom-pain-tolerance
[xxi] https://directorsblog.nih.gov/2020/08/11/addressing-the-twin-challenges-of-substance-use-disorders-and-covid-19/
September 18th, 2020
The AKA receives and reviews many questions about kratom and the inaccurate attacks from the FDA that deliberately distort the facts. To help combat this process, the AKA is providing a top ten list of questions and answers that refute unfair claims and pervasive misconceptions.
1) Is the FDA right that kratom is an unapproved drug?
No, kratom is properly classified as a food under the provisions of the U.S. Food Drug & Cosmetic Act.
The FDA regulates a product based on its intended use as evidenced by the product’s labeling and claims. The FDA does not have statutory authority to make premarket approval of food products.
When kratom products are marketed with the intent for use as a food, it is immaterial that kratom does not have any “approved uses” since food products are not approved by the FDA.
When kratom is marketed with a therapeutic claim, then it is properly subject to regulation by the FDA.
2) Is the FDA right that kratom is an opioid?
No, kratom’s alkaloids do hit the mu-opioid receptors in the brain, but kratom is a plant from the coffee family and it does not have the same pharmacologic activity as classic opioids like heroin, morphine or fentanyl.
Kratom is properly classified as a “partial agonist” which has dramatically different effects than opioids on the brain or respiratory system.
Kratom does not give a consumer a reinforcing high that leads to addiction (consumers can become dependent on kratom, like a caffeine dependance).
Kratom does not have any significant impact on a consumer’s respiratory system – and it is “suffocation” that is the primary cause of opioid overdose deaths.
3) Is FDA’s claim you can you overdose on kratom true?
Consumers can harm themselves from overusing virtually any product, but research shows kratom does not cause overdose deaths like opioids do.
This question is definitively answered by the peer-reviewed published literature that specifically concluded “it appears that the risk of overdose death is >1000 times greater for opioids than for kratom.” (see https://pubmed.ncbi.nlm.nih.gov/31647958/)
The bottom line is that kratom carries little of the signature respiratory depressing effects of morphine-like opioids and kratom’s pharmacology is vastly different from opioids where most overdoses occur.
4) Is the FDA right that kratom is dangerously addictive?
No. The National Institutes on Drug Abuse (NIDA) funded studies to test the FDA claims that kratom should be a Schedule I drug because it poses a high potential for abuse. NIDA research shows kratom does not have a significant abuse liability.
The Hemby study (June 2018) concluded kratom does not have abuse potential and reduces morphine intake . . .” (see https://doi.org/10.1111/adb.12639 )
The Yue study (July 2018) concluded kratom has limited abuse liability of mitragynine and potential for mitragynine treatment to specifically reduce opioid abuse. (see DOI: 10.1007/s00213-018-4974-9 )
5) The FDA claims more than 44 people have died from kratom. Is that true?
No. An independent review of the FDA claimed deaths, and then confirmed by NIDA’s own review, found these deaths to be from polydrug use, adulterated kratom products, or an underlying health condition. The FDA’s claims are UNTRUE!
NIDA conducted its own independent review, and they came to the same conclusion.
The FDA kratom death claims are bogus, and the most egregious example is the autopsy report they tried to hide, but when disclosed, the truth was the decedent died from 2 gunshot wounds. He had also consumed a kratom tea earlier in the day. The FDA called that a ”kratom associated death.”
6) Can public health officials trust the FDA on kratom?
No. Every public policy that protects the health of the American public should be based on science, not a self-serving expansion of regulatory powers that will increase the control the FDA has over the decisions Americans make to manage their health and well-being.
In the early 1990’s the FDA made the same adverse event and death claims about vitamins and dietary supplements, and Congress was forced to step in and UNANIMOUSLY pass the Dietary Supplement Health & Education Act (DSHEA) in 1994 to reign in the FDA’s aggressive attempt to ban all dietary supplements and vitamins unless the product was submitted as a new drug application. Today, the FDA is waging the very same disinformation campaign against kratom and cannot be trusted.
7) The FDA claims kratom marketing is rampant with impermissible health claims. Is that true?
No. It is accurate that some unscrupulous vendors are making illegal therapeutic claims for kratom products. The FDA is the enforcement agency responsible for stopping that kind of advertising. The solution is for the FDA to do their job.
The vast majority of kratom products are legally marketed and labeled properly as foods. Individual consumers have the legal right to make informed choices about foods they want to consume to maintain their health and well-being. The FDA is wrong on the kratom science and wrong on the policy!
8) The FDA warns that only FDA approved drugs can help in addiction recovery. It that true?
No. The FDA insists that only FDA approved drugs are the answer to addiction recovery – and those recovery centers can only use those drugs for addiction recovery if they want to be reimbursed. The Johns Hopkins report proves the FDA is wrong and their policy traps those trying to recover.
Every American family has been impacted by the opioid crisis and the FDA has remained tone deaf to the possible solution for some by using kratom. NIDA gets it, and they are the leading federal agency helping to find solutions to the opioid crisis. The FDA has made itself part of the problem by trying to ban kratom rather than protecting the public from adulterated kratom products.
9) Does the FDA influence and manipulate content of medical news articles about kratom?
Alarmingly, it appears that is exactly what is happening. An article that appeared in MedScape Medical News (an outlet for US physicians) on August 10, 2018 on the NIDA-funded Hemby study on the addiction liability of kratom had this headline:
“No Doubt Kratom Is an Opioid With High Abuse Potential”
The problem: The Hemby study found the EXACT OPPOSITE about kratom:
“The present findings indicate the MG [kratom] does not have abuse potential and reduces morphine intake . . .”
The author, Scott Hemby, told MedScape they ”misrepresented” his comments and the research and demanded MedScape ”either change the title to accurately represent the content of our findings and of my interview OR retract the story.” More than 2 years later this inaccurate article is still on the MedScape website for physicians to rely on.
MedScape published this inaccurate article at the same time they had an MOU with the FDA on information collaboration. How can anyone doubt the FDA influences and manipulates information on kratom?
September 4th, 2020
1) Nora Volkow, Director of the National Institute on Drug Abuse (NIDA) thinks we should be studying kratom – not classifying it as a Schedule I drug.
Dr. Volkow points to exciting new basic science that “point toward the potential of this drug [kratom] in pain research as well as the need for further research on the pharmacology of kratom’s constituents, their toxicity and potential value in the treatment of Opioid Use Disorder (OUD)”
Dr. Volkow previously testified to Congress that when a substance gets a Schedule I, it makes research much harder.
NIDA. 2020, July 7. Reviewing NIDA’s 2019 Achievements and Looking to the Future. Retrieved from https://www.drugabuse.gov/
4) Jane Babin, PhD, JD, conducted an extensive analysis of the deaths the FDA claimed were associated with kratom and found all the deaths were the result of polydrug use or adulterated kratom products, and found the FDA claims to be unreliable.
None of the death reports claimed by the FDA provides a cohesive or reasonable scientific basis to conclude any of the deaths was caused by kratom, nor does the information released conclusively support any conclusion that kratom was associated to the cited death other than coincidentally. (The 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)
5) NIDA concludes “There have been multiple reports of deaths in people who had ingested kratom, but most have involved other substances . . . there have been some reports of kratom packaged as dietary supplements or dietary ingredients that were laced with other compounds that caused deaths.”
https://www.drugabuse.gov/publications/drugfacts/kratom
CDC reported postmortem toxicology testing detected multiple substances for almost all decedents, including Fentanyl and fentanyl Analogs, Heroin, prescription opioids and cocaine.
6) The FDA insists kratom has the same effects as classic opioids, but leading scientists, including Andrew Kruegel, PhD, of Columbia University disagree:
“Kratom doesn't seem to share the dangerous side effect of respiratory depression that other opioids have—that’s when someone’s breathing slows down and could stop completely. Better understanding how certain opioids produce certain effects is key to developing safer painkillers . . . The problem with saying it’s ‘an opioid’ without qualification is that it just paints everything with this broad brush, and obviously carries a negative connotation given what’s going on in the country right now.”
https://www.vice.com/en_us/article/neqn4b/fda-declared-kratom-an-opioid
9) Individual states are enacting appropriate regulations to protect consumers from dangerously adulterated kratom products. Four states have enacted the Kratom Consumer Protection Act (KCPA) and 21 states were considering passage in 2020 before the COVID-19 shutdown.
The KCPA requires (1) kratom manufacturers to follow current good manufacturing processes; (2) no dangerous adulterants or synthesized kratom alkaloids; (3) no alteration of the natural plant alkaloid content; (4) labels showing consumers contents of kratom products; and appropriate limits restricting sales to minors.
