Analysis Shows No Basis For DEA To Restrict Herb Kratom

Major New Analysis Shows No Basis For DEA To Restrict Herb Kratom

Expert Finds Potential for Abuse May Be As Low As Such Unrestricted Substances as "Nutmeg and St. John's Wort"


WASHINGTON, Dec. 1, 2016 /PRNewswire-USNewswire/ -- A long-awaited analysis by one of the world's leading experts on drug abuse and addiction concludes that there is "insufficient evidence" for the U.S. Drug Enforcement Administration (DEA) to ban or otherwise restrict the coffee-like herb kratom under the Controlled Substances Act.  According to the comprehensive analysis, kratom has little potential for abuse and dependence – as low or lower than such widely used and unscheduled substances as "nutmeg, hops, St. John's Wort, chamomile, guarana, and kola nut."  

In preparing the report for the American Kratom Association (AKA), Dr. Jack Henningfield, Ph.D., vice president of Research, Health Policy, and Abuse Liability at PinneyAssociates, concludes: "Kratom has a low potential for abuse and a low dependence liability and there is insufficient evidence of personal harm, adverse health effects or detriment to the public health to warrant control under the [Controlled Substances Act] . . . Appropriate regulation of kratom under the [Food, Drug, and Cosmetic Act] is the most effective way to protect the public health by ensuring appropriate access and oversight and to sustain the overall very low adverse personal and public health effects associated with kratom consumption."

Dr. Henningfield previously served as chief of the Clinical Pharmacology Research Branch of the National Institutes of Health's National Institute on Drug Abuse (NIDA), and is currently an adjunct professor of Behavioral Biology in the Department of Psychiatry and Behavioral Sciences at the Johns Hopkins University School of Medicine. 

A DEA comment period on kratom closes at 12:59 p.m. EST tonight.  AKA has filed its comment letter (http://bit.ly/akacomments), including the Henningfield analysis (http://bit.ly/Henningfieldreport), in the DEA public docket. 

The AKA comment letter to the DEA notes: "[K]ratom does not meet the criteria for permanent scheduling under the CSA – under schedule I or any other schedule – and DEA cannot satisfy the legal requirements for use of the emergency scheduling provision of the CSA to temporarily schedule kratom.  Scheduling kratom under the CSA would divert government resources from more critical initiatives, have a significant negative impact on a substantial number of small businesses and consumers who choose to use kratom products safely and responsibly, yet yield no positive impact on the public health."

The letter continues: "For both abuse potential and dependence liability, kratom's profile is comparable to or lower than that of unscheduled substances such as caffeine, nicotine-containing smoking cessation products, dextromethorphan, and many antihistamines, antidepressants, and other substances sold directly to consumers.  Kratom's profile also resembles that of various botanical dietary supplements such as chamomile, lavender, St. John's Wort, kava, and hops. "

Commenting on the Henningfield analysis, Susan Ash, founder, American Kratom Association, said: "Kratom is a natural botanical product consumed by millions of Americans daily.  Like caffeine, when used responsibly, kratom is enjoyable, safe, rarely associated with any serious adverse effects, and not prone to abuse.  Kratom simply does not pose an imminent threat to the public health.  Rather, kratom is more reasonably characterized as a dietary supplement, and could be ably regulated as such by FDA.  Through that regulatory framework, manufacturers and distributors of kratom could be held accountable for the safety and labeling of their products, while ensuring continued access to Americans who consume them.  We believe such an approach would represent a much more efficient use of governmental resources than the scheduling process could provide."

The AKA comment concludes that singling out kratom for scheduling would be inconsistent with federal handling of other supplements:  "For example, the botanical substances St. John's Wort, Valerian, and Kava Kava are known to have reinforcing effects and to act as sedatives, and have been the subject of hundreds or thousands of calls to Poison Control Centers.  Yet, these substances have not been scheduled, but have been regulated as dietary supplements.  The same is true for guarana and kola nut, which also have certain characteristics of a drug of abuse.  Yohimbine, the primary component of yohimbe extract, is an indole-containing alkaloid that is structurally similar to [the active ingredient in kratom], yet yohimbe is available in the U.S. as a dietary supplement …None of these botanical substances is scheduled, despite sharing some characteristics with controlled substances; rather, all of them are adequately regulated by FDA through existing authority.  Kratom, with a comparable or lower potential for abuse than these substances, would likewise be best regulated" by the FDA.

In the United States, there have been few reported serious side effects associated with kratom use and no reported deaths directly attributable to the substance.  There have been no deaths, serious adverse effects, or emergency department visits reported for children.  The relative safety of kratom is consistent with several key clinical and pharmacologic properties of the substance, including its low toxicity, extremely low bioavailability (absorption into the body), and its blocking of opioid receptors that limit the possible euphoric effect and substantially reduces the risk of respiratory depression.   

Dr. Henningfield and his PinneyAssociates colleagues conducted a comprehensive review of publicly available data on the same eight factors indicative of control that the DEA and FDA will weigh in deciding if and where to control kratom:

(1)   Its actual or relative potential for abuse.

(2)   Scientific evidence of its pharmacological effect, if known.

(3)   The state of current scientific knowledge regarding the drug or other substance.

(4)   Its history and current pattern of abuse.

(5)   The scope, duration, and significance of abuse.

(6)   What, if any, risk there is to the public health.

(7)   Its psychic or physiological dependence liability.

(8)   Whether the substance is an immediate precursor of a substance already controlled through the CSA.

ABOUT AKA

The America Kratom Association, a consumer-based non-profit organization, is here to set the record straight, giving voice to those suffering and protecting our rights to possess and consume kratom. AKA represents tens of thousands of Americans, each of whom have a unique story to tell about the virtues of kratom and its positive effects on their lives. www.americankratom.org


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  • commented 2017-03-25 04:44:00 -0400
    Analysis Shows No Basis For DEA To Restrict Herb Kratom
    There is no point of banning Herb Kratom, it should be researched not banned.

    Your friend at: https://supernaturalbotanicals.com/
  • commented 2017-03-25 04:42:21 -0400
    Analysis Shows No Basis For DEA To Restrict Herb Kratom
    There is no point of banning Herb Kratom, it should be researched not banned.
    Your friend at <a href=“”https://supernaturalbotanicals.com//“>https://supernaturalbotanicals.com//”>Super Natural Botanicals</a>
  • commented 2017-03-21 23:53:08 -0400
    This is not ‘spice’ or some deathly pill. Those who take the drug deserve to continue to take it and Kratom needs to be researched, regulated, and safely distributed in the US. It must get grandfathered in but we can do it!
  • commented 2017-03-19 05:24:04 -0400
    This is excellent news! I hope the outlook looks the same way in 2017. Thanks to the AKA, BLD and wonderful supporters for your outstanding work in coming together for the community

    Your friends at http://kratomcrazy.com
  • commented 2017-03-01 09:13:12 -0500
    Due to what can only be described as an anti-opioid hysteria, my Veteran’s Administration doctor has consistently refused to adequately treat my pain issues. I suffer from a service connected disability which has resulted in severe neurological damage and non-stop pain. Out of desperation I began buying opioid medications on the street. As my tolerance to those medications increased, I sought more and stronger medications to stem the pain. Changes in FDA regulations have made pain pills much harder to obtain both legally and on the black market. Heroin, on the other hand is plentiful, cheap and available on just about any street corner in my city. I could even have it delivered to the VA hospital. What shocked me was that there were actually dealers making rounds of nursing homes in the area, selling heroin(often mixed with fentanyl) to residents’ whose pain relief medications were suddenly stopped by doctors afraid of running afoul of the FDA. I began snorting heroin in increasing quantities to deal with my pain. This never felt morally right to me. I didn’t want to support violent street gangs and smuggling cartels (not to mention suffering from a severe addiction).
    Eventually I enrolled in a Methadone clinic with the intention of tapering off the drug. That is much easier said than done. I soon realized that Methadone is actually harder to kick than Heroin. The withdrawal symptoms can last months. I was chained by the so called “liquid handcuffs” for 3 years, making multiple unsuccessful attempts at stopping. Then I discovered Kratom. By using a specially concocted blend of Kratom sold by a local store specifically for those in my situation, I was able to tolerate the painful withdrawal symptoms without relapsing. I have now been clean of opioids for almost 3 months. I still occasionally use Kratom to relieve my pain but have never experienced any withdrawals when I go without it. Rather than ban the import and sale of Kratom, the FDA should be promoting it as an extremely effective method of stopping the use of dangerous and highly addictive opioid medications.
  • posted about this on Facebook 2017-02-24 19:52:21 -0500
    Analysis Shows No Basis For DEA To Restrict Herb Kratom
  • posted about this on Facebook 2017-02-22 15:54:40 -0500
    Analysis Shows No Basis For DEA To Restrict Herb Kratom
  • commented 2017-02-19 11:52:40 -0500
    Anything has the potential to be “abused” like caffeine or sugar. Not sure what the regulations are for it in Canada but it sounds, like many other natural herbal or plant based supplements, that it can do a lot of positive things when used correctly.
  • posted about this on Facebook 2017-02-07 12:03:11 -0500
    Analysis Shows No Basis For DEA To Restrict Herb Kratom
  • posted about this on Facebook 2017-02-07 08:32:04 -0500
    Analysis Shows No Basis For DEA To Restrict Herb Kratom
  • posted about this on Facebook 2017-01-25 12:05:26 -0500
    Analysis Shows No Basis For DEA To Restrict Herb Kratom
  • commented 2017-01-24 00:08:44 -0500
    Kratom is herbal products, it is used various ways like Kratom powder, Kratom tea etc. This medicine does not give any kind of side effects.
  • posted about this on Facebook 2017-01-19 13:54:42 -0500
    Analysis Shows No Basis For DEA To Restrict Herb Kratom
  • @MEKAIDIOM1 tweeted link to this page. 2017-01-19 13:54:38 -0500
    Analysis Shows No Basis For DEA To Restrict Herb Kratom http://www.americankratom.org/analysis?recruiter_id=33110
  • commented 2017-01-13 11:48:00 -0500
    My name is Paul and I do not support the kratom ban…. I have been taking Kratom on and off for over 3 years and have never relapsed on opiates since then, this plant changed my life
  • commented 2017-01-13 03:15:06 -0500
    My name is Tom, and I am in favor of keeping kratom legal.

    Thank you
  • commented 2017-01-10 21:37:04 -0500
    I believe Kratom should be legal and widely available so we can end the prescription pill epidemic in this country!
  • commented 2017-01-10 21:14:27 -0500
    There are so many benefits to this herb and many people are benefiting from it. This plant is not a harmful substance. Please keep it legal for all. Thank you
  • commented 2017-01-09 13:41:53 -0500
    If Kratom was legal, we could regulate it and properly test it nationwide.

    Any speculation would then be defeated and we would be able to move on towards a future in which we actually try to help each other instead of scamming each other for money or power.

    It gets you high and relieves pain with little to no side effects. I’ve heard this from some reputable men on the Joe Rogan Experience podcast.

    If it helps people we should definitely legalize it.
  • commented 2017-01-07 18:06:24 -0500
    I support Kratom staying legal. It should be researched not banned.
  • commented 2017-01-04 16:13:35 -0500
    I believe Kratom among other herbs should be legal and not added to the wasteful, failed, war on drugs.
  • commented 2017-01-04 11:29:07 -0500
    I am in favor of keeping Kratom legal. I have used the plant on and off. It is a mood-enhancing, stimulating plant with mild effects. Makes me a happier, kinder, more social person with seemingly zero side effects. Please keep this available to the public! It seems like it can only be beneficial.
  • commented 2017-01-02 03:43:34 -0500
    My name is Tim, and I am in favor of keeping kratom legal.

    Thank you
  • commented 2017-01-01 19:25:24 -0500
    These agencies are in big pharmas back pocket. Even though they may not make it schedule 1 the fact that pharaceutical market is after patents on kratom compounds tells me it will be scheduled and although legal we will have to go through their imposed regulations, a doctor, a pharmacy and many less people will have it available to use as they need for the multiude of ailments it treats fit..in my opinion the dea fda and big pharma are the epidemic leave kratom unscheduled!
  • commented 2016-12-31 15:02:58 -0500
    My name is Mehdy Faik. Kratom should be legal for purchase on the over the counter market. It is a safe and helpful drug that should not be exploited by the pharma industry.
  • commented 2016-12-31 02:11:24 -0500
    This is the most ridiculous thing the DEA has done! Not only is this a safer alternative to Opiate treatment, but it helps with everyday pain that people suffer. The only reason the DEA wants to restrict this is so they can market it as another over priced drug you can only get from doctors. Keep this planet LEGAL and stop telling people int he land of the FREE what they can and cant use to help with their suffering. Outrageous!!
  • commented 2016-12-28 00:31:48 -0500
    In my opinion it should stay it will be a benefit to chronic pain suffers a great alternative to opioids.The dea is trying to make it as hard as possible for regular hard working American s to have pain relief which doesn’t make sense,not everyone is a addict.I’m hoping they got enough sense to realize once you take away someone’s pain relief most of the time they go to street drugs which will cause more overdose death’s,crime,violence.Get a grip dea there are alot of people that have real pain including me,KEEP KRATOM LEGAL PLEASE!!
  • commented 2016-12-25 21:59:22 -0500
    Keep it legal, in my opinion — it’s just a plant, after all.
  • commented 2016-12-24 22:51:53 -0500
    Is Krantom currently legal to buy ? I live in Pennsylvania. If so, where is a safe and reliable place to buy it ? Online preferably. Thanks.
  • commented 2016-12-24 11:05:24 -0500
    I am in favor of keeping Kratom legal.

    Thank you

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