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AMERICAN KRATOM ASSOCIATION·TUESDAY, JUNE 25, 2019

Dear Kratom Warriors,

AKA Chairman Dave Herman has given me permission to send this email to you today.My name is C.M. “Mac” Haddow, and I have been fighting every day to protect and preserve your right to purchase safe and unadulterated kratom in the United States.

There is no doubt that the Trump Administration’s FDA has become the biggest enemy of kratom, and even with Scott Gottlieb now gone the War on Kratom is actually expanding.

Incredibly, the Trump FDA has convinced the Minister of Health in Indonesia to impose a ban on growing and exporting kratom — and an order has been issued to have all growers stop growing and harvesting kratom plants.

Those growers have just 5 years to come into compliance, and then a total ban is in effect.The kratom farmers will have to start transitioning right away to protect their livelihood and that means big trouble for kratom consumers in the United States.

The bottom line is kratom exporters have also been warned they should stop exporting kratom.The AKA asked me to assemble a Delegation to go to Indonesia to talk with government officials, and we did.Former Congressman Matt Salmon, Utah State Senator Curt Bramble, and Dr. Jack Henningfield joined me in an official Delegation to meet with Indonesian officials last month.



When we met with the Ministry of Health officials, our worst fears were confirmed.The Trump FDA’s lies about kratom had convinced the Ministry of Health that kratom was a dangerous drug and had to be banned in Indonesia. They used the same outdated, deeply flawed, and outright deceptive so-called “science” claiming kratom is an opioid, it is as addictive as classic opioids, and it is killing people.Indonesia currently produces more than 95% of the kratom that comes to the United States.If this ban is allowed to go into effect, it will effectively end consumer access to kratom in the United States, and the FDA won’t have to do anything more to declare victory in the War on Kratom.Even if some black-market kratom gets into the United States after the Indonesian ban goes into effect, it will be so expensive that only the uber-rich will be able to afford it. And it will likely be extremely dangerous to consume because there will be no standards on growing, harvesting, and shipping.



Dave Herman, Chairman of the AKA, has asked me and others in the Delegation to go back to Indonesia and lobby the top-levels of government officials there that the Trump FDA is wrong, and how the Indonesian Ministry of Health has been badly deceived by them.

I am writing today to ask you to make as generous a donation as you can to the “Kratom Protection Fund.”

These trips to Indonesia are incredibly expensive.It looks like going to Indonesia is now likely the most important action we can take to fight back against the FDA’s ongoing war on kratom – a war they have now extended to Indonesia.We can stop this ban in its tracks – just like we did when the FDA tried to convince the DEA to ban kratom in 2016.But the AKA desperately needs your help today.

We have requested meetings with top Indonesian officials for the 3rd week in July.That means we need your commitment today to guarantee the funds are available for the Delegation to travel there.

The trip is brutally long – with flights taking nearly 40 hours each way. And the cost of sending members of the Delegation is very, very expensive.But if we don’t take the fight there right away, kratom fields will be converted to other crops, and access to kratom will end.Please make the most generous commitment you can – and please do it today!

CLICK HERE TO DONATE $25, $50, $100 OR MORE.

I have sat across the table from some of the Indonesian officials we have to convince to keep kratom legal, and we are making headway in exposing the lies of the Trump FDA.

But we must expand the list of government officials we meet with to fight against the Minister of Health’s current ban.If we don’t do this now, we will have lost the War on Kratom, and the Trump FDA will win by stopping kratom being grown in Indonesia.Please help.

Please click the donation box below or the link above to make as generous a contribution as you can afford.In reality, if we fail to act now – as in right now – kratom will no longer be available to consumers who desperately need it.

Your support and loyalty has brought us to this point where we are winning battle after battle in the United States in protecting your freedom to make your own decisions on your health and well-being.

That’s why the Trump FDA has taken the battle to where kratom is grown.

We cannot let them win.Join this fight today!Please contribute to the “Kratom Protection Fund.”

Sincerely,C. M. “Mac” Haddow
Senior Fellow on Public Policy
American Kratom Association

CLICK HERE TO DONATE

Get your orders in early, as our shop will not be taking orders for 2 weeks in May.

February 2019 – Following “Reefer Madness” style fear-based reports from news outlets in North Mississippi, the town of Columbus, MS has decided to ban kratom.

Kratom is a natural, over-the-counter product that people commonly use to improve their well-being; however, some claim the plant is addictive.

People in favor of Kratom brought their concerns before council members during Tuesday night’s council meeting.

Just last week Mayor Robert Smith signed into law, banning the sale and distribution of Kratom within city limits. With the ban in place, if someone is caught using, selling or distributing Kratom, they could be fined $1,000 and also possibly face time behind bars.

Those in support of Kratom say the product should be regulated, not Banned.

“Regulate it and make it 18 and up so no children can get a hold of it and make sure that it’s tested and that it’s safe. You cannot send an addict back to something that they cannot control because they need something for pain. Like I said, it was torture and I literally moved back to Mississippi so that I could be legal and get off of pain medication again,” said Bethany Cook.

In the state of Mississippi, Kratom is currently banned in the city of Columbus and Union County.

WASHINGTON, DC – August 14, 2018  | AKA

FDA did not independently verify or perform due diligence on death reports cited in an effort to force DEA to list kratom as a Schedule 1 substance.

Peer-reviewed documentation concerning 44 deaths that the Food and Drug Administration (FDA) has cited to persuade the Drug Enforcement Administration (DEA) to place natural kratom on the Federal Government’s Schedule 1 list of illegal substances disclose errors and omissions on the part of the FDA that the American Kratom Association (AKA) claims can only be seen as “deliberate.”

In a detailed white paper released today, AKA scientist claim, “The FDA has also misled the DEA, the Centers for Disease Control (CDC), and the National Institute on Drug Abuse (NIDA) with incomplete, inaccurate, extrapolated, and distorted information on adverse events and deaths allegedly associated with the use of kratom to encourage unwarranted legislative and regulatory restrictions on kratom at the federal, state, and local government levels.”



Among the most significant claims, the AKA offers evidence of duplicated case reports, omissions of “cause of death” conclusions and inaccurate autopsy and toxicology reports, as well as redacted statements from experts contradicting FDA claims.  According to AKA, the FDA reports that associate kratom use with 44 deaths are so “poorly documented they could not pass basic standards for publication in any credible scientific journal, even as a letter or comment.”

The most egregious examples cited by AKA include cases where:

·         The FDA failed to adequately disclose and account for material facts from the peer-reviewed Case Report of nine deaths in Sweden that were published in 2011 in the Journal of Analytical Toxicology.  That report concluded the deaths were actually the result of adulteration of kratom powder with a toxic dose of O-desmethyltramadol.

·         Two deaths claimed in the documents released by the FDA are the same death reported twice (FAERS ID No. 14449343 and FAERS ID No. 14254346).

·         Other deaths were from abuse of loperamide (FAERS ID Nos. 12665823 and 12665824), heroin (FAERS ID No. 174035), acetaminophen (FAERS ID No. 14554565), and other drugs or drug cocktails.

·         The FDA stripped source data (FAERS ID No. 14449343) that cited U-47700 (PINK) as the primary cause of death, when kratom was listed as the fifth of six substances in the toxicology report.

·         The FDA even attributed suicides (FAERS ID No. 14554565 and FAERS ID No. 12639556); a homicide, with a gunshot wound to the chest (FAERS ID No. 12639316); cardiac arrhythmia while swimming (FAERS ID No. 191303); deep vein thrombosis (FAERS ID No. 12639594), and the fall from a window (FAERS ID No. 1342166) to kratom.



“Not only is the FDA’s effort to frame kratom as a culprit in these otherwise unrelated deaths sloppy and lacking in scientific integrity, but one can only conclude that it has been done deliberately,” said Dave Herman, Chairman of the AKA.  “We invite those who want the truth to go to our white paper, get the information, and join us in our demand that the FDA follow the science.”

According to the AKA, none of the FDA reported 44 deaths document any specific cause that is consistent among the cases that can be linked specifically to kratom; a vast majority of the cases document polydrug use by the decedent and, in a few cases, the possible use of adulterated kratom products.  In most cases, the cumulative contributions of multiple drugs and interactions between drugs are not even considered by FDA.

“The DEA, CDC, and NIDA depend on the FDA for accurate information,” said Herman.  “This misinformation has already resulted in bans on kratom in six states and in a number of local jurisdictions.  Likewise, it creates a completely unjustified bias against kratom by law enforcement officers, coroners and medical examiners, and state prosecuting attorneys’ groups.  We call on the FDA to make this right.”

Among measures requested by the AKA, the FDA must:

·         review the FAERS database to ensure complete and accurate records of all source documents;

·         reevaluate and revise its kratom-related policies based on corrected and accurate scientific evidence;

·         work with the DEA, CDC, and NIDA to update policy documents to reflect accurate and unbiased assessment of the risks of kratom use;

·         immediately lift the current Import Alert on kratom;

·         rescind its November 14, 2017 Public Health Advisory on kratom; and,

·         commence appropriate enforcement action against companies and individuals who are producing adulterated kratom products that pose a real and present danger to the public.

In addition, the AKA calls upon the DEA to reject the FDA’s 8-Factor Analysis and scheduling recommendation and return it to FDA for a full scientific reanalysis of the data and conclusions in that submission.



ABOUT AKA

The American Kratom Association (AKA), a consumer-based non-profit organization, focuses on setting the record straight about kratom and gives a voice to those who are suffering by protecting their rights to possess and consume safe and natural kratom.  AKA represents millions of Americans, each of whom has a unique story to tell about the virtues of kratom and its positive effects on their lives.  www.americankratom.org

 

MEDIA CONTACT

Benjamin May, (202) 413-0119 — [email protected]


 

August 2, 2018 | Dave Herman, Chairman AKA

Kratom Warriors:

You cannot pick up a newspaper or hear a news report out of Washington, DC that does not expose the bias held by rogue individuals within our government.

All of that is mind-boggling because Americans have the right to trust their government.

And that includes the FDA.

You and I know the FDA has been waging a false war against kratom, and they are trying to make anyone who uses it into a criminal.

But the AKA has been provided shocking documents from email conversations between FDA staffers that apparently were mistakenly released to a kratom vendor.  The documents were supposed to be routine updates on the status of a large amount of kratom that had been seized under the FDA’s Import Alert in 2016.

But I can tell you, this update was anything but routine.



The FDA staff, who are required by law to be fair, objective, and free from bias — showed they are horribly biased against kratom.  In fact, these documents show how deep and wide the bias in the FDA is against kratom.

FDA Commissioner Gottlieb’s bias has infected the entire bureaucracy at the FDA.

Here’s the proof:

On July 12, 2018, an FDA staffer sends an email to a superior and asks if she will “create work assignments” so they can conduct additional tests on seized kratom being held under the Import Alert.

What followed was incredible:

“. . . hopefully it will test positive and can get a voluntary destruction.”

But that is not all!

The FDA staff confirmed that the required testing to justify the original seizure “confirmed the product to be kratom.”

That is all that is legally required under the Import Alert.

But then the staff points out the testing did not include microbiology testing.

That is the FDA standard for testing foods for contaminants.  It is not a test that is typically done under Import Alert seizures.

Then the key question:

“We are testing for micro?”

This seizure of kratom was supposed to protect the public from kratom that the FDA has demonized since its first Import Alert on 2012.

But then the FDA staffer showed the deep and pervasive bias against kratom itself:

“. . .hopefully linking this product to the ongoing outbreak of Salmonella .”

This from the government agency that is supposed to be about science, and about protecting consumers.

The law requires the FDA to act on science, without bias.

The FDA’s mission is not to go on witch-hunts against safe botanicals like kratom.



I admit I am beyond angry — I am beyond furious — I am utterly speechless about this obvious bias at the FDA against kratom.

But I want to fight back.

We need our team of lawyers to examine these documents and provide a plan of action to fight FDA Commissioner Gottlieb on the credibility of their War on kratom.

Then, we need to spread this message far and wide to every media outlet in America.  I want to hire a public relations firm to help with that effort.

Finally, I want every member of Congress to see this evidence.

Will you help me do this?

We need your help to raise the money to fund this important effort.

Together, we can win this war, but only if you help today!

When we have stood together before, we have been successful.

So I am asking for your help today.  I am deeply grateful for all of the help you have provided in the past.

And I am honored today to stand shoulder-to-shoulder with you to fight this battle.

Let’s expose the FDA bias together.

I am asking you give whatever you can to take this battle right to FDA Commissioner’s front door.

And trust me, I will be knocking very loudly.

You can count on that — AND SO CAN FDA COMMISSIONER GOTTLIEB!

Sincerely,

Dave Herman

Chairman, AKA

#teamAKA  #followthescience  #educatingthemasses


 

The U.S. Food and Drug Administration (FDA) recently gave final approval for the first non-opioid drug shown to lessen the severity of opioid withdrawal symptoms. Meanwhile, President Trump signed into law groundbreaking “right to try” legislation allowing the terminally ill to explore unapproved medical treatments as a last resort.

In light of these developments, researchers and advocates of the botanical Kratom were hopeful for increased support for the study of the herb as a new treatment for opioid withdrawal symptoms, acute and chronic pain, and a range of mood disorders.

Instead, the FDA has spoken out against Kratom, ignoring a history of safe use and existing research. By overstating safety concerns, the FDA has dismissed any possibility that Kratom might have benefits.


Advocacy groups and researchers who have studied Kratom for years argue that this is not the time to be closing the door on any possible new treatments or preventions. With daily fatalities due to opioids exceeding those from automobile accidents, it is clear that new approaches and solutions to the opioid epidemic are needed.

Instead, the FDA recommendation to the Drug Enforcement Agency (DEA) to schedule (as in, effectively ban) Kratom and its alkaloids threatens fledgling efforts by researchers to investigate the alkaloids as potential new pain treatments, would hinder scientific advances as well as crucial preclinical and clinical studies.

Given that surveys suggest millions of Kratom users purchase products in the U.S. as a preferred therapy for a variety of disorders including as a path and maintenance strategy away from opioids, banning lawful sale will put many at risk of resuming licit or illicit opioid use.

In February 2018, the FDA commissioner released a statement declaring products derived from the leaves of the Southeast Asian tree Mitragyna speciosa (Kratom) and its alkaloids mitragynine and 7-hydroxymitragynine as opioids similar to morphine and heroin.

The justification was primarily based on a computer model, the Public Health Assessment via Structure Elucidation (PHASE), which is a “novel” approach with little application and no validation data published.



In the case of Kratom, the FDA appears to be lacking transparency, with Commissioner Scott Gottlieb publicly attributing “scores of deaths” to Kratom consumption. In reality, FDA has identified 44 case reports worldwide over more than a decade; all but one involved consumption of other drugs or substances that can be causative in a fatality.

These “findings” make it unclear if Kratom is responsible for even just that one death, much less any other. To get some perspective, compare that one case over more than a decade to the 115 deaths each day in the U.S. from opioid overdoses.

So what do we know about Kratom?

The alkaloids naturally occurring in Kratom are not classic opioids like morphine or heroin. This is why Kratom consumption does not lead to classic opioid symptoms, such as the feared respiratory depression, which is often the cause of death for opioids like morphine and fentanyl.

Of note, none of the 44 deaths that involved Kratom were from respiratory failure and there has been no observation in the literature that Kratom users experienced respiratory depression.

Surveys and observational studies have indicated the majority of Kratom users in the U.S. use the powdered leaves for alleviation of mild to moderate acute or chronic pain as well as for an emotional or mental condition.

A smaller number of users indicated that they consume Kratom to mitigate withdrawal symptoms from illicit or prescription drug dependence. The fact that doses used between these different indications did not differ suggests a low likelihood for dependence development.

Nonetheless, the FDA issued an import alert, based on the assertion that Kratom is dangerous, thus permitting automatic detention of Kratom materials without physical examination.

The alert has resulted in several imports of Kratom products being seized at ports and has forced many consumers to obtain products through internet distributors that may be located outside the country.

The recent salmonella contamination of Kratom products highlights the risks associated with inconsistent enforcement of the mandatory 2007 Current Good Manufacturing Practice (CGMP) rule for dietary supplements by the FDA.

The import alert combined with a failure to treat Kratom leaves as a dietary supplement and enforce CGMP regulations has forced Kratom products into an underground, grey market that permits adulterated and substandard products to flourish while driving legitimate products out of the marketplace.



The FDA should consider that Kratom fits right into the current push in Washington to allow for creative approaches for treatment of pain and opioid addiction. As current research and epidemiological studies indicate, Kratom use in the U.S. is on the rise.

It is in the interest of public health to take an approach to regulating Kratom products that permits ongoing access to Kratom but with oversight as is provided for other dietary supplements. The FDA has the ability to enforce appropriate quality controls for Kratom, ensuring consumers have access to products manufactured properly, rather than scheduling Kratom and forcing consumers to unregulated, illicit markets.

Paula N. Brown, Ph.D., is director of applied research, BC Institute of Technology, Canada research chair, Phytoanalytics and adjunct professor of biology, University of British Columbia.


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July 2, 2018 | AKA

​The American Kratom Association applauds the landmark science study published in the Addiction Biology journal that concluded that mitragynine “does not have abuse potential and reduces morphine intake, desired characteristics of candidate pharmacotherapies for opiate addiction and withdrawal . . .” that directly contradicts the FDA claims on kratom having the same effects of a classic opioid.

​The study, co-authored by Christopher R. McCurdy, Scott E. Hemby, Scot McIntosh, Francisco Leon, and Stephen J. Cutler, isolated the potential high abuse of 7-hydroxymitragynine (7-HMG) when it is “adulterated or concentrated in commercially available kratom products, but noted that 7-HMG constitutes only 2 percent of the alkaloid content of kratom.”



​The study is found at Addiction Biology Kratom Article June 27 2018​

​Dr. Jack Henningfield, one of the world’s leading experts on addiction, and the behavioral, cognitive, and central nervous system (CNS) effects of drugs, highlighted the importance of this landmark study that challenges the FDA claims.

​“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.“

​Dave Herman, Chairman of the American Kratom Association, called upon newly-appointed Acting Drug Enforcement Administrator Uttom Dhillon to return the FDA recommendation for scheduling of kratom back to the FDA for additional evaluation and research. “This new study confirms the growing body of evidence that the FDA has demonized kratom unfairly, and the time has come to allow the science to speak, not a bias against natural plants and herbs,” Herman concluded.

American Kratom Association


 


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