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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.
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
Benjamin May, (202) 413-0119 — [email protected]
August 2, 2018 | Dave Herman, Chairman AKA
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!
#teamAKA #followthescience #educatingthemasses
07/07/18 | BY PAULA N. BROWN, OPINION CONTRIBUTOR
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.
FOR IMMEDIATE RELEASE
American Kratom Association | Media Contact: Pete Candland ([email protected])
Inaugural Kratom Leadership Summit showcases collaboration between scientists, advocates, community
ATLANTA, GA—More than 50 leading kratom vendors and advocacy groups gathered to discuss the future of kratom in America at the first Kratom Leadership Summit on Monday, April 30. Hosted by the American Kratom Association, attendees discussed strategies to keep the plant legal despite efforts to ban it by the Food and Drug Administration.
“The Kratom Leadership Summit brought together dozens of leading actors in the kratom community for the first time to find common ground to overcome the challenges before us,” said American Kratom Association Board Chairman Dave Herman. “It was amazing to see so many kratom vendors and advocates dedicated to improving the lives of people nationwide through collaborative efforts.”
The Summit included presentations by leading addiction researcher and keynote speaker Dr. Jack Henningfield, molecular biologist Dr. Jane Babin, and Georgia state representative Vernon Jones. Rep. Jones moderated a number of the discussions, and provided his perspective as a lawmaker and kratom consumer.
“As a kratom consumer, I see the benefits of this plant each and every day,” said Jones. “As a public servant, I stand with the millions of Americans who, like me, understand the importance of hosting a dialogue among diverse opinions to pave a path forward for kratom industry standards and policy prescriptions.”
Henningfield told attendees that the FDA and those fighting to ban kratom are misguided in their understanding of the plant’s effects and its purported opioid-like qualities. “Kratom is no more addictive than a cup of coffee — and the available data show as much,” said Henningfield.
Dr. Henningfield discussed at length the four scientific surveys conducted on kratom and kratom users. Citing these surveys as well as his own peer-reviewed research, he said that the FDA and other kratom opponents mislead the public and lawmakers when they compare kratom to traditional opioids. “To compare this slight possibility of mild addiction, on par with caffeine, to the devastating and deadly addictions found in real opioids is to drive a lot of the fear and misunderstanding prevalent in the media.”
In addition to discussing the science of kratom and addressing the current outbreak of salmonella in some kratom products, many of the Summit’s multi-hour sessions were dedicated to creating open dialogue among key players in the kratom industry, vendors and advocacy organizations alike.
Mac Haddow, Director of Government Relations for AKA, stated that the best way to ensure a safe and legal product is together as an industry. “Communication is everything. Talking to one another through weekly meetings or conference calls is one way we can collectively identify threats like salmonella and address the key steps we as an industry must take to self-regulate and expose bad actors in the kratom space who refuse to maintain acceptable standards.”
Kratom advocacy organizations in attendance such as the Botanical Education Alliance and the Kratom Trade Association likewise said the Summit created a valuable starting point for collaboration.
“The Kratom Leadership Summit was a successful first step to uniting around common principles, with the kratom community coming together to put aside differences and discuss a way forward for the industry,” concluded Herman.
“This event and the enthusiasm it fostered proves this movement is a force to be reckoned with. The Summit’s sessions and the discussions shared by the attendees have reinvigorated and inspired those involved in the production and distribution of this life-changing plant.”
About the American Kratom Association
The American Kratom Association (AKA), a consumer-based non-profit organization, is here to set the record straight about kratom and give a voice to those who are suffering and protect their rights to possess and consume kratom. AKA represents millions of Americans, each of whom have a unique story to tell about the virtues of kratom and its positive effects on their lives.
June 11, 2018 | American Kratom Association
URGENT SITSA UPDATE!
The FDA has lobbied the Speaker of the House and they are trying to force the SITSA Bill to the House Floor without the amendment to protect kratom from a back-door scheduling maneuver.
The House of Representatives Rules Committee will hear this bill on Tuesday afternoon.
It is critical if you live in the Congressional District of one of these House of Representatives (who serve on the Rules Committee) CALL THEM IMMEDIATELY AND ASK THEM TO SUPORT THE POCAN AMENDMENT TO PROTECT KRATOM.
All Kratom Warriors should contact their own Congressman and tell them to support the Pocan Amendment.
Your help is urgently needed. Call immediately to protect kratom.
RULES COMMITTEE Members
Questions & Answers on SITSA
First, follow the link on the SITSA post. “Only” contact those that are on your list, in your district, on the rules committee.
Second – what do I say?
Simply say: If you are calling the House Rules Committee and speaking to your Representative, simply tell him, ” I am calling to ask you to support the Pocan Amendment to the SITSA Bill. (He/she will know what you’re talking about, in regards to SITSA. If they say they can’t support the amendment then ask him to Simply vote no on SITSA)
Next – why is this important?
SITSA as drafted would significantly expand the universe of drugs or substances that DEA could immediately control with little notice to legitimate stakeholders or input from experts and with few curbs on the authority of DEA. In so doing, the proposed law would give DEA the unfettered ability to eliminate access to such substances, despite what may be longstanding and legitimate non-medical uses (e.g., industrial uses, uses in foods, uses in dietary supplements) and would substantially curtail and burden legitimate scientific research and product development. Furthermore, despite the reference to synthetic analogues in the title
of the legislation, the legislative language is so broad as to sweep in a range of drugs or substances. In essence, DEA (working with FDA) could schedule kratom on the claim that it is an opioid analogue (a claim publicly made by FDA Commissioner Gottlieb on Nov. 14, 2017). SITSA does not require any justification from NIDA or HHS on the science, and the AG has complete discretion.
Add to that, if SITSA passes and the Attorney General Sessions decides to ban Kratom using SITSA, we have no recourse for 5 years. Zero recourse…
Once it is scheduled “temporarily” under SITSA for 5 years, the AG can unilaterally continue it — there is no judicial review permitted. The only claim would have to be on Constitutional grounds, and that is a very expensive and lengthy process with a very uncertain outcome.
Those who make the claim that kratom could not be scheduled under SITSA have clearly not read the definitions that are so broad — and combined with Gottlieb’s claims — puts kratom squarely in the sights of the regulators.
We don’t have time to argue or speculate. The calls need to made ASAP.
May 31, 2018
It seems yet another state is targeting kratom.
On May 16, the Louisiana House unanimously approved a resolution (HR177) from state Rep. Frank Hoffmann directing the department to study kratom (the plant itself) and products containing kratom, to determine whether it should be classified as a “controlled dangerous substance.” The resolution directs the department to submit a report to the House Committee on Administration of Criminal Justice no later than two months before the beginning of the 2019 legislative session.
As of May 18, this resolution was presented to the Secretary of State in accordance with the Rules of the House.
Although this resolution is aimed at “studying” kratom. The outcome could swing either way, depending on what kind of studies are done.
What can you do? Send an email, call, or write to the Louisiana Department of Health.
Secretary: Dr. Rebekah Gee
Deputy Secretary: Michelle Alletto
Louisiana Department of Health
P.O. Box 629
Baton Rouge, LA 70821-0629
Business Hours are Monday-Friday 8:00 a.m. – 4:30 p.m.
Louisiana Department of Health
628 N. 4th Street
Baton Rouge, LA 70802
Phone: (225) 342-9500
Fax: (225) 342-5568
A quick phone call, letter, or email can make a difference. Don’t be afraid to speak to your representatives, they work for YOU, and will be respectful and will listen without judgment. Please be respectful to the staffer, as these are the people that will get your voice in the right hands.
It’s important that you do not claim that you are using kratom to treat or cure serious symptoms or diseases. Kratom should be positioned as an Herbal substance. Herbal substances cannot treat or cure, only drugs can do so.
SEATTLE – Kratom grows in Southeast Asia. Its leaves can be chewed, made into pills, ground and steeped into tea or added to food.
The leafy green plant is widely available and advertised as a safe, organic and natural “cure” for opioid addiction, pain relief and even cancer.
In 2016, kratom products exceeded sales of $1 billion in the U.S. alone.
But there’s a problem.
Kratom — a natural opioid — has not been approved by the Food and Drug Administration and may soon be banned in the U.S.
“I don’t know anything about the cancer claims,” said Kenneth Thummel, PhD. “That’s a bit of a stretch to me.”
Thummel, the chairman Chair of the University of Washington’s department of pharmaceutics, is concerned by the lack of research that has been done on kratom to determine its efficacy and safety.
He’s also concerned kratom is widely available for sale – in stores and online — with no instructions for dosage or serving size.
“The dose makes the poison,” he told KIRO 7 from his office at UW on Wednesday. “How much are people taking, and is there any instruction about what you shouldn’t exceed?” he asked.
Another problem, according to Thummel, is “adulteration of the product. There’s no regulation on the manufacturing of it. There are cases where products clearly were adulterated with very potent opioids to enhance the product, and that can be fatal,” he said.
The FDA claims kratom has contributed to the deaths of at least 36 people. Click here for more information.
On Wednesday, Special Agent Melvin Patterson told KIRO 7 that the Drug Enforcement Administration is “still waiting for analysis” before deciding whether to designate kratom a Schedule I drug, illegal because it has high abuse potential, no medical use and severe safety concerns.
Heroin, LSD and cocaine are all Schedule I drugs.
Shilo Jama believes making kratom illegal “would be the most idiotic thing” the DEA could do.
As executive director of the People’s Harm Reduction Alliance in Seattle, Jama said he’s seen people successfully treat their opioid addictions using kratom.
“I’m not against kratom in any way,” Jama said. “Kratom has shown to be successful, and for the people who use it for treatment, I think it’s great they found an easy solution that they don’t have to go through a doctor” to utilize.
Jama said kratom is a valuable option for addicts who live in areas where treatment options are not widely available.
He believes, however, that the strength and dosages of kratom should be regulated. “I am for regulations. I’m not for limiting people’s access to a potential treatment option” he said.
Before consumers believe the widespread claims that kratom can cure addictions abd even cancer, Dr. Thummel would like it to be carefully studied, which he admits would be more difficult if it is designated a Schedule I drug.
“The public is taking a risk in believing the claims,” Thummel said. “I’m not saying that it’s a very unsafe product, but research needs to be done to establish one way or the other about safety.”
What are you’re thoughts? Create an MKS account and voice your opinion.