The AKA’s new California lobbyist mistakenly sent a letter to California Assemblyman Haney that misstated the AKA position on 7-Hydroxymitragynine, and Assemblyman Haney has now been informed of the error.
The FDA’s consistent bias against valuable harm reduction tools is exposed in their latest rush to demonize products like kratom and psychedelics that are helping people.
AMERICAN KRATOM ASSOCIATION CALLS ON THE FDA TO BE FULLY TRANSPARENT AND ACCOUNTABLE IN THEIR SAFETY ALERT ON KRATOM PRODUCTS
OFFICIAL STATEMENT FROM THE DESK OF CONGRESSMAN MATT SALMON (RET.) CHAIRMAN OF THE AMERICAN KRATOM ASSOCIATION
Watch full briefing here: https://youtu.be/OW34ztFNaDk
The American Kratom Association (“AKA”) encourages every kratom consumer to follow these basic consumer guidelines for kratom use:
The FDA’s refusal to properly regulate kratom products puts consumers at significant safety risk – the burden is now thrust on consumers to carefully review kratom products they choose to purchase.The FDA’s refusal to properly regulate kratom products puts consumers at significant safety risk – the burden is now thrust on consumers to carefully review kratom products they choose to purchase.
Florida becomes the 11th state to enact a Kratom Consumer Protection Act
The American Kratom Association (AKA) today released the following statement regarding the end of the Food and Drug Administration’s (FDA) comment period on a potential international ban by the World Health Organization (WHO) on kratom, an herbal supplement used by millions of Americans as an energy supplement and for pain management, specifically as an alternative to opioids and for opioid addiction treatment: “The FDA's conduct regarding WHO’s potential ban of kratom is an incredible disappointment to the millions of Americans whose lives have been changed for the better by kratom, a non- addictive herbal supplement that has shown incredible promise as an opioid alternative and an effective treatment for those battling opioid addiction. In 2016, Americans made their voices heard and successfully defeated FDA’s attempt to criminalize the use of kratom. Congress has repeatedly reaffirmed the will of the people, most recently just one month ago, when the U.S. House passed spending bills with language that supported kratom as an alternative to opioid therapy and funded more kratom research. “It seems at almost every turn, the FDA has tried to stifle the voices of kratom advocates, via conflicting directions, an uncharacteristically short comment period, and numerous hurdles to get comments accepted. FDA’s actions disregard the will of Congress and disrespect the American public who have spoken resoundingly in favor of kratom. Despite these barriers, we have collected more than 60,000 comments before the FDA’s deadline with plans to continue submitting comments until the WHO’s deadline on September 24. We are working with numerous partners in Congress to ensure that Americans’ voices are heard and that any effort from the World Health Organization to prevent the manufacturing and distribution of kratom is stopped once and for all. “Too many American lives have been improved by kratom – with many more standing to benefit – for us to now stifle or completely ban its use in the United States. We are grateful for the many scientists, experts, lawmakers, and everyday Americans who have helped us through this process, and we are hopeful that the resounding support for this incredible herbal supplement will be recognized, and a ban will ultimately be opposed.” Mac Haddow, Senior Fellow on Public Policy at the AKA. The AKA will host a webinar briefing Wednesday, August 25 at 8PM to discuss next steps required to stop an international kratom ban. Participants may register at https://us02web.zoom.us/webinar/register/WN_0rAOUtllSj-8MirEh8e8uA Press should include their name and media outlet for the zoom call. Following is background related to the FDA’s inappropriate handling of comments and potential consequences of FDA’s misguided actions: The FDA received notice of the proposed WHO Expert Committee pre-review of kratom on June 10, 2021 but delayed the required Federal Register Notice soliciting public comments for 42 days until July 23. When FDA finally announced a comment period, they only provided a 17-day window (11 business days) for scientists and the public to prepare and submit comments. Not only is that an unreasonable length of time but also a violation of requirements dictated by the Controlled Substances Act and procedural safeguards of the Administrative Procedures Act. It is also a stark departure from the typical 30 to 60-day comment period that FDA permits on such matters. In order to guarantee a fair process and reasonable comment window, AKA filed a lawsuit to extend the comment period and won. To comply with the lawsuit, FDA reopened the comment portal, but their website was no longer setup to receive comments directly, instead pointing people to a different website which created confusion and established a barrier to public input. At the recommendation of an FDA representative, the AKA attempted to hand deliver comments on August 9, but no staff were present to receive them. When the AKA Executive Director called the FDA, a representative said to redeliver the next day (past the deadline) or to submit electronically. The AKA submitted nearly 40,000 comments electronically, per FDA’s instructions, yet so far, receipt of comments has not been acknowledged by FDA or recorded publicly.
WASHINGTON, D.C. – The American Kratom Association today applauded U.S. Sen. Mike Lee of Utah and Congressman Mark Pocan of Wisconsin for their efforts to prevent a potential international ban on kratom, an herbal supplement used by millions of Americans as an energy supplement and for pain management, specifically as an alternative to opioids and for opioid addiction treatment. Their letter calls on Biden Administration officials – specifically U.S. Ambassador to the United Nations Linda Thomas-Greenfield and Health and Human Services Secretary Xavier Becerra – to oppose a move by the World Health Organization (WHO) that could add kratom to the 1971 UN Convention on psychotropic substances. Full text of the letter is included below. “We are grateful for Sen. Lee and Congressman Pocan’s support in urging the Biden administration to oppose efforts at the international level to ban kratom,” said American Kratom Association Senior Fellow on Public Policy Mac Haddow. “American consumers, scientists, and lawmakers have previously and clearly voiced their opposition to domestic efforts to schedule kratom as a controlled substance. It is critical that federal officials at Health and Human Services and our representatives to the UN stand firmly in defense of the will of the American people and not allow the whims of international actors to dictate our domestic policy.” “There is still no conclusive evidence that would warrant the United States voting in favor of an international control of this substance,” Lee and Pocan write in the letter. “Instead, the Food and Drug Administration encourages more research to better understand kratom’s safety profile, including the use of kratom combined with other drugs. Given the absence of data showing kratom’s purported harms, a vote in favor of controlling this substance would raise serious questions. If there is no scientific basis for control, Congress has not deliberated the need for control, and the clear interests of the American people are against control, then the United States should not be voting in favor of controlling that substance on the international stage.” The World Health Organization (WHO) Expert Committee on Drug Dependency (ECDD) is currently reviewing kratom among other substances and may make a recommendation to the UN Commission on Narcotic Drugs as soon as early December for kratom to be controlled under UN conventions. In accordance with 21 USC 811(d), if a substance is deemed controlled under the 1971 Convention, the United States’ treaty obligations require that such substance also be controlled domestically. Full text of letter: October 19, 2021 Linda Thomas-Greenfield United States Ambassador to the United Nations 760 United Nations Plaza Manhattan, New York City, New York 100017 The Honorable Xavier Becerra Secretary Department of Health and Human Services 200 Independence Ave, SW Washington, DC 20201 Dear Ambassador Thomas-Greenfield and Secretary Becerra, We are writing to ask that the United States oppose any effort to add kratom and its alkaloids to the 1971 UN Convention on psychotropic substances as a banned substance. The World Health Organization (WHO) Expert Committee on Drug Dependency (ECDD) is currently reviewing this issue and may make a recommendation to the UN Commission on Narcotic Drugs as soon as early December for kratom to be controlled under UN conventions. It is our understanding that in accordance with 21 USC 811(d), if a substance is deemed controlled under the 1971 Convention, the United States’ treaty obligations require that such substance also be controlled domestically. This obligation forfeits the will of the American people, ties the United States to the whims of the majority of international actors, and diminishes the need for public health experts to thoroughly evaluate substances that lead to domestic decisions based on evidence and data. In 2016, 145,906 Americans including consumers, scientists, and state and federal lawmakers, raised their voices in opposition to the Department of Health and Human Services’ (HHS) proposal to schedule kratom as a controlled substance. However, due to many factors, “in part on new data, and in part on the relative lack of evidence,” the HHS decided in 2018 to rescind its request for the U.S. Drug Enforcement Administration (DEA) to schedule kratom as a Schedule I controlled substance under the Controlled Substance Act. Since then, there is still no conclusive evidence that would warrant the United States voting in favor of an international control of this substance. Instead, the “Food & Drug Administration encourages more research to better understand kratom’s safety profile, including the use of kratom combined with other drugs.” Given the absence of data showing kratom’s purported harms, a vote in favor of controlling this substance would raise serious questions. If there is no scientific basis for control,5 Congress has not deliberated the need for control, and the clear interests of the American people are against control, then the United States should not be voting in favor of controlling that substance on the international stage. Sincerely, Michael S. Lee United States Senator Mark Pocan United States Congressman
Major Kratom Announcement coming Wednesday Oct 27th. We're very excited to shared some postivie news on kratom internationally that will help American kratom consumers. Go to the kratom community page on Reddit at Noon Eastern on Wednesday the 27th- Reddit.com/r/kratom to find out the news first! We do want to note that this isn't related to the WHO ECDD meeting earlier this month.
The American Kratom Association (AKA) earlier today presented arguments to the World Health Organization’s (WHO) Expert Committee on Drug Dependence (ECDD) which is currently holding a week-long critical review of 5 substances and a pre review of 2 substances. Today the committee heard from preregistered speakers regarding the substances being reviewed, particularly kratom. The AKA’s delegation expertly and articulately demonstrated that existing and emerging scientific studies confirm kratom should not be banned and that kratom has many merits for continued human use. In the interest of transparency, the AKA has requested that the WHO ECDD provide a public link to today’s information session. “All public presentations on kratom were clearly opposed to the international scheduling of kratom. In fact, only one of the speakers addressed an issue other than kratom, demonstrating both how united the scientific community studying kratom is against a ban, and how unnecessary it was to include kratom in the WHO ECDD’s prereview process,” said Mac Haddow, Senior Fellow on Public Policy at the AKA. Haddow continued, “Clearly the anti-kratom sentiment is coming from one source: the FDA. Although we didn’t hear the anti-kratom speakers today, the FDA will have the ability to make their views on kratom known as a part of the member-state submissions. However, based on the strong presentations made on the science of kratom during the presentations this morning, I believe we have established the position that the FDA is unfairly biased against kratom.” The ECDD will remain in non-public discussions over the next four days, and then the review of member state submissions between now and early December. Their announcement of any decisions related to will be made public at that time. The committee could rule in several ways, which include taking no action at all or announcing a full, critical review of kratom. The AKA is fully prepared to present all facts and evidence necessary should a critical review be implemented.
WASHINGTON, D.C. – September 16, 2021 – The American Kratom Association (AKA) highlighted significant findings in a new analysis that confirms kratom's safety profile and clearly demonstrates that the World Health Organization (WHO) and U.S. Food and Drug Administration’s (FDA) efforts to ban or restrict the herbal supplement are without merit. “The recent 8-FA affirms what previous studies have concluded: that kratom is safe and that efforts by FDA and WHO to ban it are unfounded,” said Mac Haddow, Senior Fellow of Public Policy at the American Kratom Association. “We are encouraged to have these results finalized prior to the World Health Organization’s October meeting and hopeful that it and the tens of thousands of public comments gathered so far in support of kratom will put the brakes on efforts to schedule this supplement under the Controlled Substances Act. What the kratom community has long urged for is reasonable oversight by FDA to ensure its safe manufacture and usage in the U.S. so that its benefits can be realized to the fullest extent possible.” “Our study concludes that there is no evidence kratom poses an imminent threat to public health and that kratom is not like opioids in its safety and addiction risks,” said Dr. Jack Henningfield, who oversaw the 8-Factor Analysis. “Furthermore, our findings confirm the conclusion made by former Assistant Secretary of Health Brett Giroir that millions of people who use kratom as an opioid alternative or to treat opioid addiction would be at risk of relapse and overdose should possession of kratom become criminalized. In order to ensure safe use of kratom and to limit its abuse and misuse, our report concludes that such issues are best addressed by allowing the legal sale of kratom with appropriate FDA oversight as a dietary supplement and ingredient.” In summary, the report concludes: There is no evidence that kratom poses an imminent threat to public health, which is a requirement for emergency scheduling and a key consideration in permanently scheduling a substance. Thousands of people using kratom to combat opioid addiction would be at risk of relapse and overdose should sale of kratom be banned. Banning kratom would foreseeably lead to an illicit kratom market with increased problems related to contaminated and adulterated kratom products. Current problems with contaminated or inappropriately marketed kratom can be best solved by reasonable FDA oversight, whereas a scheduling ban would leave consumers hostage to illicit and unregulated kratom. Dr. Henningfield’s findings reaffirm an earlier study from 2018. Since that study, there have been more than 100 new published scientific studies, reviews, and commentaries by leading kratom experts, and an accelerating research pipeline funded in part by the US National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA). These studies provide an increasingly strong evidence base for regulation and policy and provide a fuller characterization of how kratom works and how it provides the benefits that many people report as their reason for use, but without narcotic-like addiction and overdose risks. The studies include the types of state-of-the-art animal abuse and physical dependence / withdrawal studies that FDA requires for new medicines and which DEA relies on for drug scheduling decisions. New clinical studies in humans provide initial assessments of kratom’s physiological health and safety related effects on liver, kidney, and cardiovascular function, as well as brain function, using magnetic resonance imaging techniques. The AKA has long fought efforts from the FDA and now WHO to schedule kratom as a controlled substance. It is currently collecting comments ahead of an October 11-15 meeting of the WHO Executive Committee on Drug Dependency where a recommendation will be made on whether to implement international restrictions or a ban on kratom.
On August 9th the American Kratom Association (AKA) submitted over 50,000 comments to the FDA from kratom supporters opposing an international ban on kratom. This unprecedented level of public outcry comes after the news broke that the FDA has asked the World Health Organization (WHO) to consider an international ban on kratom. The AKA led the effort to collect tens of thousands of comments, even with an artificially compressed schedule to that only allowed the public 17 days to prepare and submit comments. Earlier in the weekend, the AKA filed a complaint in the United States District Court for the District of Columbia against the U.S. Department of Health and Human Services (HHS); HHS Secretary Becerra; the U.S. Food and Drug Administration (FDA); and Acting FDA Commissioner Woodcock. The complaint sought to extend the deadline for the comment period to a later date in August in order to give citizens a reasonable amount of time to comment. After negotiations with the FDA and the U.S. Attorney’s office and the exposing of a clear kratom bias in the comment process, an extension of the deadline to August 24th will start on August 16th. The AKA is still collecting comments via AmericanKratom.org and ProtectKratom.org
