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Grant County Board Of County Commissioners Please Sign In For The Record PUBLIC HEARING To Consider an Ordinance Prohibiting the sale or Distribution of Kratorn DATE September 8, 2026 TIME 11:30AM Please Print Your Name Clearly NAME REPRESENTING CONTACT INFO: PHONE/E-MAIL u�2 7) e ct j https:Hgranteountywa.sharepoint.com/teams/BOCC/Shared Documents/General/Teinplates/Public Hearings/0 Sign In Sheet, Open Record.doex 9/14/26, 4:46 PM Inbox - Chelsey C. Sanford - Outlook • y Outlook Potential Kratom Ban From Kameron Bishop <kameron.bishop16@gmai1.com> Date Sat 9/5/2026 12:26 PM To Commissioners <Commissioners@grantcountywa.gov> **EXTERNAL EMAIL** This email originated from outside Grant County's network. Do not click links or open attachments unless you recognize the sender and know the content is safe. My name is Kameron Bishop. I have been a kratom user for approximately eight years. My journey with kratom began after I sought g g treatment through pain management for a chronic pain condition. Because I couldn't leave work on short notice for a surprise pill count, I was treated like a criminal and discharged as a patient. With nowhere else to turn, I relied on the maximum recommended dose of Motrin to manage m pain g Y until I ended up in the emergency room with holes in my stomach. A friend suggested I try kratom. Like many people, I had heard mixed things about it, so I did my own research before deciding to try it. To my amazement, it worked. Not only did it help relieve my pain, but it also helped with my depression ression and anxiety. I don't take it when I don't need it. On more difficult days, I take a little more so I can function and continue living my life. I am a mother of six, ranging in age from 10 to 29. I've worked a physically demanding job for years, and I'm also about to become a grandmother. I look forward to playing with my grandbaby and continuing to enjoy the life I've worked so hard to build. A blanket ban on kratom would be devastating for people like me. I don't want to return to pain clinics that treat patients like criminals, and I can't safely rely on over-the-counter pain medications without causing serious harm to my body. I'm not asking you to ignore legitimate safety concerns. I'm asking you to make a distinction between 70h products, concentrated extracts, and synthetic compounds versus natural whole -leaf kratom. Please choose regulation over prohibition so that responsible adults like me can continue livingproductive, , healthy lives. Regulation looks like age restrictions, clear labeling, lab testing and limiting sellers to reputable vendors. Many places have adopted the KCPA, I humbly ask you to do the same. Thank you for your time. https://outlook.office.com/mail/id/AAMkADQ4MzlwNWIwLTU2NzYtNGZmNyO4OTBiLWNIMTFhYWZjMjVhNgBGAAAAAAAboifPT1 S%2FSo84RNgvDy... 1 /1 9/14/26, 4:45 PM Inbox - Chelsey C. Sanford - Outlook • Outlook Please oppose a full ban on Kratom leaf From Austinrunaway <Austinrunaway@proton.me> Date Tue 9/8/2026 1:37 AM To Commissioners <Commissioners@grantcountywa.gov> **EXTERNAL EMAIL* This email originated from outside Grant County's network. Do not click links or open attachments unless you recognize the sender and know the content is safe. Hello Elected Official I am just writing to help prevent a ban on Kratom . I am a disabled Veteran with PTSD and my wife got me to take this stuff 11 years ago. I find life very hard sometimes and am unable to calm down. I start scanning and scanning and scanning, cannot sleep and I am scared sometimes, stress doesn't help. I take Zoloft, and somedays it does enough, and somedays it doesn't. This stuff helps me chill out without having to get drink beer, and as much as I love going to the VFW, it isn't good mentally to drink every day or reach for a bottle of pills. I don't wanna take anxiety medication everyday of my life because it isnt a good thing long term. I don't wanna have to drink to chill out, and I do use medicinal THC sometimes, but it makes me even more on edge and I get paranoid sometimes, so I feel worse. I have only ever used the powder stuff and that's all I plan on ever using. If I take too much, I puke, then I drink water. There is a "ceiling effect" so if you take too much you vomit, that's it. I have used it for years, and feeling nauseous is the only side effect, and feeling kind of thirsty, that's it. I also have back pain from a old biking injury and it helps that too if ibuprofen isnt enough. My wife uses it for her crushed sciatica nerve pain because she had a spinal fusion surgery. They left a bone shard in her spine, then had to get a laminectomy to remove it 2 days later. She suffers every single day of her life and doesn't wanna take pain killers, so she drinks a little kratom tea. If she wasn't able to get the stuff she probably wouldn't be here. She refuses to become a slave to the opioid train and a prisoner to the pharmaceutical companies for the rest of her life, and I cant blame her. It seems to help her not drink, it has been over 5 years, she was a pretty bad alcoholic because of her back pain. Some days she can get away with taking a bunch of ibuprofen but some days she cant and somedays she doesn't get out of bed, and nothing helps, just rest. It is hard to watch and makes me feel helpless not being able to help her. If you would make this stuff unobtainable you would make her suffer even more than she already does. You would make a disabled Army veteran that served The United States Of America, that went to both Iraq and Afghanistan, suffer mentally and physically and that just wouldn't be ok. I would also have to watch her suffer and that would make my mental health suffer because military people find it very hard not being able to help their loved ones. I think you should make it so that you have to be at least, 21 like alcohol and THC stuff, in order to buy it. You should also only sell powder, so the deliberate mislabeling of product would go away. I don't know, nor have I ever tried anything other than the kratom plant leaf. I appreciate your time and hopefully you will please listen to The American Kratom Association, they have some solid scientific studies and information that they have been working on this stuff for at least https://outlook.office.com/mail/id/AAMkADQ4MzlwNWIwLTU2NzYtNGZmNyO4OTBiLWNIMTFhYWZjMjVhNgBG boifPT1 S%2FSo84RNgvDy... 1/2 9/14/26, 4:45 PM Inbox - Chelsey C. Sanford - Outlook 20 years at least. Due to a full ban on kratom instead of the 70H synthetic stuff my wife and I have had to leave the state of Kansas and move back to her home state of Texas because natural kratom is legal. We had just bought a house in Kansas to be closer to her sister but now that is done. We have had to rent the house out having to start all over again. I have now had to go to a new VA hospital in Austin and find all new doctors which has pushed me to my breaking point with all of this stuff. Please take soldiers like me into consideration when making your decisions please, because this has really brought mental suffering for me and my wife. Im just trying to survive here, we. both are and I know you can understand this. I appreciate you reading this and I hope you have a good day. Thank You Micah Huxtable Army Veteran that served 1 tour in Iraq and 1 tour in Afghanistan Sent from Proton Mail for Android. https://outlook.office.com/mail/id/AAMkADQ4MzlwNWIwLTU2NzYtNGZmNyO40TBiLWNIMTFhYWZjMjVhNgBGAAAAAAAboifPT1 S%2FSo84RNgvDy... 2/2 9/14/26, 4:55 PM Inbox - Chelsey C. Sanford - Outlook x-„ Outlook Public Regarding Kratorn Ordinance From Jennifer Gillis <jennw0913@gmail.com> Date Tue 9/8/2026 8:37 AM To Commissioners <commissioners@grantcountywa.gov> **EXTERNAL EMAIL** This email originated from outside Grant County's network. Do not click links or open attachments unless you recognize the sender and know the content is safe. I'm reaching out to provide public comment for the upcoming discussion regarding kratom ordinance. I would like to share a few important points while considering regulation. There is a significant difference between natural kratom products and 7-hydroxymitragynine (7-OH) products. The growing concerns and reported issues are largely tied to 7-OH products, which are often marketed as a more pure or more potent form of kratom. This has led many consumers —including long-time natural kratom users — to unintentionally develop addiction and dependency on these highly concentrated products and experience negative consequences. Reasonable regulations such as age restrictions, keeping products behind the counter, proper labeling, and mandatory lab testing are appropriate measures. In fact, most reputable natural kratom vendors already follow these standards. The key is clear differentiation between natural kratom and 7-OH products. On July 1,2026 the DEA announced that they would be scheduling 7oh products and stated clearly in the press release they are NOT targeting Natural kratom: "These actions are not intended to regulate natural leaf kratom that does not contain enhanced levels of 7-OH. Although 7-OH occurs naturally in trace amounts in the kratom plant, scheduling 7-OH above a certain threshold level does not intend to capture the kratom botanical leaf in the present temporary scheduling recommendation." Link to the DEA press release: https://www.hhs.gov press-room/hhs-fda-support-dea-7-oh-scheduling.html Natural kratom is simply a leaf from a tree that is dried and ground into powder, traditionally prepared as a tea. In contrast, 7-OH products are typically sold in tablet form, often in brightly colored packaging with names like "Perks" or "Opia,It and frequently display 117" prominently on the label. These products are distinctly different in both form and effect. https:lloutlook.office.com/mail/id/AAkALg HYQDEapmEc2byACgAC%2FEWg0A4ecA.ibGZfE2LBOC2gNiTUwAAHVCopwAA?nativeVersion=1.... 1/2 9/14/26, 4:55 PIVI Inbox - Chelsey C. Sanford - Outlook Twenty years ago, I was diagnosed with transverse myelitis and became a chronic pain patient. After years of struggling to find relief, I discovered natural kratom. It gave me a second chance at life. Because of that, I made a promise to myself to use my voice to advocate for kratom. One of the biggest things that gets overlooked in these conversations are the people who are benefiting from natural kratom. There are countless chronic pain patients who, for one reason or another do not have access to adequate pain management and they will be left behind to suffer, if this is banned— not because of anything they did, but because the 7-OH industry chose to market these products as "kratom," creating confusion and causing harm in communities across the country. Many who rely on natural kratom, particularly those in the chronic pain community, may not even be aware that discussions like this are taking place. I felt it was important to speak on behalf of those individuals and share my experience. I hope that you'll consider following other areas who have decided to restrict the 7oh products and keep natural kratom available for those who are able to live a better quality of life because of it. Recently the North Dakota Governor had enacted an emergency scheduling and a special session for legislation to really look into what was best for the state and they decided to enact regulations on natural kratom that includes age restrictions and restricting the 7oh products and other synthetic products altogether. Thank you for your time and consideration, Jennifer Gillis https:lloutlook.office.com/mail/id/AAkALgAAAAAAHYQDEapmEc2byACqAC%2FEWgOA4ecAibGZfE2LBOC2gNiTUwAAHVCopwAA?nativeVersion=l .... 2/2 9/14/26, 4:36 PM Inbox - Chelsey Co Sanford d Outlook Outlook Grant County ordinance no 26-_-CC (chapter 6.60 — Kratom sale and distribution prohibited) From Brandie Foster <Iv2f1y_1014@yahoo.com> Date Sat 9/5/2026 4:21 PM To Commissioners <Commissioners@grantcountywa.gov> **EXTERNAL EMAIL** This email originated from outside Grant County's network. Do not click links or open attachments unless you recognize the sender and know the content is safe. Dear Kevin Please oppose this draft as written and distinguish natural leaf Kratom from synthetic 7—OH. And establish a reasonable 7-OH concentration threshold rather than implementing a total ban. Please hear my story of using Kratom as a responsible knowledgeable person who has done my research about it and only uses it in a responsible way. have struggled with restless leg syndrome, insomnia, and anxiety for many years. I tried every medication available for restless leg syndrome, but none provided relief without causing debilitating side effects. The restless legs were the biggest barrier to sleep, and without proper rest I was unable to function normally. At one point, my lack of sleep nearly cost me my job. I often wondered how I could continue living like this. About two years ago, I discovered kratom. After carefully researching it, I began taking a small amount at night. I can't explain how wonderful it was to be able to lie still for the first time in years! Kratom has been the only thing that has ever effectively relieved my restless leg symptoms and insomnia without any negative side effects. For the first time in years, I was able to sleep consistently. Because of that, I can now function like a normal person: I can work, participate in daily life, and feel present again. It also helps me with anxiety when needed and with some severe back pain I get after working a really long day. Without kratom, I truly believe I would not be able to function as I do today. For me, it has been life -changing. I strongly support responsible regulation, including quality control and age restrictions. However, I respectfully ask that it not be banned entirely. Kratom is genuinely helping people like me who use it responsibly and rely on it to live a productive, healthy life. Sincerely Brandie Foster Sent from my Phone https:lloutlook.office.com/mail/id/AAMkADQ4MzlwNWIwLTU2NzYtNGZmNy®4OTBiLWNIMTFhYWZjMjVhNgBGAAAAAAAboifPT1 S%2FSo84RNgvDy, - 1/1 9/14/26, 4:36 PM Kratom Public Comment Emails - Chelsey C. Sanford - Outlook Outlook Important Kratom Information - Please read before your meeting this week From lora@plantsandherbals.org <lora@plantsandherbals.org> Date Sun 9/6/2026 5:50 PM To Commissioners <Commissioners@grantcountywa.gov> Cc Dr. Heidi Sykora<drheidisykora@plantsandherbals.org> 0 4 attachments (3 MB) KCPA_Checklist_Form - Fillable - 7.10.26.pdf; Natural vs Synthetic Kratom Flyer - June 2026.pdf; Model Ordinance to Regulate Kratom and Ban 7-01-1 and Synthetics.docx; FDA Single Ascending Dose Study 2026.pdf; **EXTERNAL EMAIL** This email originated from outside Grant County's network. Do not click links or open attachments unless you recognize the sender and know the content is safe. Dear Grant County Commissioners - I am writing because I know you will be discussing a kratom ban ordinance at your meeting this week. The purpose of this email is to address several areas of concern that many cities have about kratom and to reinforce that the problem lies with the synthetic products like 7-OH ... not natural leaf kratom. I hope this email sheds some light on many of these issues and help you in your quest to put good regulation in place in your city. I will be listening and participating via Zoom, so am happy to answer any questions you may have at the meeting. By way of introduction, my name is Lora Romney. I am a 9-year kratom consumer who uses natural kratom to manage severe chronic facial pain (Trigeminal Neuralgia). Kratom has been a critical part of my health journey. I am also a kratom advocate, educator, and the president of the International Plant & Herbal Alliance (www. p[antsand herbals. org). I work closely with Dr. Heidi Sykora (Chief Science Officer and retired healthcare professional). I want to emphasize to you that we are in full support of strict natural kratom regulation in Rensselaer County and a full ban on synthetics. The DEA and DOJ support this position and currently three of the four synthetic products are schedule one: pseudoindoxyl, MGM15 & IVIGIV116. The scheduling of 7-OH should take place this month as well. The government has made it very clear that they are not interested in scheduling natural leaf kratom: "This action is directed at deliberately manufactured and concentrated opioid products, not traditional botanical kratom." DOJ Sept 1 2026 about:blank?windowld=SecondaryReadingPane25 1/7 9/14/26, 4:36 PM Kratom Public Comment Emails - Chelsey Co Sanford - Outlook Since you will be discussing kratom and synthetics, I am addressing some of the most common issues we hear below: is there a difference between kratom and 7-OH? Natural leaf kratom is quite literally plant material that is either ground into a powder (can be sold as capsules) or concentrated into an extract. These products contain trace amounts of naturally occurring 7-OH (less than 2%). These products only partially attached to the mu opioid receptors. They do not suppress breathing. 7_-hyAroxynLitragynine (7-OH) is not kratom. These products are chemically created from one trace metabolite of the kratom plant (7-OH) that occurs in trace amounts in the natural plant (most often less than 1%). 7 OH has a 14 times greater mu opioid receptor binding affinity than morphine and science has shown 7-OH can cause respiratory depression similar to traditional opioids. 7-OH (and other synthetically derived kratom alkaloids like pseudoindoxyl, MGM 15 and MGM 16) had no safety record prior to market entry, and to date, there has been no science confirming any safe use of these products. These synthetic products absolutely need to be removed from your store shelves. They are incredibly addicting and cause extreme withdrawals due to its very short half-life. Why do consumers need access to natural leaf kratom? There are many in Washington that are pain patients and have lost access to any pain medication due to the opioid crisis. These people are like me .... in severe pain. They need options. People in severe pain cannot merely wish their pain away. With the lost of opioids, many have found relief through natural leaf kratom. To take away this viable pain control option is cruel. Especially when science has shown that natural leaf kratom can be a safe and effective tool for managing chronic pain. Others, especially veterans, use kratom to help with their anxiety and PTSD. For many, kratom is a harm reduction tool that has allowed them to exit from illicit drug addiction. Just today I saw this post in a patient sight for those living in Washington. This message is very clear. Patients have been abandoned and they need options! about:blank?windowld=SecondaryReadingPane25 2/7 9/14/26, 4:36 PM Kratom Public Comment Emails - Chelsey C. Sanford - Outlook ib Mike !rx �' Cornment Sear Washington State DPF x m es ra � tr itWtofinda provider who will prescribe my old dosage, of 1 nag oxycodone ever 6 hoursin Whidbey Island r a. It's hard to travel to Brittle with a child. If anyone knows of a provider, please private message` l feel like all my recent health issues are partly becausemy chronicpain isn't being controlled and I can't even get my acute pain controlled at the moment. I've had ulcers in my mouth since August 17th, hospitalized for 5 days, and now none of my r 'r Will prescribe m any 'n n i 6lon . I'm beyond desperate. Itrn trying to holdit together. I need to find a new PCP rapain management doc, Baker clinic refuses so see me because refused bup years ago after it did not help, over 10 plus years, and I'm still on their list to not be seen. University of Washington was NO help. l can barely eat or drink due o the pain right now and even on high dose ste rot I'+ lost 20lbs sincethis recent hospital stay due to the mouth ulcers. I don't care if I have to pay a trrrsshi fee for direct primary care or not. 'm Just beyond miserable* WL) L 'Ike, r-comment ) share What about the most recent report about the drastic increase in poison control calls? Please refer to the graph below. This information was pulled directly from poison control data (source can be provided upon request). Notice the large spike in cases starting in 2023. This is the year that 7-hydroxymitragynine (7-OH) was introduced into the market. To give you an idea of how quickly these products took off I wanted to share an observation. I attended the CHAMP convention in Las Vegas in 2023. There were three vendors handing out samples. One year later, that number jumped to over 300 vendors handing out samples at one convention! Synthetic sales have skyrocketed. Often these products make up the majority of products sold on the shelves. This MUST change. These products can be dangerous since they have been found (in animal studies) to suppress breathing and cause rapid addiction. about:blank?windowld=SecondaryReadingPane25 3/7 9/14/26, 4:36 PM Kratom Public Comment Emails - Chelsey C. Sanford - Outlook aHISTORICAL TREND OF REPORTED CALLVOLL MES (20IS-2025) 0� POISON CONTPO[- DATA ANALYSIS: EARLY REPORTING (2015.2017) 23.9 Million Consumers Est.) 3,434 3,000 SYNTHETIC 2,500 STABLE CALL PERIOD P 2,000 15.6 Million introduction . Consumers (Est.) derivative. 1,525 1,489 1,540 synthetic 1,500 1,357 1226 1,278 1,146 1Consumer base 1,000 833 grew 53L," 430 while calls stayed 500 258 flat. Then syntheti 7-01-1 hit the P market • nd calls O doubled in one year. 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 'A 1 How do federal agencies (FDA, DEA, NIDA) feel about kratom? On July 29, 2025, the FDA held an emergency press conference warning of the public health threat posed by 7-OH products and announced they were working with the DEA to begin scheduling these synthetic compounds. Commissioner Marty Makary made clear that the FDA is not targeting natural kratom. He stated: "We are not targeting the kratom leaf or ground kratom. We are targeting the concentrated synthetic byproduct that is an opioid." In August 2026 the DEA mandated that the following synthetics are now Schedule One: pseudoindoxyl, MGM15 & MGM16. All products containing these ingredients can be removed from store shelves. The DEA has announced that the final comment period for scheduling 7-OH ends on September 10, 2026. We expect a scheduling announcement shortly after that date. At that point, all products containing unnatural levels of 7-OH can be removed from store shelves. Once again it was made very clear that the scheduling target is synthetics ... not natural leaf kratom. "This action is directed at deliberately manufactured and concentrated opioid products, not traditional botanical kratom.99.DOJ Sept 1 2026 The National Health Institute (NIH) has launched a new human study on mitragynine as a treatment for Alcohol Use Disorder. The NIH would never conduct a human study on a substance that could potentially harm the participants. https://www.nih.gov/news-events/news-releases/nih-research-clears- way--- study-experimental-treatment-opioid-use-disorder about:blank?windowld=SecondaryReadingPane25 4/7 9/14/26, 4:36 PM Kratom Public Comment Emails - Chelsey C. Sanford - Outlook The FDA conducted their own Single Ascending Dose Study that showed that kratom was safe up to 12g in 5 minutes. This would be equal to taking 24 capsules in 5 minutes. The only side effect shown was nausea. This was present in the placebo group as well. (see attachment). We are concerned about "'kratom" deaths. We need to do something about this. There has not been a documented "kratom only" death with natural leaf product. Death data always involves polydrug use. In a hearing it was recently shared that there were 158 kratom related deaths in Utah over the past several years. When questioned, over 90% had fentanyl and/or meth in the tox screen. Several percentages were suicides and the remaining did not identify if the death involved natural leaf kratom product or 7-OH/synthetics. Kratom does not cause respiratory depression and there is no mechanism of death that has ever been found due to kratom intoxication (like pulmonary edema ... mouth foaming). Kratom does not respond to Narcan since it is not a fully binding opioid. It only tickles the opioid receptors. On the other hand, 7-OH fully binds with opioid receptors and does respond to Narcan. If you hear about a kratom death, it is critical to evaluate what product the person was taking and if there is polydrug involvement. Can dependence and withdrawal occur? Withdrawals from natural leaf kratom are typically mild. Rarely (unless there are cases of extreme abuse) is it necessary to use medical assistance (like suboxone) to detox from natural leaf kratom. Most individuals taper and experience mild discomfort similar to caffeine withdrawals. On the other hand, the withdrawals from 7-OH are extreme. Many seek help from professionals due to extreme withdrawal symptoms. Withdrawals can occur with 7-OH within 3-7 days of daily use. Tolerance builds quickly. We are concerned with product variability, untested product, contamination, and high levels of 7-OH. This is the exact reason why regulation is so important. Products sold on your store shelves should be properly labeled, include recommended serving sizes, appropriate FDA warnings, reflect the quantity of 7-OH in the product and be able to show that third -party laboratory testing has occurred. The attached Kratom Consumer Protection Ordinance outlines some of these safety features in good regulation. For clinicians and emergency providers, it is important to ask what substance is being consumer if an adverse event or overdose is occurring. This is critical! Too often physicians do not distinguish the difference between natural leaf kratom and 7-OH when evaluating their patients. If an adverse event has occurred, it is critical that the product type is reported. If a death occurs, a full toxicology report should be conducted. In many cases, when kratom is found at the scene, it may be the only substance tested, while the specific type of kratom product is not identified in the report. This type of reporting leads to inaccurate death reports and data that influences public policy. about: blank?windowld=SecondaryReadingPane25 5/7 9/14/26, 4:36 PM Kratom Public Comment Emails - Chelsey C. Sanford - Outlook "My son/daughter died from kratom. All kratom products must be banned..1.1 It is common for parents in a group called Kratom Danger Awareness (KDA) to reach out to local lawmakers. They testify all over the country saying their adult children were lost to kratom. These members have experienced real and painful losses. They deserve genuine compassion and acknowledgment. As a matter of scientific completeness, it may be worth knowing that in cases where toxicology reports have been obtained through FOIA requests, several have indicated polydrug involvement alongside kratom, an obvious medical issue, or there is no indication of what product was consumed. I share this not to cast doubt on anyone's grief, but to encourage a review of the full toxicological picture when it is available before drawing conclusions about natural leaf kratom specifically. It is also worth noting that some KDA members are active participants in kratom-related litigation, which is context that is not typically disclosed during public testimony. It is critical that you obtain the full toxicology report and autopsy from these claimed deaths and have an independent third -party professional review them to determine if the cause of death is justifiable. Please see this website: www.open- truth.org. You will see reports of how information is twisted for an anti-kratom narrative. Ordinances should be based on science and facts, not emotion and fear. Regulation sounds difficult. How are we able to tell the difference between natural leaf kratom and synthetic products? It is overwhelming to consider how to implement good regulation in your city. This is where we can help! Our attached Compliance Check List is just one of several documents that we can share with you that show you how it is very possible to differentiate between natural leaf and synthetic. It is absolutely possible to regulate so that natural leaf is preserved for those who rely on it for health and wellness while removing synthetic products from store shelves. ----------------------------------------------------------------------------------------- I deeply respect your commitment to public health and safety, and I urge you to consider the complexity of this issue carefully. A local ban on kratom could have serious unintended consequences —especially for individuals like me who rely on natural kratom to manage chronic pain, reduce anxiety, and support harm reduction. Like many others, I've found that kratom not only improves quality of life but also helps consumers avoid more dangerous alternatives such as opioids or illicit substances. Thoughtful regulation —not prohibition —is the most effective path forward. Currently there is consumer protection legislation called the Kratom Consumer Protection Ordinance that many communities have passed. Twenty-one states have passed versions of this bill as well. Since the DEA is scheduling synthetics, it is a great time to ensure that the remaining products left on the shelf fit KCPA criteria. about: blank?windowld=SecondaryReadingPane25 6/7 9/14/26, 4:36 PM Kratom Public Comment Emails - Chelsey C. Sanford - Outlook A good ordinance sets the following regulations: g 1 . Age restriction (typically 21 +) 2. Strict GMP regulations for safe packaging and distribution. 3. Appropriate labeling based on requirements for dietary supplements: ingredients, serving size, warnings, etc. Marketing/packaging should not be appealing to youth. 4. Language that restricts the amount of 7-hydroxymitragynine (or other synthetic kratorn derivatives) allowed in the product. In natural plant kratom, the levels of 7-OH are less than 2% of the overall alkaloids (or 1 mg/serving). This would be a safe level in all products and would eliminate the synthetics from your shelves. This language will mirror the DEA's recommendation for 7-OH levels. We hope you will consider advocating for smart regulation rather than a complete ban. Education, good regulation, and not prohibition, is the most effective way to protect the public. Thank you for your time and consideration. We are happy to answer any questions you may have! Lora Romney 801-557-1144 about:blank?windowld=SecondaryReadingPane25 7/7 Natural Kratom eaf Synthetic Alkaloids This is KRATOM: Natural Leaf Kratom Products A H CHRIST0PNER.S i , RED BALI Mitragynine 4 o2 0.95 °b 7-Hydroxymitragynine 0.029n Speciogynine 017% SpeciociGatine 0.261, Paynatheine 0.23% Exp: 10!2027 Batch: 1560- t` _ IIII I II IIIII IIII I�I IIII /�� 8 50007 18174 1 100% PURE ITRAGYNA SPECIOSA Packaged in USA Nrr WT. 4oz (112) Giwms •7 . Supplement Facts WARNMG: Deh..lo,rp am wna, p -'u.ta MN. ha.. a.a .n, A jg..1 rw t-b.:,a �r�.y, .N ary adwrw -.11�.'M14 AYIV CaIM. Glut fdr uN IH 7 W-r r yc.y .orvn Do til w f .e, Mnl Pla-9 to b.aznn* tn.vlaart, a rtieiinj. oo -0 M-4m vas Padl,d In a an fnr•w .� • wr _ t rt dp. C-,A aaM.00W� pvfw.wt.N ro donna aqr at.twk wH It-W rmvart.yt. por to ta,.. K..v oft d M" of d"11 . alv,•, in a a". a, KMM- C C %& m.da: W. al .7 a,.a m.v "-Act Vat PM{�,�.f. or Oi?,W 0.,n010, ,O 09" dit a" malkabcm v dtw sabwa:s. V- ue tatutq oat 7— dumu er4r c y tp Ma w y ) 1. jro*l K, - — , •open ra. al." 10 m,w - ";a. —, nH_Wwy a f� ILM 4 Up w.w t.an --+-Mv . M yal f•M ma bacolamow .a :ran-..wlch PrNdrv,�W u..rr,.la.wdl%; e.e ronor..eww aann.y atteo may Oe haw t�, r.rwe 0"M"Jb vevcwrw F. p.. AtYa k: an,m pin.dnr arh. m —ay ..a,m vnlw.. at..V-4 "' e••p. t,d -rod a.uad "M aa ..rv.rh+ n ■ _♦-hMA •'r darabt. tatW .el raid F n,eF rani "Aq. GnnsugAwi'a Onjw-c Bwan"t► Po 0— 281 Dveu.&Wr NJ 06023 (bV91202-biJBt} n..t. �hnat[KYw�r�,.rr7nni;-'�nlar,cild opfll Fka .It rl on.w I, l.rw --"& ,�- a.IngN b n.atM, -wary. v .aftaaro. nr ' pY.. -M t"e .q .4 :itM,nla r V TlL1Mbk0Q"V%l 'V,.Iy Twa:.. alb .. by Vw KCPA (K,a C.-+wow s i. r •net. S:alwn.m. ^ u+u net b.a, ,dpro. W oY fnu F-d ana DrIG Ad-1— 36- `T.N omau:--, a•. nol Int.ndW b alpndt.. '_•e.t. fir♦, r ✓.wnl arty a._aase 0trialophWs Orpnic BolattirA GREEN _n "tin. hln .1/itr.:pnf Sy>.rrw 11St I(X1r ,•r Pregna 9: Do not use if you are t or breast ant, Plan to become pfegr herbal Proast feeding Before using any 0 kr)a acts, make sure you have full and any a edge of the her, its workin e uo averse reactions it may CaU' e Un�� t transfer this product to any physir 21 years of age. Consult a_ and their nlan to discuss these Alkaloids Keep teractions prior to use. Storp out Of the reach of children' C a cool, dry Place. pprBOkpher's Organic Botani�69 (609) 2x2 81 Deepwater, NJ 08 ac6880 ka9eq in USA OH=,VFt, eo hm6on-e �tt..1(rataYi�IIaYW - - `:r�r�' SYASNINS BLIND Xt v 0 In'1dien9re 1ts: Green Borneo, DI Getable Capsules re het Wa°e atDissolve 2 Capsule$ in d Enjoy. Se�ing Size: 2 (420mg) CaPsule5- �eryln9s "er Container: 50 Product name mimics opioids (Opia, Perks, 7-Oxie, or similar), Product mimics medication (cough syrup), Product contains semisynthetic or synthetic 7-01-1, or synthetic kratom analogues (including pseudoindoxyl, MGM-15, or MGM-16) Inhalable or injectable See Full IPHA Compliance Guidelines for details. International Plant and Herbal Alliance. May 2026 IPHA ORDINANCE NO. AN ORDINANCE PROHIBITING THE SALE & DISTRIBUTION OF 7-HYDROXYMITRAGYNINE (7-OH) PRODUCTS AND REGULATING KRATOM PRODUCTS Section 1. Findings and Purpose The governing bodyfinds and declares that: 1. Kratom (Mitragyna speciosa) contains naturally occurring alkaloids, including mitragynine and trace, non-pharmacologic levels of 7-hydroxymitragynine(7-OH). 2. Concentrated, isolated, or synthetic forms of 7-OH have been shown to bind to opioid receptors and can produce euphoric, sedative, or mood -altering effects at higher doses, creating a potentialfor abuse, dependence, and public health harm. 3. The FDA's 2025 assessment characterizes 7-OH as a potent p opioid receptor agon ist with abuse potential and risk of severe dependence, stating: "Critically, 7-OH produces respiratory depression, physical dependence, and withdrawal symptoms characteristic of classical opioids, such as morphine, fentanyl, oxycodone, and hydrocodone. 4. Scientific research and public health advisories have raised concerns about kratom products containing elevated, isolated, or synthetic concentrations of 7-OH, which may increase the potential for abuse and harm to the public. 5. The purpose of this Ordinance is to protect public health and safety by restricting access to kratom and 7-OH products containing more than 2% 7-OH in the alkaloid fraction or more than 1 mg per serving. Section 2. Adoption of Article A new Article is hereby adopted, entitled: "Prohibition on Sale or Distribution of 7-Hydroxymitragynine (7-OH) Products and Regulation of Kratom Products:' The Article shall read as follows: ARTICLE X. PROHIBITION ON SALE OR DISTRIBUTION OF 7-HYDROXYMITRAGYNINE (7-OH) PRODUCTS AND REGULATION OF KRATOM PRODUCTS Sec. X-1. Authority and Purpose This Article is enacted pursuant to the jurisdiction's general police powers to protect public health, safety, and welfare. Its purpose is to regulate access to kratom and 7-01-1 products containing more than 2% 7-OH of total alkaloids or more than 1 mg per serving. Sec. X-2. Def i nitions For purposes of this Article: (a) "7-OH product" A product containing 7-hydroxymitragynine in concentrations exceeding natural levels found in Mitragyna speciosa Leaf, including: 0 more than 2% of total alkaloids, or • more than 1 mg per serving. Products containing onlytrace, naturally occurring Levels of7-OH are not included. (b) "Attractive to children" Packaging, Labeling, or imagery reasonably expected to a pp to children, including but not Limited to: • cartoons, toys, robots • real or fictional humans • fictional animaLs or creatures 0 decorative fruits orvegetatiles • imagery or phrases commonly used in marketing to children • imitation of candy, cereal, snack, or sweet packaging • use of "candy," "candies," orvariants 0 brand names or close imitations of brands marketed to children • packaging easily confused with commercially available children's food products • any other packaging determined, based on all relevant facts, to be attractive to children (c) "Kratom leaf" The leaf of the kratom plant (Mitragyna speciosa), in anyform. (d) "Kratom leaf extract" Means a preparation obtained from Mitragyna speciosa leaf that retains the natural leaf alkaloid profile, including non-pharmacologic levels of 7-hydroxymitragynine, and has not been enriched, isolated, concentrated, fortified, or otherwise altered to increase the proportion of any individual alkaloid. (e) "Natural leaf alkaloid level" The alkaloid profile naturally occurring in unprocessed kratom leaf, including: g • no more than 2% 7-OH of total alkaloids, and • no morethan 1 mg per serving. (f) "Kratom product" A product consisting of kratom leaf, kratom leaf extract, or both. (9) "Total kratom alkaloids" The sum of mitragynine, speciociliatine, speciogynine, paynantheine, and 7-hydroxymitragynine. sec.X-3. Prohibited Conduct (a) Age Restriction. No person shall sell, offerforsale, or distribute a kratom product to any individual under 21 years of age. (b) 7-OH Concentration Limit. No person shall sell, offerfor sale, or distribute a kratom or 7-OH product containing: g • more than 2% 7-OH of total alkaloids, or 0 more than 1 mg per serving of 7-OH. (c) Products Attractive to Children. No person shall sell, offer for sale, or distributes kratom product that is attractive to children. (d) Age Verification. Any person seLLingkratom products shall conduct age verification sufficient to ensure compliance with subsection (a). Sec. X-4. Packaging Requirements Kratom products offered for retail sale shall be packaged in child -resistant packaging that remains child -resistant forthe Life of the product. (Additional packaging standards may be inserted here if required.) Sec. X-5. Violations and Penalties (insert penalty structure appropriate forthe adopting jurisdiction, such as administrative fines., civil penalties, or business License actions.) Section 3. Severabitity If any section, subsection, sentence, clause, or phrase of this Ordinance is held invalid, the remaining portions shall remain in fuLLforce and effect. Section 4. Effective Date This Ordinance shalltake effect as provided by Law. ORIGINAL CONTRIBUTION A Pilot, Dose -Finding, Pharmacodynamic and Pharmacokinetic Study of Orally Administered Botanical Kratom Chad J. Reissig, PhD,I Ling Chem PhD,I Srikanth C. Nallan; PhD,I E. Gregory Hawkins, PhD,I Steven Galan MD,1 Katherine Bonson PhD,l Siva Rama Raju Kanumur� PhD Christopher R. McCurdy, PhD,2,3,4 Abhisheak Sharma PhD,2,3 Beatrice Setnil� PhD ,5�6 Denise Milava� PhDs Debra Kelsh, MD,S and Dominic Chiczpperino, PhDl Background: Kratom (Mitragyna speciosa) is a plant indigenous to Southeast Asia. This pilot study evaluated the pharmacodynarnic (PD) effects, safety, and pharmacokinetics (PK) of kratom and several of its alkaloids. Methods: Recreational polydrug users (8 participants/cohort; 6 active: 2 placebo, N = 40) completed the study. Participants had experience with opioids but were otherwise healthy. This study uti- lized a double-blind, between -subjects design where participants randomly received a single dose of placebo or kratom. The kratom used in the study had alkaloid levels representative of botanical kratom products (i.e., leaf) previously characterized in the literature and contained trace levels of 7-hydroxymitragynine (7-014). The starting dose was 1 g and doses of 3, 8, 10, and 12 g were adminis- tered after safety reviews after each dose. After dosing, pupillometry and assessments of subjective effects were performed, and blood samples were collected. Safety assessments included adverse events (AE) monitoring, laboratory tests, vital signs, ECG assessments, physical examination findings, and assessment of suicidality. Results: No deaths or serious adverse events (SAES) occurred. Somnolence, vomiting, and nausea were the most common AEs reported. Kratom alkaloid concentrations showed generally orderly, dose -related effects. At doses >:3 g, kratom produced pupillary constriction. Few dose -related effects were observed, although the 12 g dose of kratom produced increases on several subjective measures including ratings of "drug liking." Conclusions: This study investigated the safety of single -sourced botanical kratom; the results may not be representative of other kratom-containing products. Kratom produced some opioid-like effects including pupillary constriction, and the 12 g dose produced Received for publication September 29, 2025; accepted December 28, 2025. From the 'United States Food and Drug Administration, Silver Spring, MD; 2Department of Pharmaceutics, College of Pharmacy, Uni- versity of Florida, Gainesville, FL, Translational Drug Develop- ment Core, Clinical and Translational Science Institute, University of Florida, Gainesville, FL; 4Department of Medicinal Chemistry, College of Pharmacy, University of Florida, Gainesville, FL; 5Altasciences, Overland Park, KS; and 6Department of Phanna- cology and Toxicology, University of Toronto, Toronto, ON, Canada. US Food and Drug Administration under contract 75F40121 C00199. Address correspondence to: Chad J. Reissig, PhD, United States Food and Drug Administration, 10903 New Hampshire Ave. Building 51, Silver Spring, MD 20903 (e-mail: Chad. reissig@fda.hhs.gov). Supplemental Digital Content is available for this article. Direct URL citations are provided in the HTML and PDF versions of this article on the journal's website, www.psychopharmacology.com. Copyright © 2026 Wolters Kluwer Health, Inc. All rights reserved. ISSN: 0271-0749 DOI: 10.1097/JCP.0000000000002158 effects commonly associated with drugs of abuse such as visual analog scale (VAS) ratings of drug liking, good effects, and high. Key Words: kratom, abuse, pharmacokinetcs, pharmacodynamics (J Clin Psychopharmacol 2026;00:000-000) ratom (Mitragyna speciosa) is a wetlands tree native to Southeast Asia including Thailand, Indonesia, and Malaysia.' Kratom has been used for centuries in a variety of sociocultural contexts including the treatment of opioid withdrawal, pain relief, and for mood -enhancing effects.'-3 In the United States, kratom began increasing in popularity in the 1990s. According to the National Survey on Drug Use and Health, an estimated 1.7 million Americans aged 12 and older used kratom in 2021.4 Characterizing kratom use is complicated by a heterogeneous product landscape that includes teas, tablets, extracts, and whole leaf products with varying routes of administration and alkaloid content. Much of the data regarding the use patterns of kratom in the United States is derived from survey -based studies. For example, Garcia-Romeu et al. found that most regular kratom users reported using 1 to 3 g (49%) or 4 to 6 g (33.4%) per consumption.5 In other survey studies, the self - reported average consumption of kratom powder was 4 to 5 g per serving with a range of 2.6 to 7.5 g.6,7 When quantifying mitragynine levels consumed through the use of kratom products, individuals self -reported consuming an average of 31.3 mg of mitragynine/serving, corresponding to 78.3 to 134.6 mg of mitragynine per day.8 As of November 2025, no drug products containing kratom or its components have been approved by the US Food and Drug Administration (FDA) and FDA has concluded that: "...kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury and, therefore, dietary supplements that are or contain kratom are adulterated under section 402 (f) (1) (B) of the FDIC Act. Further, FDA has determined that kratom, when added to . food, is an unsafe, food additive within the meaning of section 409; food containing an unsafe food additive, such as kratom, is adulterated under section 402(a) (2) (C) (i). On the basis of these determinations by FDA, kratom is not lawfully marketed as a dietary supplement and cannot be law/ully added to conventional foods. "9 Journal of Clinical Psychopharmacology . Volume 00, Number 00, ■ ■ 2026 www.psychopharmacology.com Copyright © 2026 Wolters Kluwer Health, Inc. Unauthorized reproduction Of this article is prohibited. p p iblted. Reissig et al Journal of Clinical Psychopharmacology • Volume 00, Number 00, ■ ■ 2026 Despite the lack of regulatory oversight of kratom and kratom-related products, there has been substantial scientific interest in the pharmacology of kratom and its alkaloids. More than 40 alkaloids have been identified in kratom, the most abundant of which is mitragynine. Mitragynine accounts for —66% of the total alkaloid content, and 4 additional alkaloids (speciociliatine, speciogynine, paynantheine, and corynantheidine) make up roughly 20% of the alkaloid content.1,10 The minor alkaloids make up the remaining —14% of alkaloid content of the leaf material and there are few data describing the pharmacological effects of these minor alkaloids. Research efforts investigating kratom have focused primarily on its alkaloid constituents and mitragynine has been the subject of most of these studies given its abundance in the kratom in the tree. Mitragynine has affinity for, and binds to mu-opioid receptors.11 Mitragy- nine also has affinity for a variety of receptor subtypes including adrenergic (ala, alb, ald, a2a, alb, and a2A adenosine A2A, dopamine D2, and serotonin (5-HT1A, 5- HT2B, 5-HT2C, and 5-HT7) receptors.12-14 The effects of mitragynine on mu-opioid receptors vary by the assay system utilized. For example, in vitro functional assays have characterized mitragynine as a full agonist,15 partial agonist, 11,16 and as an antagonist.17 In vivo assessments of antinociception using the hot plate test have shown that mitragynine functions as an agonist, producing a degree of antinociception similar to classic opioids such as morphine and oxycodone. 1s,19 In contrast, mitragynine did not produce significant antinociception in, hot plate tests utilizing rats.17 Drug discrimination procedures have been used to examine the stimulus effects of mitragynine and model its subjective effects. In a drug discrimination study that trained rodents to discriminate mitragynine from vehicle, administration of morphine produced full sub- stitution for the mitragynine cue.20 In a second group of animals trained to discriminate morphine from vehicle, administration of mitragynine produced full substitution for the morphine stimulus cue (i.e., symmetrical general- ization). Of note, the substitution of mitragynine for the morphine cue was dose -dependent: where the middle dose of mitragynine produced full generalization to the mor- phine cue but the low and highest doses examined did not.20 Although the drug discrimination results from Harun and colleagues seem to be in keeping with mitragynine's mu- opioid receptor binding profile, disparate drug discrimi- nation results have been reported. For example, in separate groups of rats trained to discriminate either mitragynine or morphine from saline, mitragynine failed to produce full substitution for the morphine stimulus cue, and morphine did not substitute for the stimulus effects of mitragynine.17 Interestingly, a variety of other opioids did substitute for the mitragynine stimulus cue including fentanyl, nalbu- phine, and buprenorphine.17 The authors hypothesized that the incomplete substitution of mitragynine for morphine (and vice versa) may be due to rate -limiting effects, and that the stimulus effects of mitragynine are dose -related and may be mediated by more than mu-opioid agonist effects alone. The rewarding properties of mitragynine have also been examined using conditioned place preference (CPP). In CPP studies with isolated mitragynine, rats demon- strated a place preference for mitragynine that was similar to stimulants and morphine, suggesting its rewarding properties.21 X A follow-up study using naloxone sug- gested that although opioid receptors mediated the acquisition of CPP, they were less involved in CPP expression after it was acquired.23 In contrast, when the reinforcing effects of mitragynine were examined directly using self -administration procedures, mitragynine was not self-administered in rats previously trained to self- administer morphine.24 Although data characterizing the pharmacology of the minor alkaloids are sparse, 7-hydroxymitragynine (7-OH) has been the subject of numerous research efforts. 7-OH is typically reported to account for < 0.05% of dried kratom leaf mass, a substantially lower proportion than mitragynine.25 7-OH has been postulated to be a post- harvest artifact of kratom and is also formed as a metabolite of mitragynine in humans.26 7-OH has received considerable attention due to its greater affinity and activity at mu-opioid receptors relative to mitragynine and the other kratom alkaloids.11,27 Importantly, 7-OH is self- administered in preclinical models, demonstrating its reinforcing effects and potential for abuse.24 Despite the extensive literature on kratom and its alkaloids using in vitro, in vivo, and epidemiological data to characterize its pharmacology and use patterns, pro- spective and properly controlled clinical studies are sparse. For example, Trakulsrichai and colleagues conducted a prospective study of the pharmacokinetics (PK) of kratom by administering kratom tea to regular kratom tea users. However, there was no placebo or positive control comparator, and subjective effects (i.e., abuse -related measures) were not assessed. In addition, the dose range of kratom was relatively limited and only 3 mitragynine equivalent doses were examined: 6.25, 9.96, and 11.5 mg.28 Vicknasingam and colleagues examined the effects of kratom tea on pain tolerance using the cold pressor test. The authors found an increase in analgesia, though only a single dose of kratom tea was administered and mitragy- nine 9(1.6 mg/kg) was the only alkaloid measured in the tea. Tanna et al.30 also assessed the PK profile of a 2 g tea, whereas Huestis et al.31 performed a double-blind, dose - escalation study of 0.5 to 4 g encapsulated dried leaf kratom powder administered orally to assess its PK profile. Other clinical assessments of kratom have allowed participants to self-administer their own kratom products in uncontrolled, outpatient settings without active or placebo comparators.32-34 Given the dearth of rigorously controlled clinical studies of kratom, along with an absence of abuse - related outcome measures, the objective of this single ascending -dose study of botanical kratom was to generate pilot data on its behavioral effects and safety profile and to inform the design of a future human abuse potential (HAP) study. MATERIALS AND METHODS Study Design This single -center, single -dose, randomized, adaptive, double-blind, placebo -controlled study consisted of 5 single ascending -dose cohorts. Dose levels could be adjusted to higher or lower doses following a review of the safety, tolerability, and pharmacodynamic (PD) data from pre- vious cohorts by a Safety Review Committee (SRC). The SRC consisted of the principal investigator at the investiga- tional site, the study manager, and personnel from FDA's scientific team. The study was conducted at Altasciences 2 I www.psychopharmacology.com Copyright © 2026 Wolters Kluwer Health, Inc. All rights reserved. Copyright © 2026 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. p p hiblted. Journal of Clinical Psychopharmacology • Volume 00, Number 00, ■ ■ 2026 A pilot, PD and PK Study of Botanical Kratom company in Overland Park, Kansas. The study received ethical approval from an Institutional Review Board and was performed under an Investigational New Drug Application (IND). Kratom The kratom used in the study was obtained from Sun Distribution, Super Organics. The kratom was powdered, raw leaf, and administered in 500 mg, size 00 capsules. To meet the chemistry, manufacturing, and controls (CMC) requirements for the IND, repeated stability testing was performed and the kratom met USP guidelines for heavy metals, microbial load, pesticides, mycotoxin, residual solvents, and moisture content. The kratom product was analyzed for alkaloidal content using a validated method UPLC-MS/MS as reported earlier,35 and stability studies were performed at room temperature in a stability chamber (25°C and 60% RH) for 13 months. Kratom product was found stable (acceptable limit, 90% of initial content) and the alkaloid content seemed to be consistent with that reported in the published literature (Table 1).8,36 For each cohort, matching placebo capsules containing 500 mg of microcrystalline cellulose were administered. Quantitative Analysis Using UPLC-MS/MS Two separate bioanalytical methods were developed and validated for quantitative analysis of mitragynine and 7-hydroxymitragynine and speciogynine, speciociliatine, and paynantheine at Alta Sciences and University of Florida, respectively. In brief, mitragynine and 7-hydrox- ymitragynine were quantified using AB Sciex API5500 triple quadrupole mass spectrometer coupled with Shi- madzu Nexera X2 ultra high-performance liquid chroma- tography system (UPLC-MS/MS) for a linearity range of 0.5 to 500 and 0.2 to 100 ng/mL, respectively. Analysis was conducted in multiple reaction monitoring (MRM) mode using precursor to product ion mass transitions of m/z 415.22 > 397.30, 399.23 > 238.10, 418.24 > 400.20, and 402.25 > 238.10, respectively, for 7-hydroxymitragynine, mitragynine, 7-hydroxymitragynine d3, and mitragynine d3, respectively. 7-hydroxymitragynine d3 and mitragynine d3 were used as an internal standard for 7-hydroxymitragynine and mitragynine, respectively. Chromatographic separation was achieved using a gradient flow (0.6 mL/min) of mobile phase consisting of methanol and water containing 0.5% formic acid and a Raptor biphenyl (100 X2.1 mm, 2.7 µm) column. UPLC-MS/MS analysis of speciogynine, speciociliatine, and paynantheine was carried out using Waters Acquity Class I Plus UPLC coupled with a Waters Xevo TQ-S Micro triple quadrupole mass spectrometer for a linearity range of 1-250 ng/mL in human plasma. The chromatographic separation was achieved using Waters Acquity Premier CSH C 18 (1.7 µm, 2.1 x 10 mm) with Vanguard fit guard column using the mobile phase consisting of aqueous ammonium acetate buffer, (2.5 mm, pH-3.5 ± 0.1) (A) - acetonitrile (B) with a gradient elution. The column and autosampler temperatures were kept at 55 and 4 °C, respectively. The mobile phase was delivered at a flow rate of 0.5 mL/min, and the injection volume was set to 2 µL. The source temperature was 150°C, Ion spray voltage was set at 500 V, desolvation temperature was 500 °C, desolvation gas flow was 900 L/h, and the cone gas flow was 50 L/h. The mass spectrometer was operated in positive ion mode and detection of the ions was performed in MRM mode, monitoring the transition of mlz 399.25 precursor ion [M+H]+ to the ni/-7 174.16 product ion for speciogynine and speciociliatine (collision energy 32 V and cone voltage 60V), tnlz 397.16 precursor ion [M+H]+ to the m/z 174.16 product ion for paynantheine (collision energy 30 V and cone voltage 58 V), m/z. 402.21 precursor ion [M+H]+ to the m/z 177.06 product ion for internal standard (collision energy 30 V and cone voltage 26V) (mitragynine-d3). Both bioanalytical methods were vali- dated for selectivity, specificity, accuracy, precision, cali- bration and range, carryover, matrix effect, dilution integrity, and stability following FDA/ICH M 10 guidelines for bioanalytical method validation. Participants A total of 40 healthy male and female, nondependent, recreational polydrug users with prior opioid experience were included in the study (8 subjects in each of the 5 cohorts). Recreational drug users were defined as those who had used opioid drugs for recreational purposes (i.e., for psychoactive effects) at least 10 times in the subject's lifetime and at least once in the last 12 weeks from screening. Inclusion criteria included a history of recrea- tional use of 2 or more perception -altering (eg, lysergic acid diethylamide (LSD), kratom, cannabis, dronabinol, ket- amine, phencyclidine, dextromethorphan, 3,4 methylene- dioxymethamphetamine (MDMA), mescaline, psilocybin, tryptamine derivatives or ring -substituted amphetamines with perception -altering effects) or stimulant drugs (eg, TABLE I. Alkaloid Composition and Stability of Kratom Capsules (25°C/60% RH) Timepoint (mo) Alkaloid* 0 1 2 3 6 13 Mitragynine Speciogynine 5.22 ± 0.65 0.99 ± 0.12 5.08 ± 0.35 0.96 ± 0.07 4.90 ± 0.51 0.90 ± 0.10 5.22 ± 0.46 0.97 ± 0.08 5.07 ± 0.71 0.92 ± 0.13 5.38 ± 0.32 Speciociliatine 2.02 ± 0.24 1.98 ± 0.14 1.98 ± 0.21 1.94 ± 0.17 1.98 ± 0.26 0.94 ± 0.07 1.82 ± 0.12 Mitraciliatine 7-hydroxymitragynine 0.29 ± 0.03 0.06 ± 0.01 0.28 ± 0.02 0.06 ± 0.01 0.29 ± 0.03 0.03 ± 0.01 0.31 ± 0.02 0.03 ± 0.00 0.29 ± 0.04 0.25 ± 0.02 Paynantheine 1.34 ± 0.16 1.32 ± 0.09 1.26 ± 0.13 1.33 ± 0.12 BLLOQ 1.28 ± 0.18 0.04 ± 0.01 1.19 ± 0.08 Corynantheidine 0.14 ± 0.02 0.13 ± 0.01 0.13 ± 0.01 0.13 ± 0.01 0.13 ± 0.02 0.14 ± 0.01 Corynoxine A 0.05 ± 0.01 0.05 ± 0.01 0.05 ± 0.00 0.04 ± 0.00 0.04 ± 0.01 0.04 ± 0.00 Corynoxine B Mitraphylline BLLOQ BLLOQ BLLOQ BLLOQ BLLOQ BLLOQ BLLOQ BLLOQ BLLOQ 0.03 ± 0.00 BLLOQ BLLOQ *Alkaloids content(s) are expressed as the milligram (mg) amount per 500 mg capsule. BLLOQ indicates below the lower limit of quantitation (1 ng/mL equivalent to 32 ng/capsule); RH, relative humidity. Copyright © 2026 Wolters Kluwer Health, Inc. All rights reserved www.psychopharmacology.com 13 Copyright CO 2026 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. p p hlblted° Reissig of al Journal of Clinical Psychopharmacology • Volume 00, Number 00, ■ ■ 2026 cocaine, amphetamine, methamphetamine, methylpheni- date, methcathinone, and other synthetic cathinones) on at least 5 occasions in the participant's lifetime. Polydrug recreational users with prior opioid experience were selected to ensure familiarity with a broad range of psychoactive drug effects. This population is considered appropriate and face -valid for evaluating the pharmacody- namic profile of escalating kratom doses, given its reported spectrum of activity ranging from stimulant -like effects at low doses to opioid-like sedation and dissociative/halluci- nogenic effects at higher doses.37-39 Experienced recrea- tional polydrug users also represent the typical participant population enrolled in HAP studies, which this SAD study was designed to inform.40 All participants provided written informed consent form (ICF) and agreed to use appropriate contraception methods (eg, abstinence, systemic contra- ceptives, intrauterine device, double -barrier method, etc.). Exclusion criteria included: (1) Difficulty swallowing capsules; (2) females who were lactating or pregnant; (3) self -reported sensitivities to kratom; (4) significant history of disease including gastrointestinal, liver or kidney disease, cardiovascular, pulmonary, hematologic, neurological, psychiatric, gastrointestinal, endocrine, immunologic, oph- thalmologic, or dermatologic disease; (5) smoking or a history of heavy smoking; (6) excessive caffeine intake; (7) other physiological diseases or abnormalities identified at screening, including ECG abnormalities and QT prolonga- tion; and (8) additional criteria, including a history of substance use disorder and intake of kratom in the 14 days before study participation. Procedures After successful screening, participants were confined to the clinical site from the day before drug administration until 48 hours after drug administration. Subjects were randomized 6:2 (active: placebo) to kratom or placebo in each cohort. Kratom or placebo was administered under double- blind conditions. Study treatments were administered in the morning, 30 minutes after a standardized high -fat breakfast (fed state) after an overnight fast of at least 10 hours. This approach was chosen to increase tolerability, facilitate dose escalation, and mitigate nausea and vomiting previously reported under fasted conditions.30 Capsules were admin- istered with —240 mL of water at room temperature. Given the large number and size of capsules required for certain cohorts (range of 2 to 24 size 00 capsules), an additional 240 mL of water was allowed if required. Time of dosing was set equal to the time when the first capsule was administered to the subject. The dosing procedure had to be completed within 5 minutes. Dosing procedures completed up to 2 minutes outside the allowed time window were not considered protocol deviations but were documented. Start and end times of dosing and the volume of water consumed were recorded. All capsules were swallowed whole and not chewed or broken. Safety Safety assessments included adverse event (AE) monitoring, clinical laboratory tests, vital signs (blood pressure, pulse, respiratory rate, oxygen saturation, and body temperature), ECG assessments, physical examina- tion findings, and assessment of suicidality using the Columbia -Suicide Severity Rating Scale. At the investigator's discretion, additional safety assessments could be performed as needed to ensure subject safety. Pharmacokinetic Assessments Blood samples for PK measurements were collected predose and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, and 48 hours, post -dose. Samples were collected from an intravenous catheter or direct venipuncture, if necessary. The time of PK blood sample collection was calculated relative to the time of treatment administration. PK measurements of the study included plasma concentrations of mitragynine, 7-hydroxymitragynine, speciogynine, spe- ciociliatine, and paynantheine using validated bioanalytical methods (see Supplemental Digital Content 1, http://links. lww.com/JCP/Bl9 and 2, http://links.lww.com/JCP/B24). Pharmacodynamic Assessments Before completing computerized PD measures, all participants underwent a standardized training and practice session. Participants who seemed to have difficulty differ- entiating between bipolar and unipolar VAS (eg, making errors such as selecting a score of 50 to indicate the absence of a drug effect on a unipolar scale) or difficulty distinguishing between "at this moment" and "overall" measures received additional training focused on these distinctions. Participants were monitored to ensure that PD assessments were completed appropriately. Reasonable attempts were made to rouse participants who fell asleep during testing. If a participant was unable to complete PD assessments in a timely manner before the next required procedure or timepoint due to an AE or other clinical concern, the PD assessment at that timepoint was aborted. Pupillometry Data from a series of frames were used in the calculation of pupil size. Measurements were collected using a handheld electronic pupillometer (NeurOptics VIP- 300 Pupillometer System, CA) under mesopic lighting conditions. For each participant, the same eye was used for all assessments when feasible. The pupillometry assess- ment was completed immediately before the administration of other PD measures at each prespecified timepoint. Visual Analog Scales (VAS) All VAS were scored on a 0 to 100 scale and measured at predetermined time points. The VAS were structured as either bipolar or unipolar scales, depending on the subjective effect being measured. Bipolar scales asked about the neutrality, direction, and intensity of a subjective opinion, whereas unipolar scales only asked about the extremity or intensity of a subjective effect. When VAS were administered as bipolar scales, a neutral point equal to 50 was included in the scale [eg, drug liking, overall drug liking (ODL), take drug again (TDA), drowsiness/alertness VAS]. The neutral point reflected a state whereby a subject was experiencing neither negative nor positive effects (eg, neither dislike nor like the effects of the drug) and was labeled with an anchor, such as "neither like nor dislike." When VAS were administered as unipolar scales, anchors were presented using text such as "not at all" (score = 0) to "extremely" (score =100; eg, good, bad, high, and any drug effects VAS). Unipolar scales did not include a neutral point but rather, a rating of "0" reflected the complete absence of a subjective effect, whereas a rating of "100" 4 I www.psychopharmacology.com Col)yright © 2026 Wolters Kluwer Health, Inc. All rights reserved, Copyright © 2026 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. Journal of Clinical Psych opharmacology • Volume 00, Number 00, ® ■ 2026 A pilot, PD and PK Study of Botanical Kratom reflected the maximum presence of a subjective effect (eg, no good effects = 0, extremely good effects = 100). Scales that referred specifically to drug (eg, drug liking, good drug effects, bad drug effects, and any drug effects VAS) were not administered at predose. Bowdle Visual Analog Scale An adapted computerized version of the Bowdle VAS, consisting of 13 unipolar items, was administered to assess perceptual changes. Each item was scored from 0 ("not at all") to 100 ("extremely") with lower scores indicating fewer perceptual and psychedelic effects. The individual items were: 1. My body or body parts seemed to change their shape or position (BODY) 2. My surroundings seemed to change in size, depth, or shape (SURROUNDINGS) 3. The passing of time was altered (TIME) 4. I had feelings of unreality (REALITY) 5. It was difficult to control my thoughts (THOUGHTS) 6. The intensity of colors changed (COLORS) 7. The intensity of sound changed (SOUND) 8. I heard voices or sounds that were not real (VOICES) 9. I had the idea that events, objects, or other people had particular meaning that was specific for me (MEANING) 10.I had suspicious ideas or the belief that others were against me (SUSPICIOUS) 11.I felt anxious (ANXIOUS) 12.I felt high (HIGH) 13.I felt drowsy (DROWSY) Responses to items 1, 2, 3, 5, 6, and 7 were summed to produce a "subjective external perceptions" composite score. Response to items 4, 8, 9, 10, and 11 were summed to produce a "subjective internal perceptions" composite score. Items 12 and 13 were not included as they were administered as part of the individual VAS items. If a response to one of the items was missing, the associated composite score was not calculated. ®rug Similarity VAS Drug Similarity VAS items provided an estimate of how similar the test drug was to drug classes with which participants were familiar. On a unipolar scale ranging from "not at all similar" to "very similar," participants were asked to compare a drug they had taken previously to the test drug. A drug use history was completed during screening and used to create a subject -specific drug similarity measure. Drugs that a subject had not used often ( < 2 lifetime uses of a given drug), were not included in their questionnaire. Addiction Research Center Inventory (ARCI) The Addiction Research Center Inventory (ARCI)41-43 Morphine -Benzedrine Group (MBG), Amphetamine (A), Benzedrine Group (BG), Pentobarbi- tal -Chlorpromazine -Alcohol Group (PCAG), and lysergic acid diethylamide (LSD) scales were administered alongside the basic VAS measures. The 49-item ARCI was a shortened version (49 true - false items) compiled by Martin and colleagues from the original 550-item ARCI.41-43 This version contained 5 scales, which measured the following effects: Euphoria— MBG scale; Stimulant effects —Amphetamine scale and BG scale; Dysphoria—LSD scale; and Sedation—PCAG scale. Subjects indicated their responses by selecting "false" or "true." One point was given for each response that agreed with the scoring direction on the scale (i.e., true items received a score of 1 if the answer was "true;" a score of 0 was given when the answer was opposite to the scoring direction). The following scales were administered: • Euphoria: Morphine -Benzedrine Group (MBG) scale • Stimulant effects: Amphetamine (A) scale, Benzedrine Group (BG) scale • Dysphoria: Lysergic acid diethylamide (LSD) scale • Sedation: Pentobarbital -Chlorpromazine -Alcohol Group (PCAG) scale Statistical Analyses For measures collected within 24 hours, the peak responses [maximum (Emax) or minimum (Emin) , as appropriate] were the endpoints. The primary pharmaco- dynamic endpoint was Emax of drug liking VAS. Key secondary endpoints included Emax scores of high VAS, overall drug liking VAS, and take drug again VAS. Inferential statistics using the aforementioned peak responses were performed on the primary and key secondary endpoints. Because of the large number of endpoints and the large number of comparisons in the study, for controlling overall type I error rate only descriptive statistics were calculated for other endpoints. ANOVA model was prespecified for the statistical analyses for the primary and key secondary endpoints. The 1-sided Dunnett test at 5% significance level was used for the comparisons between each dose of kratom and pooled placebo.44 For the sensitivity analysis, Hodges -Lehmann estimator was used to estimate the difference between each dose of kratom and pooled placebo.45,46 The 1-sided Mann - Whitney U test (or called Wilcoxon rank sum test)47,48 at 5% significance level was used to test the null hypothesis that: "the observations produced by kratom and pooled placebo have the same distribution" versus the alternative hypothesis: "the distribution of observations produced by kratom is shifted to the right of that of pooled placebo." The Benjamin -Hochberg procedure49 was used to adjust multiplicity for the comparisons between each dose of kratom and pooled placebo for each endpoint. As the dosing escalating study is exploratory in nature, the type I error rate adjustment was not performed for the multi- plicity among endpoints. RESULTS Safety Analyses and Adverse Events All 40 enrolled participants in the study were included in the safety analysis population. Overall, 18 of the 40 participants (45.0%) that received kratom or placebo experienced a total of 38 treatment -emergent adverse events (TEAEs) and 33 of the TEAEs (86.8%) were considered related to study drug (Table 2). The most commonly reported TEAEs were somnolence, vomiting, and nausea. Somnolence occurred in 1 of 6 participants (16.7%) receiving kratom 8 g, 3 of 6 (50.0%) receiving kratom 10 g, and 2 of 10 (20.0%) receiving placebo. Vomiting occurred in 2 of 6 participants (33.3%) in each of the kratom 8 g and 12 g cohorts, and in 1 of 6 (16.7%) in the kratom 10 g cohort. Nausea occurred in 2 of 6 participants (33.3%) receiving kratom 8 g, and in 1 of 6 (16.7%) in each of the kratom 10 g and 12 g cohorts. Nausea and vomiting Copyright O 2026 Wolters Kluwer Health, Inc. All rights reserved. www.psychopharmacology.com 15 Copyright © 2026 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. Reissig et al Journal of Clinical Psychopharmacology • Volume 00, Number 00, ■ ■ 2026 TABLE 2. Summary of Treatment -Emergent Adverse Events by MedDRA Preferred Term and System Organ Class System Organ Class and Kratom 1 g Kratom 3 g Kratom 8 g Kratom 10 g Kratom 12 g Pooled MedDRA Preferred (N = 6) 2 (N = 6) 6 (N = 6) 16 (N = 6) 20 (N = 6) 24 Placebo Overall Term Capsules Capsules Capsules Capsules Capsules (N =10) (N = 40) Subjects with at least one * 1 (16.7) 1(16.7) 5 (83.3) 4(66.7) 3 (50.0) 4(40.0) 18 (45.0) TEAE Ear and labyrinth 0 0 0 1 (16.7) 0 0 1 (2.5) disorders Tinnitus 0 0 0 1 (16.7) 0 0 1 (2.5) Gastrointestinal disorders 0 0 3 (50.0) 2 (33.3) 2 (33.3) 0 7 (17.5) Dry mouth 0 0 0 1 (16.7) 0 0 1 (2.5) Nausea 0 0 2 (33.3) 1 (16.7) 1(16.7) 0 4(10.0) Vomiting 0 0 2 (33.3) 1 (16.7) 2(33.3) 0 5 (12.5) General disorders and 0 0 0 1 (16.7) 1 (16.7) 0 2(5.0) administration site conditions Chills 0 0 0 1 (16.7) 0 0 1 (2.5) Feeling hot 0 0 0 0 1 (16.7) 0 1 (2.5) Infections and infestations 0 1 (16.7) 0 0 0 0 1 (2.5) Viral upper respiratory 0 1 (16.7) 0 0 0 0 1 (2.5) tract infection Investigations 0 0 0 0 0 1 (10.0) 1 (2.5) Blood pressure systolic 0 0 0 0 0 1 (10.0) 1 (2.5) increased Musculoskeletal and 0 1 (16.7) 0 0 0 0 1 (2.5) connective tissue disorders Neck pain 0 1 (16.7) 0 0 0 0 1 (2.5) Nervous system disorders 1 (16.7) 0 2 (33.3) 4(66.7) 1 (16.7) 3 (30.0) 11 (27.5) Dizziness 0 0 0 2 (33.3) 0 0 2(5.0) Headache 0 0 1 (16.7) 0 1 (16.7) 1 (10.0) 3 (7.5) Paresthesia 1 (16.7) 0 0 0 0 0 1 (2.5) Presyncope 0 0 1 (16.7) 0 0 0 1 (2.5) Somnolence 0 0 1 (16.7) 3 (50.0) 0 2(20.0) 6(15.0) Psychiatric disorders 0 0 2 (33.3) 2 (33.3) 0 0 4(10.0) Anxiety 0 0 0 1 (16.7) 0 0 1 (2.5) Euphoric mood 0 0 1 (16.7) 1 (16.7) 0 0 2(5.0) Irritability 0 0 1 (16.7) 0 0 0 1 (2.5) Renal and urinary 0 0 1 (16.7) 0 0 0 1 (2.5) disorders Leukocyturia 0 0 1 (16.7) 0 0 0 1 (2.5) Skin and subcutaneous 0 0 0 0 1 (16.7) 1 (10.0) 2(5.0) tissue disorders Hyperhidrosis 0 0 0 0 1 (16.7) 0 1 (2.5) Pruritus 0 0 0 0 0 1 (10.0) 1 (2.5) Data are reported as n (0/0). *Each TEAE was counted only once for each subject within each MedDRA SOC and PT. MedDRA indicates Medical Dictionary for Regulatory Activities; N, number of subjects who received the specified treatment; n, number of subjects in a category; PT, preferred term; SOC, system organ class; TEAE, treatment -emergent adverse event. were not observed in the pooled placebo group. No serious adverse events or deaths were reported, and no participants discontinued the study due to TEAEs. Pu pi Ilometry Mean (SE) pupil diameter over time at each dose level of kratom and placebo is illustrated in Figure S 1 (Supplemental Digital Content 3, http://links.lww.com/ JCP/B20). Minimal fluctuations in pupil diameter were observed for placebo and kratom 1 g. In contrast, kratom doses of 3, 8, 10, and 12 g produced decreases in pupil diameter (i.e., constriction), with an apparent dose -related effect. Mean maximum pupil constriction over time was 0.9 mm for kratom 1 and 3 g, 2.2 mm for kratom 8 g, 1.9 mm for kratom 10 g, and 2.4 mm for kratom 12 g compared with 1.1 mm for placebo. Summary statistics for maximum pupil constriction are presented in Table 3. Dunnett test44 was used to test the difference in means between each dose of kratom and pooled placebo for maximum pupil constriction. The results showed that the means of maximum pupil constrictions produced by 8 and 12 g of kratom were significantly smaller (i.e., produced more pupil constriction) than that in the pooled placebo group (P < 0.05). Pharmacokinetic Results All doses of kratom produced a measurable plasma concentrations of the targeted alkaloids. Mitragynine Plasma concentration -time profiles for mitragynine are shown in Figure 1, and PK parameters are summarized in Table 4. After a single oral administration of kratom under fed conditions, mitragynine was absorbed into the systemic 6 I www.psychopharmacology.com Copyright © 2026 Wolters Kluwer Health, Inc. All rights reserved. Copyright CC 2026 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. Journal of Clinical Psychopharmacology • Volume 00, Number 00, ■ ■ 2026 A pilot, PD and PK Study of Botanical Kratom TABLE 3. Summary Statistics for Maximum Pupil Constriction (mm) Kratom l g Kratom 3 g Kratom S g Kratom 10 g Kratom 12 g Pooled Placebo Parameter (N = 6) (N = 6) (N = 6) (N = 6) (N = 6) (N =10) Mean (SE) -0.9 (0.2) -0.9 (0.2) -2.2 (0.3) -1.9 (0.3) -2.4 (0.4) -1.1 (0.3) Median -0.7 -0.8 -2.2 -1.7 -2.3 -0.8 Min, max -1.9, 0.3 -1.5, -0.5 -3.0, -1.2 -3.1, -1.3 -3.9, -1.1 -2.6, 0 circulation with a median time to reach peak plasma concentration (Tmax) ranging from 3.0 to 5.0 hours across cohorts 1 to 5. Mean observed peak plasma concentration (Cmax) ranged from 41.7 to 378.5 ng/mL with increasing kratom doses from 1 to 12 g. The mean estimated area under concentration -time curve up to the last timepoint (AUCo_T) ranged from 305.4 to 3271.2 h•ng/mL. An increase in mitragynine Cmax, and AUCp_T was noted with an increased dose of kratom; however, dose -proportionality could not be concluded because of the limited number of subjects in parallel dosing cohorts. 7-Hydroxymitragynine Concentration -time profiles for 7-hydroxymitragynine (7-OH) are shown in Figure 2, with PK parameters provided in Table 4. After a single oral administration of kratom under fed conditions, 7-OH produced a median Tmax ranging from 2.8 to 6.0 hours for cohorts 1 to 5. The mean observed Cmax ranged from 6.7 to 58.4 ng/mL with increasing kratom doses from 1 to .12 g. The mean estimated AUCo_T ranged from 53.5 to 574.3 h•ng/mL. An increase in 7-OH Cmax, and AUCo_T was noted with an increased dose of kratom; however, dose -proportionality could not be concluded because of the limited number of subjects in parallel dose cohorts. Mitragynine S00 400 300 c 0 200 0 100 0 Paynantheine Plasma concentration -time profiles for paynantheine are shown in Figure S2 (Supplemental Digital Content 3, http://Iinks.lww.com/JCP/B20), with PK parameters pro- vided in Table 4. Paynantheine produced a median Tmax ranging from 2.99 to 5.04 hours for cohorts 1 to 5. The mean observed Cmax ranged from 7.7 to 66.7 ng/mL with increasing kratom doses from 1 to 12 g. The mean AUCo-T estimate ranged from 47.0 to 727.6 h-ng/mL. An increase in paynantheine Cmax, and AUCo_T was noted with increased dose of kratom; however, dose -proportionality could not be concluded because of the limited number of subjects in parallel dose cohorts. Speciogynine Plasma concentration -time profiles for speciogynine are shown in Figure S3 (Supplemental Digital Content 3, http://Iinks.lww.com/JCP/B20), with PK parameters pro- vided in Table 4. Speciogynine had a median Tmax ranging from 2.54 to 5.04 hours for cohorts 1 to 5. The mean observed Cmax ranged from 6.3 to 58.9 ng/mL after administration of kratom doses from 1 to 12 g. The mean estimated AUCo_T ranged from 53.4 to 819.2 h•ng/mL. An increase in speciogynine Cmax, and AUCo_T was noted with increased doses of kratom; however, dose -proportionality U 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 Time (hours) FIGURE 1. Plasma concentration -time profiles of mitragynine (Mean ± SD) by cohort in healthy participants (N = 6, each). The inset displays the 0 to 2 hours profile. Copyright © 2026 Wolters Kluwer Health, Inc. All rights reserved www.psychopharmacology.com 17 Copyright © 2026 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. Reissig et al Journal of Clinical Psychopharmacology • Volume 00, Number 00, ■ ■ 2026 TABLE 4. Pharmacokinetic Parameters of Mitragynine and 5 Additional Alkaloids After a Single -Dose Oral Administration of Kratom to Healthy Participants Parameter* (Unit) Cohort 1 (1 g) N= 6 Cohort 2 (3 g) N= 6 Cohort 3 (8 g) N= 6 Cohort 4 (10 g) N= 6 Cohort 5 (12 g) N= 6 Mitragynine (mg) 9.8-10.7 29.4-32.3 78.4-86.1 98.0-107.6 117.6-129.1 Cmax (ng/mL) 41.7 (35.4) 118 (39.7) 197.5 (44.7) 318.1 (51.4) 378.5 (48.9) Tmax (h) 4.0 (2.5-6.2) 3.0 (2.5-4.0) 5.0 (2.5-6.1) 3.5 (2.5-4.0) 2.0 (1.0-6.0) AUCo_T (h-ng/mL) 305.4 (37.9) 784.8 (48.5) 1942 (38.0) 3254 (68.0) 3271 (48.2) XZ (1/h) 0.042 (21.5) 0.038 (14.6) 0.04 (24.5) 0.034 (29.5) 0.045 (22.1) Thalf (h) 17.28 (21.3) 18.64 (15.2) 17.47 (32.4) 22.07 (30.2) 15.9 (17.6) 7-hydroxymitragynine (mg)t 0-0.12 0-0.36 0-0.96 0-1.2 0-1.4 Cmax (ng/mL) 6.7 (32.4) 17.8 (48.9) 34.0 (32.9) 48.4 (41.3) 58.4 (38.9) Tmax (h) 4.0 (2.5-6.2) 3.5 (3.0-4.0) 6.0 (3.0-10.0) 4.0 (3.0-4.0) 2.8 (1.5-6.0) AUCo_T (h-ng/mL) 53.5 (40.4) 132.9 (64.5) 412.6 (37.2) 459.1 (49.3) 574.3 (33.9) Metabolite: parent ratio (%) 17.5 16.9 21.2 14.1 17.6 Paynantheine (mg) 2.38-2.68 7.14-8.04 19.04-21.44 23.8-26.8 28.56-32.16 Cmax (ng/inL) 7.7 (34.3) 19.0 (26.5) 29.7 (49.0) 66.7 (54.8) 65.8 (52.0) Tmax (h) 4.02 (2.5-6.18) 2.99 (2.5-4.0) 5.04 (3.0-6.14) 3.0 (2.5-4.0) 3.29 (1.5-6.01) AUCo_T (h-ng/mL) 47.0 (40.3) 132.9 (33.1) 320.2 (41.8) 725.2 (62.4) 727.6 (54.7) XZ (1 /h) 0.13 (44.4) 0.077 (100.3) 0.043 (26.2) 0.041 (41.9) 0.049 (21.1) Thalf (h) 6.33 (50.2) 15.26 (60.2) 16.86 (23.8) 19.07 (35.0) 14.7 (20.5) Speciogynine (mg) 1.8-1.98 5.4-5.94 14.4-15.84 18-19.8 21.6-23.76 Cmax (ng/mL) 6.3 (30.4) 15.8 (27.2) 23.2 (43.5) 58.9 (60.3) 55.5 (55.9) Tmax (h) 4.02 (2.5-6.18) 3.0 (2.99-4.0) 5.04 (3.0-10.02) 4.0 (3.0-6.0) 2.54 (1.5-6.01) AUCo_T (h•ng/mL) 53.4 (36.0) 154 (28.6) 341 (43.3) 819.2 (63.7) 790 (57.4) Xz (1/h) 0.086 (69.6) 0.052 (45.7) 0.039 (16.9) 0.038 (37.6) 0.047 (19.4) Thalf (h) 11.06 (50.3) 15.91 (42.8) 18.09 (17.0) 20.26 (34.9) 15.20 (19.3) Speciociliatine (mg) 3.64-4.04 10.92-12.12 29.12-32.32 36.4-40.4 43.68-48.48 Cmax (ng/mL) 39.1 (30.0) 106.6 (22.4) 168.9 (40.3) 388.1 (56.0) 409.7 (47.3) Tmax (h) 4.02 (3.0-8.04) 5.0 (3.0-9.99) 8.07 (3.0-12.0) 5.0 (4.0-8.0) 5.06 (2.0-10.01) AUCo_T (h-ng/mL) 573.9 (49.7) 1910.9 (24.9) 3359.2 (37.4) 7904.8 (60.6) 7449.8 (49.6) XZ (1/h) 0.072 (33.3) 0.059 (24.8) 0.056 (41.1) 0.043 (18.7) 0.062 (16.6) Thalf (h) 11.17 (52.6) 12.55 (30.5) 14.04 (35.1) 16.39 (18.0) 11.41 (14.8) *Doses are approximate based on measured alkaloid levels in capsules (Table 1). tSome capsules were verified to have levels of 7-hydroxymitragynine below the limit of quantitation. XZ indicates elimination rate constant; AUCo_T, area under concentration -time curve up to last timepoint; Cmax, peak plasma concentration; Thalf, elimination half-life; Tmax, time to reach Cmax* could not be concluded because of the limited number of subjects in parallel dose cohorts. Speciociliatine Plasma concentration -time profiles for speciociliatine are shown in Figure S4 (Supplemental Digital Content 3, http://links.lww.com/JCP/B20), with PK parameters pro- vided in Table 4. Median Tmax ranged from 4.02 to 8.07 hours for cohorts 1 to 5. Mean Cmax ranged from 39.1 to 409.7 ng/mL with increasing kratom doses from 1 to 12 g. The mean estimated AUCo-T ranged from 573.9 to 7904.8 h•ng/mL. An increase in speciociliatine Cmax, and AUCo_T was noted with increased doses of kratom; however, dose -proportionality could not be concluded because of the limited number of subjects in parallel dose cohorts. Pharmacodynamic VAS Results Statistical Analysis on the Primary and Key Secondary Endpoints In the tables and figures, K 1, K3, K8, K 10, K 12, and P denote 1, 3, 8, 10, and 12 g doses of kratom, and pooled placebo, respectively. Table 5 summarizes the mean, SD, minimum (Min), the first quartile (Q 1), median (Med), the third quartile (Q3), and maximum (Max) rating for the primary and key secondary endpoints for all 6 treatments. As shown in Table S 1 (Supplemental Digital Content 3, http://links.lww.conl/JCP/B20), mean Emax values pro- duced by 8 and 12 g kratom had at least 10 points difference from the placebo group for the primary and all key secondary endpoints. A noticeable difference in median values between each dose of kratom and pooled placebo was found for the comparison between kratom 12 g and pooled placebo for all primary and key secondary measures except Emax of Take Drug Again VAS. The median TEmax for the primary endpoint was calculated and occurred -1 hour post -dose for 12 g kratom. Figure S5 (Supplemental Digital Content 3, http://links.lww.com/JCP/B20) shows the mean dose -response curves for these 4 endpoints. The mean dose responses produced by kratom 10 g for the primary and key secondary endpoints were all smaller than those produced by kratom 8 g. We plotted the heat maps for the individual time -course response profiles for 8, 10, and 12 g doses of kratom for the primary measure of drug liking VAS in Figure S6 (Supplemental Digital Content 3, http:// links.lww.com/JCP/B20). Among the 6 participants who received kratom 8 g, one participant (ID 35) reported a drug liking VAS score of 100 at every timepoint, including the first assessment (i.e., 15 min after administration). Without including this subject, kratom 8 g would not show any meaningful effect on assessments of drug liking. Thus, it is possible the 12 g dose was the only dose to produce meaningful changes on subjective measures of drug effects. Figures S7A and S7B 8 1 www.psychopharmacology.com Col)yright © 2026 Wolters Kluwer Health, Inc. All rights reserved. Copyright © 2026 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. Journal of Clinical Psychopharmacology • Volume 00, Number 001 ■ ■ 2026 A pilot, PD and PK Study of Botanical Kratom E C C 0 U 60 60 40 20 7„HOrdroxymitrag nine 0 ? 4 6 8 10 12 14 16 18 20 22 24 26 26 30 32 34 36 38 40 42 44 46 48 Time (hours) FIGURE 2. Plasma concentration -time profiles of 7-hydroxymitragynine (mean ± SD) by cohort in healthy participants (N = 6, each). The inset displays the 0-2 hours profile. (Supplemental Digital Content 3, http://links.lww.com/ JCP/B20) display the mean time -course profiles for drug lilting VAS and High VAS. In human abuse potential studies, the placebo range is typically considered to be between 40 and 60 for drug liking VAS. Figure S7A and S713 (Supplemental Digital Content 3, http://Iinks.lww.com/JCPB20) shows that the mean time -course profiles are bounded between 40 and 60 except the mean liking score of kratom 10 g that is below 40 eight hours post dose. For High VAS, the mean time -course profile for kratom 12 g is > 20 from 1.5 to 6 hours post dose. The peak mean response to kratom 12 g (33.7) occurred 6 hours post dose. As no data were collected between hours 6 and 8, it is possible, albeit unlikely, that the time to peak mean response occurs at hour 7. Figure S8 (Supplemental Digital Content 3, http://links. lww.com/JCP/B20) shows mean values with SDs for overall drug liking VAS and take drug again VAS 12 and 24 hours post dose for each treatment. Even though the means produced by pooled placebo were below 50, the means produced by kratom for these 2 endpoints were below, or close to 60. Inferential Statistics An ANOVA model was used to test treatment differences for the primary and key secondary endpoints. To control for multiplicity, Dunnett's test was used to compare the means of kratom groups to pooled placebo. Significant treatment differences were demonstrated only for drug liking Emax and High Emax. The analysis results are presented in Table S 1 (Supplemental Digital Content 3, http://Iinks.lww.com/JCP/B20). The mean differences between kratom 12 g and pooled placebo were 18.5 and 45.9 for drug liking Emax and High Emax, respectively. The analysis results show that the mean of kratom 12 g is significantly larger than that of pooled placebo at the significance level of 5% for these endpoints. The limitation of this inferential analysis is that the sample size for each treatment was very small. The assumptions of the ANOVA model were not met. As a sensitivity analysis, Hodges -Lehmann estimator was used to estimate the difference between each dose of kratom and pooled placebo, the Wilcoxon Rank Sum test was conducted for each comparison, and Benjamini- Hochberg procedure was used for multiplicity adjustment. In the sensitivity analysis a significant result was only demonstrated in the comparison between kratom 12 g and pooled placebo for High Emax. However, clearly the difference in distributions between 8, 10, and 12 g doses of kratom and pooled placebo does not differ only in location. Therefore, the results from both the Dunnett test and Wilcoxon Rank Sum test should be interpreted with caution. Descriptive Statistics for other Endpoints Descriptive statistics are provided for 8 VAS end- points: Emax scores of any effects, bad effects, good effects, feeling drunk, bowdle external perceptions composite, bowdle internal perceptions composite, and Emin scores of drowsiness/alertness, and relaxation/agitation, and 5 ARCI Emax endpoints: A, BG, LSD, MBG and PCAG, as well as Drug Similarity VAS. Table S2 (Supplemental Digital Content 3, http://links.lww.com/JCP/B20) summarizes mean and SE for these endpoints produced by 8, 10, and 12 g doses of kratom and pooled placebo. For kratom 12 g, VAS assessments of any effects, good effects, psychedelic effects (as measured through the Bowdle VAS), and bad effects were larger than those produced by 8 and 10 g doses of kratom and pooled placebo. Sedative effects (including PCAG) and LSD Copyright © 2026 Wolters Kluwer Health, Inc. All rights reserved www.psychopharmacology.com 19 Copyright U 2026 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. Reissig et al Journal of Clinical Psychophormacology • Volume 00, Number 00, ■ ■ 2026 TABLE 5. Summary Statistics for Primary and Key Secondary Pharmacodynamic Endpoints Endpoint: Em,,X TRT N Mean (SD) Min Q1 Med Q3 Max Drug liking VAS P 10 50.2 (0.4) 50.0 50.0 50.0 50.3 51.0 Kl 6 50.7 (1.6) 50.0 50.0 50.0 51.0 54.0 K3 6 51.7 (4.1) 50.0 50.0 50.0 52.5 60.0 K8 6 60.2 (20.0) 50.0 50.0 50.0 70.8 100.0 K10 6 52.2 (2.4) 50.0 50.0 51.5 54.5 56.0 K12 6 68.7 (22.6) 50.0 50.0 60.0 95.0 98.0 High VAS P 10 0.4 (1.0) 0.0 0.0 0.0 0.3 3.0 K1 6 0.5 (1.2) 0.0 0.0 0.0 0.8 3.0 K3 6 1.2 (2.9) 0.0 0.0 0.0 1.8 7.0 K8 6 10.8 (12.1) 0.0 0.0 9.0 21.3 28.0 K10 6 8.5 (13.0) 0.0 0.0 3.5 16.0 34.0 K12 6 46.3 (34.6) 0.0 22.5 37.0 83.5 94.0 Overall drug liking VAS P 10 45.1 (15.5) 1.0 50.0 50.0 50.0 50.0 K1 6 50.2 (0.4) 50.0 50.0 50.0 50.3 51.0 K3 6 50.0 (0.0) 50.0 50.0 50.0 50.0 50.0 K8 6 61.8 (20.5) 50.0 50.0 50.0 78.3 100 K10 6 55.7 (32.4) 2.0 37.3 55.0 79.8 100 K12 6 67.0 (19.5) 50.0 50.0 63.0 85.0 94.0 Take drug again VAS P 10 45.9 (16.4) 0.0 49.8 50.0 50.0 60.0 K1 6 53.3 (7.7) 50.0' 50.0 50.0 55.5 69.0 K3 6 50.0 (0.0) 50.0 50.0 50.0 50.0 50.0 K8 6 65.2 (19.7) 50.0 50.0 59.0 79.8 100 K10 6 49.8 (42.0) 0.0 0.8 56.0 89.5 100 K12 6 61.0 (21.0) 42.0 48.0 50.0 83.0 95.0 E..ax indicates peak response expressed as the maximum response; K, kratom dose; Max, maximum; Med, median; Min, minimum; P, placebo; Q1, first quartile; Q3, third quartile; (1 = 1 g, 3 = 3 g, 8 = 8 g, 10 = 10 g, 12 =12 g); TRT, treatment; VAS, visual analog scale. (dysphoria) were also larger for kratom 12 g than those produced by other doses of kratom and pooled placebo. The drug similarity unipolar VAS items provide an estimate of how similar the drug classes with which drug users have familiarity with are compared with the test drug. On a 100 mm scale ranging from "Not at all similar" to "Very similar," participants are asked to compare the drug they received that day to a drug they previously declared having familiarity/experience with taking. Drugs that a participant has not personally experienced often enough to use as a standard of comparison ( < 2 lifetime uses of a given drug), are not included in the questionnaire. Most subjects had experience with benzodiazepines, nicotine, opioids, and THC. One subject in the kratom 10 g group and 3 subjects in the placebo group did not have experience with nicotine. One participant in the kratom 8 g group did not have experience with benzodiazepines. From the summary statistics of Drug Similarity scores for benzos, caffeine, cocaine, ketamine, LSD, MDMA, methadone, nicotine, opioids, PCP, placebo, speed, Sudafed, and THC, Table 3 (Supplemental Digital Content 3, http:// links.lww.com/JCP/B20) displays summary statistics for par- ticipants choosing benzodiazepines, opioids, and THC which produced larger means compared with other choice of drugs by participants in 8, 10 and 12 g doses of kratom groups. Placebo ratings are also included. Although all participants in the pooled placebo group correctly recognized that placebo was not a benzodiazepine or opioid, -75% of these participants assigned a Drug Similarity score of 100 to THC. DISCUSSION This study was designed to evaluate the safety and tolerability, PK, and PD of single ascending oral doses of kratom in healthy, nondependent recreational polydrug users with opioid experience and to inform dose selection for a future human abuse potential study of kratom. Overall, using the specific botanical kratom sourced for the study and in a controlled clinical setting, kratom was generally well -tolerated in healthy subjects after oral doses of 1, 3, 8, 10, and 12 g. No serious adverse events (SAEs) or deaths occurred and no participants discontinued due to adverse events (AEs). The most frequently observed AEs were somnolence, nausea, and vomiting, which were observed at doses >_ 8 g. The tolerability findings were likely attributable to kratom exposure rather than capsule burden, as placebo -treated participants who received an equivalent number of matched capsules did not exhibit similar AEs. However, the small sample size (n = 6 per dose) was insufficient to thoroughly characterize the safety profile of the kratom used in the study, and the study was not powered to capture rare or infrequent AEs. Kratom doses of 8, 10, and 12 g produced measurable pupillary constriction relative to placebo. These data seem consistent with the reported agonist and partial agonist effects of kratom alkaloids (eg, mitragynine, speciociliatine, and 7-OH) on mu-opioid receptors. The magnitude of pupillary constriction produced by kratom was relatively mild, with a mean maximum constriction of -2.4 (0.38) mm at the 12 g dose. Although limited by cross -study comparisons, other investigations have reported larger reductions in pupil diameter after administration of classic opioids (eg, >_ 3.0 mm after 40 mg oxycodone).50,51 Although pupillary constriction may be considered a sign of mu-opioid receptor activation, many of the kratom alkaloids also exhibit affinity for mu-opioid receptors, as well as adrenergic, serotonergic, dopamine, and adenosine receptors, and their intrinsic efficacy at these receptor subtypes varies.12-14752,53 Moreover, the efficacy and activity of the alkaloids at these receptor subtypes can 10 I www.psychopharmacology.com C61,7yright © 2026 Wolters Kluwer Health, Inc. All rights reserved. Copyright © 2026 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. Journal of Clinical Psychopharmacology • Volume 00, Number 00, ■ ■ 2026 A pilot, PD and PK Study of Botanical Kratom vary, giving rise to the complex pharmacology of kratom that has led some authors to describe kratom as an "atypical opioid.1154 Generally, kratom doses of 1 and 3 g were similar to placebo across subjective measures and did not show effects on VAS assessments of drug effects. Compared with placebo, increased at -the -moment drug liking and high, and overall drug liking, as well as a desire to take the drug again were observed for kratom 12 g. Kratom doses of 8 and 12 g showed increases in endorsements of positive subjective effects with 12 g showing the highest responses compared with placebo for most measures. However, across the primary and key secondary endpoints, only the 12 g dose showed a statistically and clinically significant difference compared with placebo for drug liking and High Emax. The 12 g dose was also associated with increased ratings of feeling drunk, and good drug effects compared with placebo. These ratings were generally >_ 10 points above placebo, suggesting they were clinically significant and may be indicative of an abuse potential. Of interest, the 10 g dose did not show a similar degree of increase, despite being the intermediate dose of 8 and 12 g. Consistent with these findings, the 10 g dose showed a trend of pupillary constriction that was not as pronounced as the 8 or 12 g doses. Bad. drug effects were highest for the 12 g dose compared with placebo. The mean Emax of bad drug Effects produced by the 12 g dose was 25.5. Compared with placebo, the 8 and 12 g doses were associated with increased drowsiness and 8, 10, and 12 g doses were associated with increased relaxation. When examining psychedelic effects, only the 12 g dose showed elevated Bowdle VAS scores (mean External Perceptions 80.8; Internal Perceptions 67.3). Taken together with the AE profile (which did not show notable increases in the 10 g dose compared with 8 and 12 g), these data do not support the hypothesis that negative effects suppressed subjective responses at the 10 g dose. Rather, the apparent elevation in effects at 8 g seems to have been driven by a single participant (ID 001-035). This subject produced maximum ratings of drug liking at every timepoint, including the 15-minute post -dose time period where absorption of kratom is expected to have been minimal. This underscores the need for caution when interpreting data from small cohorts and highlights the potential value of qualification phases to identify and manage atypical response patterns in future studies. The ARCI responses showed that the 12 g dose produced higher ratings of PCAG (sedatives) and LSD (dysphoria) compared with placebo. When assessed for similarity with known drugs of abuse, all doses of kratom were rated as being similar to THC (minimum similarity score = 82, maximum similarity score =100). Kratom doses of 8, 10, and 12 g were also reported to produce effects similar to benzodiazepines and opioids. Irrespective of dose, kratom was not found to produce effects similar to drugs with stimulant or psychedelic - like properties including caffeine, cocaine, LSD, ecstasy, phencyclidine, or amphetamines. Despite the limitations in the study due to few subjects in each dose cohort, plasma mitragynine, 7-hydroxymitragynine, paynantheine, speciogynine, and speciociliatine were measur- able at every dose, and increased with dose as assessed by the extent of absorption after single doses of kratom from 1 to 12 g. Notable increases in the coefficient of variation were also observed with the administration of 10 g kratom for all compounds, with a general increase with increasing dose. Future studies may incorporate a larger sample size to decrease the variation observed in the PK data. Peak plasma concentrations (Cmax) of speciociliatine increased with dose as assessed by peak concentrations across the 1 to 12 g range. Plasma mitragynine, 7-hydroxmitragynine, paynantheine, and speciogynine increased in a slightly less than dose -proportional manner as assessed by peak concen- tration (Cmax) after single doses of kratom from 1 to 12 g. The lack of dose -related increases in (Cmax and AUC) was seen in doses above 8 g, and continued with subsequent doses of 10 and 12 g under fed conditions. These data suggest there is saturation in absorption of these compounds. It is important to note that the number of capsules also increased with increasing doses. Given the large number of capsules necessary to administer the higher doses (eg, 20 and 24 size 00 capsules for the 10 and 12 g doses), it is possible the large volume of botanical plant matter inhibited or slowed absorption. Median times to peak concentration for mitragynine, 7- hydroxymitragynine, paynantheine, speciogynine, and specio- ciliatine were all similar, with median Tmax values ranging from 2.00 to 8.07 hours. We note that the Tmax values generally did not occur before the 2-hour timepoint and did not coincide with peak effects on subjective measures. The interaction of PK and PD effects is complex. Although reviews have found that maximum ratings of dug liking generally occur no later than peak plasma concentrations Tmax or Cmax alone may not be predictive of abuse potential.55 The average range of elimination for mitragynine and speciociliatine was similar between cohorts 1 to 5, with values ranging from 11.17 to 22.07 hours. There were only 2 additional blood sample measurements after 12 hours at 24 hours and the last sample at 48 hours. This sampling schedule is limited in accurately determining the elimination rates for all kratom alkaloids in this study. With these limitations considered the average range of elimination half-life values for 7-hydroxymitragynine, paynantheine and speciogynine were not similar between cohorts 1 to 5, with values ranging from 6.69 to 19.07 hours. Increases in average range of elimination generally correlated with increased dose. Notably, other studies of encapsulated dried kratom powder found differences in Tmax values, producing peak mitragynine concentrations 1 to 1.3 hours after administration and 7-OH Tmax values 1.2 to 1.8 hours after administration.31 However, the dose range was lower (0.5 to 4 g) and participants received kratom under fasting conditions. The present study administered kratom in the fed state, after a high -fat meal and preclinical data have demonstrated food effects in the bioavailability of mitragynine.56 Interestingly, when examining the Cmax values at identical (1 g) doses, broadly similar values were obtained, although there was substantial variability in our study due to the small sample size.31 An additional consideration when interpreting findings is the composition of kratom and the method of administration. Botanical formulations can vary greatly in the composition of the alkaloids that contribute to their pharmacological effects. Although mitragynine is the most abundant alkaloid isolated from kratom, minor alkaloids such as 7-hydroxymitragynine (which exhibits greater opioid potency than mitragynine and morphine)37,38 and speciociliatine (which also has greater opioid activity than mitragynine)13 may exert disproportionate influence on abuse -related and safety outcomes. The specific composition of the kratom used in this study contained —5 mg of mitragynine per capsule (1% by weight) and low levels of 7- hydroxymitragynine (ranging from undetectable amounts to 0.07 mg/capsule). The kratom used in our study had alkaloid values similar to what has been reported in the literature;8910,36 however, it may be anticipated that different kratom Copyright © 2026 Wolters Kluwer Health, Inc. All rights reserved, www.psychopharmacology.com 111 Copyright U 2026 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. Reissig et al Journal of Clinical Psychophormacology • Volume 00, Number 00, ■ ■ 2026 formulations with different alkaloid compositions or amounts may have variable pharmacological effects. The kratom sold in the United States is commonly in the form of dry plant material filled into capsules. In contrast, kratom use in Asian countries is commonly consumed as an herbal tea or chewed. Variability in composition, preparation, and administration may all affect bioavailability and exposure. In this study, dry plant material was filled into oral capsules, as would be commonly available in the United States. Future studies may examine various strains or the effects of isolated alkaloids in characterizing the safety, PK, and PD effects of kratom. In summary, in the current study, orally administered botanical kratom was well -tolerated with the most com- monly reported AEs observed at the highest doses (eg, 8-12 g) and classified as mild in severity (i.e., grade 2 or lower). Doses >_ 8 g produced modest pharmacodynamic effects, including pupillary constriction, and all doses produced measurable plasma concentrations of key kratom alkaloids. Kratom alkaloid exposure was generally dose proportional and the time to maximum plasma concentrations ranged from 2 to 4 hours. The highest dose of kratom (12 g) was associated with increases in a variety of subjective effects measures associated with abuse potential, including statisti- cally significant increases in drug liking and also on a positive measure of drug effects "high" relative to placebo. When subjects completed drug similarity measures, kratom effects were reported as resembling those of THC, and being somewhat similar to opioids and benzodiazepines. The small sample size, between -subjects design, and absence of a qualification phase to reduce variability in response measures (eg, inappropriate responding on VAS measures) limit conclusions regarding the subjective effects and abuse potential of kratom. Appropriately powered studies are required to further characterize kratom's PD profile, safety, and its relative potential for abuse. Finally, although the botanical kratom used in the study was well - characterized, it is unknown how the kratom used in our study compares to the variety of kratom-related products available in the commercial marketplace. Although the kratom used in this study had an alkaloid profile consistent with botanical products reported in the literature, it seems to have a substantially different alkaloid composition relative to newly emergent "spiked" or enhanced kratom- related products in the commercial marketplace.57-59 Further studies are necessary to more thoroughly charac- terize the abuse potential of botanical kratom and determine the effects of the various alkaloids on its pharmacological effects. AUTHOR DISCLOSURE INFORMATION C. M. has served as an expert witness in several kratom lawsuits. B. S. and D.K. are full-time employees of Altas- ciences. D. M. is a part-time consultant o f Altasciences. The remaining authors declare no conflicts of interest. DATA AVAILABILITY STATEMENT Funding Source: This study was funded by the US Food and Drug Administration under contract 75F40121 C00199. Ethics Statement: Clinical studies with Kratom were conducted by Altasciences Inc. following approval of an institutional review board and written informed consent from participating subjects. Study procedures were carried out in accordance with the Declaration of Helsinki. Disclaimer: The opinions expressed in this article are those of the authors and should not be interpreted as the position of the US Food and Drug Administration. REFERENCES 1. McCurdy CR, Sharma A, Smith KE, et al. An update on the clinical pharmacology of kratom: uses, abuse potential, and future considerations. Expert Rev Clin Pharmacol. 2024;17:131-142. 2. Grundimann O, Brown PN, Henningfield J, et al. The therapeutic potential of kratom. Addiction. 2018;113: 1951-1953. 3. Henningfield JE, Fant RV, Wang DW. The abuse potential of kratom according the 8 factors of the controlled substances act: implications for regulation and research. Psychopharma- cology (Berl). 2018;235:573-589. 4. SAMHSA. 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Kotz S, Johnson NL, Read CB. Encyclopedia of statistical sciences. New York: Wiley; 1989. Hollander M, Wolfe DA. Nonparametric statistical methods, 2nd ed. New York: Wiley; 1999. Mann HB, Whitney DR. On a Test of whether one of two random variables is stochastically larger than the other. Ann Math Stat. 1947;18: 50-60. Benjamini Y, Hochberg Y. Controlling the false discovery rate: a practical and powerful approach to multiple testing. J R Stat Soc Ser B (Methodological). 1995;57:289-300. Setnik B, Roland CL, Cleveland JM, et al. The abuse potential of Remoxy((R)), an extended -release formulation of oxy- codone, compared with immediate- and extended -release oxycodone. Pain Med. 2011;12:618-631. Shram MJ, Henningfield JE, Apseloff G, et al. The novel uncompetitive NMDA receptor antagonist esmethadone (REL-1017) has no meaningful abuse potential in recreational drug users. Transl Psychiatry. 2023;13:192. Ellis CR, Racz R, Kruhlak NL, et al. Evaluating kratom alkaloids using PHASE. PLoS One. 2020;15:e0229646. Leon F, Habib E, Adkins JE, et al. Phytochemical character- ization of the leaves of Mitragyna speciosa grown in U.S.A. Nat Prod Commun. 2009;4:907-910. Raffa RB, Pergolizzi JV, Taylor R, et al. Nature's first "atypical opioids": Kratom and imitragynines. J Clin Pharm Ther. 2018;43 :437--441. Zhao L, Li Z, Fang L, et al. Association of partial systemic exposure and abuse potential for opioid analgesics with abuse deterrence labeling claims supporting product -specific guid- ance. EClinicalMedicine. 2021;41:101135. Ortiz A, Maxwell EA, Kuntz M, et al. Fasting improves oral bioavailability of mitragynine in healthy female Beagles. Am J Vet Res. 2025;87(1):1-6. Lydecker AG, Sharma A, McCurdy CR, et al. Suspected adulteration of commercial kratom products with 7-hydrox- ymitragynine. J Med Toxicol. 2016;12:341-349. Ogozalek S. The Tampa Bay Times tested 20 kratom products. Here's what we found. Tampa Bay Times. 2023. https://www. tampabay.com/investigations/2023/12/09/tampa-bay-times- tested-20-kratom-products-heres-what-we-found/ Smith KE, Boyer EW, Grundmann 0, et al. The rise of novel, semi -synthetic 7-hydroxymitragnine products. Addiction. 2024; 120(2):387-388. Copyright © 2026 Wolters Kluwer Health, Inc. All rights reserved. www.psychopharmacology.com l 13 Copyright © 2026 Wolters Kluwer Health, Inc. Unauthorized reproduction 'of this article is prohibited. 9/14/26, 4:34 PM Kratom San discussion - Chelsey C. Sanford v Outlook Outlook Kratom Ban discussion From K M <kathmag1990@gmai1.com> Date Tue 9/8/2026 3:02 AM To Commissioners <commissioners@grantcountywa.gov> **EXTERNAL EMAIL** This email originated from outside Grant County's network. Do not click links or open attachments unless you recognize the sender and know the content is safe. Dear commissioners, My name is Kathy Magliaro, and I am not a constituent living in your district. I do however travel, and the decision you make regarding Natural kratom leaf will absolutely impact me, and my family when we have to travel for family gatherings or vacation. I am writing to share my personal experience with a debilitating neurological condition and to urgently request your support for sensible regulations that protect consumer access to natural kratom leaf. Can you for a minute Imagine your life as it is now, you are able to work, you are able to socialize with friends and family. And you most certainly do not have to structure your day around prescriptions, when to take them allowing time for them to kick in to be able to do the basic daily necessities like showering, maybe cooking, or some cleaning. Well my life was also once like that. Up until 2005. And in 1 moment that all changed. I felt an explosive pain in my head and face that was so violent in pain, i really thought I had been shot. When I realized I wasn't, I couldn't believe I felt that. Then it happened again, and again. That was the 1 st day I had the pain from what was later in 2007 diagnosed as trigeminal neuralgia. That was the day that Trigeminal Neuralgia would begin stealing my life away piece by piece. That was also the day I would realize in order to live, I had to fight. One of the things I would have to fight daily is dark thoughts that became more pronounced as the mo the, and years went on without anything helping my pain. You see this particular nerve disease has the nickname for being the suicide disease. Because so many patients do not find adequate treatment for their pain, they opt for that option as the way that will end their pain once and for all. For years, I suffered from trigeminal neuralgia, a condition often described as the most painful affliction known to medical science. The unpredictable, shock -like facial pain completely destroyed my quality of life. Traditional pharmaceutical options left me dealing with severe side effects, brain fog, and very little actual pain relief. I especially felt entirely hopeless in 2018 when Drs told me there was nothing more they could try for treating my Trigeminal Neuralgia. That was when I hit a very low low. But I fought for myself, my children and my husband, who had all essentially become my caregivers. And in 2019 1 found Natural botanical kratom leaf. about:blank?windowld=SecondaryReadingPane24 1/2 9/14/26, 4:34 PM Kratom Ban discussion - Chelsey C. Sanford - Outlook My life changed when I discovered natural botanical kratom leaf. This natural herb gave me my life back. It provided the profound relief that prescription medications could not, allowing me to manage my pain, return to my daily routine, and function as a productive member of society. Kratom did not just improve my life; it truly saved it. Please know that my goal was not simply pain relief, I wanted to also live life again productively. This leaf allows that because it has zero psychoactive effects, it doesn't create a high like Medical Cannabis does. I did try that too, but I couldn't function, so that was not an option. Natural botanical kratom leaf does not cause that. It simply helps alleviate my pain to a degree that I can function. I understand the desire of lawmakers to ensure public safety regarding herbal supplements. However, bans or overly restrictive measures will force citizens like me back into debilitating pain or toward dangerous pharmaceutical alternatives. strongly urge you to support sound, common-sense regulations and please distinguish Between Botanical Natural kratom leaf, and much more potent semi synthetic and synthetic products like 7- OH. Proper regulation will protect the public by:Ensuring all Botanical Natural Kratom leaf products are unadulterated and free of dangerous contaminants.Implementing strict age restrictions to prevent minors from purchasing it. Requiring clear, accurate product labeling. Please protect the rights of consumers and patients who rely on this plant for their health and well- being. Do not strip away access to a safe, natural botanical that has given so many chronic pain patients their lives back.Thank you for your time, your leadership, and your consideration of my story. Please make my email and shared personal story as part of the public testimony and record. Sincerely, Kathy Magliaro Email kathmag1990C�gmail.com Massachusetts about:blank?windowld=SecondaryReadingPane24 2/2 9/14/26, 4:46 PM Inbox - Chelsey C. Sanford - Outlook . Outlook Please Reject the Proposed Blanket Kratom Ban in Unincorporated Grant County From Venus Usher <kratombutterfly@gmail.com> Date Mon 9/7/2026 1:54 PM To Commissioners <Commissioners@grantcountywa.gov> **EXTERNAL EMAIL** This email originated from outside Grant County's network. Do not click links or open attachments unless you recognize the sender and know the content is safe. Dear Commissioner Burgess, I am writing as a kratom consumer advocate who is concerned about the proposed ordinance that would prohibit the sale or distribution of kratom products throughout unincorporated Grant County. I understand that I am not a Grant County constituent, but I am asking you to consider the broader human impact of this proposal and what a blanket ban would mean for people who rely on access to responsibly manufactured kratom. A blanket prohibition is not the right solution. It treats traditional natural leaf kratom the same as concentrated and potentially much higher -potency products instead of addressing the specific products and practices that may create greater risks. There are reasonable regulatory options available that would allow the county to protect consumers without eliminating access for responsible adults. These could include a minimum age requirement, mandatory product testing, accurate labeling, manufacturing standards, and appropriate restrictions on concentrated products. Natural leaf kratom should not be lumped together with every concentrated or enhanced product simply because they are all sold under the word "kratom." There is also a human cost to these sudden bans that is easy to overlook. Many people living with chronic pain do not follow local government meetings or know that a ban is being considered. They may not find out until they walk into the store where they normally purchase their plain leaf kratom and discover that it is no longer available. Those people deserve better than having an important option disappear without their voices being heard. They deserve to live with dignity and to have access to clean, properly tested and responsibly regulated products rather than being pushed toward an unregulated market or left without an option that has helped them manage their lives. I also encourage the Commissioners to consider less restrictive approaches, including age restrictions, testing, labeling and product standards, rather than an outright prohibition. https:l/outlook.office.com/mail/id/AAMkADQ4MzlwNWIwLTU2NzYtNGZmNyO4OTBiLWNIMTFhYWZjMjVhNgBG boifPT1S%2FSo84RNgvDy... 1/2 9/14/26, 4:46 PM Inbox - Chelsey C. Sanford - Outlook Please reject the proposed blanket ban and consider responsible regulation that protects consumers while preserving lawful access to natural leaf kratom. Thank you for taking the time to consider my concerns, even though I am not a constituent of Grant County. I hope you will consider the experiences of people who may never know this ban is being discussed until it directly affects their access. Sincerely, Venus https:lloutlook.office.com/mail/id/AAMkADQ4MzlwNWIwLTU2NzYtNGZmNyO4OTBiLWNIMTFhYWZjMjVhNgBGAAAAAAAboifPT1 S%2FSo84RNqvDy... 2/2 9/14/26, 4:43 PIVI Inbox - Chelsey C. Sanford - Outlook 0 Outlook Please Keep Natural Leaf Kratorn Legal From Liam Reagan <1iamjefreagan@yahoo.00M> Date Sun 9/6/2026 4:58 AM To Commissioners <Commissioners@grantcountywa.gov> 0 2 attachments (479 KB) FDA%20U.S.%20FOOD%20&%20DRUG.pdf,- PDF.pdf,- **EXTERNAL EMAIL** This email originated from outside Grant County's network. Do not click links or open attachments unless you recognize the sender and know the content is safe, Dear Commissioners Kevin Burgess, Rob Jones and Cindy Carter, My father served as a USAF fighter pilot and drinking was part of a pilot's persona, and an acceptable activity for most in the 1960s and 70s. I followed in my parent's footsteps, but after decades of drinking, it accelerated into full blown (albeit semi -functioning) alcoholism. I served my country building nuclear submarines in an outside machinist capacity, but after decades of wear and tear on my body, my back broke down very painfully (degenerative disc disease, osteoarthritis, spinal stenosis and sciatica.) I was eventually forcefully retired at full disability. I needed a walker to get to the bathroom and could not help my wonderful d.utiful wife do household activities. I say all of that to tell you that by just taking two or three teaspoons of lab tested unadulterated kratom leaf powder per day, I was able to stop the cravings of alcohol (six years sober) and relieve my pain enough to drive, do.household chores and not use my walker. I can help my wife once again. I cannot tell you how glad that makes me feel. I am only one of millions of people to whom kratom has returned some semblance of normalcy; many have much worse ailments than I have, and their stories are desperate and heartbreaking. You likely have enough life experience and know what addiction can do to an individual and/or a family. Kratom brought me back to my Lord, my wife and family, and continues to help me live a life I thought was behind me. I don't get drunk or high. Only synthetic or concentrated unnatural substances in this arena, such as 70H (7-Hydroxy Mitragynine) or MGM-1 5 & 16 (semi -synthetic derivatives known for their higher potencies as agonists of opioid receptors) make people high, and not natural leaf kratom. Many folks with an addictive personality and people experiencing chronic pain take kratom responsibly to live normal lives. https:lloutlook.office.com/mail/id/AAMkADQ4MzlwNWIwLTU2NzYtNGZmNyO4OTBiLWNIMTFhYWZjMjVhNgBGAAAAAAAboifPT1 S%2FSo84RNqvDy... 1/2 muox-ohelseyo.aonford Outlook It doesn't cure |ife'sills, but itsure helps the multitudes offolks like me; some estimates ranging into the tens of millions. | humbly ask that you allow people to make the choice to buy natural krakznm unadulterated, properly examined and labeled, kept away from those under 21, available to good people who don't want to get high, and only want to live without excruciating pain or addiction. If you have an extra minute, please skip to tirnestarnp 09:30 for a short segment clearly showing the difference between natural leaf kratom and addictive synthetic 70H: htt s:/Ivoutu.beZsBWkK9Rs I wish you well. Thank you so much for your time. Sincerely, Jef Reagan FDA and HHS Opinions Below: U.S. FOOD & DRUG ADMINISTRATION July 29, 2025 Dear Colleague I am writing to warn you about an opioid that few physicians may be aware of. It's called 7- hydroxymitragynine (7-Of-1). 7-OH is found in trace amounts in the kratom plant leaf. But this is not our focus. Our primary concern is the concentrated form of 7-OH. This is an important distinction. These concentrated 7-OH opioid products are far more dangerous than traditional kratom. leaf products. Concentrated 7-OH products have exploded in popularity in recent years, with vape shops, gas stations and comer stores selling pills, gummies, candies, and even eve -catching products like ice cream cones containing 7-OH. You may also see 7-OH referred to as 7-OHMG, 7-Hydroxy, 7- HMQ1 or 7. Additionally, some kratom leaf products marketed as "spiked" or "enhanced" may contain 7-011 at a level 500% higher than would be naturally expected in kratom leaf. Not -ably, one study in the Journal of Medicinal Chemistry found 7-OH to be 13 times more potent than morphine. Aside from addiction, 7-OH side effects include withdrawal symptoms, insomnia and anxiety, seizures, and fatal respiratory depression. The FDA is seeing *increases in adverse events and related reports to poison control and is concerned about the growth of 7-011 product sales nationwide. We have already issued warning letters to several firms for illegally distributing 7-OH products and are working alongside our partners at the DEA to move forward with adding certain 7-OH products to the controlled substances schedules. Like many physicians, I find it painful to recall the many opioid prescriptions I wrote in the early 2000s for routine procedures, unaware of the high potential for abuse. Our recognition of the abuse potential and our delayed response as a medical community resulted in a national health crisis. Let's not get caught flat footed again. In addition to the FDA's ongoing regulatory activities and education efforts, I appreciate your vigilance on this issue. For more information, please refer to our new report and educational resources, which can be found at www.fda.p ov/O7-H. , Sincerely, Martin A. Makary, M.D., M.P.H Commissioner of Food and Drugs U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20903 Search DE ----------------------------------- - ---------------------------- - ---------- Who We A What We I Drug Enforcement Administrat��n Careers</c Resource! DEA to Temporarily Schedule 7—OFF Sumit A Til and Related GebUpdaes Scam Alert < https:1/ww\�.1.de a, gov1press-re I e a sesl2026107101 I'd ea-temporarl I y-schedu I e- 7-oh- and -re I a ted-subst a nces-protect-pub I ic 7/10/26, 11:57 AM Page 1 of 7 ances St F)r otect F) u k)lic af etif July 01, 0 • For I ediate Release 0 0 Contact: DEA Public Affairs hone Nu berm 571 776-250,Vkf 0( ) WASHINGTON -Today, the U.S. Drug Enforcement Administration filed its intent to temporarily place https://ww.dea.gov/press-releases/2Q26/a7/D1Jdea-temporarily-schedule-7-oh-and-related-substances-protect-public 7/10/26, 11:57 AM Rage 2 of 7 7�hydroxymitagyn'ine (7�OH) and three related substances minto Schedule I of the Controlled Substances Act (CSA). Prior to DEA w N 0 N this notice, the Department issuing f ea hand Human Services 11'o H [t (HHS) confirmed synthet'ic 7�OH, and the three related substances 0 have no accepted medical use and a hiogh potenti'at for abuse. 0 irwo Notices of Intent (N01) wer sent to the F.ederal Register Wednesday, July 1,.2026, One N01 addresses 7�OH above a specified threshold. The second N01 https://www.dea.gov/press-releases/2026/07/01/dea-temporarily-schedule-7-oh-and-related-substances-protect-public 7/10/26, 11' 57 AM Page 3 of 7 ,?.ddresses mov'ing 7J hyd roxym itragyn i ne� related E M substances,(mitragynine pseudoindoxyl, MGM�15, and MGM� 16) into Schedule 1 of the CSA. it,ince the temporary schedul'ing orders take effect, the M 0 manufacture, distribution, sale, and possession of covered 7�OH substances w'111 become sub ect t* criminal, civil and administrative M 0 provisions of the Controlled Substances Act, https://ww w.dea.govjpress-releasesl20261071011dea-temporarily-schedule-7-oh-and-related-substances-protect-public 7/14/26, 11:67 AM Page 4 of 7 Today's action targets highly concentrated, synthetic 7-OH products, which pose a growing threat to public safety and health. Temporarily scheduling these substances underscores the emphasis thAff is AF Administration has put on the safety, health and well-being of the American people," said DEA Administrator Terrance Cole. "This action gives law enforcement and public health partners the tools needed to ff add,ress this emerging threat. I ie a recia S W pp te the FDA' https://www.dea.gov/press-releases/2020/07/01/dea-ternporari#y-schedule-7-oh-anci-related-substances-protect-public 7/10/26, 11.57 AM Page 5 of 7 scientific expertise and our continued partnership with HHS to address emerging threats, and we will continue to act aggressively when dangerous substances threaten Americans." "I commend the DEA for taking decisive action to address these addictive and harmful substances, " said HHS Secretary Robert F. Kennedy, Jr. "7-OH, MP, MGM-15, and MGM-16 are dangerous oploids that fuel addiction and put American lives at risk. HHS https://www.dea.gov/press-releases/2026/07/01/dea-temporarily-schedule-7-oh-and-related-substances-protect-pudic 7/10/26, 11,57 AM Page 6 of 7 reviewed the sc'ience and recommended this action. The Trump Administration will cont'inue 0 using every available authority to 0 stop these deceptive products, hold bad actors accountable and 0 0 N protect American f ami [ ies. 77 7�OH mis a psychoactive substance with oplold�llke effects and similar 0 0 0 risks. In its botanical form 7-OH 'is found 'in tr ace amounts'in the Mitragyna speciosa plant, a tropical. evergreen tree indigenous to https://ww w.dea.gov/press-releases/2026J07/01/dea-temporarily-schedule-7-oh-and-related-substances-protect-public 7/10/26, 11.57 AM Page 7 of 7 9/14/261 4:39 PM Inbox - Chelsey C. Sanford - Outlook p" n Outlook Kratorn I A Mother's Mission From Misty Brown <mistyb0512@gmai1.com> Date Sun 9/6/2026 1:31 PM To Commissioners <Commissioners@grantcountywa.gov> **EXTERNAL EMAIL** This email originated from outside Grant County's network. Do not click links or open attachments unless you recognize the sender and know the content is safe. There is a critical scientific difference between whole -leaf kratom and the products being sold today as "7-hydroxymitragynine,11 or 7-OH. Whole -leaf kratom is simply the dried leaf of Mitragyna speciosa. Its primary alkaloid is mitragynine. When someone consumes kratom, the human body naturally converts only a very small amount - typically well under one percent -into 7-OH through normal liver metabolism. This process is slow and self-limiting. By contrast, the 7-OH products now appearing on the market contain laboratory -isolated or chemically converted 7-hydroxymitragynine in amounts far beyond what the human body could ever produce from kratom leaf. At those levels, 7-OH behaves much more like a conventional opioid and carries much higher risk. When these high -potency 7-OH products are lumped with natural kratom, it leads to misleading risk assessments and poor public policy. Regulating or restricting 7-OH does not require banning whole - leaf kratom-and that distinction matters. We are expecting the DEA to schedule 70H soon. They've already scheduled Mitragynine Pseudoindoxyl, MGM 15 & 16. Here's my testimony... From 2006 to 2019, 1 lived trapped in FDA -approved pain pills, benzodiazepines, and muscle relaxers prescribed for my degenerative disc disease. Over 11 years, chronic pain management turned into full-blown addiction. What began as dependency slowly became a cycle of misuse, desperation, and shame. In April of 2019, 1 was dismissed from pain management after failing a required pill count. I was short on my medication and couldn't find what I needed. Cut off from prescriptions, I turned to the streets, and in that desperation, I slipped into cocaine use while trying to find another doctor. By June of 2019, 1 was in withdrawal and at rock bottom when I watched a documentary called A https://outlook.office.com/mail/id/AAMkADQ4MzlwNWIwLTU2NzYtNGZmNy®4OTBiLWNIMTFhYWZjMjVhNgBGAAAAAAAboifPT1 S%2FSo84RNgv®y,.. 1/2 9/14/26$ 4:39 PM Inbox - Chelsey C. Sanford - Outlook Leaf of Faith. That moment changed everything. The next day, I walked into a shop, showed my ID, and bought whole -leaf kratom..not synthetic 7-OH. Kratom quieted the relentless cravings. The voice that kept saying, "one more pill, one more snort, one more escape," finally went silent. For the first time in over a decade, I felt stable. Kratom gave me the breathing room to heal and allowed me to rebuild my life. have not returned to pain management in over six and a half years. Today, I am a thriving mother, a first-time grandmother, and a contributing member of society. I am no longer a burden to my children. I am an example of recovery. will always be grateful that I had access to safe, lab -tested, whole -leaf kratom. And that is why speak out to protect others who are still fighting for their lives. Been Reborn, Misty Brown Kratom Consumer, Advocate &. Activist est. 2019 https://outlook.ofice.com/mail/id/AAMkADQ4MzlwNWIwLTU2NzYtNGZmNyO4OTBiLWNIMTFhYWZjMjVhNgBG boifPT1 S%2FSo84RNgvDy... 2/2 9/14/26, 4:40 PM Inbox - Chelsey C. Sanford - Outlook Outlook Kratom, please don't ban natural kratom, natural and synthetic are not the same From sacia fawcett <saciafawcett@gmail.com> Date Sat 9/5/2026 4:06 PM To Commissioners <Commissioners@grantcountywa.gov> **EXTERNAL EMAIL** This email originated from outside Grant County's network. Do not click links or open attachments unless you recognize the sender and know the content is safe. Hello, I'm writing to ask that you please reconsider whether banning all kratom products without differentiating between natural leaf kratom and the concentrated synthetics like 7oh is appropriate. I would beg you to instead enact regulations that differentiate between the two and ban the synthetics only. Natural kratom is a powerful harm reduction tool that helps the community and should remain available for the people who might need it. The DEA even specifically said they are not worried about the naturally occuring kratom, only the synthetic derivatives in their recent scheduling announcement. Banning an herbal tea that helps people get off of and stay away from hard drugs and alcohol is not going to make anyone safer. I think you'll find a lot of people would be negatively impacted by a blanket ban for reasons you might not expect. I'm one of the people who's life was saved by access to this botanical and I want everyone to have the same chance at recovery I got when I found natural kratom. I'm a 40 year old woman, I'm disabled and suffer from agoraphobia, panic disorder, and treatment resistant depression. I also have several allergies and medication sensitivities which limit what I can take. There has never been a medication that I've found that works without making me so impaired I'm not able to function anyway. I used to abuse alcohol trying to make the panic stop but a little over five years ago I developed severe acute pancreatitis and almost died, they told me if I kept drinking I was going to die an agonizing death. Because of the agoraphobia I couldn't really go to any kind of support group meetings or anything like that and was completely on my own. After I got out of the hospital I started desperately searching for a safe alternative and I found kratom. Not only did it completely eliminate my alcohol cravings (and I now have over five years sober) I noticed it was having a positive effect on my anxiety and mood disorder. Up to this point exposure therapy had just been too painful to attempt and with no medication that worked I was too scared to try. But after I found kratom I knew I finally had something to help with the pain and symptoms and was able to start slowly working on exposures. Recently I was able to go to a Dr appointment by myself, I've been able to visit my elderly father, I even finally went to the dentist, it had been so long I almost lost my teeth. I had been housebound for literal years trapped in one room before this, so many Drs failed to help me, there just isn't anything else that works as well as this plant that doesn't also cause extreme fatigue or impairment. It has only improved my life, I have never felt the need to raise my dose and I don't suffer any kind of withdrawal if I don't take it. I can't describe what it's like to go from being completely housebound to being able to walk outside again after years. To be completely free of the horrible alcohol cravings. I firmly believe I would have started drinking again and would have died if I hadn't found kratom. https://outlook.office.com/mail/id/AAMkADQ4MziwNWIwLTU2NzYtNGZmNyO4OTBiLWNIMTFhYWZjMjVhNgBG boifPT1S%2FSo84RNgvDy... 1/2 9/14/26, 4:40 PIVI Inbox - Chelsey C. Sanford - Outlook I hope you will listen to all the people telling you this plant helps them, that it saved them. I know so many people who have gotten their life back thanks to natural kratom, my younger sister has a similar story. I told her about kratom and she now is also coming up on five years sober after an alcohol addiction almost took her life as well. my experience is not unique. Recently my boyfriend used it when he developed a tooth abscess and wasn't able to get an appointment for over a week,he was in excruciating pain. If he hadn't had kratom he wouldn't have been able to work and could have lost his job. My elderly father has bulging discs in his back and sciatica and found it actually helps where nothing else ever has and he's been able to participate in physical therapy more often. And I believe my aunt that, drank to deal with her chronic pain which Drs refused to treat appropriately would still be alive if I had discovered kratom just a few months sooner, months after she died from complications of alcoholism I found the thing I know would have saved her. So many people benefit from kratom in so many different ways you might not expect. This isn't something people are just taking for fun. It deeply saddens me thinking the thing that helps so many could be ripped away. Please differentiate between the synthetic and natural products and preserve access to natural kratom. Please enact regulations that serve everyone including responsible kratom consumers, we matter too, our families .matter too. Sincerely, Ashley Davidson https:lloutlook.office.com/mail/id/AAMkADQ4MzlwNWIwLTU2NzYtNGZmNyO4OTBiLWNIMTFhYWZjMjVhNgBGAAAAAAAboifPT1 S%2FSo84RNqvDy... 2/2 9/14/26, 4:40 PM Inbox - Chelsey C. Sanford - outlook a Outlook Kratom From Andrew Nye <anye843@gmai1.com> Date Mon 9/7/2026 3:58 PM To Commissioners <Commissioners@grantcountywa.gov> **EXTERNAL EMAIL** This email originated from outside Grant County's network. Do not click links or open attachments unless you recognize the sender and know the content is safe. Good afternoon, am writing you today to ask you to support appropriate regulation on botanical kratom, but not a full ba n. Botanical kratom is a very different product from those that get lumped together as "kratom". The best example I can give is a cup of coffee versus a 1000mg caffine energy drink. There have been deaths, especially in young people, from drinking too much caffine from energy drinks, but banning coffee has never been on the table. I have yet to see a botanical kratom death that did not have other substances involved. This distinction is recognized by all of our federal health agencies including DEA, FDA, HHS, and NIDA. It is even recognized worldwide through the World Health Organization. None of these agencies have recommend a ban on botanical kratom products. DEA is currently acting to schedule kratom related compounds, but they specifically leave a carve out for botanical products. If they believed botanical kratom to be such a danger, would this not be the perfect time for federal action? It is a common criticism of kratom that there is not slot of science behind it. That is simply no longer true. Purified mitragynine, the main alkaloid in kratom, just passed an independent review board for approval as an investigatory new drug in treating opioid use disorder. Independent review boards have strict safety standards before they will allow human testing, and kratom has met this due to the amount of scientific literature showing it's safety profile. I am passionate about this issue because botanical kratom has helped me in two very important ways. I have struggled with treatment resistant mental illness for over a decade. A couple years ago, I was having such bad anxiety that I would wake up every morning in panic. I was prescribed Ativan, a benzo, which did help my anxiety. Sadly I began to abuse this medication because it worked so well, and because it is addicting. This was over a holiday period, and I still do not remember an entire Christmas day because I was near a blackout most of the time. https://outlook.office.com/mail/id/AAMkADQ4MzlwNWIwLTU2NzYtNGZmNyO4OTBiLWNIMTFhYWZjMjVhNgBGAAAAAAAboifPT1 S%2FSo84RNgvDy... 1/2 9/14/26,4:40 PIVI Inbox - Chelsey C. Sanford - Outlook I luckily recognized the problem before it grew out of hand, and quit the medication. This resulted in severe rebound anxiety. I found out about botanical kratom through anxiety forums online and decided to give it a try. It did help my anxiety, and also stopped me from reaching back into my Ativan and starting my abuse again. I took kratom on and off for anxiety for a year, without any withdrawal or feelings of dependency on days where I did not take it. I was then diagnosed with Crohn's disease. This has caused me immense intestinal/abdominal pain on an almost daily basis. Medications exist for Crohn's, but they are largely trial and error and never fully eliminate bad days. Once again, I turned to kratom and found it extraordinarily helpful in managing my pain and keeping me out of bed. My gastro doctor is aware of my use and is not bothered by it. Opioids are not prescribed for Crohn's related symptoms, and I can't take advil as my stomach lining is injured from my disease. My options are limited, and without botanical kratom, my quality of life would decrease. I am just one of millions who use this plant responsibly across the country. Most of us are using kratom for medical reasons, whether that be chronic pain, chronic illness, or opioid withdrawal. Banning botanical kratom will hurt many, and I beg you to consider supporting regulation instead, as has been done in many states. Thank you for your time, Andrew Nye https:lloutlook.office.com/mail/id/AAMkADQ4MzlwNWIwLTU2NzYtNGZmNyO4OTBiLWNIMTFhYWZjMjVhNgBGAAAAAAAboifPT1 S%2FSo84RNqvDy... 2/2 9/14/26, 4:40 PM Inbox - Chelsey C. Sanford - Outlook yY Outlook MEETING please read From Shannon Lee <shannonharelc183@gmail.com> Date Mon 9/7/2026 8:25 PM To Commissioners <Commissioners@grantcountywa.gov> **EXTERNAL EMAIL* This email originated from outside Grant County's network. Do not click links or open attachments unless you recognize the sender and know the content is safe. Dear, Grant County Council Board Members, Please see my true testimony below... My name is Shannon I know that you are discussing kratom..l wanted to reach out and tell my success story. I have been taking natural organic leaf kratom powder which is tested and vetted for many years now since 2017. 1 have had many issues with my lower back due to working in healthcare as a CNA/ HHA. Over time, lifting and moving patients caused a number of issues and resulted in a considerable amount of extreme pain. went to many different doctors in hope of finding ways to ease my chronic lower back pain. I have had MRIs, CAT scans, and X-Rays and I was formally diagnosed with degenerative disc disease and many other painful permanent back injuries. There is no permanent solution to my immense pain. Because the pain was so severe in 2017, 1 was put on a pain medication regime to try and reduce the extreme pain I was experiencing. Unfortunately, OTC medication, prescribed pain medication and even injections did not work. I decided to stop taking everything since there was no point in medicating with no results. That's when I discovered natural leaf kratom powder. My doctor and I spoke about it. He said he had other patients that were using natural leaf kratom for their pain management. My doctor was excited that it was helping my pain. My lower back pain went from a steady 10 to a 0! It was a miracle! Natural Kratom has drastically improved my quality of life. I was able to return to work without suffering in agony on a daily basis. Every town and city that bans Natural Leaf Kratom Brings our state and our whole country closer to a full total ban which would be catastrophic for chronic pain patients like myself. https:Houtlook.office.com/mail/id/AAMkADQ4MzlwNWIwLTU2NzYtNGZmNyO4OTBiLWNIMTFhYWZjMjVhNgBGAAAAAAAboifPT1 S%2FSo84RNgvDy... 1/2 9/14/26, 4:40 PM Inbox - Chelsey C. Sanford - Outlook ( The DEA just released their recent ban on Synthetic 7-01-1 and did NOT add natural Leaf organic kratom leaf to that list please look into the DEA's newest memo regarding the ban on 7-01-1 They stated they are not interested in the natural whole leaf kratom plant they only want to ban the synthetics like 7-01-1 and MGM and others that are dangerous) We need to regulate Natural Leaf organic Kratom that has been around for centuries for our city's, towns and our Beautiful state. ( synthetic 7-01-1 marketed as "kratom" is not the same as Natural Organic whole leaf Kratom they are two totally different things. The synthetic is dangerous and acts like and opioid and that is the reason why there is so many issues with people over dosing,,,, Natural whole leaf Kratom is the safe plant that has been around centuries consumed by pain patients on a daily basis and is not dangerous) A total ban would be devastating if you decided on a total possession ban, ban or even a sales ban in your town will have a domino effect on other near by and all across WA on Natural Organic Whole Leaf Kratom so many chronic pain patients like myself would suffer in agony. The last ordeal we need in our community is for many people already suffering to get into trouble seeking natural pain relief and or suffer even more. And we do not want these chronic patients to run to the streets over dosing on street drugs or synthetic products looking for pain relief as you know doctors are not writting for pain medication due to the opioid epidemic that has and is happening. Please think about the many people lives this natural plant is saving out here and please make the right decision to regulate Natural whole leaf Kratom for the sake of the very people that depend on you to listen to them and come up with a great ordinance to regulate Natural Organic whole leaf kratom. Your's Truly, Shannon Hareld https://outlook.office.com/mail/id/AAMkADQ4MzlwNWIwLTU2NzYtNGZmNyO4OTBiLWNIMTFhYWZjMjVhNgBG boifPT1 S%2FSo84RNgvDy... 2/2 9/14/26) 4:40 P M Inbox - Chelsey C. Sanford - Outlook Outlook My Wife Relies on Natural Kratom for her Autoimmune Issues From Maria Corral <corralmaria506@gmail.com> Date Sun 9/6/2026 12:03 PM To Commissioners <Commissioners@grantcountywa.gov> **EXTERNAL EMAIL** This email originated from outside Grant County's network. Do not click links or open attachments unless you recognize the sender and know the content is safe. Good Morning Commisioners, I'm at writing to respectfully ask you to oppose any ordinances to ban kratom in its natural leaf form. The natural leaf is nothing like the synthetics like 70H that are causing trouble all over the country. The DEA has made the distinction very clear: they are moving to ban the synthetics like 70H, but not the natural leaf that helps so many. My wife has an auto immune issue and has a very hard time functioning when she has a flare up (which is every 2-3 weeks). She has tried every medication they can give her. She can't take NDIADS due to a stomach sensitivity, and Tylenol is just not strong enough and is toxic to her liver. Natural kratom leaf is the only thing that helps her feel well enough to work and help take care of our 2 year old special needs son. Over 23 states and over 100 cities have looked at the kratom situation and chose to regulate natural kratom, while banning the synthetics (70H). This is a common sense middle ground and keeps natural plain leaf Kratom available for people like my wife who rely on itjust to live a normal life. There are a million options between a "Wild West" market and a full on "strip access from those who need it" ban. Please don't take the easy way out. There are so many examples of sensible regulations implemented across the country that you can use as a template to find a sensible middle ground That's why it's important to separate the natural powder from the gas station products. There are a few ways of doing this: 1. Ban the synthetics by limiting 70H to 0.05% by weight, or 1 mg or serving. And outright ban Mitragynine Pseudoindoxyl, and MGM15. This is what the DEA is doing and many counties have followed suit. This gets the synthetics like 70H off the shelves. 2. Ban kratom from gas stations but not specialty shops. You can achieve this by basically saying "any establishment that sells alcohol can not also sell kratom products". Any gas station or convenience store will choose alcohol every time. So those are gone. Specialty tobacco shops don't sell alcohol. And kava bars don't sell alcohol. And online kratom vendors don't sell alcohol. This is a pretty simple solution I think. And it gets rid of those shots in gas stations. https://outlook.office.com/mail/id/AAMkADQ4MzlwNWIwLTU2NzYtNGZmNyO4OTBiLWNIMTFhYWZjMjVhNgBGAAAAAAAboifPT1 S%2FSo84RNgvDy... 1 /2 9/14/26, 4:40 PM Inbox - Chelsey C. Sanford - Outlook 3. Ban all forms of kratom besides the regular kratom leaf powder, and encapsulated kratom leaf powder. This is what North Dakota just did in their kratom special legislative session. 99% of people who find real therapeutic value from kratom use this form anyway. The industry won't like it, but who cares? Your obligation is to your constituents. I can send you examples of ordinances for all three of these solutions if you'd like. Ashland, MA board of health also settled on number 3 above. And they did a TON of research and spoke with a lot of scientists and other Departments of Health. Please just consider these options, because an outright "kratom sales ban" has a lot of unintended consequences. I'm hope you're willing to discuss this further. In the meantime, I'll look for those ordinances so you can see what's worked in other localities. It's important to note that out of all of the localities that have enacted one of the options above, ZERO of them have come back to do a full kratom sales ban. I think that's pretty telling. Kind Regards, Chad Thank you for your consideration. Kind Regards, Chad Corral https://outlook.office.com/mail/id/AAMkADQ4MzlwNWIwLTU2NzYtNGZmNyO4OTBiLWNIMTFhYWZjMjVhNgBGAAAAAAAboifPT1 S%2FSo84RNgvDy... 2/2 9/14/26,4:40 PIVI Inbox - Chelsey C. Sanford - Outlook Please Adopt Grant County's Kratom Sales Ban — Do Not Exempt "Natural Leaf" From Dan gibbs <dangibbs6370@roadrunner.com> Date Tue 9/8/2026 6:21 AM To Kevin R. Burgess <krburgess@grantcountywa.gov>; Rob Jones <rjones@grantcountywa.gov>; Cindy Carter <ccarter@grantcountywa.gov> Cc Commissioners <Commissioners@ g ra ntcou ntywa.gov > 0 2 attachments (346 KB) Increases in Kratom-Related Reports to Poison Centers — National Poison Data System, United States, 2015-2025.pdf, FDA-SAD_Study-National-Fact-Sheet.pdf; * *EXTERNAL EMAIL** This email originated from outside Grant County's network. Do not click links or open attachments unless you recognize the sender and know the content is safe, Dear Commissioners Burgess, Jones and Carter, My name is Dan Gibbs, and I am the father of Austin Gibbs. Austin was my only child. He was 25 years old. He died on December 6, 2023. The night before, he ate dinner, went to his bedroom expecting to wake up the next morning. He never did. Following a complete medicolegal death investigation, including autopsy and toxicology, Coroner Dr. Kent Harshbarger, a forensic pathologist, certified Austin's cause of death as "Intoxication by mitral!ynine.11 C:7 Please understand the significance of that finding. Kratom was not simply detected in Austin's system. Mitragynine— the primary active alkaloid in ordinary kratom—was determined to be the cause of his death. No other intoxicating substance was identified by the coroner as contributing to his death. https://outlook.office.com/maii/id/AAMkADQ4MzlwNWIwLTU2NzYtNGZmNyO4OTBiLWNIMTFhYWZjMjVhNgBGAAAAAAAboifPT1 S%2FSo84RNqvDy... 1/3 9/14/2614:40 PIVI Inbox - Chelsey C. Sanford - Outlook It was not fentanyl. It was not heroin. It was not alcohol or a prescription opioid. And Austin was not using one of today's isolated high-7-OH products. He was using ordinary kratom, That is why I strongly urge you to adopt the ordinance before you as written and reject attempts to create a "natural leaf" exemption or concentration threshold. The recent FDA -funded human study tested botanical kratom with alkaloid levels representative of leaf products. At doses of 3 grams and above, researchers observed pupillary constriction —an opioid-like effect. At 12 grams, participants reported increased drug liking, good drug effects and feeling high. Somnolence, nausea and vomiting were the most common adverse effects. That study does not establish a safe dose for repeated daily consumption. Meanwhile, the real -world numbers are going in the wrong direction. CDC documented 14,449 kratom, exposure reports to U.S. Poison Centers from 2015 through 2025, with 62% involving kratom as the single reported substance. Reports reached 3,434 in 2025— approximately a 1,200% increase from 2015. Even more recently, America's Poison Centers reported 3,190 kratom and kratom-derivative exposures in just the first six months of 2026, putting 2026 on pace for another dramatic increase. I also ask you to listen carefully to the arguments you will hear from advocates. You will hear that a few grams or a couple teaspoons "gave me my life back," allowed someone to get out of bed and work, relieved severe chronic pain, stopped opioid withdrawal, or allowed them to replace prescription opio ids or even heroin. I do not dismiss what those individuals believe they experienced. But lawmakers cannot accept those stories as evidence of kratom's powerful benefits while ignoring what those same stories reveal about its pharmacological potency. If a few grams of an unapproved botanical can supposedly relieve severe pain, suppress opioid withdrawal or substitute for powerful opioids, that should trigger more scrutiny —not less. https:lloutlook.office.com/mail/id/AAMkADQ4MzlwNWIwLTU2NzYtNGZmNyO4OTBiLWNIMTFhYWZjMjVhNgBGAAAAAAAboifPT1 S%2FSo84RNqvDy... 2/3 9/14/26, 4:40 PM Inbox - Chelsey C. Sanford - Outlook FDA itself states that kratom compounds may produce classic opioid- related effects including sedation, physical dependence, withdrawal and respiratory depression that may lead to death. So before anyone asks you to weaken this ordinance, please ask one question: What is the scientifically established safe dose of mitragynine for repeated human consumption? How much per day? How frequently? For how many months or years? At what exposure does dependence or withdrawal begin? What dose is safe with antidepressants, stimulants, benzodiazepines, alcohol or other medications? Where are the controlled human studies establishing those answers? A company can print a serving size on a package. A label cannot create a safe dose that science has never established. An age restriction would not have protected Austin. He was 25. A purity requirement would not have changed mitragynine's pharmacology. And banning only isolated 7-OH would not have removed the substance the coroner determined caused my son's death. Please do not allow this hearing to become a false choice between "dangerous 7-OH" and "safe natural kratom." My son's death demonstrates why that distinction is inadequate. I respectfully ask you to adopt Grant County's prohibition on the sale and distribution of kratom as written —without anatural-leaf exemption and without an arbitrary concentration threshold. When you vote, please remember one name: Austin Gibbs. Age 25. Died December 6, 2023. Cause of death: Intoxication by mitragynine. No other intoxicating substance identified as contributing to his death. Please do not wait for Grant County to have its own Austin. Respectfully, Dan Gibbs Father of Austin Gibbs https:Houtlook.office.com/mail/id/AAMkADQ4MzlwNWIwLTU2NzYtNGZmNy04OTBiLWNIMTFhYWZjMjVhNgBGAAAAAAAboifPT1 S%2FSo84RNgvDy... 3/3 gg, Outlook Please Reject the Proposed Grant County Kratom Ban From Dana Dissent <dana.avedisian@gmail.com> Date Tue 9/1/2026 5:37 AM To Commissioners <commissioners@grantcountywa.gov> **EXTERNAL EMAIL** This email originated from outside Grant County's network. Do not click links or open attachments unless you recognize the sender and know the content is safe. Dear Commissioners Burgess, Jones, and Carter, I am writing to respectfully ask you to reject the proposed ordinance prohibiting the sale or distribution of kratom products within unincorporated Grant County. I understand the responsibility you have to protect the health and safety of Grant County residents. also understand why concentrated, enhanced, and chemically altered 7-01-1 products have raised legitimate concerns. But those concerns should not be used as a reason to prohibit traditional natural leaf kratom. What concerns me most is that the proposed ordinance does not make that distinction. It broadly encompasses traditional natural leaf, extracts, products containing mitragynine in any quantity, natural and synthetic 7-OH, synthetic alkaloids, and other kratom derivatives. Traditional kratom leaf naturally contains mitragynine. The proposed ordinance also explicitly includes the raw leaves of the Mitragyna speciosa plant. That means this is not simply a proposal targeting high potency extracts or synthetic 7-OH products. Traditional botanical kratom leaf is included in the prohibition. This is particularly concerning because Grant County's own public health materials have recognized a meaningful distinction between traditional kratom leaf and concentrated or enhanced 7-01-1 products. If the primary concern is concentrated or chemically altered 7-OH, why does the proposed ordinance prohibit traditional natural leaf as well? There is an important question that I believe deserves an answer before this ordinance is adopted: What changed between the recommendation to target 7-01-1 products and the eventual proposal to prohibit all kratom products, including traditional natural leaf? If the concern is concentrated or synthetic 7-01-1 products, regulate those products directly. If the concern is adulteration, require testing and accurate labeling. If the concern is youth access, establish and enforce age restrictions. If the concern is products containing undisclosed or dangerous ingredients, prohibit those ingredients. There are responsible regulatory tools available that address specific risks without eliminating access to an entire natural botanical product. This issue is personal for me. I have lived with severe chronic pain for 25 years. For nearly two decades, I was treated with high doses of prescription opioids and gabapentin. Those years took an enormous toll on my life. Pain, along with the side effects of the medications used to treat it, affected my independence, my ability to function, and my sense of control over my own life. Under the guidance of my pain management physician, I eventually transitioned away from prescription opioids and began using traditional natural leaf kratom. I have now been off prescription pain medications for approximately six years. Kratom did not make my chronic pain disappear, and it does not control my pain in the same way prescription opioids did. I still live with pain every day. But I am alert and awake, and I am no longer battling medication side effects on top of the pain. What natural leaf gave me was something I had lost over many years: freedom, independence, dignity, and the ability to be present, functional, and more in control of my own life. That is why I am asking you to look carefully at what this ordinance would actually do. A blanket ban would not simply remove dangerous products from the marketplace. It would also remove access to traditional natural leaf products used responsibly by adults, including people who use them as an alternative to prescription pain medications. Grant County does not have to choose between doing nothing and banning everything. You can protect consumers while distinguishing traditional natural leaf from concentrated, enhanced, synthetic, adulterated, and mislabeled products. A targeted regulatory framework could address age restrictions, labeling, testing, adulteration, manufacturing standards, and high potency or synthetic 7-OH products without eliminating responsible adult access to traditional natural leaf. Please reject the proposed blanket ban and instead pursue evidence -based, targeted regulations that address the specific products and practices that create legitimate risks. Thank you for taking the time to consider the perspective of someone whose life has been meaningfully affected by access to traditional natural leaf kratom. Sincerely, Dana Avedisian Outlook In Support of Kratom Ban in Grant County From Kelli McCann <kellianne.mccann@gmail.com> Date Tu e 9/1 /2026 1:48 PM To Commissioners <commissioners@grantcountywa.gov> Cc Caitlin E. Manell <cemanell@grantcountywa.gov> **EXTERNAL EMAIL* This email originated from outside Grant County's network. Do not click links or open attachments unless you recognize the sender and know the content is safe. Dear Chair and Members of the Grant County Board of County Commissioners, My name is Kelli McCann. I am writing in support of the proposed ordinance that would prohibit the sale and distribution of all kratom products in Grant County. My oldest child and only son, Benjamin, died from acute mitragynine intoxication on 09/12/2024. Benjamin used kratom to manage pain from psoriatic arthritis, believing it was a safe, natural alternative to prescription medications as harmless as coffee. This misconception cost him his life and has left our family with indescribable heartbreak. Although I reside in Montana, my advocacy for banning kratom extends nationally because this is not just a state issue; it is a matter of humanity. Kratom is sold and shipped across the United States, and my son received his supply from an out-of-state vendor. Regulation alone will not protect the public and may even foster a false sense of safety, reinforcing the misconception that kratom-related issues have been resolved. Kratom contains mitragynine, 7-hydroxymitragynine, and more than 40 additional alkaloids whose safety, interactions, and long-term effects remain inadequately studied. Available data have shown a significant increase in kratom-related adverse effects, including addiction, severe medical outcomes, and death. If kratom is not banned in its entirety, access to those alkaloids remains, along with the ability to continue creating more dangerous derivatives. The following resources provide additional context for why stronger action is necessary: Association between state -level kratom regulations and poison center -reported severe medical outcomes and healthcare use: A United States national analysis. Addiction. Advance online publication. https://doi.org/10.1111/add.70416 Increases in kratom-related reports to poison centers National Poison Data System, United States, 2015-2025. Morbidity and Mortality Weekly Report, 75(11), 139- 145. https://www.cdc.gov/mmwr/volumes/75/wr/pdfs/mm7511al-H.pLf How a natural leaf has evolved into a national concern. Spectrum News, August 2026. Includes discussion from Dr. Christopher "Chris" McCurdy explaining that people can overdose on both kratom and 7-OH, and that kratom cannot be described as safe without the necessary safety studies. bttps:////voutu.be/AlArGYOIuDQ?si=ntliETEKOE7XsT7N Massachusetts issued an emergency order on August 28, 2026, placing kratom into Schedule I under state law. httr)s://www.mass.gov/kratom Ar— - Deadly Dose: A Tampa Bay Times Investigation - Deep -dive journalism into the kratom industry, fatalities, and regulatory gaps. httpa�.//pLojectAampaba com/investigations/deadly-dose/kratom- ___ industry! The bottom line is kratom is a psychoactive substance with incomplete research. People are using it medicinally without medical oversight while it is sold in gas stations, smoke shops, and online in unlimited quantities. Public health warnings about kratom did not begin with synthetic derivatives or newer high -potency products. Those products have made the situation even more urgent, but the concerns already existed. The emergence of stronger derivatives should not be treated as a separate problem that excuses kratom; it is the result of action not taken nearly 10 years ago. Grant County now has the opportunity to act before more families are harmed. Please support banning kratom in its entirety to protect Grant County residents from the devastation kratom has caused many individuals and families. Thank you for your time and consideration. Respectfully, Kelli McCann (Benjamin's mom) /19 9/14/26, 4:39 PM Inbox - Chelsey C. Sanford - Outlook Outlook Kratom ban From Matthew May <brothermay2005@gmai1.com> Date Sun 9/6/2026 7:18 PM To Commissioners <Commissioners@grantcountywa.gov> **EXTERNAL EMAIL** This email originated from outside Grant County's network. Do not click links or open attachments unless you recognize the sender and know the content is safe. My name is Matthew May, and I'm a resident of Spokane, Washington. I'm submitting this statement in opposition to a ban on kratom. Several years ago, I sustained a back injury at work. Since then, I've lived with chronic back and neck pain that regularly disrupts my sleep. Kratom has been an effective part of how I manage this pain it allows me to sleep through the night, and it helps me get through demanding physical workdays, including manual labor, when the pain would otherwise make that difficult. For me, kratom functions as a practical tool for managing a legitimate, ongoing medical issue. I would ask the council to consider a more targeted approach: rather than banning kratom outright, I'd support regulating or banning 7-hydroxymitragynine (7-01-1) specifically. 7-01-1 is a concentrated, semi - synthetic compound with a much higher potential for dependency than natural kratom leaf products, and treating it separately from kratom itself would address safety concerns without eliminating access to a product that many people, including myself, rely on responsibly. Thank you for your consideration. Matthew May https://outlook.office.com/mail/id/AAMkADQ4MzlwNWIwLTU2NzYtNGZmNyO4OTBiLWNIMTFhYWZjMjVhNgBG AboifPT1S%2FSo84RNgvDy... 1/1 GRANT COUNTY BOARD OF COUNTY COMMISSIONERS EMAIL To: I Legals Columbia Basin Herald From: I Caitlin E. Manell Clerk of the Board Fax: (509) 765-8659 Pages: 1 (including coversheet) Phone: (509) 765-4561 Phone: (509) 754-2011, ext. 2931 Re: Public Hearing Notice Date: August 12, 2026 ❑ Urgent El For Review El Please Comment 0 Please Reply El Confidential Please publish the following on August 25 and September 1, 2026 and bill the Grant County Commissioners: We also require an Affidavit of Publication. Please place the ad in 9 pt font and your normal six -column format, columnar, as shown. Feel free to contact me at the number listed above. IOTICE IS HEREBY GIVEN 'HAT AN OPEN RECORD 'UBLIC HEARING WILL BE IELD September 8, 2026 at 11:30 .m. in the Grant County .ommissioners' Hearing room, .ourthouse, Ephrata, WA to consider a Ordinance prohibiting the sale or istribution of Kratom products Within the geographical confines of nincorporated Grant County. A cop) f the Ordinance being considered an be found at: Itps://wwW.grantcoLiLi wa. o�v/741/ Jpcoming-Public-Hearings, or may le requested by email to ommissionersna , p-rantcountvwa. gov. Grant County is also providing access to this scheduled hearing via Zoom audio. To participate in the hearing please call i. to the hearing at 1 (253) 205-0468, enter the access code (914 5357 5883) and assword (26229323) and you will be joined to the meeting in a `muted'status until such time as the hearing allows for ublic testimony. If you have any questions about this procedure, please all the Commissioner's Office in advanc f the hearing. Caitlin E. Manell, Clerk of the Boar( Commissioner's Office. NOTICE IS HEREBY GIV- EN THAT AN OPEN RE- CORD PUBLIC HEARING WILL BE HELD Septem- ber 8, 2026 at 11:30 a.m. in the Grant County Com- missioners' Hearing room, Courthouse, Ephra- ta, WA to consider an Ordi- nance prohibiting the sale or distribution of Kratom products within the geo- graphical confines of un- incorporated Grant Coun- ty. A copy of the Ordinance being considered can be found at: https://www. grantcountywa.gov/741/ Upcoming-Public-Hear- 'ings, or may be request- ed by email to commis- sioners@grantcountywa. gov. Grant County is also providing access to this scheduled hearing via Zoom audio.To participate in the hearing please call in to the hearing at 1 (253) 205-0468, enter the ac- cess code (914 5357 5883) and password (26229323) and you will be joined to the meeting in a `muted' status until such time as the hearing allows for pub- lic testimony. If you have any questions about this procedure, please call the Commissioner's Of - lice in advance of the hearing. Caitlin E. Manell, Clerk of the Board, Com- missioner's Office. �09004/53902 'ub: August 25, 2026 & Deatember 1. 2026 1, Blaze Griffith -Steele, do solemnly swear that I am the Principle Agent of the Columbia Basin Herald, a newspaper established and regularly published five days a week in the English language, in and of general circulation continuously for more than six (6) months prior the 31st day of March, 1944; that said newspaper is printed in an office maintained at its place of publication in the City of Moses Lake, Washington; that, said newspaper was approved and designated as a legal newspaper by the order of the Superior Court of the State of Washington for Grant County on the 31 st day of March, 1944; and that said order has not been revoked and is in full force and effect. That the annexed is a true copy of Legal Notice # 09004/53902 KRATOM ORDINANCE as it was published in regular issues (and not in supplement form) of said newspaper once each WEEK for a period of 2 consecutive WEEKS commencing on the 25TH of AUGUST 2026 and ending on the 1ST of SEPTEMBER 2026,both dates inclusive and that such newspaper was regularly distributed to its subscribers during all of said period, that the full amount of fee charged for the foregoing publication is the sum of $68.20. ,Blaze kGriw'tfth�-t�eele Subscribed and sworn to before me this., iSTDAY OF SEPTEMBER2026, 0000�a 0 Y � Bob Ray Richardson Notary Pubt Notary Public. in and for the State of Washington \Nas Ingtoll h' "I. Residing in Moses La '4"Aate 0 ke, Washington el'it V"Kpifes 11 - 29 C'01�n till osslor, M34