The American Kratom Association (AKA) applauds the announcement of the FDA’s decision to withdraw its “Proposed Collection; Comment Request: Risk/Safety Considerations and Motivations for Purchase and Use of Kratom and Psychedelics Alone and in Combination with Other Substances” originally published on August 2, 2024.

“The FDA has once again shown its clear bias against any harm reduction tool that does not fit into a new drug application model,” stated Mac Haddow, Senior Fellow on Public Policy with the AKA. “This is the latest embarrassing mistake driven by a few anti-kratom staff at the FDA, and it is time for Commissioner Califf to exercise direct oversight and order the Agency to reassess its biased attacks on kratom and psychedelics.”

The FDA announced its swift withdrawal of the Federal Register Notice that was originally published on August 2, 2024, in a new Notice on August 9 (https://public-inspection.federalregister.gov/2024-17793.pdf).  The FDA explained that it withdrew the study because “circumstances occurred necessitating changes to the scope of the study.

“The FDA’s few anti-kratom staff are repeatedly undermining the Agency’s credibility on harm reduction strategies,” Haddow continued.  “The National Institutes on Drug Abuse is light years ahead of the FDA in identifying harm reduction tools, like kratom and psychedelics, that make a real difference in improving the health and well-being of those struggling with pain and mental health issues, including saving the lives of many who otherwise would lose their struggles.”

“It is well past the time that Commissioner Califf should convene a stakeholder meeting with leading scientists, policy experts, and consumer advocates to determine the next best steps to protect access to safely manufactured, properly labeled, and age restricted kratom products,” concluded Haddow. “Until then, the FDA remains trapped in the web of their own making that unfairly demonizes products like kratom and psychedelics that, when properly used, are helping people who struggle with addictions and mental health issues and that are saving lives.”

Let’s talk about the timing on this. The Administration announces a war on opioids. Glaxo Smith Kline owns the patent on the crystallized (manipulated) version of Mitragyna Speciosa. In this patent, it fully describes their scientific testing which shows minimal side effects. In fact Glaxo Smith Kline describes it as being harmless compared to many controlled substances. Now let’s look at the FDA Head, Dr. Scott Gottlieb. Prior to his assignment at the FDA, he sat on several big Pharma boards INCLUDING Glaxo Smith Kline. He is also a member of GSKs “New Product Investment Board”. Americans aren’t dumb. When you look at this in totality, Dr. Gottlieb knows that Kratom isn’t dangerous, he’s seen this GSK patent, so everyone do the math. This is perfect timing for GSK to release their crystallized version of Kratom as a controlled substance and charge hundreds of dollars for a bottle of crystallized Kratom capsules. And look at who is going to benefit from a ban on raw leaf Kratom. The one and only Glaxo Smith Kline AND Dr. Scott Gottlieb.

https://www.google.com/patents/US3256149

I'm a self employed family physician doing Direct Primary Care, with no industry ties to maintain and no party lines to toe. I do, however, have patients with chronic pain and addiction issues who benefit greatly from kratom. I've decided the best contribution I could make to this cause is to become a spokesperson. I'm ready.

Before I do any speaking for the cause though, I need to be as well -versed as possible in all the hard science kratom has backing up its efficacy (and failing to back up its potential for harm). I'm talking about well designed studies with large ns. I'm going to argue strictly the facts as we know them.

I'd appreciate if folks could reply to me with PubMed links to any of the major studies we have on our side, that I ought to be able to quote chapter and verse.

I'll post in this sub links to any opinion articles, debates, or guest posts to others' blogs/vlogs that I end up doing. If you need a medical professional to give a levelheaded, scientific and supportive opinion on kratom, PM me the details and I'll see what I can come up with.

Edit: Thanks for my first ever gold, kind stranger! I feel very appreciated, and will do this community and this plant proud.

Per the AKA:

In the end, the voices of the hundreds of kratom advocates were heard loud and clear. The Ohio Board of Pharmacy has decided to put the kratom ban in a To Be Refiled (TBR) status and it will not be the subject of a Hearing before the Joint Committee on Agency Rule Review (JCARR) on Monday. The kratom issue has been removed from that agenda.

GOOD JOB GUYS!

Why would the BoP take the ban this far and then drop it all of the sudden though?

Sorry guys I'm not trying to scare people but it's kind of needed. We HAVE to get more comments on AKA's site. Please, if you care about kratom or even just feel the FDA has completely stepped over the line and want to help, leave a comment. Feel free to share your kratom story or just leave one sentence "please keep kratom legal". That's it! Should take you all of 1 min. Share with friends & family. Co-workers. Anyone. Anywhere. Even people from other countries can comment.

https://www.protectkratom.org/whocomments

In response to public outcry from the kratom community and scientists, the Ohio Board of Pharmacy has canceled their meeting today that was going to Schedule and ban all kratom. Thank you to everyone who responded so quickly. The AKA is working hard to educate the Ohio Governor Office and BOP so they enact kratom consumer protection and not criminalization. More to come

Please upvote, I'm worried there will be confusion and it will reduce a turnout of voices and I'm not seeing this anywhere in large print.. just in the comments. Let's not act like this wasn't a clever trick on behalf of the FDA. I don't put anything past them.comments need to go HERE

This may have already been posted.

https://www.prnewswire.com/news-releases/fda-fails-to-provide-credible-data-and-science-to-justify-scheduling-kratom-as-schedule-i-substance-300769627.html

WASHINGTON, Dec. 20, 2018 /PRNewswire/ -- The U.S. Food and Drug Administration's efforts to have kratom listed as a Schedule I substance under the Controlled Substances Act (CSA) is filled with errors and omissions, according to a new report from the American Kratom Association (AKA).  The AKA report maintains that FDA fails to meet the burden of proof necessary to propose such a radical change in Kratom's regulatory status.

"To meet the standard, which would put kratom on par with heroin, LSD, Quaaludes, and peyote, the FDA must submit an eight-factor analysis that conclusively demonstrates with scientific evidence that kratom is dangerously addictive and presents a risk to the safety of the public," explains Charles M. "Mac" Haddow, Senior Fellow of Public Policy at the American Kratom Association.  "They have clearly failed to meet that prerequisite."................