What Role Did HHS Play in DEA’s Decision to Ban Kratom?

Publisher’s Note: We appreciate the splendid reaction you have made to our posts.  Your comments are viewed by regulators, the press and Congressional staff.  We apologize for not responding to the questions you raised in your comments or the questions you raised in the submissions to CRE via the contact link on this website.  Rest assured a member of our staff reads all submissions and the comments are  placed in a database which we use for our advocacy operations. That said, we simply do not have the resources to be as responsive to your requests as your have been to ours.

CRE continues to read and benefit from the hundreds of comments we received. One reoccurring theme is that HHS had its fingers in the DEA decision to ban kratom.

CRE has not been able to verify these statements but CRE has asked  DEA to release the letter it sent to HHS requesting its  views on a range of topics. CRE has not been provided with the said letter.

Of particular interest to CRE was whether DEA informed HHS of the fact that a black market would emerge as a result of imposing a ban on kratom. Another question that arises from a detailed review of the record is the nature, if any, of discussions  between HHS and DEA before DEA sent a formal request to HHS.

Much of the aforementioned discussions are considered “deliberative” and necessary for the proper  functioning of the federal government. We agree.

However whether such deliberations are shielded from an interrogatory or subpoena will be determined by a federal judge in the event DEA is challenged under the Administrative Procedure Act for failing to provide the public with the opportunity to comment on the ban it imposed by an administrative action.

Next the atrocities associated with a black market.

50 comments. Leave a Reply

  1. J

    The DEA should be required to release the letter. I hope someone somewhere makes them accountable on this before it’s too late. Thank you CRE, for always speaking the truth!

  2. Nicholas orvar

    The Dea needs to be finally exposed yes we appreciate all the work they do dangerous to to keep our country safe and the bad drugs out but this Kratom ban has crossed the line it is truely an attack on our own citizens . The safe effective alternative for so many in chronic pain to simply those who would like a nice mood boost like coffee in the day to keep them energized while they work and pay there taxes to the government who s agencies are supposed to be for the people and there we’ll being I have a feeling this Kratom ban has brought the dea into a battle they will regret entering and may the truth be exposed

    • Anonymous

      they bring in the drugs

  3. Anonymous

    Thank you, CRE, for investigating the ramifications of a black market for kratom should the DEA’s ban go into effect. I am terrified to think in two weeks my choices will be to either return to the high levels of main associated with my medical condition for which kratom has been the only effective treatment or to learn how to purchase from a black market.

    As a responsible, productive, and law-abiding member of society this is an unfair choice I never thought I would have to make. I fear for those who are successfully using kratom to come off of prescription opioids as 30 days notice is not enough time to plan an alternate strategy, if in fact one were to exist. Thousands of people will end up back on the truly dangerous drugs if they do not enter the black market to continue obtaining kratom.

    This is a national tragedy, and thankfully CRE is working overtime to investigate and bring this to attention of the regulators and lawmakers before it is too late.

    • Max

      A lot of people will have to go back on pain medication but most Drs are afraid to give prescriptions for them. People who are poor with no insurance will be forced to use heroin or the like. It is much easier to get heroin than it is to get a prescription from a dr.. I dont blame the Drs because many have been persecuted for helping people in pain. If your dying you MIGHT be able to get pain meds ? If the ban on kratom goes through it is like saying the govt. can ban any natural substance they see fit. All herbal medicine will be at risk. God please help us.

  4. KeepKratomLegal

    Thank you CRE, you are working hard and its appreciated.

  5. Heather

    Thank you so much for your efforts, it won’t be forgotten. The DEA should absolutely be required to release that letter. By the DEA trying to avoid public comment (especially after public comment ended up overturning many state’s initial plans to ban kratom) it is clear the DEA is not acting in the best interest of the people.

    This reckless decision, if it goes through, will prove to be a tragic one. Kratom has helped thousands get off opiates & other dangerous prescription drugs & thousands more avoid getting on them to begin with. In the midst of an opioid epidemic, banning a harmless herb that helps so many is insane.

  6. Anonymous

    Thank you, The stress in all this is overwhelming, We the people are doing all we can,Its nice to know you are here to help us.

  7. Chris

    Well, the only thing we know is that Secretary Burwell did not advise against scheduling Kratom, otherwise no action would’ve been taken by the DEA by law (21 USC 811(b)). It’s a shame that the DEA, HHS and FDA are playing whack-a-mole with synthetic drugs that only exist because of their misguided attempts at a nanny state while things like Kratom get caught in the crossfire.

  8. Jessica Geary

    Thank you so very much for standing up for the Kratom community and for people in general. When an organization begin’s to cause harm to the very people who they are supposed to be protecting,action needs to be taken

  9. Candace

    Please CRE help us. I feel like I have a death setenence hanging around my neck. The health care system is so messed up. I can’t go back to being a guinea pig for testing of rx drugs. I refuse to go back to being bedridden and drugged to a comatose state all the while they same doctors that have overmedicated me are asking why i can’t drive or work on thirty different rx drugs. They know i can’t even stand up or use a toliet but are asking me why i can’t drive. I refuse, I’d rather be dead. Give me liberty or give me death.

  10. Paul P

    Certainly there was prior communication to the May letter sent by DEA to HHS? Emails? Meetings?

    The public has a rght to know what was discussed, and what communications preceded the letter. And then, of course, the letter itself.

    This decision will cause undue harm to many thousands of law-abiding citizens. The DEA has already changed its narrative regarding the alleged “deaths” related to kratom. They have already acknowledged, in the press, that kratom shows medicinal value. They have publicly acknowledged the suffering of veterans and many many others with a variety of health conditions that this ban will harm.

    I am no expert on Sunshine Laws. But the communications that led the agency to compile so much erroneous dats in their Letter of Intent needs to be scrutinized. Transparency is critical in the operation of a democratic government. Why are we making exceptions for this action?

  11. Joe

    I do hope this information is made available to the public. It is bewildering that federal agency functionaries have made a decision the would negatively impact the lives of so many Americans out of view of the public on whose behalf they purport to be acting. Testimonials of citizen’s regarding their responsible use and associated health benefits of kratom available on this site and social media are legion. Who then does this ban benefit?

  12. Kelly

    Thank you CRE for taking up our cause. All information regarding this decision should be released. We deserve to know what our governmental agencies are doing and we deserve a say so. They are suppose to exists to aide us not just large Pharmaceutical Companies. Those of us choosing Kratom to help with Chronic pain conditions,including Vets with PTSD and/or chronic pain and people trying to end their dependence on synthetic opiates deserve the ability to make that choice without becoming criminals by utilizing a tea. This is a major overreach by the DEA. They exist to help protect us not to create a state that deems such are large population of tea drinkers as criminals. This smacks of nothing less than creation of a prison state. We deserve better. I have been imprisoned ,metaphorically, all my adult life. Now when I have finally found a method to relieve my pain enough so that I may leave my house in less pain. The DEA wants to put me in prison. There needs to be a shift in the DEA’s paradigm

  13. Emily

    Thank you CRE. I feel hopeless. I can’t go back on prescription medication, they rotted my teeth, gave me terrible mood swings, damaged my liver and took any energy I had just to name a few. The side effects are as bad if not worse as my fibro and auto immune disease. The DEA is going to slowly kill me by forcing me back on that poison. Why can’t we chose a natural solution? Kratom changed my life. I’m a mother, a school teacher and a wife.

  14. Anonymous

    Get rid of the crooked DEA! Thank you CRE!

  15. Dan

    I hate to make assumptions, but let’s be honest, as a kratom user I know for a FACT what the DEA is saying about this plant is false. There is also nothing negative proven about kratom. So why would they do this? Is this what our authorities have become? Your shutting down businesses in 30 days, going against our neighboring countries and leaving hard working good people with grim options for their own health. Doesn’t pharma make enough money? Kratom is not their plant to take. If the info about a patent on the active ingredients is true, we have a big problem here. Their ruining people’s lives because of greed and their getting away with it.

  16. Karen

    I was an IV heroin addict for 3 years. Got onto methadone. I was constantly exhausted and sick. Tried to get off and went through hell. These are the “meds I’m supposed to take.” Then with my will to stay off drugs, switched to suboxone from advice from a doctor. That was worse. Missing work to get the meds on certain times. It was terribly expensive. I would be deathly ill if I couldn’t afford it and the detox from it was worse than opiate detox, it lasted months. Let’s not forget the lies I was told about its effects on my body that were proven lies when I physically went through it. I then found kratom. Six years clean, I feel amazing daily. No anxiety or depression that led me to opiates in the first place. I graduated college as a CPA. I have my life back. Why is this option being taken away from me? I tried the meds that doctors and government tell me to take. They were terrible, I mean awful. DEA your risking people’s lives doing this. You’ll be putting us in imminent danger. This is disgusting. Why is emergency scheduling being used? What’s the emergency? It’s blatantly obvious this screams of bribery and corruption.

  17. Anonymous

    I believe that the days of government agencies, such as the DEA, making actions without the input of the American citizens needs to be over. In regards to the DEAs dealings and communications with HHS, this information is a right of the American people to see. Government secrecy needs to end, and many steps have been taken by other government agencies to become more transparent, which I applaud. However, the DEA has not taken any steps to become more transparent. Why not? Do they have something to hide? If not, then they need to make all documents and communications that lead to the decisions they have made and continue to make accessible to the CRE and public.

  18. Anonymous

    Thankyou CRE. Show us the letters!

  19. J

    To understand HHS’s role, one needs to know what HHS has been doing with kratom imports for many years.

    Did you know that when an importer loses a kratom shipment to a seizure, HHS is the department that sends a violation letter to the importer? They are the entity that sends notice of supposed US Code Title 21 violations. Many times, the charges are not true, and most importers are unfortunately simply “guilty” by association. If an exporter sends material to an importer which unlawfully sells the material as an unapproved drug (or if the matera is misdeclared), then ANY importer also dealing with the same exporter eventually receives bogus charges in the form of a letter from HHS. Accusations of Mislabeling, Misbranding, and Adulteration are just some of what recipients are charged with. Even non-businesses (individuals) are charged for no apparent reason. Many businesses and individuals witnessed their material being seized merely for the reason: “kratom is on the DEA’s Drugs of Concern list” (when the plant is not on such list… it was removed from that list a few years ago).

    In every case the HHS sends a letter to an importer, they require the importer to show substantial proof that kratom is NOT a public health threat, and that until it is recognized as being safe to the public, it is being seized and destroyed. This cannot be Constitutional. HHS is basically saying the material is “guilty until proven innocent”, despite its obvious innocence as illustrated by NIH, NIDA, USDA, University of Massachusetts, University of Mississippi, and several other studies and reports from the public. HHS has been abusing their authority for a long time, and they, along with the DEA, have been ignoring government research and interests.

    The role played by HHS in the DEA’s proposed ruling is at LEAST one of continued cooperation to what has been going on for a long time. By not objecting to the proposed ruling, HHS’s justification for the illegal seizures of the past and present is more warranted (in their eyes). HHS has been hoping for this DEA move since they found out what kratom was!

    If the CRE would like evidence of HHS’s role and actions when dealing with kratom imports, please create a portal where the public can upload scanned documents. The information within these documents may be helpful in understanding why/how HHS and DEA are working together to crush kratom importation.

    • Joe

      Very informative, thank you for your post. I hope the CRE gets access to these documents.

  20. Anonymous

    The DEA has been silent, for the most part, through this whole process. And they are just hoping to pass this ban under the radar. Unfortunately, when ones rights are taken without just cause, people choose to rise up and fight for what they believe in. Thank you CRE for calling them out on their suspicious actions, and I hope congress is able to take an active role in reversing this as well. Your organization is spot on with each article that is posted.

  21. Anonymous

    Please tell me that this cannot keep going on….it’s disgusting how malignant these government agencies have become when it comes to matters like this.

  22. Nicole

    Kratom saved my life. It gave my kid back his mother it gave my parents back their child. I don’t understand why the DEA wants to take away the only real option we have as chronic pain suffers have other than being and addict on opiates or resorting to worse suboxen or even heroin. Kratom saves life’s period.

  23. Sharon Thompson

    Thank you CRE for bringing more exposure to the Kratom issue. As one of the hundreds of thousands of normal American people who have used it as a natural way to deal with chronic pain rather than using prescription pain medications with multiple side effects, I applaud more transparency regarding this issue. Why all the secrecy to begin with? The Kratom community has been and continues to be cooperative with providing information the DEA and HHS would be interested in hearing. Is it unreasonable to expect the same in return?

  24. Anonymous

    Dear CRE,
    Please keep fighting for us! I need to be a mother a wife and a small business owner. I don’t want to go back to being bedridden. I love my life now. I am healthy and feel great. My health problems are many.Arthritis is one, but the degenerative disc in my neck and lower back probably are the worst. prescription drugs are not an option for me, I have seen how they destroy lives.In the seven years I’ve been on kratom I have not ever needed to increase my small dose. it seems to have antioxidant and antiviral effects also, as I have a young son in Middle School and I have not been sick once! No colds and I do not get the flu shot, I have not had the flu in 7 years. Its a healthy supplement for me. with the added benefit of reducing pain and also the depression and anxiety that comes with having so many illnesses. it is not a cure-all but I’ve got my life back. My son has his mother back. My husband has his wife back. My mother has her daughter back. now I can take care of all of them instead of them taking care of me! BTW I’m not a kid anymore, I am 52 years old and drink this tea Responsibly. thank you so much for fighting the fight for us.

  25. Anna

    Dear CRE – please help us fight the unecessary classification of Kratom to Schedule I by the DEA.

    I have never been addicted to any drugs not have I ever used illegal drugs. After years of suffering with unbearable restless legs syndrome, seeing several doctors and trying prescription meds (which never worked), I found Kratom. It does have medical benefits with very little risk. It is not an option. It does not cause addiction. There is no definitive proof that Kratom caused any deaths. The only known side effect of overdose is feeling nauseous. Over-the-counter and prescription meds cause far more harm than the Kratom plant.

    By scheduling Kratom as an illegal substance, the DEA is taking away an herbal remedy that helps hundreds of thousands of productive, working, law-abiding citizens.
    Thank you for looking into this very serious issue.

    • Anna

      My post should say “It is not an opiod” instead of “it is not an option”. Darn that autocorrect feature!

  26. Max

    Please sign the petition for BOTANICAL EDUCATION ALLIANCE. They are fighting with us. God Bless you all.

    https://www.botanical-education.org/petition/

  27. Max

    PLEASE READ AND CALL THESE POLITICIANS. IT MUST BE DONE BY MONDAY 9-19-16. THE BEST WAY TO SAVE OUR BELOVED KRATOM. SENATOR MARK POCAN HAS WRITTEN A DEAR COLLEAGUE LETTER FOR HIS PEERS TO SIGN , CONTACT THE POLITICIANS LISTED AND ENCOURAGE THEM TO SIGN. PLEASE SHARE.

    http://speciosa.org/the-following-members-should-be-contacted-immediately-via-in-person-meetings-phone-calls-emails-and-letters/

  28. Katherine

    It seems as though skullduggery is afoot in all this. The whole reason for the proposed ban is based on flimsy statistics and the whole “no public comment needed” comment from the DEA is infuriating. This will absolutely create a black market and for what? Something that helps people? ! Unfathomable!

  29. Chris

    I find it very troubling and concerning that, without public comment, Congressional hearings or an analysis of the economic impact, a Government agency can create laws and then seek budget authority to enforce the law that they created.

  30. Theresa Warren

    The DEA should disclose the information it claims to have regarding kratom. Most of what had been shared in the letter of intent and 3-factor analysis is unsubstantiated allegations. The discussions with HHS prior to taking this action are a matter of great public interest. It’s very curious that a product that has been used safely for hundreds of years is suddenly an imminent threat.

  31. John D

    There is dirt here that needs sifting. The folks at the CRE are truly doing “god’s work”. True patriots.

  32. Clinton Huffman

    The DEA is doing something very irregular and this should be investigated.

  33. Marie

    I am thankful that the CRE works for me and my family and friends, and not AGAINST we the people like the crooks in the DEA.
    Classifying kratom as schedule 1 is a crime against sick and disabled people. People who have not had productive lives in years, decades even, are working and smiling with the ease that kratom gives. My kids are happy that I take it. I was just about to go off ssdi because I’ve been working full time. I don’t know what I will do without it; pharma made me worse.

  34. Anonymous

    Thank you @ the CRE for the wonderful and ‘righteous’ work you do!

  35. Anonymous

    Something I noticed as peculiar is the ”15 deaths” the DEA claims yet doesn’t even specify if in the US, worldwide?

  36. Brittany Jordan

     I’ve used Kratom safely, responsibly and successfully for a couple of years to treat my depression, anxiety and physical pain from type II bipolar disorder and back pain. I continue to use Kratom while taking up healthy practices of prayer, mindfulness, exercising self control and personal ethics. All of these things used together help me to maintain a calm mind and satisfied sense of being. 

    Kratom is absolutely, without a doubt, the best natural intervention I have stumbled across. I am extremely grateful to have had it.

    Kratom, with its alkaloids, needs to have some conclusive studies done, SOON, to verify that this IS a promising plant and has endless potential. Kratom, with its alkaloids, is scaring the FDA. Allowing the DEA to schedule Kratom as a Schedule 1 substance is extreme and unnecessary. Scheduling Kratom this way prevents science to study it’s effects in a medical setting. This is overreach is terrible and harmful to most of society. It is undemocratic. It is a thievery of basic human rights. 

    Please step in and stop this perversion of what this country was founded and built. Freedom and the pursuit of happiness.

    There is currently a petition to the Whitehouse that has yielded over 70K signatures in 7 days. We the people deserve to be heard, but the DEA claims there is no reason for public comment. 

    Please help us get the word out about this amazing plant, it helped me with my mental illness but countless people use this tea for chronic pain, lupus, endometriosis, PTSD and a myriad of other health concerns. 

    This is me. We are human beings: 

    https://www.youtube.com/watch?v=kzRlc08sNV4 

  37. Anonymous

    Thank you CRE. Please keep helping us fight this.

  38. Law Abdiding Citizen

    Ironically someone researched and found a copy pf HHS April 2016 letter to DEA giving their blessing to schedule kratom, as there were “no research studies” going on.

    I have a SS of the letter which was copied from aMs. Desalvo’s Twitter account.

    There is currently an opiod epidemic in this country. Placing this plant on Schedule I will negate any chance of it being researched for the many beneficial effects it offers; not the least of these being safe pain relief and its well known benefit of helping with opiod addiction.

    • J

      Whoa, send this letter to CRE. There were absolutely research studies going on.

  39. Anonymous

    So much of this seems to be originating from the CDC. Some of them look to have an interest in the addiction industry. Tom Friedan, CDC director and Andrew Kolodny, head of Pheonix rehab centers, go back a long way. They worked together at the NYC Health department and wrote some papers together touting Suboxone. Can’t make money off Suboxone and sddiction treatment centers if a natural way to treat pain and addiction is legal.

  40. Anonymous

    Keep calling your Congressman. The deadline for he or she to sign is on Thursday now. The DEA and HHS have an agenda that does not have the best interest of the American people at heart. If not now, then at some point, these documents will come to light and show what DEA and HHS do not want Americans to see. Hopefully enough Congressman will have the best interests of the people they serve and not those of the drug companies. Keep fighting this CRE! You are on the side of the truth!

    • J

      The deadline has fortunately been extended to Friday for Congressmen/Congresswomen to sign on to the Pocan/Salmon Dear Colleague Letter! New info has surfaced which will be included in the Letter to the DEA. This along with many Congressional Representatives wanting to research more before signing the Letter is why the extra day of delay is in the People’s favor. 🙂

  41. Laura

    One thing that I can’t wrap my head around is why the DEA has to go from having kratom completely unregulated to banning it outright, without a public comment period. Even if they don’t let the public have their say, how are they allowed to ignore the published studies from the National Institutes of Health and the USDA Agriculture Service saying kratom is relatively benign, and the patent applied for by universities funded by NIH funds applying for a patent saying kratom alkaloids have great potential for medicinal value.

    When bath salts and Spice/K2 (synthetic marijuana) were banned, no one rallied around those drugs to defend them. Can’t they tell from the great public outrage caused by this proposed kratom ban, and the thousands of law-abiding Americans who are rushing to say “I Am Kratom”, telling their personal stories, and engaging in activism (many for the first time in their lives); that this natural herb is a completely different case?

    I understand that maybe before the ban was announced that DEA may not have been aware that the majority of kratom users are not “druggies” seeking some type of “high”. Given how kratom was mis-marketed irresponsibly in head shops and online “legal high” shops (which every responsible kratom user despises, by the way), and how extracts were allowed to be sold unregulated, I can understand how they may not have known that majority of kratom users are middle class adults using for medicinal or therapeutic purposes. But now that many of us have “come out of the kratom closet” and identified ourselves as productive, healthy adults who depend on this herb to be able to maintain our productive, employed, healthy status, I don’t understand why they continue to proceed with the ban. Don’t they know they are alienating a large segment of productive American society? And that if the ban goes through they would be criminalizing those same productive, law-abiding citizens?

    Why have they not replied to the CRE’s letters and requests for information? It baffles me why we are all having to fight so hard for something that is so obviously beneficial. Although I believe that the natural form of the leaf (not extracts) should be sold unregulated to legal responsible adults, I think stepping in and outlawing extracts, and even controlling the supply of plain leaf kratom and taxing it would be a much more reasonable step, if they must interfere at all.

    One interesting thing is that although there were definitely irresponsible vendors before this ban was announced, due to the democracy of google and online review sites, the market largely regulated itself as kratom consumers told each other by word of mouth about great vendors, and bad ones lost business for the same reason, word of mouth.

    I don’t even recognize this country anymore. I am ashamed at how I and all the other mature, responsible American citizens are being treated. What kind of country does this to its people?

    • J

      “…how are they allowed to ignore the published studies from the National Institutes of Health and the USDA Agriculture Service saying kratom is relatively benign, and the patent applied for by universities funded by NIH funds applying for a patent saying kratom alkaloids have great potential for medicinal value. ”

      After reading the proposed ruling at the Federal Register again, It appears that the DEA only considers current NDA’s and INDA’s to prove accepted medical value (ridiculous):

      From the proposed ruling: “According to the FDA, in a letter dated May 18, 2016, there are no approved new drug applications, or investigational new drug applications for mitragynine or 7-hydroxymitragynine. As such, kratom products have no accepted medical use within the United States.”

      If they had said “there are no studies on mitragynine…” then it would be a completely different story. The wording is key to them being able to ignore the plethora of past and current research. It is odd that “accepted medical use” requires two very specific applications from the FDA directly. This is quite wrong, and that needs to be changed to reflect the times.

  42. Rachel M

    In the 1970’s, the federal government tried to prohibit the sale of vitamins and minerals, and were maliciously attempting to thwart the will of the people via their intent. But the people – with the help of Senators and the media – fought back; petitions were signed by the millions and the government ultimately backed down. The government tried again years later but the people again resoundingly said NO. Now I hope and pray our efforts at overturning this ridiculous, and patronizing ban on a God-given plant that is helping legions of human beings is equally successful and that we, the people, also thwart a government which apparently chooses to demean the sacred oath “of the people, by the people and for the people” of which we are all supposed to abide. The DEA is clearly not acting FOR THE PEOPLE and more frightening, its rigidity and overreach – absent public and transparent discourse – is reminiscent of third world countries and dictator governments, not the United States of America. Exactly which constituency do you represent DEA?

  43. John D

    What is the state of the FOI request for documents related to DEA-HHS contact WTR kratom? Last I heard it was in some sort of paperwork limbo.

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