December 2021 Update: We’re unbelievably excited to share the news: the WHO Committee has officially “concluded that there is insufficient evidence to recommend a critical review of kratom.” In other words, we won! Kratom is here for the long haul – there won’t be an international ban. Read our post on this monumental victory!. Stay tuned for a more in-depth break down of the news in the coming days. And thanks again for every kratom consumer who took the time to submit a comment for the WHO review board. Now let’s take a moment to celebrate – cheers!
September 2021 Kratom Ban Updates
Like our last update concerning the “2021 Kratom Ban,” it is pertinent to note that there will NOT be a ban in 2021. In fact, in a worst-case scenario, kratom will not be banned until 2023. So, there is no need to panic-buy, but there is cause for concern. Get educated, then stand up for your rights.
If you missed our past two updates regarding the “kratom ban,” check them out, as they explain the history of kratom and how it has evolved towards its current legal status. Our first article on the topic explored the challenging legal history of kratom, ranging from the first ban on kratom in 1943 in Thailand to today’s fight.
Our follow-up post explored the specifics of the 2021 ban, including the timeline and legal arena. Both of those articles explained how to leave a positive comment on the federal register, to implore the officials to leave kratom legal – when kratom narrowly escaped being made illegal in 2016, it was partially due to the insurgence of comments submitted by kratom users. So what is left to do?
Brief Overview
Before we begin with our September updates, we’ll quickly give a lay of the land. On July 23rd, kratom was listed on the federal register with an assortment of other substances, many with little history of human use. Per the Controlled Substance Act, the federal register is the first step to criminalizing a substance.
Following kratom’s listing, the kratom community jumped into action. The first deadline for comments was August 8th, a mere 16 days after the federal register listing first appeared.
By the 8th, just over 50,000 comments had been submitted. Yet 16 days is less than the reasonable amount of time required by the Controlled Substance Act.
So, the AKA took the FDA to court, and was able to have the comment period reopened through September. After leaving a comment, the next question is what else can we do?
American Kratom Association (AKA) September Updates
On August 25th, following the conclusion of the extended comment period, the AKA hosted a public zoom meeting. Joining the meeting were Mac Haddow (senior fellow of the AKA), Pete Candland (AKA’s executive director), David Carlucci (former New York State Senator). Geoff Laredo (Former NIDA – National Institute of Drug Abuse – representative), and Curt Bramble (Utah State Senator).
How Did the Comment Period Go?
To begin, Mac mentioned that there is a fear of suppression of comments. The FDA directly interfered when they reduced the amount of time, and made it difficult for people to comment through software that was purposely difficult to navigate.
Mac said that the AKA had separately received 63,000 comments through their “protectkratom.org” portal before the “FDA’s arbitrary deadline.” Since the trial will be held October 11th, the AKA has decided that they will continue receiving public comments through this other portal until September 4th. The AKA will submit these comments to the WHO during the hearing, Independent of the FDA and the comments on the Federal Register.
Timeline
- The first proposed final comment date conclusion for the Federal Register was 8/9/21.
- The AKA was able to reopen the comment period beginning August 9th.
- Once the comment period concludes, the FDA will read the comments. Having read the comments, they will prepare their statement to the WHO concerning their recommendation. More than likely, they will argue that kratom should be listed under the International Convention on Psychotropic Substances (ICPS).
- The WHO will then present their argument to a UN expert Committee in Geneva, Switzerland. Tailored by the recommendation of the FDA, but also including the comments submitted by AKA. This will occur in October.
- The UN Committee will assign an expert panel If they decides that kratom should be included in the ICPS. The panel will then do further research for a year before making a final decision.
- If everything goes wrong for kratom (e.g. FDA makes a bad recommendation. The WHO fully sides with the FDA. The expert panel ignores the science regarding kratom and reiterates the FDA’s position) then in October of 2023 kratom would become illegal by international treaty.
- If kratom is added to the ICPS, then the DEA would begin the process outlined in the Controlled Substance Act for criminalizing substances based on the US’s treaty obligation to the ICPS. Presumably as early as Oct. 2023. There will then be a comment period for about a month. After the comment period ends, kratom will become a controlled substances.
Mac’s goal for the AKA is to collect a total of 75,000 comments before September 4th.
Isn’t 75,000 Comments Low?
Many have asked Mac why we haven’t gotten over 100k signatures. By most estimates, there are nearly 15 million kratom users in the United States. Mac said, based on these numbers, it is clear that many kratom consumers are not engaged. Still, 63,000 is a significant number, unprecedented in many areas.
Activist Fatigue
The FDA has attacked the kratom community repeatedly over the past 5 years. Advocates are facing fatigue, compounded simultaneously by a confusing regulatory process. Everyone’s bandwidth is being stress-tested.
At the same time as they are orchestrating the global kratom ban, the FDA is attacking kratom on the state level. The FDA argued to the Department of Agriculture in Oregon against passing the Kratom Consumer Protection Act (KCPA). Even though it passed the state legislature with resounding approval, the Governor vetoed it.
The FDA argued that because the KCPA conflicted with other laws, it would prevent the FDA from helping the Department of Agriculture with anything. Like Mac said on the call, this is a blight on the FDA, and would erode public trust in the institution.
Oregon governor Kate Brown has said she would sign the KCPA next year if the regulatory agency watching over kratom is shifted from the FDA to another regulator.
Infighting Among Kratom Advocates
After discussing the fatigue factor and how it leads to reduced activist numbers, Mac went on to address information being distributed which does not fit with the AKA’s narrative. Mac pointed to an article in The Kratom Herald which advised people to stock up on kratom. Mac stated that the Herald was misguided in making that claim, and believes that the vendor who owns journal was motivated by a desire for a surge in panic buying.
To be completely honest, we steer clear of the infighting – there’s too much that needs be done over the next 12 months to turn against each over. We’ll have plenty of time for that AFTER we vindicate kratom on the international stage.
This Could Be the Final Attempt
If we beat the international ban, this is the “nail in the coffin” of attempts to ban kratom. We must use social media, use our influence, use everything we can.
It should be possible to win. In fact, HHS’s original critique of the FDA was the “poor science.” Since then, there have been over 100 new peer reviewed papers and studies demonstrating the safety of kratom.
There is now more scientific evidence, so it should be easy to prevent the ban if the FDA is honest in their review. If the FDA isn’t, then maybe the WHO or UN council will be. And considering the FDA has been spreading false information about kratom for years, we expect them to change course now.
More specifically, the FDA repeatedly cites problems about deaths, injuries, and poison control calls associated with kratom. All of these issues have been definitively refuted.
Kratom has no more deaths associated with it than caffeine. And even with caffeine there is certainty that it alone caused the death, whereas with kratom, every death is associated with a combination of drugs. But it gets better: they even attributed a death associated with a gunshot wound to the chest to a kratom. You can’t make this stuff up.
The FDA Will Have to Face the Music When they are at the Meeting in Geneva
The hearing will be on October 11th. The hearing will be in front of the Expert Panel on Drug Dependence. It is slated to last two hours, and is in a public setting.
Each speaker will be given five minutes. Because there is not enough time for everyone to speak at the hearing, the AKA said that they will have to vet people. Mac even said they may make an application. There is a written testimony available, but it too is limited to 500 words per person.
After the trial, if the Expert Panel doesn’t immediately dismiss the case due to a lack of scientific credulity, they will open a period for more investigation called a “critical review.” Then there will be a year for interested parties to provide more info. The best-case scenario is to repudiate the FDA’s suggestion and have kratom removed from the list of substances pending criminalization.
(Policy Implications: prohibiting a substance hinders future research into its potential benefits. Imagine, for example, how many tools we lost when the government banned psychedelics without a critical review of potential benefits. Beyond that, criminalization of any drug or substance, whether or not it has value to the practice of Western medicine, is wrong. Harm reduction should be our goal as a society, and that requires education. Lack of education, paired with an unknown and unregulated substance, makes that substance dangerous. It is never the fault of a drug in and of itself.)
UN and WHO
If the WHO comes back after its fact-finding year and decides to ban kratom, they will present their reasoning to the UN. WHO recommendations are rarely flouted by a UN commission. If the UN adds kratom to the International Convention on Psychotropic Substances (ICPS), then the US is obligated to schedule it, as this is a condition of the US’s Controlled Substance Act. According to Mac, the fight isn’t entirely over if this happens, but it would be very challenging road.
To prevent this, we have to be aggressive. “We want to make decisions independent of the FDA about what is best for our health and well-being” Mac concluded.
Statements by Geoff Laredo
Geoff worked as a fed for 30 years at the HHS. The last thing he says he wants to do it get up on a soapbox and rail against the FDA. The FDA is supposed to be the gold standard, and Geoff said he is intensely disappointed.
Geoff thinks what we’re doing is the best strategy – frontloading the effort to kill the attack upfront during the October 11th hearing. If we lose on October 11th, we have several retreat points, things get harder, but there would still be some possibility of success.
Why Comments Scare Bureaucrats
Speaking from his decades of experience working in government, Geoff conceded that when bureaucrats see tens of thousands of comments, it overwhelms them because they have to read them all; the bureaucratic effort is too much for them. Writing your comment actually does help, however, because while the FDA might not read it, the WHO and UN likely will.
Geoff worked closely with NIDA, and believes they are paying attention. The AKA speaks with NIDA regularly to make sure they are paying attention. In many other circumstances, federal bodies don’t talk to each other regularly or very well. Since the FDA has to consult with NIDA before issuing a scheduling recommendation, this relatively high level of communication could work in our favor.
Geoff believes NIDA really could be an ally in this. NIDA members expressed concern when they found out that they were not informed about the Giroir letter. Yet, this is primarily the FDA’s game, and they’re keeping us in the dark on an uneven playing field. Geoff concluded by saying that all of this is very frustrating for a career public health player, especially during the COVID crisis when everyone hopes the FDA would be pristine.
David Carlucci
David served in the New York Senate for 10 years, and has been working with the AKA to pass the Kratom Consumer Protection Act (KCPA) in state legislatures. Emulating Mac and Geoff, David motivates us for the big push next month. “In the next 29 days, we need to kick it into overdrive!”
Curt Bramble
The Utah state senator outlined the history of the war on kratom. He said that, “the root of the battle with the FDA started with adulterated products in Sweden, and contaminated products.” Virtually every death worldwide we’ve been able to identify was related to contaminated products, not solely kratom.
Curt goes on to say that bad actors in the industry are finding ways to adulterate kratom with other products. In 2009, in Sweden, a kratom containing product called Krypton was adulterated with O-desmethyltramadol, an opioid and metabolic byproduct of tramadol which is stronger than tramadol itself.
He concluded by saying that adulterated products will provide the evidence that the FDA needs to pass the ban. The FDA will claim that one bad actor represents the whole industry, and ignore all the stories about kratom saving lives.
Global Alliance of Kratom Advocates
Mac did want to share some great news about kratom rallies around the world. Thailand is worried about the ban derailing all of their work to decriminalize kratom. Thailand legalized kratom on August 23rd. Now, farmers can sell regulated kratom to the global market. Thousands of convicted Thai prisoners jailed on drug charges related to kratom will be released. A global ban on kratom would seriously hamper their progress.
Indonesian and Malaysian officials will also support the AKA’s argument in front of the world court. Indonesia is the largest exporter of kratom in the world. Says Mac, “Indonesian kratom farmers have been supporting their family during the COVID shut down through kratom sales.” The Indonesian government wants to protect this burgeoning industry.
Reminder to Comment on Protectkratom.org
Mac concluded the AKA call by stressing the seriousness of the battle ahead, but also of how lucrative the payoff of a victory is. “If we win this battle, the FDA will be in a terrible position. They would have lost three times now, two federal, and then the international battle that is happening now.”
Mac is tired, but says he’s going to drink some kratom and work until October 11th. According to Mac, there is no sleep until we’ve won.
FAQs:
We’ve reproduced the question and answer portion of the kratom ban update call below. When not specified, the speaker is Mac Haddow. Otherwise, the name of the respondent will be listed before his answer.
Q: How confident is the AKA in stopping the ban?
A: With the help of kratom advocates, we’ll win. If it’s based on science, we’ll win, if it’s based on public health, we’ll win. If it’s about harm reduction, we’ll win. But just because we’re confident doesn’t mean we can leave anything to chance. The AKA has even hired a very expensive PR firm and an outside law firm to assist.
Confidence is increased by the fact that the US attorney and the judge lost trust in the FDA during the last court case. From everything concerning Alzheimer’s medication to the KCPA’s passing, the “FDA has been taking them on the chin lately, this would be a black eye.”
Q: Should be hoarding kratom in preparation for a ban?
A: No. We’re going to win. If the worst case scenario occurs, then we’ll have another year for the “critical review.” Worse case scenario, there are 2 years before you should start stocking up.
Q: Who is going to be advocating for kratom in the scientific community?
A: Swogger, McCurdy, Etc. These scientists and many more will present their research on kratom to the WHO expert panel. The AKA will advise the WHO that these are the eminent experts on kratom and so the scientists should get to speak longer than the five minutes allotted to the public.
Q: Do we know why the FDA refuses to see the reality? The evidence is so much on the side of kratom.
A: There is not a unanimous opinion of kratom in the FDA. Hennifield’s results were welcomed by the scientists at the FDA, and it was the policy people who were upset by it. The policy people challenged the results even though it fit their criteria.
In the future, the FDA needs to allow vendors that want to sell kratom as a supplement to be able to submit a New Dietary Ingredient (NDI) application and be treated fairly. Since the problem is not of science but of policy, the tides may change democratically.
Q: Would this ban announcement be ammunition to propose bans in different states?
A: Mac: There is no credible evidence that kratom is dangerous, so nothing has changed on the state level.
Curt: I don’t believe that a ban will go viral across the state level based on the foundation that the AKA has been laying for two and a half years. We should only be worried about the states if the federal government makes a policy decision. Even in states where kratom has been illegal, kratom users have spoken publicly about their use of the illegal drug in public hearings. So we can expect a flood of support in any state we go to fight against proposed bans.
David: This only works when we have aggressive grassroots members sharing their stories with lawmakers. Most people still do not know what kratom is. It doesn’t need to be a high priced lobbyist to turn the tide of public opinion. It could be you, reaching out to your state senator or your state representative. Call them, leave them a message, send them a handwritten note. Lawmakers respond to their constituents. We need to use as much energy as we can over the next month, because this will either set us forward or set us back. I urge everyone to do what they can.
Tangential: Donate to the AKA
Mac: We’ve retained lawyers in Malaysia, Indonesia, Thailand, and Laos. Collecting comments in Thailand and Indonesia. Have a law firm working with the Indonesian government. We budgeted about $1.5 million to put info in front of the WHO. So far the AKA has raised about $750k. Encourage your vendors to donate.
Pete: $1.5 million is on top of the regular number for fighting for kratom on the state level. So we’re going to keep rattling the tin cup. This is the biggest endeavour they’ve taken since 2016. All hands on deck. If we don’t fund this, the reality is this could all go away.
Q: Could we petition the WHO for more than five minutes of speaking time?
A: Mac: We’re working with experts to prepare the scientists for an effective 5 minute presentation. This is the WHO bylaw, and they are in the right to make this rule. There may be a time extension if there is a lot of interest.
Geoff: When you testify in front of the US Congress there is a five minute time limit. So this isn’t a specific injury against kratom.
Q: What are the other agencies’ stance on kratom? NIDA, DEA?
A: Geoff: It is still a little bit of a mystery as to what and if there is an official position on Kratom in the DEA. When the DEA had an opportunity to schedule kratom, they didn’t take it. That is unprecedented. They usually take any unobstructed runway to schedule a substance.
I don’t know this for sure, but with the new administration, I don’t think that the leadership at the DEA knows what kratom is. NIDA scientific staff are quite opposed to scheduling for all the same reasons we are. There are insane difficulties to research Schedule 1 compounds, so it kills any knowledge generation, and thus NIDA is against it. The way we talk about this plant matters. We need to talk about relying on science. We can’t do what the cannabis people did and say “it’s a plant, it’s okay” the Feds do not care. The Feds will not pay attention to that kind of talk. [I recommend that kratom advocates] just utilize the scientific argument.
Mac’s Response: An Inside Story of the 2016 Ban
Mac: Washington is a political town. In 2016, we were within hours of scheduling kratom. Scott Gottlieb was throwing his weight around. Went to the Trump White House and Brian Harrison, deputy chief of staff at HHS, asked Dr. [unclear] to look into it further. Mr. Harrison would not schedule without seeing the science. After a two week independent review, Dr. [unclear] said that the FDA was wrong and they could not go through with it. In the late night they had to remove it from the scheduling order to prevent Gottlieb from rushing it through regardless.
Aftering being asked by Rep. Pocan in a Congressional hearing, new HHS Secretary Becerra said he trusted the FDA because they do everything through science. Well, the AKA has to educate him because the FDA is not pure, they are wrong. They have a bias against anything that is not on a path to providing them money from an NDA.
Q: Who will be on the committee at the WHO?
A: We’re hoping for it to be scientists. Although it will probably be a combination of science and politics. We think we’ll have the upper hand because the WHO people are scientists.
Announcement
Starting Sept 1st, the AKA has someone who is willing to match donations. If you plan on donating to the AKA, please hold off until September. The anonymous donor is a vendor.
The AKA is also interested in anyone with resources (like cameras) offering their services for free. This would help with critical production needs and would also extend the AKA’s budget.
Parting Words
As we get closer to the October 11th deadline, it is important to remember Mac’s motivating words. “The story of kratom is of lives being saved, not of the FDA trying to ban it. We have the science, we have the messaging, we can’t lose unless we get apathetic.”
Finally, we’d like to remind everyone reading this that we are working on a kratom tea survey with Dr. Oliver Grundmann out of the University of Florida. The survey is structured so that anyone drinking kratom tea from our tea bags will be able to report the effects to the researchers. We’ve analyzed all of our tea bags and know exactly how much of eight different alkaloids are in each. Together, this research will provide new insights into how and why people use kratom tea.
The results of this survey will present evidence for the safety of kratom, as well as novel information regarding the subjective profile of different alkaloids. Once the comment period is over, the best thing we can do to prevent a kratom ban is to support the science. Not only that, but we’re helping reinforce in the minds of the public and the WHO expert panel that kratom is a tea, not some mystery powder.
