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How the American Kratom Association is Helping Kratom Fend Off the FDA

How the American Kratom Association is Helping Kratom Fend Off the FDA

In the history of the U.S., the DEA has attempted to place a drug under the Controlled Substances Act. In 82 cases, their efforts succeed. Here’s the story of how kratom broke the mold.

 

When it comes to misinformation, we rarely consider our own federal agencies as culprits. However, in the case of kratom, the U.S. Food and Drug Administration (FDA) has waged what amounts to an all-out war in efforts to keep the plant (or, more specifically, its leaves) out of the hands of some 11 to 16 million consumers across the country.

On Tuesday, Bloom & Oil spoke with Top Tree Herbs co-founder Sam Weber about some of the ways in which kratom – a tree native to Southeast Asia with a diverse array of reported benefits – continues to be misunderstood in the eye of the mainstream.

While Weber’s primary focus is on offering kratom in the form of pre-packaged tea bags, Mac Haddow of the American Kratom Association (AKA) has been on the frontlines of a battle to prevent the U.S. Drug Enforcement Agency (DEA) and FDA from banning the substance for reasons devoid of fact and merit.

As the AKA’s Senior Fellow on Public Policy, Haddow has stayed busy, first in thwarting efforts to see kratom be scheduled under the Controlled Substances Act, and later on a state-by-state basis. As the fight continues, Haddow reveals how the misinformation at the heart of these agencies’ efforts has subsequently spread to our larger understanding – or, in many cases, fear – of kratom.

How did you become the AKA’s Senior Fellow on Public Policy?

I was actually hired by the American Kratom Association to help with the fight to resist the DEA’s scheduling of mitragynine and 7-hydroxymitragynine, which they published in the Federal Register on August 31st, 2016. That notice was done under what’s called the ‘Emergency Power’ section of the Controlled Substances Act, which means that within 30 days, it automatically kicks in. There’s no public comment period and there’s no judicial review on it. That section was designed for street drugs that pop up where the DEA simply cannot effectively go after them under the normal scheduling procedure, which takes a lot more time. The idea that the FDA, in their application for this, could list kratom as the equivalent of a drug that was killing people on the street, and label it an emergency was absurd on its face because what they listed, at the time, were 33 deaths that had occurred worldwide.

Not even in the United States — worldwide — and that was over a six-year period. It wasn’t like it just popped up and they had to swat it down. This was clearly an abuse of the authority that was granted to the DEA, and, in this case, the FDA, for recommending it for that section of the Controlled Substances Act. When I was hired, I told the AKA that they didn’t have much of a chance because there was no precedent. The DEA had never withdrawn a scheduling notice using this section of the law before. In fact, all 82 previous scheduling efforts had been successful. The only opportunity that I saw — as well as the others who joined in the effort — was to establish a record that would show the abuse of the authority of the FDA and the DEA in taking this action. What we didn’t fully contemplate was the outrage of the kratom-consuming public, which at that time was estimated to be between three and five million people.

And what role did they play?

Thousands of people called or emailed the DEA, notwithstanding the fact there was no formal comment period. Nonetheless, we reached out and solicited signatures. On a letter from U.S. Congressmembers of the House, we got 51 members to sign: 26 Republicans and 25 Democrats. We also got 13 members of the Senate.

In terms of a diversity in philosophies and political leanings, you had Bernie Sanders on one hand, who is clearly one of the most liberal members of the Senate. At the time, Senator Orrin Hatch, who has since retired, was one of the most conservative but both senators shared this belief that the decision made by the DEA was incorrect. That led to the unprecedented withdrawal of the scheduling notice on October 13, 2016. First time it ever happened.

Then the DEA told the FDA to do an expedited review of the 8 factor analysis. The ‘Emergency Power’ section allows for three factors to be considered, all related to safety. The 8 factors is a far more comprehensive look at the actual structure of the substance, including its safety profile and an assessment of its addiction liability. The DEA asked the FDA to have that done by December 1, 2016. In the interim, they opened a public comment period to allow for individual kratom consumers to make comments.

I’d imagine a lot of folks made comments?

During that interim space, between October 13 and December 1, there were 23,232 comments that were submitted officially for the record, 99.1% of which were opposing the scheduling of kratom.

They were really across-the-board too: you had veterans, law enforcement officials, medical professionals, and the average consumer all saying this was a mistake and shouldn’t be done. We’d also been contacted by a former NIDA researcher who had done dozens of these 8 factor analyses and understood exactly what the criteria was. He volunteered to help on a pro bono basis. His name is Dr. Jack Henningfield.

On the day before it was due, he submitted an 8 factor analysis, which is what the FDA was obligated to provide in justification for it. The FDA failed to meet the deadline, so we went into a limbo period. Up until that time, my experience had been working in the dietary supplement industry and the natural substance industry. I had worked for Senator Orrin Hatch, who was the champion of dietary supplement, vitamin, and natural product, consumers. Then I worked for a while at the Department of Health and Human Services (HHS) where the FDA is, of course, a party of that agency and that department, and I got a firsthand look at the way that the FDA operates — particularly with its bias against any product that they don’t like that does not go through the new drug application process.

I actually saw what literally is a deja vu moment where what the FDA tried to do in 2016 with kratom — and have continued since then to try to do — is equivalent to what the FDA attempted to do in the early 90s when they demonized all dietary supplements and all vitamins by claiming that they were killing people and that they were dangerously adulterated.

They said these products had all of these terrible interactions with existing prescription medications and that all of them had to be banned from the marketplace and put through the new drug application process. At that time, emails weren’t available — this was the early 90s — so hundreds of thousands of consumers sent letters and made phone calls. In fact, the volume of calls about what was called the Dietary Supplement Health and Education Act (DSHEA) was so high that it famously shut down the US Capitol switchboard.

What that bill did was it significantly limited the authority of the FDA to try to keep dietary supplements off the market. It made an important step to require the safety profile to be submitted in what’s called a ‘new dietary ingredient notification,’ so the manufacturers have to prove that it’s a safe product. That helped to eliminate the adulterated products, which were in fact, as the FDA correctly pointed out, killing people. That’s true with kratom, so we obviously need the same kind of regulatory scheme that would restrict the FDA’s ability to overreach and restrict their regulatory aggressiveness in this area going forward.

After that was pulled, what happened next?

At some point, the American Kratom Association had to pivot from playing defense, because the FDA is very aggressive in their disinformation campaign. They did finally submit an 8 factor analysis on October 17th, 2017 — almost a year after it was due — and then they started to demonize kratom by calling it an opioid, which isn’t true. They called it an ‘opioid analogue,’ which is untrue.

They claimed that their phase modeling system — which is a trumped-up computer system, like they wouldn’t accept a new drug application that was evaluated by that system — but they wanted to make a major policy change, like scheduling kratom, based on predictive modeling that was all based on their claim that the binding affinity of the mitragynine and 7-hydroxymitragynine to new opioid receptors in the brain was so significant that it mimicked and actually mirrored the activity of opioids.

That is pharmacologically incorrect but they had to make that claim in order to get meet the criteria for the Controlled Substances Act. They literally lied about the criteria and the basis for it in order to squeeze and shoehorn themselves into that position, which I think was to their detriment. What happened was the National Institute on Drug Abuse (NIDA) and the FDA collaborated together and formulated a recommendation, which they then submitted to HHS.

HHS is supposed to do an independent evaluation. Then, if they concur, they send it to the DEA and the Department of Defense (DoD). That’s what happened in 2017. The FDA consistently refused to meet with the AKA but we did secure a meeting with the Assistant Secretary for Health, who was the delegated agent at HHS to make these recommendations. We made a presentation and we believed that they’d accepted the information we provided. They had asked for supplemental information, which we gave them, and then we didn’t hear a word.

What we didn’t know is that on August 16, 2018, the HHS had formally rescinded the scheduling recommendation. The reasoning that they provided was, in essence, that the FDA had not proven its case and that emerging science undermined the claims about the addiction liability of kratom. They were referencing two NIDA-funded studies that showed there was no addiction liability to kratom and that legitimate scientists disagree about the role that kratom played in these deaths.

That, of course, has now been proven to be absurd for them to claim that there are cases of death from kratom.

Can you elaborate on that?

Absolutely. In fact, what they show is polydrug use, which NIDA has confirmed, and underlying medical conditions and some adulterated kratom products. That’s what’s causing these deaths, all of which are not the standard that the Controlled Substances Act requires. That and then the letter made what we think were the most powerful point, which is that by banning kratom, you would put millions of kratom consumers at risk of significant harm, including death, because you would force them off of kratom and onto more dangerous opioids that have a much larger safety profile than kratom ever could.

By doing that, you will actually cause more people to die. If you believe anything about our healthcare system, it should be that we believe in harm reduction and that our policies to reflect that. Well, in this particular case, the FDA got caught flat-footed with their hand in the cookie jar. They were wrong.

The interesting thing is that we didn’t know that decision had actually been made. It was only because of the oversight efforts of Congressman Mark Pocan from Wisconsin and Congressman Morgan Griffith from Virginia, who asked for and received the letter that had been transmitted. The explanation for why the letter had not been made public was that the FDA insisted on invoking what’s called a ‘regulatory review provision’ that exempted them from the FOIA (Freedom of Information Act). It took members of Congress asking for this letter, and when they received it, it exposed the big lie that the FDA has been telling about kratom for a long time.

Title: How the American Kratom Association is Helping Kratom Fend Off the FDA (kratom leaf)

What exactly does that ‘Big Lie’ consist of with regards to kratom?

There were two things in the letter that were especially astounding.

First, the day after the FDA knew that the HHS had formally and officially rescinded the scheduling recommendation, Scott Gottlieb, then Commissioner of the FDA, went on a Twitter tirade about the dangers of kratom and continued to prosecute that case in webinars and any other form the FDA could find to talk to state agencies and law enforcement, with public health officials, with medical examiners and coroners, all to encourage them to blame kratom for these deaths, even though that couldn’t be supported from a scientific basis.

All of that was happening after they knew that the HHS had formally rescinded the recommendation on the basis that the FDA didn’t prove their case but they continued to tell the big lie to the American people.

When they were caught, when the letter was released, the FDA’s excuse was that they have no duty or obligation whatsoever to share news of the rescission and yet they publicly announced when it was submitted to the FDA and the DEA and made a big deal about it. For them to say that they don’t have any duty or responsibility flies in the face of what we believe about a credible and trustworthy agency that is tasked with protecting the public health. When the Assistant Secretary for Health says that by scheduling kratom, you’re putting millions of Americans at high risk of being forced onto more dangerous substances?

If there’s a more compelling case to show that the FDA has lost the trust of the American people, I don’t know what it is. They simply booted this badly and they should have accepted responsibility for the bad actions that they took.

Tell me more about pivoting from defense to offense when it comes to kratom consumer protections.

In 2016, when they lost that battle, the FDA then went out encouraged states to ban kratom. They convinced six states to do it between 2012 and 2016 but from 2016 onwards, there were 18 states that proposed bans on kratom and we’ve won in every one of those states.

We showed the science and we explained to lawmakers that public policy is best served by allowing for kratom to remain on the market, so the FDA sharpened their attacks. They made it clear that there are adulterated products out there and that said kratom products are killing people, so we went on the offense by encouraging states to pass the Kratom Consumer Protection Act (KCPA).

What that state law does is what the FDA should be doing right now: it bans the sale of any kratom product that is adulterated with a dangerous substance, be it fentanyl, morphine, heroin, buprenorphine, etc. There’s any number of substances that these bad actors are adding to kratom to give it a kick that the natural product does not have. They want to encourage sales and increase sales.

What’s the solution presented by the Kratom Consumer Protection Act?

To ban all of those dangerous substances and require that there be no synthesized alkaloids added to a kratom product. You ban those and you require that all kratom be manufactured using Good Manufacturing Practices for foods and then you label it appropriately. If the state wants to do it, they can also add an age limit. You basically put a protective shield around kratom consumers in the states where this law is enacted.

We saw four states that passed it in 2019: Utah, Georgia, Arizona, and Nevada. In 2020, we were well on our way to doubling that number, or more, and then Covid-19 hit. We’ve had great success in the state of Missouri. It passed 144-0 in the House and went to the Senate’s general laws committee and passed unanimously on a ‘do pass’ recommendation. It’s now waiting senate floor action.

In the state of Oklahoma, it passed 96-1 in the House and 45-1 in the Senate. It’s now awaiting the governor’s signature. The Texas House of Representatives just passed it 118-9 and it’s now headed to the senate there. We’re seeing that kind of energy and inertia building across the country, in various states where these legislators are evaluating this.

We’re seeing action in Wisconsin, Rhode Island, and in Vermont — and those are banned states. We’ve got a meeting scheduled with the Secretary of Health in Arkansas, another banned state where they acted on the FDA’s misinformation campaign. We’re hoping that they’ll rescind it. We’re working hard to be on the offense to protect American consumers, which the FDA has an obligation to do but refused to honor because of their bias against natural products, particularly kratom.

For the states that did enact bans, will it now require a two-step approach to undo the ban and then put in the KCPA?

It’s a complex process, depending on the state.

In Wisconsin, the Senate Health Committee, last year, before COVID, had opened up what’s called a bill file. They did it unanimously, so bipartisan, and it would rescind the ban and replace it with the Kratom Consumer Protection Act. In the state of Rhode Island, another banned state, same thing. The state Health Director initially opened up a formal review of the ban, in the first place, and we were disappointed that they testified at the first hearing on the Kratom Consumer Protection Act saying that they wanted to maintain their position and just repeating all of the FDA’s misinformation. That was very disappointing to us.

In the state of Vermont, it’s going to require a two-step process: one to rescind the ban and one to replace it with the KCPA. The same will be true in Indiana. In the state of Alabama, we were unsuccessful in getting the bill filed this year only because they were already fighting a battle on medical marijuana and our chief sponsors simply decided to give it until the next session but we’ll be teed-up to do that in January.

Arkansas is another interesting situation. They also banned it because of the FDA. In fact, it was a single doctor who’s in the addiction recovery business who recommended to the state’s Department of Health, back in 2015, that kratom should be banned. The document they use repeated all of the FDA’s untrue statements about kratom. The Secretary of Health there has agreed to a meeting. The reason that’s important is that the Arkansas legislature only meets every other year and they just concluded their work this month, so this is going to be something where we have to fight on the administrative level, and then, hopefully, get the legislature to affirm it when they meet in two years.

Each state is a little different. They each require some tweaking of our legislation proposal. In some states, we’ve also seen this ridiculous opposition form, which is fully uninformed. Mississippi is a prime example of that.

There’s a very active anti-kratom group led by the Mississippi Medical Association and they’re doing the FDA’s bidding, so it’s been very difficult to win them over, even though in the last session, we had the Senate Drug Policy Committee unanimously replace a ban bill with the Kratom Consumer Protection Act. However, it had to be referred jointly to another Senate committee, the Judiciary Committee, and that chairman bowed to the wishes of the Mississippi Medical Association. Again, all owing to bad information the FDA has pushed.

But we’re doing great in the U.S. and we’re going to see more success in the next year or so. I think we’re going to overwhelm them, eventually, to the point where the FDA will finally have to do the right thing.

Would every state passing the KCPA be enough in the AKA’s eyes?

Ultimately, it’s going to take congressional action, just like they did for DSHEA. When we get to a critical mass of states that have passed the KCPA, I think that will create the inertia at the federal level for there to be a federal bill filed which corrects what the FDA is doing and properly regulates kratom so that we’re protecting consumers against contaminants and adulterants and making sure that it’s manufactured with Good Manufacturing Practices and that it’s not subject to salmonella and E. coli and heavy metals. Those are all risks that are present if you don’t have these kinds of regulations in place.

Title: How the American Kratom Association is Helping Kratom Fend Off the FDA (kratom protestors)

As best as you understand it, how many kratom users are there in the U.S.?

An interesting byproduct of the attack by the FDA, and their attempt to have kratom scheduled in 2016, was literally an explosion of use because it drew attention to a product that many people on social media platforms were reporting had saved their lives.

You have a consumer study that was done by Dr. Oliver Grundmann, out of the University of Florida, which looked at the adult kratom consumer population in America. What he determined was that about a third of kratom consumers use it like you would a cup of coffee in the morning: for an energy boost and increased focus. Another third uses it for benefits in smoothing out moods and reducing anxiety, while a third group uses kratom to manage acute and chronic pain as a replacement for opioids or other painkillers, either prescribed by physicians or that they otherwise got hooked on in order to manage their pain.

We don’t have any opposition to a doctor having those kinds of medicines in their toolbox to help people but when people find themselves trapped in a cycle of taking these chemically-manufactured substances and then replace it with kratom, we think that’s appropriate use, individually, as well. It’s not something that should be advertised or marketed by any kratom manufacturer as having a therapeutic benefit if it has not gone through the new drug application process. We understand that there are appropriate restrictions on what individual manufacturers can say in terms of its intended use, but an individual can put it to whatever use that they choose, and they’ve found it beneficial.

Looking at each one of these groups that represents a third of kratom users, I think that third group is expanding a little bit as people understand that this is a potential lifeline away from addiction and overdose, particularly during Covid-19, where we’re seeing a spike in overdose deaths.

The FDA has severely restricted our ability to collect valid data about the transactions that are done by kratom retailers in the United States, so we looked to Indonesia, where 95% of kratom raw materials that come into the United States originate from. I went over there and participated in a symposium, in 2019, where the kratom growers made a presentation about the volume increase in exports per month, and then per year, and the Minister of Agriculture provided their data.

What it essentially came down to is that you’ve created a marketplace where, today, just over 4600 metric tons of kratom is being imported into the United States from Indonesia every month. Well if you break down the metric tons into grams and then break that out by what the average consumer uses in a day, depending on the number of grams that are consumed on an average basis, we’ve determined that there are between 11 and 16 million kratom consumers, which is up from 3 to 5 million in 2016. Remember, the average consumed is important because some people may use kratom, say, two or three times a week while others are using it at higher dose levels, three or four times a week, or even every day at even higher dose levels.

Based on the volume of kratom raw materials that are being shipped to the United States every month, it’s a reasonable conclusion. We would like to have something more specific, that’s driven by actual sales data, once we’re successful in getting the import alert removed. I think that that will open the door for that kind of analysis.

That’s a huge number!

There was a report that was just issued, from a government-funded study, where the researcher determined that there were just over two million kratom consumers in the United States, but you have to look at the methodology. First off, they were only looking at people that are in that third category of kratom users, who are trying to manage acute and chronic pain as a replacement for other drugs. And, by the way, it’s a growing area because Johns Hopkins University did a study on adult kratom users in this space and they found that 87% of those kratom users reported that they had significant reduction in withdrawal symptoms from the opioids they were taking. And 35% reported they were opioid-free within a year. That’s dramatic.

That’s what’s fueled, I think, a lot of the growth in the kratom marketplace: people who are successfully using this as an alternative to highly addictive and potentially deadly opioid medications. In that context, it’s understandable that we would see this dramatic increase in the usage of kratom. But the FDA, of course, continues to demonize it.

Can you explain how the “import alert” they have on kratom works?

The import alert gets in the way because they aggressively try to get the Customs and Border Patrol agents to interdict the kratom — seize it — which isn’t their job, by the way. The import law was intended to identify a specific shipper in a foreign country that was shipping a contaminated or adulterated product. They would put that company on the red alert list to stop them and, of course, the border people can do that. They can actually look and see the origination on the bill of lading and they can do it when kratom comes in.

So, they ban all kratom — which was never the intent of the law, to allow them to do that — and then it’s harder and that’s why the Customs people really don’t have the time to deal with this nonsense, to prosecute what is an off-the-rails agenda by the FDA.

The basis for their import alert, by the way, is twofold. One, they claim that it’s an unapproved drug. Well, the FDA does not have the authority to interdict a bulk raw material shipment of any product because its intended use is not defined until a manufacturer finishes a product and then says ‘buy my kratom because it will help you with opioid withdrawal.’ That is an impermissible heath claim and there, it is an unapproved drug, but if kratom is a food, and it’s manufactured as a food and sold as a food, without any of the medical claims either as a structure function claim under dietary supplements or as a drug, the FDA has no authority. None. And yet they’ve extended their authority to do this.

The second thing is that they claim the reason they have the import alert is because kratom is an unapproved drug, that is a dangerous substance that’s a dietary supplement. Again, unless you market it as a dietary supplement, and unless you make it a structure function claim, the intended use doctrine, which applies to commercial speech, isn’t there. But the FDA doesn’t care very much about that law because they’ve been successful in trying to convince the people that they have a legitimate important alert. Congress needs to narrow that authority so that they don’t have that broad discretion.

Back of the napkin math, what percentage of imports are actually getting seized?

Every seizure is too much. We get reports on a regular basis where there’ll be a seizure made and that’s unfortunate, because, again, it’s not what the import alert was intended to do. There’s a volume of kratom raw materials that’s coming through the mail being shipped to small vendors or to individual consumers and that’s probably the worst environment for them to be buying that kratom raw material from.

We know that there are regions in Indonesia where kratom is harvested where, because of the land that it grows on, there’s heavy metal contamination that’s dangerous. Those areas should be banned from production of kratom products but there’s no screed on that. The other thing is that you have salmonella and E. coli that come from improper handling and harvesting processes used by some of the small farmers. Over in Indonesia, we support a process of testing for those contaminants, discarding any of the raw material that fails that test, and then only shipping pure uncontaminated, non-adulterated kratom raw material.

We’ve got some work to do in that area. Until you have that process in place, you really cannot win this battle with the FDA, so we’re going to continue to fight for this and to make sure that we get rid of that import alert. I think that there are too many seizures that go on right now because the customs people occasionally do have some time, and when they do see it, they’ll seize it, which just does the FDA a favor.

Any last thoughts here?

One concluding remark I would make for any kratom consumers buying their kratom based on the price, you need to look at two other things: is this product tested and is it manufactured using GMP practices?

If the FDA were doing its job — and they’re not — but if they were, all kratom raw materials would be regulated to go through a Good Manufacturing Practices process, which costs money, equipment, and requires testing, as well as record-keeping and documentation and traceability. All of that would be in place. The guys that are selling the cheap kratom right now aren’t doing any of those things, so I tell people all the time, ‘If you’re looking for a place to buy your kratom, first go to the American Kratom Association website and look at the list of GMP-approved vendors.’ Those are companies who have submitted to an independent third-party audit documenting and validating that they’re following these procedures that would otherwise be required by the FDA if the FDA were doing their job. Anyone who’s buying a kratom product from someone who’s not GMP-certified is putting themselves at risk.

But more importantly, they’re opening the target range for the FDA, because all the FDA needs is to be able to prove that there are these contaminated, adulterated products coming into the United States and that no one’s regulating them appropriately. Thus, I encourage every kratom consumer to forget the price and look at GMP-qualified vendors, then shop for price among that cohort of the kratom marketplace. Buying just because it’s cheap is a fool’s errand and it’s dangerous and it hurts the industry overall and I encourage everyone to stop doing it.

If you’re buying directly from a farmer over in Indonesia, that needs to stop too, because if you saw what I saw when I was there — the pictures of what the current state of harvesting and processing practices are for those small farmers, who can’t afford the necessary food-grade grinding equipment to preserve the quality of the kratom raw material — you would understand the risks that you’re putting yourself in. For that reason, I encourage people to pay attention to that as best they can.

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