Public Comments Show How 7-OH Ban Would Harm Pain Patients

By Crystal Lindell

Leigh Ann Matthews is a 51 year old woman with chronic pain. She lives alone, makes less than $2,000 per month, and can’t afford health insurance.

She relies on 7-OH for pain relief, and doesn’t know how she’ll be able to work if it’s banned.   

“Please don’t make me suffer with chronic pain by taking away the ONLY thing that has helped me tremendously,” she wrote. “I have no family or friends to lean on or help me. I don’t abuse 7-OH. I’m so afraid.”

Matthews is one of the thousands of people who have shared their stories in the Federal Register in response to the DEA announcing plans to make concentrated forms of the kratom alkaloid 7-hydroxymitragynine (7-OH) an illegal Schedule 1 controlled substance.

As of July 24, more than 20,000 comments had been submitted to the Department of Health and Human Services (HHS).  Reading through them makes some common themes jump out. There are thousands of personal, individual stories that are clearly coming from real people with real fears. 

Many are chronic pain patients, who say that 7-OH has given them their lives back. In fact, a search for the phrase "my life back" turns up 290 comments. A search for "chronic pain" returns 2,608 results.

"I'm a 50-year-old male with multiple sclerosis. I live my life with chronic pain,” wrote Gabriel Duley. “It is so hard to get out of bed to even take a shower. Doctors do not prescribe pain medications. Please do not take 7-OH away. It's the only thing that has given my life back to me."

Tyler Bartone is 30 years old and lives in Ohio. He wrote that he has suffered from chronic pain since he was 22, after a motorcycle accident broke both of his legs.

"Oxycodone, hydrocodone, Suboxone, and tramadol all got tried over those years, and none of them let me function the way I needed to,” Bartone wrote. “When I found 7-OH, that changed. I can walk my dogs now. I can play with my kids. I stopped relying on opioid pain medication because this actually worked for my pain in a way [that] those didn't."

He shared that he takes 30 to 60 mg of 7-OH spread across 4 to 5 doses a day, and that amount has stayed steady for the 1 to 2 years he has used it. 

"What scares me is what happens after a ban like this. People in my situation, and others I know who rely on 7-OH daily just to function, would be left with two options: go back to opioid prescriptions that didn't work as well, or turn to street drugs,” Bartone explained. “I know people would die from that second option. That is the real hazard here, not the milligrams in a tested tablet.”

Bartone said he would support rules that “keep this market honest.” Rules like a 21 and up age requirement, mandatory lab testing with published results, child-resistant packaging, and clear dosage labeling. 

Unrealistic Threshold

The DEA’s scheduling order limits the amount of 7-OH to no more than 0.05% of a product by weight or volume, the equivalent of about 0.5 mg 7-OH per tablet. Virtually all 7-OH products currently on the market have much higher dosages. Bartone thinks it’s an unrealistic threshold.

“I'm asking HHS to set any threshold based on how people actually take this, not a number that erases the product entirely,” Bartone said. 

Katherine Loperena, a 33 year old who works in sales and suffers from chronic pain, also shared her story. She said for the past 1 to 2 years she has used more than 60 mg of 7-OH a day, split across 2 to 3 doses. 

"What scares me most is going back to the days when chronic pain decided whether I could work or not," she wrote. "I lost jobs because the pain became too much to push through, and I spent years choosing between showing up in agony or protecting my income. Before 7-OH, I had tried oxycodone, alcohol, cannabis, and over the counter pain relievers, and none of [them] gave me a real way to manage day to day life."

Lindsay Huffman also shared how 7-OH has helped her manage the chronic pain she’s had for five years.

“Without it, I would have no way to treat my pain,” she writes. “It has been massively beneficial to my quality of life. Banning it would affect thousands of people who just want to be able to function and have finally found some hope."

Kyle Whitman wrote just one sentence: "Please don’t do this."

Lane Reeves said simply, "This (7-OH) should be available for chronic pain patients with no insurance!"

Rolando Smith shared how he uses 25 to 50 mg of 7-OH daily, which he says “has made my life so much more enjoyable through the ability to no longer feel immense pain all day long.”

“I take 7-OH not to feel anything such as a high, but rather to just eliminate the feeling of pain that usually lasts hours each day,” Smith explained. “7-OH is a perfect substance for my pain compared to other painkillers I have received as I am not a fan of overly euphoric or ‘high’ feeling drugs.”

Smith said he’s had no issues with withdrawal or dependence from using 7-OH.

“I've been an on and off user for about a year now, and find it easy to quit when I want to lower my tolerance or run out of supply and feel too lazy to get more. Personally I have not felt negative effects physically or mentally with using this substance and I never feel the need to take any more than what makes my pain disappear,” he wrote.

Patricia Metz shared how she takes 7-OH a few times a week to help with chronic pain from a serious injury. Without it, she doesn’t think she’d be able to work and provide for her child.

"This product has given me back a quality of life I couldn't otherwise have," Metz writes. "I have had six surgeries, countless hours of physical therapy, and spent years working with pain management with no meaningful result. 7-hydroxymitragynine is far safer than prescription pain management and far more accessible.

“There are thousands of people with a similar story who rely on 7-OH, many of whom are scared to death right now because they feel the rug being pulled from under their feet and see a future of pain ahead. I fear that removing access to this valuable resource will drive a good number of those people to dangerous and deadly street drugs."

The American Kratom Association (AKA), which represents natural leaf kratom vendors who have lost market share to 7-OH, is in favor of banning 7-OH products. It recently sent a letter to HHS, claiming many of the public comments in support of 7-OH are ”Coordinated, Duplicate, Fictitious, and Financially Incentivized.”

According to the AKA, many of the comments are anecdotal personal stories that should not be considered as part of the scientific analysis of an appropriate 7-OH threshold. The letter also said some 7-OH vendors are offering discounts to consumers who show that they have left a comment. 

There is still time to leave a public comment on the scheduling of 7-OH before the July 31 deadline. 

In 2016, the DEA dropped another effort to ban kratom after a public outcry. At the time, the DEA received over 22,000 public comments in the Federal Register, a record number on any issue. It seems likely that record will be broken again.

No One Called Kratom an Opioid Until They Wanted It Banned

By Pat Anson

The DEA’s recent decision to classify concentrated forms of the kratom alkaloid 7-OH as an illegal controlled substance has resurrected an old argument: Is kratom itself an opioid? 

Kratom comes from the leaves of the Mitragyna speciosa tree in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. Kratom is a botanical cousin of the coffee plant, which relieves pain through a natural alkaloid we all know: caffeine.

No one calls caffeine or coffee an opioid, do they? 

Only in recent years has the “opioid” label been attached to kratom, mainly by government regulators and the addiction treatment industry. Former FDA commissioner Scott Gottlieb, MD, was the first to do so, warning in 2018 that kratom should not be used to treat pain or any other medical condition. 

“Claiming that kratom is benign because it’s ‘just a plant’ is shortsighted and dangerous,” said Gottlieb, who now serves on the board of directors for Pfizer. “It’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated, sold and used recreationally.”  

Gottlieb’s remarks were based on an FDA computer analysis of kratom, which found that 7-hydroxymitragynine (7-OH), mitragynine and other kratom alkaloids share similarities with opioid analgesics.

Like morphine and oxycodone, the alkaloids bind to mu-opioid receptors in the brain and relieve pain. But unlike opioids, they are partial agonists that do not cause respiratory depression. The vast majority of kratom-related “overdoses” occur because people mixed kratom with other substances that depress breathing, such as alcohol or benzodiazepines.  

Nevertheless, Gottlieb insisted on calling kratom an opioid.

“Based on the scientific information in the literature and further supported by our computational modeling and the reports of its adverse effects in humans, we feel confident in calling compounds found in kratom, opioids,” Gottlieb said.

Critics called the FDA analysis “junk science,” citing numerous errors and signs of bias. 

One such critic was Brett Girior, MD, Assistant Secretary for Health and Senior Advisor for Opioid Policy at HHS, who said the FDA analysis of kratom was based on "embarrassingly poor evidence.” It was Girior who put a temporary end to the FDA’s efforts to have the DEA classify kratom’s alkaloids as Schedule One controlled substances.

“While mitragynine and 7-hydroxymitragynine have many properties of an opioid, scheduling these chemicals at this time in light of the underdeveloped state of the science would be premature,” Girior wrote in a 2018 letter to the DEA administrator. “There is significant risk of immediate adverse public health consequences for potentially millions of users if kratom or its components are included in Schedule I.”

‘The DEA Should Control Kratom’

Flash forward 8 years, and the FDA is once again trying to schedule 7-OH and kratom is being called an opioid, although the science behind that claim really hasn’t changed. 

“Like other opioids, kratom is highly addictive: Repeated use leads to tolerance, dependence and the need for progressively higher doses,” wrote Andrew Kolodny, MD, an addiction treatment psychiatrist, in a recent op/ed in the The Washington Post. 

“The DEA should control kratom in all its forms. Until it does, an opioid will be available for purchase without a prescription, the number of Americans suffering from opioid use disorder will keep rising, and there will be no end to the opioid crisis in sight.”

Kolodny is a familiar name to many pain sufferers. He is the founder and president of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that played an influential role in getting the CDC to draft its controversial 2016 opioid prescribing guideline.

The CDC’s recommendations led to millions of patients being abruptly taken off opioids or reduced to ineffective doses. Some died by suicide or turned to the black market for relief, which helped fuel the fentanyl crisis.

Meanwhile, Kolodny and several other PROP members went on to make millions of dollars testifying as “expert witnesses” in opioid litigation cases. Their demonization of opioid medication is what led many Americans to start using kratom as a pain reliever.

That irony isn’t lost on pain patients, who left some choice comments about Kolodny and his op/ed on PNN’s Facebook page.

“He's a pain grifter making his $$$$ off people suffering from chronic pain,” said one. 

“He'll naturally piss on any treatment for chronic pain that doesn't include Suboxone or a shrink trying to gaslight you into saying nothing is wrong!” said another.

“If kratom hadn't saved my life over 20 years ago, I wouldn't be alive to be able to type this comment and call this article out as blatant misinformation,” wrote another pain sufferer.

Koldony testified in federal court a few years ago that he stopped treating patients when he became Medical Director for Opioid Policy Research at Brandeis University. In his op/ed, Kolodny said he was treating addiction again and that “a growing share” of his patients developed opioid use disorder by consuming kratom. 

At a recent public hearing in Georgia, Kolodny went further, claiming “all of the patients” he was treating had become addicted to kratom. He said a substance doesn’t have to come from the opium plant to be an opioid, citing the skin of the waxy monkey tree frog, which contains “an extremely potent opioid” that is stronger than morphine.

Kolodny also cites a misleading CDC study that found “poisonings and hospitalizations involving kratom have risen 1,200 percent over the past decade.” 

That 1,200% increase sounds horrific, but it is based on fairly small numbers. The total number of “adverse events” involving kratom was 538 in 2025, compared to 43 cases in 2014. That’s where the 1,200% figure comes from. About half of those reports were considered “intentional misuse” or suspected suicide attempts.

The 1,200% spike in cases reflects the simple fact that more Americans are using kratom today than in 2014. Conservative estimates put the number at 2 million, although the kratom industry has a much higher estimate of 20 million. Either way you slice it, 538 cases out of 2 or 20 million kratom users is a very low rate for adverse events. 

Coincidentally, in 2025 the FDA received 538 reports of adverse events involving Suboxone, a medication used to treat opioid use disorder. And there were over 4,800 adverse events involving aspirin that same year. 

No one talks about banning Suboxone or aspirin, or protecting us from waxy monkey tree frogs.  

Kratom Treats Addiction 

Just like the labeling of kratom as an opioid, the term "kratom use disorder" is also a recent invention, first used in 2021 by a group of addiction psychiatrists seeking to establish a clinical consensus for diagnosing and treating kratom addiction with Suboxone. 

One of the ironies in that framing of kratom is that the National Institute of Health recently announced plans to investigate the kratom alkaloid mitragynine as a treatment for addiction.

Many kratom users are already doing so. In a 2016 PNN survey of over 6,000 kratom consumers, about one in ten said they used kratom to reduce their cravings for opioids or alcohol, with over 90% saying it was “very effective.”

“This is an herbal blessing that has kept me from drinking,” said one. “If it becomes illegal, I fear we may never truly be able to study and treat ailments that kratom helps with.”

A more recent survey by 7-Hope Alliance, a 7-OH advocacy group, found that 23% of 7-OH consumers use it to self-treat opioid addiction. The vast majority – 74% – use it to relieve chronic pain.

Mac Haddow, a lobbyist and spokesman for the American Kratom Association (AKA), thinks the effort to frame kratom as an opioid is being driven by the addiction treatment industry.

“I think the more difficult problem is with addiction recovery centers because they’ve become very active in the kratom space, and they're calling it an opioid. They want to say that because they have to be able to qualify a so-called kratom addicted person in order to be reimbursed for the treatments that they provide,” Haddow told PNN.

“To me, that's problematic because that's a profit-centered assessment as opposed to a medical assessment, and clearly they are in the business of calling it an opioid so they can get reimbursement.”

‘7-OH Opioid Products’

One of the weirder ironies in the labeling of kratom is that the AKA, which represents natural leaf kratom vendors, is leading the fight to have concentrated 7-OH products banned. The AKA has even resorted to calling 7-OH an opioid, just like Kolodny and Gottlieb.

In a recent PNN op/ed, Haddow said 7-OH manufacturers have created “7-OH opioid products.” 

“They took a naturally occurring trace alkaloid found in kratom leaf and chemically manipulated it into highly concentrated 7-OH-dominant opioid products, then pushed those products into the marketplace without the guardrails that would apply to any legitimate opioid drug product,” Haddow wrote.

7-OH advocates say the AKA is trying to drive out competitors who have cornered a large share of the kratom market with a superior product. Asked to explain how 7-OH could be an alkaloid in small amounts but an opioid in larger doses, Haddow said 7-OH manufacturers turn it into a “completely different compound.”

“I could be wrong, but I think that the conversion from its trace amounts into a highly concentrated amount, then its activity on the new opioid receptors, is what distinguishes it,” Haddow explained. “It's not natural. There's nothing natural about the 7-OH that's sold in these highly concentrated forms because it's been chemically managed.” 

The DEA disagrees. In its scheduling order for 7-OH products in the Federal Register, the DEA says the 7-OH molecule chemically remains the same – whether in natural leaf kratom or in concentrated versions.

“Despite the different origins of 7-hydroxymitragynine, the chemical structures of synthetic and naturally occurring 7-hydroxymitragynine are identical. Consequently, the intrinsic pharmacological profile, receptor affinity, and mechanism of action of 7-hydroxymitragynine molecule remain unchanged regardless of its source.”   

They may share the same molecule, but the DEA is not seeking to ban natural leaf kratom, only the concentrated 7-OH formulations. It says those products “pose significant safety risk to unsuspecting consumers by exposing them to high doses of opioids.”

There’s that pejorative word again: opioids.

To be clear, 7-OH products are potent analgesics. And like any drug, when used excessively or irresponsibly, they can pose safety risks. 7-OH manufacturers haven’t done themselves any favors by selling their products without warning labels and in child friendly packaging that resembles candy.

7-OH products have been easy to get in gas stations, smoke shops and online, but that era is rapidly coming to a close. Several states and dozens of cities and counties have already banned 7-OH products, and soon there will be a nationwide ban on them.  

Like other attempts at prohibition, whether for alcohol, marijuana or prescription opioids, there will be unintended consequences. 7-OH products seem destined to become hot items on the black market and it’s reasonable to assume that drug cartels will start selling counterfeit 7-OH tablets or exotic new formulations of kratom alkaloids.

The DEA will have new drugs to target and more people to arrest. And the addiction treatment industry will have millions of new patients to prescribe Suboxone to.

No one called kratom an opioid until they wanted it banned. And figured out a way to make money from it. 

“That's a fair assessment. I agree,” says Haddow.

Banning 7-OH Will Make Consumers Less Safe

By Jeff Smith

The DEA’s rushed proposal to ban 7-OH is a horrendous mistake.

7-hydroxymitragynine, or 7-OH, is an alkaloid from the kratom plant. Many adults use it for serious chronic pain and to help with withdrawal from dangerous opioids. A lot of them say they use 7-OH because whole-leaf kratom was not enough to alleviate their chronic pain. 

Despite initially opposing the scheduling of concentrated 7-OH products, Mac Haddow and his American Kratom Association (AKA), which represent the whole-leaf kratom industry, have spent the last year trying to ban them with fanatical zeal.

In his recent PNN op/ed, Haddow finally acknowledges that these pain patients exist and that their suffering should not be dismissed. But belated sympathy is not enough when the policy he supports, and – indeed – has been spending millions of dollars to lobby, would eliminate access, expose consumers to the consequences of illegal possession, and push people toward products no regulator can inspect. 

This should trouble anyone who cares about ending the opioid crisis. Untreated and undertreated pain are a core reason so many people turn to prescription opioids. When they cannot get adequate pain care, some look for relief wherever they can find it, including the black market – which comes with the risk of illicit fentanyl. 

For some chronic pain patients, 7-OH has been one of the few tools that allow them to work, care for family, avoid withdrawal, and stay away from more dangerous substances.Those consumers deserve transparency, real standards, and the freedom to make informed decisions.

The Holistic Alternative Recovery Trust (HART) has long supported rules around 7-OH, including requiring accurate labels, independent testing, age restrictions, serving limits, contaminant screening, responsible packaging, and enforcement against false medical claims.

Haddow and the AKA have chosen another path. They offer no comparable solution for chronic pain patients. They are trying to make sure adults cannot use 7-OH at all, regardless of the consequences for thousands of people.

Let’s be clear about what classifying 7-OH as a Schedule One controlled substance will mean. Legal access to 7-OH would be cut off for ordinary consumers, potentially for years. The DEA’s own statement says covered 7-OH products would be subject to criminal, civil, and administrative provisions of the Controlled Substances Act, including those for possession.

Haddow has claimed that this prospective ban is mainly about manufacturers, not consumers. But that is disingenuous. Consumers would still face the legal consequences of possession, and many would lose one of the few tools they say has helped them manage pain.

Those who keep using 7-OH anyway will not be safer. Indeed, they will be in much more danger than they are now. Schedule One will not create labels, require testing, set serving limits, punish only bad manufacturers, build a lawful pathway for adult access, or help consumers speak openly with doctors. Instead, it will push consumers toward unregulated supply chains, unknown products, and sellers no regulator can inspect.

Haddow and the AKA have pursued this course by painting 7-OH as a public health emergency. But their evidence does not support the solution they prescribe. They often point to adverse-event reports involving 7-OH or kratom-related products. But many of those reports do not clearly establish what product was used, how much was taken, whether it contained 7-OH, or what other substances were involved. 

Further, many reports involve more than one substance, underlying health conditions, products of unknown strength or composition, or labels that do not identify what the person consumed. It is almost impossible to determine whether whole-leaf kratom was involved in an overdose or a concentrated 7-OH product. 

Regardless, Haddow and the AKA have traveled to one state after another, filling the heads of state legislators and regulators with unprovable scary stories more characteristic of a moral panic than a public health issue.

But the truth is, this was never about safety. As recently as early 2025, Haddow did not call for a  ban on 7-OH. The reason for his 180 degree shift was explored in a recent piece in The New York Times. The article described an influence campaign by kratom companies and their allies to protect their whole-leaf products by urging federal action against 7-OH competitors. 

According to The Times, Secretary of Homeland Security Markwayne Mullin disclosed an investment worth as much as $1 million in Botanic Tonics, the company behind Feel Free, which has consistently urged a 7-OH ban. 

The Times also reported that Botanic Tonics donated $1 million to a political committee associated with Health and Human Services Secretary Robert F. Kennedy Jr., and that company founder Jerry W. Ross used access to Vice President JD Vance to urge a 7-OH crackdown.

That is the context in which consumers should read Haddow’s argument. This is about money, market share, and one part of the kratom industry trying to use federal power against another.

Even opponents of 7-OH should be wary of the ramifications of their strategy. Haddow says banning concentrated 7-OH will protect natural kratom leaf, but history gives consumers little reason to trust that prohibition will stop there. 

In 2016, the DEA tried to place both mitragynine and 7-OH into Schedule One before backing down after public backlash. The arguments now being used against 7-OH are the same arguments used against whole-leaf kratom for years, and there can be little doubt that they will resurface again.

That spillover is already happening. The AKA’s campaign against 7-OH has helped create a political environment in which some legislators now see all kratom as a liability. Kansas recently made kratom and 7-OH Schedule One controlled substances, and Tennessee enacted a new criminal law governing kratom.

There is still time to stop this. The DEA should stand down, Congress should hold hearings, and the Trump administration should replace the ban with a responsible adult-use framework for 7-OH. 

Adults should not be abandoned to withdrawal, untreated pain, lost work, and illicit drug markets because one part of the kratom industry decided that protecting its own products mattered more than protecting the consumers it claims to represent. 

Jeff Smith is National Policy Director of the Holistic Alternative Recovery Trust (HART), an advocacy group funded by 7-OH manufacturers.  

Banning 7-OH Will Save Lives

(Editor’s Note: Last week the DEA said it would classify concentrated versions of the kratom alkaloid 7-hydroxymitragynine (7-OH) as illegal Schedule One controlled substances. In response, PNN’s Crystal Lindell — a 7-OH consumer — wrote an op/ed sharply critical of the DEA’s decision and the role played by the American Kratom Association (AKA), which lobbied for the move. The column below is the AKA’s response.)  

By Mac Haddow

I do not question the sincerity of Ms. Lindell in her Op-Ed describing her personal experience or the seriousness of the pain she describes. No one should minimize the suffering of chronic pain patients, and no one should dismiss the fear that comes when a person believes the product they rely on may no longer be available.

But that does not change the core issue: the Controlled Substances Act was enacted to protect consumers from dangerous drug products — not to punish consumers. When manufacturers create, market, and sell products that present a significant threat to public safety, federal law exists to intervene. 

That is exactly what has happened with chemically manipulated 7-OH opioid products.

The blame for this situation does not rest with the American Kratom Association, natural kratom leaf consumers, regulators, or anyone advocating for responsible consumer protections. The blame lies entirely at the feet of the 7-OH manufacturers who deliberately bypassed federal law and basic safety requirements in pursuit of profits.

These companies did not follow the required pathways for market entry. They did not submit lawful safety data. They did not comply with the federal requirements that exist to protect consumers from dangerous drug products. 

They took a naturally occurring trace alkaloid found in kratom leaf and chemically manipulated it into highly concentrated 7-OH-dominant opioid products, then pushed those products into the marketplace without the guardrails that would apply to any legitimate opioid drug product.

Worse, they deceived hundreds of thousands of natural kratom leaf consumers into believing they were purchasing ordinary kratom products. They traded on the reputation of natural kratom leaf while selling products that are fundamentally different in formulation, potency, pharmacology, and risk. 

That deception has harmed consumers, undermined legitimate kratom regulation, and placed the entire natural kratom community at risk.

The American Kratom Association does not advocate for the purchase of any kratom product. The AKA advocates for consumer protection. That means support for policies requiring safely formulated natural kratom leaf products, proper labeling, age restrictions, contaminant testing, responsible manufacturing standards, and clear limits that prevent dangerous adulteration or chemical manipulation.

The companies you criticize for supporting the AKA are not being defended because they sell products. They are companies willing to support lobbying efforts to protect consumers through rational regulation. That is very different from the 7-OH manufacturers who chose to evade federal requirements, push chemically manipulated opioid products into gas stations and smoke shops, and then claim that enforcement against them is somehow an attack on personal freedom.

It is not.

No responsible public health policy would support allowing consumers to buy opioids from drug dealers on a street corner simply because some adults may want access to them. The same principle applies here. 

Chemically manipulated 7-OH products are opioids. They should not be easily available to anyone through retail channels with no medical supervision, no lawful drug approval, no verified safety profile, no abuse-liability controls, and no meaningful consumer protections.

This is not a debate over bodily autonomy in the abstract. It is a debate over whether manufacturers can bypass the law, create concentrated opioid products, market them as “kratom,” and sell them broadly to consumers without meeting the same safety standards that apply to other opioid products.

Alcohol and tobacco are not a justification for repeating another public health failure. The existence of dangerous legal products does not mean the government should ignore a new class of chemically manipulated opioid products being sold without adequate oversight. It means policymakers should act before the harm becomes larger.

The most important distinction is this: natural kratom leaf products and chemically manipulated 7-OH opioid products are not the same. The AKA has fought for years to protect access to natural kratom leaf for responsible adult consumers. That work is directly threatened by 7-OH manufacturers who blurred the line between kratom and opioids for profit.

Ms. Lindell's anger should be directed at the companies that created this crisis. They put consumers like her in this position. They entered the market unlawfully. They misled consumers. They ignored safety standards. They gambled with public health. And now they want natural kratom advocates to absorb the blame for the consequences of their own conduct.

The AKA will continue to support access to properly regulated natural kratom leaf products. But it will not defend chemically manipulated opioid products masquerading as kratom. Protecting consumers means drawing that line clearly — and enforcing it.

That is not betrayal.

That is responsible advocacy.

Mac Haddow is a Senior Fellow on Public Policy with the American Kratom Association.

Bitter Rivals: Kratom’s Three-Ring Circus

By Pat Anson

In recent years, you’ve probably come across stories about kratom, an herbal supplement used by millions of Americans for pain relief and to help manage conditions such as anxiety and depression. 

While the vast majority of consumers use kratom safely, there is growing concern about outlier cases where kratom is abused or has even been associated with overdoses. 

That has led to several states and dozens of cities and counties banning natural leaf kratom or a potent, concentrated kratom alkaloid called 7-hydroxymitragynine (7-OH). In some cases, they’re banning both.

Less well known is that the growing controversy over kratom is being fueled, in part, by an ongoing turf war between three rival industry-funded advocacy groups. Or, to use another cliche, a three-ring circus.

In one ring is the American Kratom Association (AKA), an organization of kratom manufacturers and vendors that sell natural leaf kratom products. 

In another ring is the Holistic Alternative Recovery Trust (HART), which represents 7-OH manufacturers like American Shaman. 

In the third ring is the Global Kratom Coalition (GKC), which was founded by JW Ross, who made a fortune selling a popular kratom-kava shot called “Feel Free.” 

Like the AKA, the GKC favors natural leaf kratom, and takes a pugnacious approach to critics and competitors. The GKC likens rival 7-OH products to “powerful prescription opioids” that should be banned or heavily regulated. 

You would think the AKA and GKC would be on the same team, since they both want to keep natural leaf kratom legal and accessible. But they are bitter rivals.

In an open letter, AKA chairman Matt Salmon said that GKC founder Ross is actually Jerry Cash, a convicted embezzler, who is trying to “make the AKA look bad” by misstating its position on kratom product formulations.

Salmon, a former congressman, also accused the GKC of launching a smear campaign against Mac Haddow, an AKA lobbyist who had his own run-ins with the law. Salmon’s letter is nearly three years old, but helps explain what is happening today.

“The most recent attacks against AKA and the personal attacks on Mac Haddow came after several ambush interviews orchestrated by Mr. Ross and his PR team providing incomplete, mischaracterized, and demonstrably false information to reporters,” said Salmon.

Kratom vs 7-OH

All three kratom groups accuse each other of jeopardizing what has become a lucrative business opportunity: selling a popular herbal supplement that is still largely unregulated by the federal government. Currently estimated to be worth over $2 billion, the global kratom industry is projected to grow to nearly $8 billion by 2032.

The latest example in this turf war is a self-styled “consumer alert” by the AKA warning about the “growing proliferation of dangerous products” containing 7-OH and other kratom extracts.   

“Consumers deserve to know the truth,” said Haddow, Senior Fellow on Public Policy for the AKA, in a press release. “These 7-OH products are not traditional kratom. They are being engineered, concentrated, and marketed in ways that create risks that are not associated with natural kratom leaf.” 

As evidence, the AKA cites lab results commissioned by the Texas Attorney General, which found that several 7-OH products contain alkaloid concentrations that exceed safety limits under state laws modeled after the Kratom Consumer Protection Act (KCPA) – legislation that the AKA has lobbied Texas and 20 other states to enact.    

One such product, Opia 7-OH tablets, contain over 16mg of 7-OH – which is 96% of their total alkaloid content – well above the 2% limit under the KCPA.  

AKA IMAGE

Critics of the KCPA say the law is misleading, doesn’t protect consumers, and is designed primarily to protect the financial interests of the AKA and other vendors who sell natural leaf kratom.    

Not surprisingly, the AKA disagrees. It wants 7-OH scheduled as a controlled substance and a ban on 7-OH being marketed as “kratom” –  moves that would preserve the legal status of natural leaf kratom.

“This is not a debate about kratom,” says Haddow. “This is about stopping a new class of unregulated, opioid-like substances from being disguised as something they are not.” 

The Holistic Alternative Recovery Trust takes issue with the portrayal of 7-OH as a dangerous opioid.

“7-OH is not a synthetic substance or a novel additive, it is a naturally occurring alkaloid found in the kratom leaf itself. Calling it anything else misrepresents the science,” a HART spokesperson said in a statement to PNN.

“This is part of a broader pattern we’ve seen from the American Kratom Association and the Global Kratom Coalition, misrepresenting the science in ways that benefit certain segments of the market, particularly whole-leaf producers, while dismissing or sidelining millions of consumers who rely on 7-OH products.”

‘Kratom Is an Opioid’

The AKA’s latest attack on 7-OH comes on the heels of the GKC’s endorsement of a bill in Congress that would target “lab-made opioids” by amending the Controlled Substance Act to include 7-OH as a Schedule One substance, in the same category as heroin.

The association with opioids is a bit of a canard, but it makes for a good headline. Kratom comes from the leaves of the Mitragyna speciosa tree, which has more in common with coffee trees than it does with poppy plants, from which opioids such as heroin are produced. 

Like kratom, coffee and other comfort foods such as chocolate stimulate endorphin nerve receptors and have “feel good” effects. You might even say they have mild “opioid-like” effects. But that doesn’t make Hershey’s Kisses opioids or Mrs. Olson a drug dealer for peddling Folgers coffee.  

Squabbling over the safety of each other’s products has not benefited kratom consumers and has contributed to sensational reporting about kratom and 7-OH causing addiction and overdoses. 

The latest example appears in The Conversation, which commissioned Dr. Andrew Kolodny to write an op/ed about kratom. Kolodny is the founder and president of Physicians for Responsible Opioid Prescribing (PROP), an influential anti-opioid activist group. 

Kolodny used a misleading CDC study about calls to poison control centers to paint a misleading portrait of kratom as just another opioid.

“For now, the evidence shows that kratom is an opioid with real risks – not a harmless supplement,” wrote Kolodny, while shamelessly ignoring his own role in restrictions on the use of opioid medication, which ironically led to greater use of kratom.

“Kratom’s rising use over the past decade coincided with the opioid crisis, as people searched for alternatives to prescription opioids,” he wrote. “Some in the kratom industry argue that only newer products with boosted levels of 7OH are dangerous. But the evidence does not support that claim. Deaths linked to kratom were already rising before the newer 7OH products appeared on the market in late 2023.”  

The three kratom advocacy groups – who all favor limited regulation – would be wise to consider that demonizing each other’s products only blurs the lines between kratom and 7-OH, which contributes to state after state and city after city enacting bans on both.

“There are legitimate concerns in the marketplace, particularly around inconsistent products, unclear labeling, and lack of transparency. Those issues deserve attention. Consumers should know exactly what they are purchasing through clear labeling, verified third-party testing, and honest disclosure of potency and contents,” says HART.

“But the solution is not to single out or ban one compound based on flawed narratives. Policymakers should instead focus on enforceable manufacturing standards and practical safeguards, such as milligram-per-serving limits, standardized labeling, and quality controls, rather than arbitrary caps that risk eliminating products people currently rely on.”

Last summer, the FDA said it would ask the DEA to have 7-OH – but not whole leaf kratom – classified as an illegal Schedule One controlled substance.

The DEA, which doesn’t even mention kratom or 7-OH in its most recent National Drug Threat Assessment, has yet to move forward on the FDA’s request. Perhaps federal agencies are just as divided about kratom as kratom advocates are.

States Wrestle with Kratom Regulation

By Mara Silvers, KFF Health News

Montana lawmakers are grappling with how — if at all — the state should rein in kratom, an unregulated plant-derived substance with addictive properties sold mainly as a mood and energy booster at gas stations, vape shops, and elsewhere.

Kratom, which originates from the leaves of a tree native to Southeast Asia, is also touted for helping relieve pain and opioid withdrawal symptoms. But it can have wide-ranging mental and bodily effects, according to the federal Drug Enforcement Administration, addiction medicine experts, and kratom researchers. Reports of deadly kratom overdoses have surfaced in recent years, though often in combination with other substances.

But the drug is in a gray federal regulatory area: It’s designated by the DEA as a “drug and chemical of concern,” but it is not considered a controlled substance. Legislation introduced in Congress in 2023 to study kratom has not advanced.

The lack of federal regulation and congressional action has left it to states to step into the complex debate over how to clean up supply chains and protect users.

The kratom industry itself wants to help address this regulatory void. A bill drafted by the American Kratom Association, a national industry lobbying group, is pending in the Montana Legislature. In its current form, the industry-dubbed “Kratom Consumer Protection Act” would ban sales to people under 18 and restrict which products can be labeled as “kratom” based on the amount and potency of two chemical components, mitragynine, and 7-hydroxymitragynine.

Similar industry-backed bills have passed in 14 states, including Oregon, Texas, Kentucky, and Maryland, according to the American Kratom Association website. Other states, including Wisconsin and Arkansas, have enacted kratom bans by listing it as a Schedule I controlled substance.

Oliver Grundmann, a University of Florida researcher who has studied kratom since 2016, said industry-written bills often hinge on producers accurately representing what’s in their products. Lawmakers and the public in Montana may not be convinced that the proposed legislation will put public health considerations above commercial interests.

“Naturally, a company is driven by profits and making sure that they can retain their profits,” Grundmann said. “I’m skeptical of self-regulation.”

Whether the Montana bill will be effective hinges on the state’s having enough resources to regulate the industry, as well as industry retailers honestly testing and marketing their products, he said.

The bill’s sponsor, Republican Rep. Nelly Nicol, said she’s trying to bring her fellow lawmakers up to speed on a substance that few people understand. Nicol said she delayed House Bill 407’s first committee hearing to give herself more time to speak with legislators and to hear from groups that support and disagree with the industry’s suggested approach. She indicated she’s open to amending the bill, though it has not yet been rescheduled for a committee hearing.

“We’re going to be changing our minds and learning things and molding this as we’re going,” Nicol said in a February interview.

Potentially Addictive

Researchers and addiction medicine experts have struggled in recent years to pin down kratom’s health effects and patterns of use. A federal survey from 2021 estimated that 1.7 million Americans age 12 and older used the substance in some way the year before the study.

Medical providers and addiction researchers in Montana say patients often don’t disclose their kratom use to health care providers. Some consider it an herbal supplement, a perception driven by its accessibility in gas stations and vape shops, rather than a mind-altering and potentially addictive drug.

Megan Zawacki, a physician assistant and addiction medicine specialist in Helena, said many of her patients seek help for misuse of other substances and aren’t easily convinced of kratom’s negative side effects.

“The majority of my patients that are using it can’t even quantify to me how much they’re using,” Zawacki said.

But if their use spirals into addiction, she said, the consequences of the substance become clearer. At her clinic in Helena, Zawacki said, more of her patients are currently being treated for kratom addiction than for opioid use disorder.

“I’ve had two patients specifically in the last calendar year tell me, ‘We need to bring legislation against kratom,’” she said. “Because it is so readily available and so misunderstood that it just is wreaking havoc on their lives.”

Depending on how it’s manufactured and how much users consume, kratom can function as a stimulant or a sedative.

Though not an opioid, its key chemical components can target opioid receptors in the brain, leading some advocates to cite its potential for helping opioid users manage withdrawal.

Zawacki and other Montana providers say they have prescribed buprenorphine to help patients stop using kratom — the same treatment often used to manage opioid addiction.

“What we have seen in recent years is even stronger extracts that focus specifically on mitragynine and 7-hydroxymitragynine. These should not be seen as ‘kratom’ any longer.”

— Dr. Oliver Grundmann, University of Florida

Some Montana advocacy groups that work to prevent substance misuse have also flagged concerns about kratom use among minors. Beth Price Morrison, with the Alliance for Youth in Great Falls, said her organization has pressured gas stations in the area to stop carrying kratom products or at least keep them behind the counter.

“Our youth are really struggling with mental health right now, and they turn to substances to cope. And this stuff is easily accessible,” Price Morrison said.

Price Morrison and Nicol expressed support for raising the age limit on kratom sales to users 21 and older, rather than 18, which is in the current draft of the American Kratom Association bill.

The legislation would allow state regulators to screen kratom products coming on the market in Montana and create a registry of permitted distributors. Vendors would be banned from selling or promoting kratom products whose concentration of 7-hydroxymitragynine exceeds 2% of the total alkaloid content.

The American Kratom Association and other supporters say that such a restriction would help weed out natural forms of kratom from synthetic, higher-potency concoctions. Some kratom researchers have endorsed this type of market regulation, citing the chaotic array of products currently allowed to sport kratom labels.

Grundmann, the University of Florida researcher, said there has been an “evolution” in the United States of products being labeled and sold as kratom.

“The kratom that was on the market then was basically ground-up leaf powder that was not further concentrated,” Grundmann said. “What we have seen in recent years is even stronger extracts that focus specifically on mitragynine and 7-hydroxymitragynine. These should not be seen as ‘kratom’ any longer.”

Grundmann, who supported a similar version of legislation in Arizona in 2019, said Montana’s bill is a starting point for regulation. He said other states, including Colorado, began with a common framework and put more guardrails in place in recent years.

Price Morrison, the youth prevention advocate, said she has broader misgivings about any bill that normalizes the sale of kratom in Montana. In an ideal world, she said, she would like to see the product banned completely.

“We know that availability drives use. And when a product is marketed as regulated, it gains legitimacy,” Price Morrison said. “And more people, including those who are vulnerable, end up using it.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

Kratom Still Widely Available Despite Safety Concerns

By Pat Anson

Kratom may be banned in six U.S. states and dozens of cities and counties, but the herbal supplement is still widely available in tobacco and vape stores despite concerns about its safety, according to a new study.

Kratom has been used in southeast Asia for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have discovered that kratom can be used to treat pain, anxiety, depression and addiction. The FDA, however, has not approved kratom for any medical condition and warns that it may cause addiction and overdoses.

“The FDA has serious safety concerns with the use of kratom in dietary supplements and conventional foods. Based on the available scientific data and information, the FDA has concluded that kratom is not lawfully marketed as a dietary supplement,” the agency warned.

To see whether those warnings are taken seriously, a team of academic researchers contacted 520 tobacco and vape shops across the United States to see if they were selling kratom.

"I spent my nights and weekends for about three, four weeks making these calls and just asking," Matthew Rossheim, PhD, Associate Professor at the University of North Texas Health Science Center, said in a press release. "What we found is that these products are widely available."

In states where kratom is legal, Rossheim and his colleagues found that over 80% of tobacco and vape stores were selling it. But even in the states where kratom and its alkaloids (mitragynine and 7-hydroxymitragynine) are banned – Rhode Island, Alabama, Arkansas, Indiana, Vermont and Wisconsin – some merchants freely admit selling kratom products. In Rhode Island, 40% of the surveyed establishments reported selling the illegal supplement.

UNIVERSITY OF MISSISSIPPI GRAPHIC

"This product, it's being marketed as being a mood stabilizer and painkiller, but then we also have several warnings from federal agencies and people who have died from overdoses," said Andrew Yockey, PhD, Assistant Professor of Public Health at the University of Mississippi. "That is the disconnect, right? There are people who think this is a fantastic product, but it's also linked to these poisonings and hospitalizations.”

About 100 deaths have been linked to kratom use, but in the vast majority of cases other drugs and illicit substances were involved.  

The family of a 23-year-old Georgia man, who died in 2021 after ingesting a potent kratom extract, filed a wrongful death lawsuit against the extract’s manufacturer. Despite the lawsuit, Black Liquid Kratom can still be purchased online, even though one kratom vendor warns the extract is “too strong for use on a daily basis.”

"One of the biggest health things that we're seeing is that these products are hitting the market without supervision," said Yockey. "And if there's no supervision, do you really know what you're putting in your system?"

Dietary supplements are loosely regulated in the United States and kratom is no exception. The American Kratom Association (AKA) is trying to improve the safety and quality of kratom through its GMP standards program, which requires participating vendors to complete an annual independent audit of their manufacturing, processing, and labeling of kratom products.

The AKA is also encouraging individual states to adopt the Kratom Consumer Protection Act, which requires vendors not to adulterate kratom products or to sell kratom in any form to consumers under the age of 18. Nevada, Utah, Arizona and Georgia have adopted similar measures of the bill.

Thailand recently adopted new regulations on the use of kratom in food and herbal products. The guidelines require kratom vendors to register with the Thai Food and Drug Administration and to meet safety and labeling standards. Kratom was listed as an illegal narcotic in Thailand until 2021, but is now regulated under the Kratom Plant Act, which allows for the use, selling, import and export of kratom. No such laws exist at the federal level in the United States.

FDA Flip Flops (Again) on Kratom

By Pat Anson

The Food and Drug Administration can’t seem to make up its mind about kratom.

Just 10 days after publishing an initial notice in the Federal Register seeking public comment on a study about the risk and safety of kratom and psychedelic substances, the agency abruptly withdrew its request.

“FDA no longer intends to proceed with the proposed study as described because circumstances occurred necessitating changes to the scope of the study,” the FDA said in a brief statement, without explaining what “circumstances” changed.

Kratom is an herbal supplement made from the leaves of a tree in southeast Asia, where it has been used for centuries as a stimulant and pain reliever. In recent years, millions of Americans have discovered that kratom can be used to treat pain, anxiety, depression and addiction. The FDA takes a dim view of that, because it has not approved kratom for any medical condition.

“Notably, kratom's unapproved status does not appear to have diminished its growing popularity, with people using kratom to reportedly ‘treat’ certain health conditions. Its chemical affinity with opioid and use among patients with opioids use disorder as a ‘treatment’ is of public health concern for the Agency,” the FDA said in its August 2 notice. “The use of this substance, that has yet to be tested and determined safe for use in human population by the Agency, is a significant concern.”

The FDA seems particularly interested in studying how consumers buy kratom or psychedelic substances, what benefits they get from them, and whether “marketing strategies nudge purchase and affect use demand.” The FDA hired a market research firm, the Brightfield Group, to conduct an “Exploratory Behavioral Economics Study” to see what motivates kratom and psychedelic users.

The agency could have saved itself some time and money by looking at the findings from a PNN survey of 6,150 kratom users. Over 90% said kratom was “very effective” at treating pain and other medical conditions, and 98% didn’t believe kratom was harmful or dangerous.

‘Embarassing Mistake’

Kratom advocates say the FDA’s withdrawal of the study notice was the “latest embarrassing mistake” the agency has made about kratom.

In 2016, the FDA joined with the DEA in proposing that kratom be classified as an illegal Schedule I controlled substance, a request that was later withdrawn due to the “significant risk of immediate adverse public health consequences” if kratom was banned nationwide. A top federal health official said FDA staff based their scheduling request on “embarrassingly poor evidence & data.”

“The FDA’s few anti-kratom staff are repeatedly undermining the Agency’s credibility on harm reduction strategies,” Mac Haddow, Senior Fellow on Public Policy at the American Kratom Association (AKA), said in a statement. “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.”

Others disagree about kratom’s safety. The Brightfield Group is tracking social media posts about kratom and is reportedly seeing more online discussions about its risks and addictive properties. While hundreds of deaths have been linked to kratom use, most cases involve other drugs and illicit substances, making it difficult to determine the exact cause of death.  

“Describing kratom as a ‘benign botanical supplement’ is dangerously misleading. Kratom has documented risks, including addiction potential. Downplaying these risks does a disservice to consumers,” says attorney Matt Wetherington, who represents the family of Ethan Pope, a Georgia man who died after consuming a potent kratom extract called Black Liquid Kratom, made by Optimized Plant Mediated Solutions (OPMS).  

Pope’s family has filed a wrongful death lawsuit against OPMS, as well as the AKA and other kratom vendors. The FDA issued a recent alert urging people not to ingest Black Liquid Kratom, a warning the AKA has characterized as a “coordinated effort” by trial lawyers to drum up more clients for a class action lawsuit.  

“The AKA's overall combative tone towards the FDA and trial lawyers is counterproductive. Constantly framing regulators as enemies undermines opportunities for constructive dialogue that could actually benefit kratom users,” says Wetherington. “No one but the FDA actually knows why they withdrew the request to study. Speculating beyond their stated reason is a fool’s errand.”

FDA Warning About Kratom Death Challenged by Critics

By Pat Anson

The FDA is warning consumers not to ingest a liquid kratom extract after the death of one person and “many reports” by users of other serious adverse events, including withdrawal, addiction, anxiety and aggressive behavior.

The FDA’s July 26th alert about Black Liquid Kratom, which is made by Optimized Plant Mediated Solutions (OPMS), contained no details about the death or any of the adverse events. It was soon challenged by the American Kratom Association (AKA), which said the “mistaken and misguided safety alert” should be withdrawn until the FDA independently verified claims about the death.   

In recent years, kratom has become a popular supplement in the United States, where it is used by millions of people to self-treat their pain, anxiety, depression and substance use problems. Although legal in most states, kratom has never been approved for medical use by the FDA.

“Products containing kratom have been marketed as foods, including dietary supplements, or drugs with claims of therapeutic benefits. However, the FDA has not approved any prescription or over-the-counter drug products containing kratom or associated compounds, mitragynine and the more potent metabolite, 7-OH mitragynine,” the alert warned.

“The FDA recently received an adverse event report of a person who died after using OPMS Black Liquid Kratom. This is one of many reports of serious adverse events individuals have reported experiencing after consuming OPMS Black Liquid Kratom.”

The agency released no other information about where or when the death occurred. Only one death involving 7-OH mitragynine is recorded on the FDA’s Adverse Events Reporting System. That case was reported in 2023, but the death may have occurred earlier.

In 2021, a Georgia man died after consuming Black Liquid Kratom. An autopsy concluded that 23-year old Ethan Pope died from cardiac arrest due to mitragynine intoxication. Pope’s family has filed a wrongful death lawsuit against OPMS, the AKA and other kratom vendors.

Kratom is normally sold as a dry unadulterated powder, but Black Liquid Kratom is a highly concentrated 50:1 extract containing up to 375mg of mitragynine — an alkaloid that acts on the same receptors in the brain as opioids.

A kratom vendor that sells Black Liquid Kratom warns the extract is “too strong for use on a daily basis.”

If the 2021 Georgia death is the one FDA is referring to in its safety alert, it raises questions about why the agency waited so long to warn consumers about the extract or why it was never recalled. Black Liquid Kratom can still be purchased from a number of kratom vendors.

"The consistently unreliable and often false statements about kratom issued by the FDA over the past decade, which is a part of its relentless and misguided pursuit of banning kratom products that is not supported by reliable science, are wrong and Commissioner Califf should hold his agency fully accountable," Mac Haddow, Senior Fellow on Public Policy at the AKA, said in a statement.

"The various autopsy reports that have claimed that kratom is the sole cause of deaths have been thoroughly refuted as incomplete, poorly documented, hastily concluded, or demonstrably incorrect."

Alert ‘Coordinated’ by Trial Attorneys

In 2016, the FDA and DEA tried unsuccessfully to ban kratom products nationwide by listing it as a Schedule I controlled substance. An Assistant Secretary for Health in the Trump administration withdrew the FDA’s scheduling request in 2018, saying it was based on “embarrassingly poor evidence & data.”

The AKA characterized the FDA’s alert as another effort to demonize kratom that was being “coordinated” by trial attorneys seeking to cash-in on product liability lawsuits. A New York law firm even cites the alert on its website, telling kratom users that it was “ready to represent you in your injury case.”

“Plaintiff’s trial attorneys have been openly encouraging clients and other anti-kratom advocates to submit complaints to the FDA on alleged deaths over the past few months and have taken to social media platforms to solicit others to do so. The FDA ‘safety alert on kratom’ appears to be the result of a coordinated effort by those trial attorneys who have a financial interest in litigation against the very company the FDA’s safety alert identifies,” the AKA said.

A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps reduce the use of opioids, and has a low risk of adverse effects. Hundreds of deaths have been linked to kratom use, but in the vast majority of cases other drugs and illicit substances were involved.  

A toxicology test on Ethan Pope found antihistamines and antidepressants in his system, but no illegal drugs or alcohol. The Georgia Bureau of Investigation classified his death as an accident.

‘Super High Concentration’ of Kratom Involved in Georgia Man’s Death

By Pat Anson, PNN Editor

The family of a 23-year-old Georgia man who died last year after ingesting a potent kratom extract has filed a wrongful death lawsuit against a kratom manufacturer and a trade association that promotes the company for following good manufacturing standards.

Ethan Pope was found dead on the kitchen floor of his apartment on December 3, with his dog by his side. Pope had recently purchased bottles of Black Liquid Kratom made by Optimized Plant Mediated Solutions (OPMS).

An autopsy concluded that Pope died as a result of cardiac arrest due to mitragynine intoxication, and his death was ruled an accident by the Georgia Bureau of Investigation.

Mitragynine is an alkaloid and one of the active ingredients in kratom, which comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever.

ETHAN POPE

In recent years, kratom has become a popular supplement in the United States, where it is used by millions of people to self-treat their pain, anxiety, depression and substance use problems. It is sold legally in most states, including Georgia, where it can be purchased at gas stations and smoke shops.

Kratom is normally consumed as a dry unadulterated powder, but the Black Liquid Kratom allegedly consumed by Pope is a highly concentrated 50:1 extract, with up to 375mg mitragynine per bottle.

“This super high concentration can be felt with just a drop or two of the extract added to your tea or coffee. Even veteran users of kratom should start slow with this liquid extract because it is so different from other liquid extracts on the market,” is how one kratom vendor markets Black Liquid Kratom.

Another kratom vendor specifically cautions that OPMS extracts are “too strong for use on a daily basis.”

It’s not clear how long, how often or why Pope had been taking kratom, but at a news conference this week his parents said they found a to-do list in his apartment that included the words “Stop taking kratom.”

The family’s lawsuit was originally filed in May and an amended complaint was filed this week, naming over a dozen different individuals, vendors and organizations, including OPMS and the American Kratom Association (AKA).    

“You don’t expect to go into a store and find something similar to heroin between energy drinks and breath mints. We intend to hold every single person and entity involved in the distribution and sale of these products responsible,” attorney Matt Wetherington said in a statement.

The lawsuit drafted by Wetherington makes frequent references to kratom as a heroin-like substance, but there is no relationship between the two. Heroin is derived from opium plants, while kratom comes from mitragynine speciosa trees. Both act on opioid receptors in the brain, however, which has led to claims that kratom is an opioid.

OPMS has not commented publicly on the lawsuit, and the AKA issued a short statement saying it rejected the lawsuit’s claims and filed a motion to be dismissed from the case.

‘100% Natural and Never Adulterated’

OPMS is featured on the AKA’s website as one of the first kratom vendors to comply with its Good Manufacturing Practice Standards Program (GMP), an effort to enhance the safety of kratom products. To get “GMP Qualified” status, vendors have to agree to annual audits, inspections and testing of every production lot of kratom.    

“Optimized Plant Mediated Solutions has been the leader in the Kratom and Kava extract industry since 2010 due to its unique cold water extraction process. All O.P.M.S. products are 100 percent natural and never adulterated,” the AKA says on its website, which includes a link where OPMS products can be purchased directly from the company.

OPMS did not immediately respond to a request for comment from PNN. The company’s website cautions consumers that “several companies illegally counterfeit” its products, adding “dangerous ingredients” that pose a “serious health threat.” It urges consumers to report any suspicious products.

Taken in low doses, kratom acts as a mild analgesic and stimulant. Consumers generally take higher doses to combat severe pain and cravings caused by substance addiction. Most users do not experience a “high” or euphoria after taking kratom.

The Food and Drug Administration has not approved kratom for any medical use and vendors can run into trouble with the agency if they claim kratom can be used to treat health conditions. The FDA tried for years -- unsuccessfully – to schedule kratom as a controlled substance, which would effectively ban its sale and use in the United States. The FDA says kratom’s effects on the brain are similar to morphine and that kratom has “properties that expose users to the risks of addiction, abuse, and dependence.”

Not all federal agencies take such a dim view of kratom. A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

About 100 deaths have been linked to kratom use, but in the vast majority of cases other drugs and illicit substances were involved.  A toxicology test on Ethan Pope found antihistamine and antidepressant medications in his system, but no illegal drugs or alcohol were detected.

FDA Seeking Public Comments on Kratom

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is seeking public comments on the medical use and abuse of kratom. In a notice published Friday in the Federal Register, the FDA said the comments will be reviewed as it prepares a response to the World Health Organization (WHO), which is considering whether to place international restrictions on kratom and six other psychoactive substances.   

Kratom comes from the leaves of the mitragyna speciosa tree in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have discovered kratom and use it to self-treat pain, anxiety, depression and addiction. The FDA has tried -- unsuccessfully so far – to schedule kratom as a controlled substance, which would effectively ban its sale and use in the United States.

Under international treaties, WHO is required to assess the use of psychoactive substances and advise the United Nations on whether they pose a public health risk and should be controlled. The annual assessment will begin in October and U.N. members have been invited to submit their recommendations.

Although the FDA said the U.S. will defer from making any immediate recommendations to WHO, the notice in the Federal Register makes plain that the agency still has a dim view of kratom. It makes no mention of the medical benefits many kratom users get from the herbal supplement.

“Kratom has a history of being used as an opium substitute in Southeast Asia. In the United States, kratom is misused to self-treat chronic pain and opioid withdrawal symptoms.”

— FDA

“Kratom is an increasingly popular drug of abuse and readily available on the recreational drug market in the United States. Evidence suggests that kratom is abused individually and with other psychoactive substances,” the FDA said.

“Kratom has a history of being used as an opium substitute in Southeast Asia. In the United States, kratom is misused to self-treat chronic pain and opioid withdrawal symptoms. Consumption of kratom can lead to a number of health impacts, including, among others, respiratory depression, vomiting, nervousness, weight loss, and constipation. Kratom has been reported to have both narcotic and stimulant-like effects.”

The American Kratom Association (AKA), a group of kratom vendors and consumers, said FDA instigated WHO’s review of kratom as a way to bypass the drug scheduling process in the U.S. The AKA is urging kratom consumers to submit positive comments about the herbal supplement.  

“The comments should be focused on the experiences that kratom consumers have had with kratom and how it has benefited them in terms of improving their quality of life, to reduce pain, to reduce anxiety and depression, to wean off of opioids, and how kratom has saved their lives,” Mac Haddow, an AKA lobbyist, said in a video. “We want the WHO to know the powerful experiences that people have had. We want to protect kratom, not only here in the United States, but also around the world.”

There’s an August 9 deadline for comments, which can be submitted here.

Asked if the FDA requested WHO to review kratom, a spokesperson told PNN the agency “does not determine for the U.S. government which substances shall be proposed” for review. WHO reviews can be requested by any member countries that are signatories to international drug control treaties.

Kratom’s legal status varies around the world. Thailand recently decriminalized kratom and will make the plants legal to grow and export in August. Kratom use is banned domestically in Indonesia, but kratom farming is still permitted. Most kratom exports come from Indonesia, where it is considered an important cash crop.

Kratom sales are legal in most U.S. states, although some states and communities have banned it. The FDA recently seized 37 tons of kratom from a vendor in Florida for alleged violations of a federal law that prohibits the sale of adulterated dietary supplements.

A federal effort in 2016 to ban kratom nationwide failed due to a public outcry. Two years later, the Department of Health and Human Services (HHS) withdrew a request to classify kratom as a Schedule I controlled substance, citing lack of evidence it can be abused or posed a public health threat. A top HHS official later said the FDA request to schedule kratom was rejected because of “embarrassingly poor evidence & data.”

Study Estimates Two Million Americans Use Kratom

By Pat Anson, PNN Editor

A new study estimates that less than one percent of Americans -- about two million people --- use kratom, an herbal supplement that’s growing in popularity as a treatment for pain, depression, anxiety and addiction.

The study, one of the first to look at kratom use in the general population, is based on data from the 2019 National Survey on Drug Use and Health – the first year the annual survey asked respondents about kratom.

Researchers at New York University’s Grossman School of Medicine looked at data from over 56,000 people who participated in the survey and estimated that 0.7 percent of adults and adolescents in the U.S. used kratom in the past year.

Kratom use was more likely by people who also use cannabis, stimulants and cocaine, and was particularly common among those who misuse prescription opioids. About 10 percent of people diagnosed with opioid use disorder reported kratom use.

“It was not surprising at all that such a large portion of people with opioid use disorder use kratom. What I didn’t expect was to find kratom use to be independently linked to cannabis use disorder,” said study author Joseph Palamar, PhD, an associate professor of population health at NYU Grossman School of Medicine.

“A lot of people who use substances to get high also use other substances to get high — alone or in combination. If anything, I hope that results of this paper demonstrate not only that a lot of people with opioid use disorder use kratom, but also a lot of people who use other drugs have been adding this substance to their drug repertoires for whatever reason.”

Men, white people, and those with depression and serious mental illness were also more likely to report using kratom. Teenagers and adults over 50 were less likely to use it.

The findings are similar to those in a 2016 PNN survey of over 6,000 kratom users. A little over half said they primarily used kratom for pain relief, while others used it as a treatment for anxiety (14%), opioid withdrawal (9%), depression (9%) and alcoholism (3%).  Over 90% said kratom was “very effective” in treating their medical condition.   

“A lot of people who use kratom rave about its ability to decrease opioid withdrawal, but kratom itself can be addicting so people need to be aware and be careful. Kratom might indeed be able to serve as a useful tool for people seeking to get off opioids, but I think more research is needed to determine exactly how it should be used and how to use it safely,” Palamar said in an email to PNN.

The study, published in the American Journal of Preventive Medicine, notes that over 150 overdose deaths linked to kratom have been reported. But most of those overdoses also involved other drugs such as illicit fentanyl, heroin and cocaine, or prescription drugs such as benzodiazepines and psychiatric medications.    

“Given the high number of poisonings involving kratom combined with other drugs, I hope that at least people who decide to use it try to avoid combining it with other substances,” Palamar said.

Kratom comes from the leaves of a tree that grows in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever. Kratom can be sold legally in most U.S. states, but vendors can run into trouble if they claim it can be used to treat medical conditions. The FDA says it has “serious concerns” about kratom because of its opioid-like properties.

A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

The American Kratom Association, an advocacy group for kratom consumers and vendors, claims that 10 to 16 million Americans use kratom. That estimate is based on exports to the U.S. reported by kratom growers in Indonesia.

FDA Updates Import Alert for Kratom

By Pat Anson, PNN Editor

Federal health officials may have dropped plans to schedule kratom as a controlled substance, but that’s not stopping the Food and Drug Administration from updating an import alert that gives the agency broad powers to seize shipments of the herbal supplement.

The alert targets dozens of kratom exporters and importers in the United States, Canada, Indonesia, Malaysia and the Philippines, and allows FDA inspectors to detain “without physical examination” dietary supplements and ingredients that contain kratom.  In an email, an FDA spokesperson told PNN the alert was updated for “minor changes” involved with one firm’s listing  

Kratom is an herbal supplement that comes from the leaves of a tree that grows in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have discovered kratom, using it to self-treat their chronic pain, anxiety, depression and addiction.

The FDA says it has “serious concerns” about kratom because of its opioid-like properties.

“Consumption of kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms,” the alert warns.

The FDA issued its first import alert for kratom in 2012, just as kratom was gaining in popularity in the U.S. Since then, several large shipments of raw kratom or kratom supplements have been seized. One of the largest seizures was in 2018, when 28 tons of kratom were confiscated at a South Carolina warehouse operated by Earth Kratom, a kratom wholesaler and vendor. The kratom was later incinerated.   

Kratom can be sold legally in most U.S. states, but vendors can run into trouble if they claim it can be used to treat medical conditions or market it as a dietary supplement.

A lobbyist for the American Kratom Association, an association of kratom vendors and consumers, said the updated alert is part of the FDA’s “disinformation campaign” against kratom.

“The FDA routinely uses the import alerts in discussions with various stakeholders to highlight their claims that kratom is not ‘legally marketed’ in the United States, and by adding a recent date by way of an update makes it appear to be a recent action,” said Mac Haddow. “The import alert is an abuse of that authority that is supposed to apply to contaminated and adulterated products.

“In fact, the objections listed in the import alerts issued by the FDA technically only apply to importers who are subsequently making illegal therapeutic claims or as a dietary supplement on marketing materials. A bulk kratom importer is not subject to FDA's authority. Kratom processors who make no claims and sell kratom as a food are not subject to any pre-market approval by the FDA.”

Federal efforts to ban kratom in 2016 failed due to a public outcry. Two years later, federal health officials quietly withdrew their request to classify kratom as a Schedule I controlled substance because of “lack of evidence” it can be abused or posed a public health threat. The FDA, however, still maintains “significant potential safety concerns” about kratom. 

A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

Feds Withdrew Request to Ban Kratom in 2018

By Pat Anson, PNN Editor

Federal health officials quietly withdrew their request for kratom to be classified as a Schedule I controlled substance in August 2018, according to a previously undisclosed letter to the U.S. Drug Enforcement Administration.

The letter from Brett Girior, MD, Assistant Secretary for Health & Human Services (HHS), to the DEA’s acting administrator cited concerns that “there is a significant risk of immediate adverse public health consequences to potentially millions of users if kratom or its components are included in Schedule I.”

Kratom is an herbal supplement comes from the leaves of a tree that grows in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have discovered kratom, using it to self-treat their chronic pain, anxiety, depression and addiction. Classifying kratom’s two active ingredients, the alkaloids mitragynine and 7-hydroxymitragynine, as Schedule I substances would effectively ban kratom by making its sale and possession illegal.  

The 2018 letter from HHS was made public this week by the American Kratom Association (AKA), an advocacy group for kratom consumers and vendors, which said it obtained the letter from Rep. Mark Pocan (D-WI).

“The decision by the FDA to not disclose the recission of their recommendation for scheduling of kratom that took place more than 2 ½ years ago has significantly misled policy makers, the media, and kratom consumers in the belief a scheduling decision was imminent,” Mac Haddow, Senior Fellow on Public Policy for the AKA, said in a statement. “Six states were duped by this messaging to pass bans on kratom sales, and a number of local county and city governments also based their bans on the FDA’s claims.

“Through all of this the FDA has remained silent and has failed to disclose that HHS reviewed their scheduling recommendation and took the unprecedented action to rescind the recommendation because the FDA had failed to meet its burden under the CSA (Controlled Substance Act).”

An FDA spokesperson said it was not up the agency to disclose the letter’s existence.

“While the FDA is an agency within HHS, the letter at issue was not the FDA’s to publicly disclose and any announcement regarding a decision to schedule or not schedule a potential controlled substance is made by the Drug Enforcement Administration, not the FDA,” the spokesperson said in an email to PNN.

‘Lack of Evidence’ Kratom is Harmful

Girior’s letter to DEA said there was a “relative lack of evidence” that kratom can be abused and posed a public health threat.

“Although there remains cause for concern for 7-hydroxymitragynine and potentially mitragynine, the level of scientific data and analysis presented by the FDA and available in the literature do not meet the criteria for inclusion of kratom or its chemical components in Schedule I of the CSA at this time,” Girior wrote. 

“There is still debate among reputable scientists over whether kratom by itself is associated with fatal overdoses. Further analysis and public input regarding kratom and its chemical components are needed before any scheduling should be undertaken.”  

The DEA tried unsuccessfully to list kratom as a Schedule I substance in 2016, calling it an “imminent hazard to public safety,” a decision that was reversed after a public outcry from kratom supporters. 

But federal efforts to demonize kratom continue to this day, led for a time by FDA Commissioner Scott Gottlieb, who claimed kratom was an opioid and should not be used to treat any medical condition. Gottlieb resigned as FDA Commissioner in 2019, eight months after Girior’s letter. The agency he led remains opposed to kratom.   

“Kratom products have been associated with significant potential safety concerns. While it is important to gather more evidence, data suggest that certain substances in kratom have opioid properties that expose users to the risks of addiction, abuse and dependence,” the FDA spokesperson said.

“There is no FDA-approved drug containing, or derived from kratom, and the agency has received concerning reports about the safety of kratom. The FDA is actively evaluating available scientific information on this issue. In addition, FDA has sent numerous letters to firms that have marketed kratom products with unsubstantiated claims that their products can treat opioid withdrawal and addiction and other serious medical conditions.”

Kratom use has been growing in the U.S. as people seek alternatives to opioid pain relievers and other pharmaceutical drugs. Most kratom users say the leaves have a mild analgesic and stimulative effect, similar to coffee.  

A recent study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and is “relatively safe” to use.

Kratom Advocates Call for End to ‘Leafer Madness’

By Pat Anson, PNN Editor

If you are curious about the herbal supplement kratom and did some research online to learn more about it, chances are you’ve come across some of the scary headlines:

“Warnings Issued on Kratom Use”

“The Herbal Supplement That Could Poison You”

“Kratom Is Unsafe for People’s Health”

“Kratom: Deadly Supplement or Supplementing Death?”

With news coverage like that, you might wonder why anyone would try kratom. But according to the American Kratom Association, there are 16 million kratom users in the United States, most taking it to treat chronic pain, addiction, withdrawal or anxiety.

Why is a popular supplement being demonized in the media? Kratom advocacy groups say many news organizations in the U.S. have succumbed to a collective case of ‘Leafer Madness’ – similar to the ‘Reefer Madness’ over marijuana.

In a media analysis released in May, the industry-funded Kratom Information and Resource Center (KIRC) concluded there was a “tsunami of unfair and unbalanced” reports on kratom.

Ninety-two percent of the nearly 2,500 media stories analyzed by KIRC were found to be negative or unbalanced. Most of the negative coverage was by local media, which was heavily influenced by FDA and CDC reports linking kratom to overdose deaths or comparing kratom to opioids. Those reports were rarely questioned by reporters who didn’t seek another opinion.

This week KIRC followed up on its media analysis by sending a petition to nine media trade organizations asking that kratom be covered more fairly.

“You are in a position to encourage your members to start reporting on the coffee-like herb kratom in a fair and balanced way. Please urge them to tell both sides of the story, seek out the reputable scientists who dispute claims made against kratom, and stop depicting kratom consumers as unsavory characters.

“To date, most ‘reporting’ about the kratom consumed today by millions of American adults without ill effect has been sensationalistic and one-sided, the modern-day equivalent of the irresponsible and inaccurate ‘Reefer Madness’ media depictions that once were used to justify keeping in place restrictions on marijuana and to stigmatize those choosing to consume it.”

The nine media trade groups receiving the KIRC petition are: The American Society of News Editors, National Association of Science Writers, Association of Health Care Journalists, News Media Alliance, Investigative Reporters and Editors, National Newspaper Association, The Association of Magazine Media, Society of Professional Journalists and The National Association of Broadcasters.

“Stop treating kratom like some kind of pinata that you can whack away at as though the rules of journalism don’t apply,” KIRC spokesperson Max Karlin said in a statement.

“Our message to the media is very simple: Get your facts straight about kratom and listen to all voices, not just those with the biggest megaphones. There is a great deal of scientific disagreement about kratom when it comes to such issues as pain management and dependency. All experts should be heard, not just a cherry-picked few who have been lined up by proponents of prohibition.”

The “scientific disagreement” over kratom stems from the fact that so little is known about it – even though it’s been used for centuries in southeast Asia as a natural pain reliever and stimulant.  There have been few clinical studies of kratom to document its risks and benefits — leaving mostly anecdotal reports to rely on.

Still Interested in Learning About Kratom?  

One can find a lengthy and balanced review of kratom that was recently published in the journal Substance Abuse and Rehabilitation.  The authors — two pharmacy professors at the University of Florida and Midwestern University in Arizona — question the claims about kratom causing overdoses, because “causality could not be established in almost all cases because of poly-drug exposures.”

And while reports of kratom addiction “are of serious concern” given the opioid crisis, Oliver Grundmann, PhD, and Charles Veltri, PhD, found no solid evidence that kratom causes dependency.

At the same time, however, they urge kratom consumers to be cautious about be exposed to kratom products that could interact with medications they are already taking.

“The labeling of Kratom products available to consumers needs to follow appropriate regulatory standards as well as quality good manufacturing practices to ensure that consumers who seek out Kratom are not exposed to adulterated or contaminated products,” Grundmann and Veltri wrote. “Health care providers should be trained on the science of Kratom and its clinical implications to assist consumers in making the right choice and avoid herb–drug interactions.”