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.”

Indonesia May Ban Kratom Exports

By Pat Anson, PNN Editor

A possible ban on the growth and export of kratom in Indonesia is raising alarm among kratom users in the U.S. and around the world.  About 95% of the world’s supply of kratom comes from Indonesia, where the herbal supplement has become a lucrative cash crop.

Kratom leaves are harvested from a tree that grows in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have started using kratom to treat pain, addiction, anxiety and depression.

Kratom advocates say the U.S. Food and Drug Administration – which opposes the use of kratom for any medical condition – has been lobbying the Indonesian government to ban kratom farming. Current plans by the Indonesian Ministry of Health call for a 5-year transition period to allow kratom growers to shift to other crops.

“If this ban is allowed to go into effect, it will effectively end consumer access to kratom in the United States, and the FDA won’t have to do anything more to declare victory in the War on Kratom,” said C. M. “Mac” Haddow, a lobbyist for the American Kratom Association (AKA), a group of kratom vendors and consumers.

“Even if some black-market kratom gets into the United States after the Indonesian ban goes into effect, it will be so expensive that only the uber-rich will be able to afford it. And it will likely be extremely dangerous to consume because there will be no standards on growing, harvesting, and shipping.”

FDA Denies Involvement

An FDA spokesman said the agency has “inquired” about kratom in Indonesia, but denied making any effort to have it banned.

“The FDA has inquired to understand the current status of kratom under Indonesian law. However, the FDA has not advocated either formally or informally about a change in law in Indonesia or any other country relative to kratom,” the spokesman said in an email to PNN.

The AKA sent a delegation to Indonesia last month to meet with the Ministry of Health and other government officials. Among the attendees was Duncan Macrae, the founder of Kratom.com and one of the first commercial growers of kratom in Indonesia. Macrae told PNN the initial meeting went well.

“When we left Jakarta we were given the green light that there would always be a legitimate path to export kratom even though the Indonesian government will almost definitely regulate and make kratom illegal for domestic use in Indonesia,” Macrae wrote in an email. “Unfortunately, since there was some (in my opinion) unnecessary outreaching to other departments such as the Agriculture & Quarantine department and also the department of trade, this has stirred up another hornet’s nest.” 

According to the AKA, the Ministry of Agriculture sent a memo in the past week to various agencies in the Indonesian government recommending the ban on kratom be formalized at all levels of government.  

Macrae fears that kratom will also be classified as an illegal controlled substance in Indonesia, which would effectively ban its growth and export.  

“Was the FDA involved? For sure yes! Unfortunately, this went through the U.S. embassy in Jakarta as well.”

— Duncan Macrae, Kratom Supplier

“This means it has no scientific or medicinal use and will even prevent further research from being done on the plant in Indonesia,” said Macrae. “Was the FDA involved? For sure yes! Unfortunately, this went through the U.S. embassy in Jakarta as well.” 

A leading Indonesian politician called on the government to ignore the “world health mafia” and conduct research on the risks and benefits of kratom before banning it.

"Once again the government does not play a ban without doing deep professional research. It is tantamount to throwing away the nation's own assets. In the end Indonesia will only be an importer of finished products from kratom leaves," Daniel Johan, Deputy Chairperson of the House of Representatives, told a local news agency. "Indonesia must master its downstream products so that it is truly beneficial for the people of Indonesia and the world, so that we do not even enter the format of world health mafia war."

Kratom is already banned for domestic use in Indonesia, although the export of raw kratom product is allowed. In 2016, about 400 tons of kratom were shipped every month from Indonesia’s top growing region -- worth about $130 million annually, according to a report from Agence France-Presse. Most of those exports went to the U.S.

The FDA has linked kratom to dozens of fatal overdoses -- although multiple substances were involved in nearly all of those deaths. The FDA has also found salmonella bacteria and heavy metals in a relatively small number of kratom products. 

Last year, the Department of Health and Human Services (HHS) recommended to the DEA that kratom be classified as a Schedule I substance – which would effectively ban it nationwide. Currently, the DEA doesn't even list kratom in its annual report on drug threats. 

The AKA is planning to send another delegation to Indonesia this month to lobby against a kratom ban.

More Overdoses Blamed on Kratom

By Pat Anson, PNN Editor

A new analysis by the Centers for Disease Control and Prevention lists the herbal supplement kratom as the cause of death in at least 91 overdoses in the U.S. from 2016 to 2017.  Multiple substances were involved in the vast majority of those cases, with over half of the deaths also linked to fentanyl, a synthetic and potent opioid that has become a scourge on the black market.

Kratom 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. In recent years kratom has grown in popularity in the U.S. as a treatment for chronic pain, addiction, depression and anxiety.  

Although kratom is not an opioid, public health officials have warned that it has “opioid-like” qualities, can be addictive and is not approved for any medical condition.

In the new study, CDC researchers analyzed over 27,000 fatal overdoses in 27 states between July 2016 and December 2017. Kratom was determined to be the cause of death by a medical examiner or coroner in 91 overdoses, with multiple substances detected in all but seven of them.

Heavy Drug Use

Most of those who died were apparently heavy drug users. In nearly 80 percent of the kratom-involved deaths, the decedents had a prior history of substance misuse and 11% had survived a previous overdose.  Fentanyl or fentanyl analogs were co-listed as a cause of death in 56% of the kratom-involved deaths. Heroin was co-listed in about a third of the kratom cases, followed by benzodiazepines (22%), a class of anti-anxiety medication, prescription opioids (20%) and cocaine (18%).

“I’m actually pleased that they are recognizing that when kratom is present in a decedent, it is usually with other substances. Instead of blaming kratom as the cause of death, it points to polysubstance use,” said Jane Babin, PhD, a molecular biologist and patent attorney. “If someone takes a lethal dose of fentanyl plus kratom, it is unreasonable to conclude that kratom was the cause of death.  The same could be said of a lethal dose of fentanyl plus anything else – cannabis, coffee, Tylenol, etc.  This is the same situation in many ‘opioid related’ deaths, where multiple substances are present.”

Babin has worked as a consultant to the American Kratom Association, an advocacy group of kratom vendors and consumers. She has disputed previous reports of kratom overdoses – attributing them to faulty lab tests and inexperienced coroners.

“When a coroner can’t find an obvious physical cause of death, they pin the death on kratom even though they don’t have a link between the cause and manner of death and what is known about kratom pharmacology,” Babin wrote in an email to PNN. “I think the bigger question that CDC and FDA need to address is why do these people take so many different substances, including prescription medications?  

“The answer is not simple and there is no quick fix.  It is easier to blame kratom or opioids and focus on those instead of addressing the complex problems of pain, mental illness and the circumstances of life that lead people to take multiple substances.  At least they ‘look’ like they are doing something.”

It was another CDC report in July 2016 that laid the groundwork for an attempted ban on kratom. The report called kratom "an emerging public health threat" due to a modest increase in the number of kratom-related calls to poison control centers. The following month, the Drug Enforcement Administration tried to schedule kratom as a controlled substance, something the agency backed away from after a public outcry.

Last week the Food and Drug Administration released a laboratory analysis that found dangerous levels of heavy metals in over two dozen kratom products. However, the agency did not consider the finding significant enough to order a recall. Kratom has never been listed as dangerous substance in the DEA’s annual National Drug Threat Assessment.

FDA Finds Unsafe Levels of Heavy Metals in Kratom

By Pat Anson, PNN Editor

The American Kratom Association’s new certified vendor program has gotten off to an inauspicious start. Kraken Kratom, the first vendor to qualify under the AKA’s Good Manufacturing Standards (GMP) program, has been flagged by the Food and Drug Administration for having dangerous levels of heavy metals in some of its products.

The FDA this week released the final test results on 30 kratom products found to contain levels of lead and nickel considered unsafe for daily human consumption. Five of the 30 samples that tested positive came from Kraken Kratom or one of its affiliated vendors.

“The analysis found significant levels of lead and nickel at concentrations that exceed safe exposure for oral daily drug intake,” the FDA said in a statement. “Based on these test results, the typical long-term kratom user could potentially develop heavy metal poisoning, which could include nervous system or kidney damage, anemia, high blood pressure, and/or increased risk of certain cancers.”

Ironically, last month Kraken Kraken became the first company to receive the AKA’s seal of approval as a certified GMP vendor. To qualify, participants must undergo a third-party audit and inspection of their manufacturing and packaging facilities.   

The company said in a statement posted online that it was never contacted by the FDA about the heavy metal findings or told to take its kratom products off the market.

“Kraken has no information regarding the samples the FDA used in their tests, including when or how the FDA acquired our products or when they tested the samples they obtained,” the statement said.

This isn’t the first time Kraken Kratom has come under FDA scrutiny. Its parent company, PDX Aromatics of Portland, Oregon, recalled thousands of kratom packages last year after samples tested positive for Salmonella bacteria. The company believes the samples that tested positive for heavy metals may have come from an FDA inspection in March, 2018.

“If these samples are from that investigation, their product lots were pulled from the market over 12 months ago as part of the extensive recall we did in cooperation with the FDA. Further, it would indicate that the FDA was rehashing old information, not in an attempt to protect the public, but as a way to target and further stigmatize kratom,” the company said.

In recent years, millions of Americans have discovered kratom, an herb grown and used in southeast Asia for centuries as a natural stimulant and pain reliever. Kratom is widely available online and in smoke shops, but the quality of what’s being sold and what country it came from are often unknown. Like other dietary supplements, kratom products are essentially unregulated and there are little or no quality controls.

That’s one of the reasons the AKA launched its GMP certification program. The organization said it wanted to protect kratom consumers from “unscrupulous vendors using sloppy manufacturing procedures” and those who adulterate kratom to boost its potency by adding substances like fentanyl or morphine.

But under the AKA’s certification program, no kratom products are actually tested for Salmonella bacteria, heavy metals, fentanyl or any other foreign substances.

“No, absolutely not. That is not our function,” AKA President Dave Herman told PNN. “The audit does not inspect the products. The audit inspects the procedures in place to manage the facility.”

Herman says third party auditors hired by the vendor and approved by the AKA only inspect manufacturing procedures — not the kratom itself. He declined to comment on the FDA’s discovery of heavy metals in Kraken Kratom products.

“I have no way of knowing when samples were taken or under what conditions they were taken,” he said. “Was it prior to an inspection? After an inspection? And without that knowledge I’m not sure I can say anything intelligent,” Herman said.

A handful of states have banned kratom and there is speculation the Drug Enforcement Administration will try again to schedule it as a controlled substance, something the agency backed away from in 2016 after a public outcry. FDA commissioner Scott Gottlieb, MD – who leaves office today -- has also mounted an extended public relations campaign against kratom.

"Over the last year, the FDA has issued numerous warnings about the serious risks associated with the use of kratom, including novel risks due to the variability in how kratom products are formulated, sold and used both recreationally and by those who are seeking to self-medicate for pain or to treat opioid withdrawal symptoms,” Gottlieb said in a statement.

“Data suggest that certain substances in kratom have opioid properties and that one or more have the potential for abuse. The findings of identifying heavy metals in kratom only strengthen our public health warnings around this substance and concern for the health and safety of Americans using it."