FDA Wants 7-OH Kratom Derivative Classified as Illegal Drug

By Crystal Lindell

The U.S. Food and Drug Administration is taking the initial steps to make the kratom derivative 7-OH an illegal Schedule One controlled substance – a classification that would put it in the same category as heroin. 

The FDA announced its plan this week, saying it was targeting 7-hydroxymitragynine (7-OH), an alkaloid that occurs naturally in kratom in trace amounts. Some kratom vendors are selling concentrated synthetic versions of 7-OH to boost its potency as a pain reliever and mood enhancer.

The FDA claims it is “not focused on natural kratom leaf products,” but in a report released as part of the announcement, the agency said it still “has concerns about the safety of kratom products more broadly."

The FDA said it is focused on 7-OH for now "because it is a substance with potent mu opioid agonist properties and significant abuse liability." The agency recently warned 7 companies to stop selling kratom products with concentrated levels of 7-OH.

“Vape stores are popping up in every neighborhood in America, and many are selling addictive products like concentrated 7-OH. After the last wave of the opioid epidemic, we cannot get caught flat-footed again,” said FDA Commissioner Marty Makary, MD.

“7-OH is an opioid that can be more potent than morphine. We need regulation and public education to prevent another wave of the opioid epidemic.”

To be clear, neither kratom or 7-OH are derived from poppy plants and they are not opioids. Kratom leaves come from Mitragyna speciosa, a tropical tree native to southeast Asia that belongs in the same botanical family as coffee. 

But because 7-OH acts on opioid receptors in the brain, the FDA claims it is essentially an opioid, a questionable argument the agency has also made about kratom itself. If that were true, you could say nicotine, caffeine, and even cow’s milk are opioids, because they also bind to opioid receptors. 

Curiously, the FDA’s news release did not mention any cases of someone overdosing on 7-OH or being harmed by it – even though the agency’s Adverse Event Reporting System has recorded two deaths and 13 other cases involving 7-OH. However, because of “ambiguity about the contributory role of 7-OH,” the FDA is downplaying the significance of those adverse events.

The only justification offered by the FDA for why 7-OH needs to be classified as a Schedule One controlled substance is the assertion that it is “increasingly recognized as having potential for abuse.” 

Jeff Smith, national policy director at Holistic Alternative Recovery Trust, a kratom advocacy group, told The New York Times the FDA has no data to support taking emergency action on 7-OH.

“If 7-OH posed the kind of urgent danger that would justify emergency action, evidence would have been presented,” Smith said. “It was not.”

Kirsten Elin Smith, a Johns Hopkins University assistant professor who studies kratom, told The Times that she was initially very concerned about 7-OH when it began showing up in kratom products. She has since changed her perspective. 

“If you had asked me a year ago, I would have said this is evil,” Smith said. “At this point I’m a little more equivocal."

The announcement from the FDA is only the first step in what can be a long process for classifying a substance under the Controlled Substances Act. The move requires the Drug Enforcement Administration to publish a notice in the Federal Register, present its evidence, and then allow for a public comment period.  

The DEA tried that with kratom in 2016, at the request of the FDA, but then backed down after a public outcry and opposition from Congress. A top federal health official later said the FDA's scheduling request was based on “embarrassingly poor evidence & data.”

FDA Warns Alkaloid in Kratom Extracts ‘May Be Dangerous’

By Pat Anson

The Food and Drug Administration is cracking down again on the kratom industry, by sending warning letters to 7 kratom vendors about illegally marketing a dietary supplement.

At issue is an alkaloid in kratom called 7-hydroxymitragynine -- known as 7-OH -- which relieves pain, improves mood, increases energy, and has opioid-like properties. 7-OH occurs naturally in kratom, but is present in only trace amounts.

Too boost its potency, some vendors are selling kratom gummies, tablets and extracts with concentrated levels of 7-OH, which the FDA says “may be dangerous.”

“7-OH is not lawful in dietary supplements and cannot be lawfully added to conventional foods. Additionally, there are no FDA-approved drugs containing 7-OH, and it is illegal to market any drugs containing 7-OH. Consumers who use 7-OH products are exposing themselves to products that have not been proven safe or effective for any use,” the agency said in a press release.         

Warning letters were sent this month to Shaman Botanicals, My Smoke Wholesale, Relax Relief Rejuvenate Trading, Thang Botanicals, Royal Diamond Imports, Hydroxie, and 7Tabz Retail. The companies were given 15 business days to respond or take corrective action.

While some of the vendors have removed 7-OH products from their websites, others continue to sell them. Hydroxie, for example, still accepts orders for chewable tablets containing up to 30mg of 7-OH on its website. There are no explicit warnings about the tablets on the webpages where they are advertised, but Hydroxie cautions consumers about 7-OH on its “Warnings” page.     

“This product contains concentrated alkaloids. The potency is significantly greater than raw leaf,” Hydroxie says. “Levels of 7-OH in these tablets are extremely concentrated. Do not use this product without first consulting a doctor about this alkaloid to ensure it is safe for you.”

Kratom has been used for centuries in southeast Asia as a natural stimulant and pain reliever, but only in the past decade has it become widely used in the United States — over the objections of the FDA, which tried unsuccessfully to ban kratom by listing it as a controlled substance.

It’s rare for someone to have an adverse reaction to natural kratom leaf, but people who consume concentrated extracts have been hospitalized or experienced overdoses.

Recently, former CDC Commissioner Robert Redfield, MD, called for kratom products containing elevated levels of 7-OH to be taken off the market.

“What we’re seeing with the compound 7-hydroxymitragynine is a textbook case of how manufacturers exploit regulatory gaps to create products that are, in essence, unregulated pharmaceuticals,” Redfield said.

“To put this in perspective: natural kratom contains less than 0.01 percent 7-hydroxymitragynine. These synthetic products contain concentrations up to 150 times higher. This is not botanical kratom — this is pharmaceutical-grade opioid chemistry operating without oversight.”

Two deaths and three other serious cases involving 7-OH mitragynine have been reported on the FDA’s Adverse Events Reporting System since 2023.  Of the three adverse events reported so far in 2025, one was considered life threatening. Another case resulted in a person being hospitalized. No other details are available.

When used cautiously, kratom advocates say 7-OH is a highly effective pain reliever and safer alternative to opioid medication.

“7-OH can be an invaluable harm reduction tool that should remain an option for the hundreds of thousands of consumers that rely on it,” the Holistic Alterative Recovery Trust (HART) said in a statement.

“HART strongly supports robust regulation and is pursuing legislation federally, and in the states, to mandate that all 7-OH products are manufactured safely, are marketed transparently, and are kept out of the hands of children.”    

Former CDC Commissioner: Kratom Has ‘Low Abuse Potential’

By Pat Anson

The U.S. Food and Drug Administration has a conflicted and contentious history with kratom, the herbal supplement used by millions of Americans to self-treat their pain, anxiety, and depression.  

Kratom has been used for centuries in southeast Asia as a natural stimulant and pain reliever, but only in the past decade has it become widely available in the United States -- over the strong objections of the FDA.

In 2016, the FDA joined with the DEA in proposing that kratom be classified as an illegal Schedule I controlled substance due to its abuse potential, a request that was later withdrawn due to a public outcry.

That setback didn’t stop then-FDA Commissioner Scott Gottlieb, MD, from launching a public relations campaign demonizing and mischaracterizing kratom as an addictive “opioid.” Gottlieb cited FDA research that an Assistant Secretary for Health later called “embarrassingly poor evidence & data.”

To improved its data, last year the FDA said it would conduct a new study on the risks and safety of kratom, and then abruptly cancelled it without explanation, claiming kratom has a “chemical affinity” with opioids and should not be used to treat medical conditions. “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 said.

The claim that kratom “has yet to be tested and determined safe” is misleading, because the FDA had just completed a pilot study showing that kratom is relatively safe, even at doses as high as 12 grams -- the equivalent of taking 24 capsules of kratom leaf powder within five minutes.   

“In 2024, the FDA completed a single ascending-dose clinical trial examining ground kratom leaf in experienced users. The results were illuminating: participants experienced no serious adverse events at doses up to 12 grams, with side effects limited to mild nausea and pupil constriction. Crucially, subjective ‘drug liking’ scores never reached statistical significance compared to placebo, indicating low abuse potential for natural leaf,” former CDC Commissioner Robert Redfield, MD, said in an op/ed published today in The Hill.

Redfield’s comment is notable, because the FDA itself has never had much to say about its 2024 study and still hasn’t posted the final results. According to the American Kratom Association, FDA researchers were "profoundly disappointed” at the lack of adverse events associated with kratom, as that doesn’t square with the agency’s long-held public position on kratom.

Redfield may be reassured of the safety of natural kratom, but he thinks the federal government should take emergency action to ban the import and sale of synthetic kratom extracts, which have elevated levels of 7-hydroxymitragynine, an alkaloiid that is present in only minute amounts in the natural leaf. Kratom extracts have been associated with serious adverse events and overdoses.  

Redfield says synthetic kratom has “pharmaceutical-grade opioid chemistry” and should be taken off the market immediately. But he thinks natural kratom is relatively safe, and cites the 2024 study as evidence.

“This clinical evidence establishes a critical scientific baseline: natural kratom leaf, when used as it has been for centuries, presents a markedly different risk profile than the synthetic products flooding American markets,” Redfield wrote. “This is not about banning kratom. Full spectrum kratom, used responsibly, appears to have acceptable safety margins based on FDA’s own clinical data. This is about preventing synthetic opioids from hiding behind botanical names.”

The FDA still has “serious safety concerns” about natural kratom, but has little evidence to back them up and is apparently slow-walking research. Only two federally-funded kratom studies are currently recruiting participants. One would study the effects of natural kratom and the potential for withdrawal, while the second trial would study the effects of kratom extracts.

Both studies are small and won’t be completed until 2028 —- over a decade after the agency tried to get kratom banned nationwide.

Banning Kratom is Foolish. Governments Should Avoid Hysteria

By Crystal Lindell

I always say the way you know that kratom is among the rare herbal supplements that actually relieves pain is that everyone is always trying to ban it. 

Unfortunately, two towns in my state - Illinois - have done just that. City councils in Marion and Herrin voted this week to ban the sale and delivery of kratom. 

The reported justifications for the bans are naive at best and outright dishonest at worst. 

According to an article about the bans, the Marion city council acted after hearing from the widow of 41-year old Blake Pieroni, who died two months ago. She blames kratom for his death.

“He initially believed, as many do, that kratom was a safe natural supplement,” said Emily Pieroni. “The first time he tried kratom was when the owner of a gas station here in Marion offered Blake kratom as an energy shot. He told him it was like a 5-Hour Energy, but safer and more natural.”

I was especially interested in this anecdote because it would indeed be quite noteworthy if kratom alone had directly caused someone's death. Such cases are incredibly rare. However, when I looked into it, I quickly found that this was not the case. 

In fact, Emily Pieroni has written publicly that her husband died by suicide. She even includes this information in her Change.org petition asking for kratom to be banned:

“At first, it seemed harmless — just a boost of energy. But it quickly became an addiction. He tried to quit three times in seven months. The withdrawal was unbearable. Eventually, the emotional toll was too much, and kratom addiction led my husband to take his own life.”

Someone committing suicide is not the same thing as someone accidentally overdosing on a substance. If her husband had been trying to avoid coffee when he died, would that be enough to blame caffeine for his death? No. 

While I’m sympathetic to the immense grief Emily Pieroni is no doubt going through, especially as someone who has lost a loved one to suicide myself, her advocacy to have kratom banned is going to cause more harm. 

In fact, it is because she is still dealing with such raw grief that the Marion and Herrin city councils should have acted with clearer heads. 

Instead, they embraced kratom hysteria, with Marion Mayor Mike Absher even calling it “gas station heroin.” 

I want to be very clear here: Kratom is not gas station heroin. It’s an incredibly mild supplement similar to coffee. In fact, kratom comes from the leaves of the Mitragyna speciosa tree, which is literally part of the coffee family.

I could also call coffee “gas station meth” but that doesn’t make it true. And it would actually be more accurate to describe kratom as “herbal coffee.”

Because in reality, kratom helps countless people, including me. I have taken kratom for years for chronic pain. It is the only thing sold over the counter that actually helps me. 

For me, kratom withdrawal symptoms are as mild as withdrawing from coffee. Yes, some people may struggle to stop drinking coffee completely, but we as a society have decided that does not mean coffee should be illegal.

I also want to note that the Herrin city ordinance bans “possession” specifically, which means police can now use it to cite or even arrest people who bought kratom elsewhere, ensnaring them in the legal system and all its ill effects. 

Many kratom users are just people with chronic pain or other health issues looking for relief. We should let them use kratom in peace. Kratom is legal in most states and the vast majority of people use it safely. About 100 deaths have been linked to kratom use, but other drugs and illicit substances were usually involved. 

I hope that other towns and municipalities considering kratom bans will also consider the immense harm those bans will cause. 

Kratom is a very mild alternative to other drugs that treat chronic pain and other health issues. That should be celebrated, not demonized. 

Instead of trying to falsely claim that kratom is the same as heroin, we should be lauding the fact that it’s nowhere near as strong as heroin, and yet it is still quite effective at treating pain.

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.

12 Holiday Gifts for People with Chronic Pain and Illness

By Pat Anson

Are doctors and pharmacists helping the DEA spy on pain patients? Does Big Pharma control how healthcare news is reported? Is the Epstein-Barr Virus the hidden cause of your chronic pain? Can kratom be used safely? Are you buzzed that Willie Nelson wrote a cannabis cookbook?

The answers to these and other questions can be found in PNN’s annual holiday gift guide. If you live with chronic pain and illness or have a friend or family member who does, here are 12 books that would make great gifts over the holidays. Or you can always “gift” one to yourself. Click on the book cover or title to see price and ordering information.

The Epstein-Barr Virus: A New Factor in the Care of Chronic Pain

Dr. Forest Tennant examines the Epstein-Barr Virus (EBV) and its hidden role in causing chronic pain. We are all carriers of EBV, which is normally harmless and dormant. But when the virus reactivates, it is carried throughout the body, infecting and damaging body tissues. Dr. Tennant says anyone with chronic pain severe enough to require daily pain medication may have EBV reactivation, and should take steps to diagnose and treat it. 

Policing Patients: Treatment and Surveillance of the Opioid Crisis

Prescription Drug Monitoring Programs (PDMPs) were launched across the country to help prevent drug abuse and save lives. In actuality, author Elizabeth Chiarello says PDMPs are “Trojan horse” surveillance tools used by law enforcement to spy on patients. PDMPs interfere with the practice of medicine by turning doctors and pharmacists into undercover agents — often pitting them against their own patients.

Greed to Do Good: The CDC’s Disastrous War on Opioids

Dr. Charles LeBaron worked for nearly three decades as an epidemiologist for the Centers for Disease Control and Prevention. Although not directly involved in the CDC’s opioid prescribing guideline, LeBaron recognized the disastrous consequences it had on patients. In this book, he gives an insider’s perspective on the CDC’s institutionalized arrogance and how its misguided strategy to reduce overdoses only made the opioid crisis worse.

Follow the Science: How Big Pharma Misleads, Obscures, and Prevails

Journalist Sharyl Attkisson exposes how the pharmaceutical industry infiltrated government and academia, enabling it to put profits over people by controlling how healthcare is covered by the news media. “We exist largely in an artificial reality brought to you by the makers of the latest pill or injection,” Attkisson writes. “Invisible forces work daily to hype fears about certain illnesses, and exaggerate the supposed benefits of treatments and cures.”

Lies I Taught in Medical School

Inspired by his own health problems, Dr. Robert Lufkin wrote this book to expose the “medical lies” that contribute to chronic illness — some of which he taught as a professor at UCLA and USC. Lufkin believes pills and procedures are prescribed too often to mask symptoms, when diet and lifestyle changes can resolve many chronic conditions like diabetes, hypertension, obesity, and cardiovascular disease.

The Big Book of Kratom: The Ultimate Manual to Understanding and Using Kratom

Author Fallon J. Smith takes a deep dive into the pros and cons of kratom, gleaned from many years of using it himself. New kratom users can learn about the various strains and methods of ingesting the herbal supplement to treat everything from chronic pain and anxiety to addiction and depression. Smith also shares important lessons about dosing, side effects, and the potential risks of kratom withdrawal and addiction.

Willie & Annie Nelson’s Cannabis Cookbook

Legendary singer/songwriter Willie Nelson and his wife Annie share their favorite recipes for getting high and full at the same time. Part travelogue and part cannabis cookbook, there’s a colorful story behind every recipe, such as Baked Eggs & Asparagus (with 17mg of THC), Vegan Cannabis Butter, Cannabis Chocolate Cake, and Buttermilk Fried Chicken (no THC).

On Call: A Doctor’s Journey in Public Service

In this memoir, Dr. Anthony Fauci shares some of the highlights — and lowlights — from nearly 40 years working for the National Institutes of Health, including the crucial roles he played in fighting AIDS, the Ebola virus, SARS, anthrax and, of course, Covid-19. Fauci grew up in modest circumstances, living above his father’s Brooklyn pharmacy, to become a health advisor to seven presidents and one of the most famous doctors in world.

Grown Woman Talk: Your Guide to Getting and Staying Healthy

Dr. Sharon Malone is an OB/GYN who wrote this book to help older women deal with the complexities of aging. Often ignored or gaslighted by the healthcare system, older women may have their chronic pain and discomfort dismissed as female hysteria caused by menopause. Dr. Malone has tips to end this “normalized suffering” and empower grown women to live better, age better, and get better medical treatment.

Long Illness: A Practical Guide to Surviving, Healing and Thriving

Drs. Meghan Jobson and Juliet Morgan wrote this book to give patients and providers a better understanding of long-lasting illnesses such as autoimmune disease, chronic fatigue, chronic pain, inflammation and Long Covid. They take a holistic approach to managing symptoms through cognitive behavioral therapy, traditional Eastern medicine, mindfulness and self-care — emphasizing that recovery is a process and not always a destination.

Toxic Stress: How Stress Is Making Us Ill

Dr. Lawson Wulsin is a psychiatrist who has found that toxic stress and childhood trauma often play hidden roles in the development of heart disease, diabetes, depression and chronic illnesses in midlife. In this book, Dr. Wulsin offers practical advice and tools to recognize signs of toxic stress in our lives, and learn how to help your mind and body recover from it.

The Long Covid Reader

Author Mary Ladd shares the stories of 45 people living with Long Covid, who recount in essays and poems how COVID-19 continues to impact their lives long after their initial infections. A long-hauler herself, Ladd spent a year gathering personal stories about Long Covid in an effort to humanize the neglected suffering of millions of people who live with a mysterious chronic illness from the “world's biggest mass-disabling event.”

These and other books about living with chronic pain and illness can be found in PNN’s Suggested Reading page.  PNN receives a small amount of the proceeds -- at no additional cost to you -- for orders placed through Amazon.

New Documentary Explores Benefits and Risks of Kratom

By Pat Anson

If you’ve heard about kratom and wondered if the herbal supplement might be useful in treating chronic pain, you’ve probably been struck by the wide range of opinions about it.  

“Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use,” said former FDA Commissioner Scott Gottlieb.

“Kratom has truly not only saved my life but also given me renewed hope. Without this plant I do not believe I would still be alive today,” said kratom user Kim DeMott.  

“The drug looks similar to brown powdered kratom, produces similar effects as heroin, and is primarily used… by people addicted to heroin,” reports the Ohio Substance Abuse Monitoring Network.

“Kratom does not make me high, nor do I experience side effects. I am now clear minded without the sedation caused by narcotics,” said Mary Ann Dunkel, one of the estimated two million Americans who use kratom, despite warnings that it is an “emerging public health threat.”  

If you’re confused by these diametrically opposed views, you’re not alone. Which is why Steve Hamm produced and directed a new 80-minute documentary called “The Mysteries of Kratom.”  

Hamm knew little about kratom until he started chatting with a neighbor, Dr. Marek Chawarski, a Professor of Psychiatry and Emergency Medicine at Yale School of Medicine. Chawarski spent years studying kratom in Southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever.

“When Marek started talking about kratom and just the potential of it being used as an analgesic, as a painkiller, and potentially being used in dealing with opioid addiction. I got really interested,” Hamm explained. “Ultimately, we decided to make this film by asking a core question. Could a leaf of a tree in Southeast Asia help us solve this terrible addiction problem that we have in the US?”

The resulting documentary by Elm City Films is mostly self-funded and takes an even-handed, journalistic approach to the subject. You’ll hear from a grieving mother who believes her son overdosed on kratom, and a pain patient who says kratom is safer and more effective than opioids.

Hamm spent a month with Chawarski in Southeast Asia, learning how kratom is grown, cultivated and used. People there prefer using fresh kratom, either by chewing the leaves or using them to make a tea. Reports of kratom abuse or addiction are rare.

“I have not seen, nor have I heard, of any fatal overdoses from kratom in Malaysia. Non-fatal, there could be possibilities of it, but again there is no documented evidence,” said Vicknasingan Kasinather, a Malaysian professor and kratom researcher

Due to growing demand in the United States, kratom has become an important cash crop in Malaysia, Thailand and Indonesia. Most of it is dried and processed before being exported, and that processing could be where some contaminants and chemicals are first introduced.  

Once it is shipped overseas, some kratom vendors take the powder and create potent synthetic extracts using an alkaloid called 7-mitragynine, which was recently implicated by the FDA in at least one fatal overdose.

“I was recently at a trade show, where a lot of kratom products are being displayed, and I see these vendors now developing novel new products, including vape pens with 7-mitragynine that by nature are dangerous. They also have 7-mitragynine extracted powders,” said Mac Haddow, a lobbyist for the American Kratom Association. “Those should be banned from the marketplace because they are not natural, they’re synthetically derived, and that’s a real threat to the public.”

Kratom products, like other dietary supplements, are only loosely regulated by the FDA. Many kratom advocates say more regulation is needed, with testing and labeling a better alternative than an outright ban on kratom, which the FDA and DEA tried unsuccessfully to impose in 2016.

“I think the more laws there are about labeling kratom products, the better. Because then there’s more information that gets out there to the consumer,” says Brian Gallagher, a kratom podcaster.  “If it was banned everywhere, then you’d go from a grey market to a black market, where there’s no regulation. We have maybe half the companies doing the right thing. When kratom is banned, zero companies will be doing the right thing.”

Hamm hopes his documentary will help people come to a better understanding of kratom’s risks and benefits, and how a simple leaf could be a solution to some of our biggest health problems.

“We look at the science, we look at the people, we look at the legal issues and the controversies that are there. We hope you all enjoy the film, and we hope it will spark a new conversation about kratom, but also about opioids,” he said..

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.

How Does Kratom Relieve Pain?

By Dr. C. Michael White, University of Connecticut

Kratom doesn’t contain just one active ingredient; rather, it is made up of many substances that induce effects in the body. This is very common for natural products, since the cells of the plant make a variety of chemicals for different purposes.

When the body is experiencing pain, it releases hormones called endorphins that stimulate opioid receptors to mildly reduce the transmission of local pain sensations to the brain. This same process also causes the release of the neurotransmitter dopamine, inducing a feeling of pleasure to neutralize the pain.

Traditional opioids, like morphine and fentanyl, stimulate these same receptors to such a degree that they more potently numb pain, induce a euphoric feeling that can lead to addiction, and suppress the drive to breathe, which can result in death.

One of the key constituents of kratom is an organic compound called mitragynine. It interacts with the same opioid receptors as morphine and fentanyl, but does not recruit the beta-arrestin-2 (the reason for breathing suppression). As a result, kratom can provide pain relief with a lower risk of slowed or stopped breathing compared to traditional opioids.

Kratom also contains a small amount of 7-hydroxymitragynine, which is thought to more potently stimulate opioid receptors, leading to a greater risk of opioidlike adverse events.

One of the risks associated with kratom use is that products can differ dramatically in the doses of 7-hydroxymitragynine. In other words, one kratom product could be more dangerous than another. When kratom is used in high doses, it can lead to seizures and other issues. Since kratom products are not FDA-regulated, there is no uniformity to the products.

Is Kratom Legal?

Kratom’s current legal status is complicated. Kratom is not a prescription or over-the-counter drug, and while it is derived from a plant, it does not meet the FDA’s definition of a dietary supplement, food or food additive.

Natural products marketed in the U.S. before Oct. 15, 1994, were grandfathered in under the FDA’s list of dietary supplements. But since kratom came on the market later, the FDA would have to find, based on a history of use or other evidence, that when used under the conditions recommended or suggested in the labeling, the natural product can reasonably be expected to be safe – like the FDA does for all new dietary supplement ingredients.

In 2016, in response to increasing calls to poison control centers, the Drug Enforcement Administration sought to ban kratom by making it a Schedule I drug. This means the agency felt it had no currently accepted medical use and a high potential for abuse. But backlash from the public and support from congressional members made the agency postpone a final decision. So kratom is currently listed as a “drug of concern.”

Seven states and some counties have banned the sale of kratom. But in 2023, the U.S. House and Senate proposed legislation to prevent the FDA from regulating kratom more stringently than they do a dietary supplement or a food additive, in order to keep the product accessible to consumers.

Kratom Research Lacking

A 2024 literature review concluded that there are no clinical trials evaluating the effects of kratom on chronic pain management.

Research on acute pain tolerance in people is limited to a 2020 study that found participants who took a dose of kratom could endure immersion of their arms in an ice bath for significantly longer than those who did not take a dose of kratom. However, this study was conducted on chronic kratom users, and their pain tolerance before they took their dose for that study was much lower compared to that of non-kratom users in other studies. This suggests that chronic kratom use is lowering people’s background pain tolerance.

This is similar to another study showing that when people tried to stop taking kratom after chronic use, they experienced significant pain throughout their body. This increased sensitivity and reactivity to pain, called hyperalgesia, also occurs with traditional opioids and is one of the reasons why people who use them chronically find it so difficult to get off them.

Taken together, these studies suggest caution before starting kratom as a treatment for chronic pain, especially if safer methods such as acetaminophen, icing and heating, and physical therapy can suffice.

Some people also claim that kratom could be a natural treatment for withdrawal and other effects of opioid use disorder, the clinical term for opioid dependence.

A few methodologically weak studies reported that participants were able to reduce or stop their use of traditional opioids and that kratom reduced the severity of opioid withdrawal symptoms. These include diarrhea, runny nose and eyes, shaking, fast heartbeat and anxiety.

However, there are no clinical trials comparing kratom to methadone, buprenorphine or naltrexone, the FDA-approved treatment options for opioid use disorder. So if patients have access to traditional FDA-approved therapies, these are the safest and best place to start.

If traditional options are not effective or patients cannot access them due to financial or logistical barriers, kratom may be a potential alternative to illegal opioid products, but it is certainly not risk free. Speaking with a health care professional is critical before making treatment decisions.

C. Michael White, PharmD, is a Distinguished Professor and Chair of the Department of Pharmacy Practice at the University of Connecticut School of Pharmacy. He has been studying the science behind kratom to help consumers better understand its potential benefits and adverse effects.

White’s research work has been funded by the Agency for Healthcare Research and Quality (AHRQ), Donaghue Foundation, Pfeiffer Foundation, and American College of Clinical Pharmacy.

This article originally appeared in The Conversation  and is republished with permission.

My Story: Kratom Helps Treat Fibromyalgia

By Jim Hunter

The following narrative is not meant as medical advice. I am not a medical professional. I am simply relating my own experience.

Most of my adult life I have suffered from a variety of symptoms that were never diagnosed by any of the doctors I saw. Eventually, I became aware that these symptoms seemed to be consistent with the list of symptoms that appear under the heading of fibromyalgia. The most conspicuous symptom was painful muscles all over my body. The one symptom often associated with fibromyalgia that I did not have was insomnia.

Do I actually have fibromyalgia? I don’t know. What I have is an assortment of symptoms that, when compared to a checklist for fibromyalgia, make it look pretty close to that mysterious affliction.  Since there seemed to be no reliable objective signs of fibromyalgia, and I seemed to have almost all the subjective ones, it seemed reasonable to diagnose myself as having it.

I treated it for a long time (years) by taking more ibuprofen than is recommended for pain relief. The ibuprofen did help some, so I took more than I should have. I am not recommending anyone else do this, but I didn’t see an alternative at the time.

Then I discovered kratom. I don’t recall how I happened to run into it. But I discovered that when I took small doses of kratom regularly throughout the day, the fibromyalgia symptoms simply went away. Above all else, I didn’t hurt anymore.

Kratom even cleared up the stomach and intestinal problems. That was a surprise. I figured that anything that tasted as harsh as kratom wouldn’t help my stomach, but it did.

As long as I didn’t take too much kratom, I didn’t have any loopy feelings. I didn’t mind the slightly euphoric sensations it sometimes generated, but I learned to fine tune it so I didn’t experience that. It simply took away all the muscle aches and pains, fatigue and stomach problems. I felt normal again and was productive.

A Complication

That happy state facilitated by kratom lasted for years. But then I ran into a glitch. I got an inguinal hernia that strangulated. The surgeon was able to push it back in, but that was clearly just a temporary solution. Clearly, I needed surgery. One can die a nasty death from a strangulated hernia.

There was a complication about whether the local hospital could do the operation or whether my condition would require a bigger hospital with an intensive care unit. They eventually agreed on the local hospital (which is what I wanted), but the only glitch was that I had barely mentioned my use of kratom and sort of played it down. I was pretty sure most of the professionals in the medical field would be suspicious of it. Kratom is, after all, reported to have a mild opioid-like effect.

I’m 83 years old. I was perfectly willing to take any reasonable risk in surgery. I am not going to live forever, and I suspect that the end will not be decades off.

But I did feel obligated to the hospital that agreed to do the operation. I had to either level with them about the kratom I was taking or get off it. I knew that if I explained everything in detail, it would raise questions again about who should do the operation and when. I imagined there might be an issue with a possible interaction of kratom with anesthesia.

I decided to get off the kratom, at least long enough for the operation. There might be some withdrawal symptoms, but they were described in the literature as mild to moderate and short lived.

So, I began phasing out my kratom, for which I calculated I needed about two weeks. Two weeks stretched into three and then four. I was feeling horrible – considerably worse than what was described as kratom withdrawal. This was neither short, nor mild or moderate.

Then my wife put her finger on the problem. The symptoms for withdrawal and fibromyalgia, though similar, were not exactly the same. I was experiencing less nausea, but more pain. The fibromyalgia was back in full force. At that point, as I saw it, I had no choice. I took a little bit of kratom once again and felt fine, except for the hernia.

It was while on the minimal dose of kratom needed for the fibromyalgia that I went in for surgery. After the operation, the anesthesiologist reported that her part of the operation went well. I was relieved. However, another problem emerged. An expected two or three-hour operation with laparoscopic surgery turned into a seven-hour ordeal.

I still cannot visualize the exact nature of the unexpected problem the surgeon encountered. Apparently, my bladder was drawn into and tangled up with the hernia. The surgeon, who had done this operation thousands of times, had never seen it before and nobody else had heard of it.

The surgeon was able to unravel the problem and repair the hernia. This led to yet another problem. I had expected to be in the hospital most of one day, but they kept me in the hospital overnight and, as far as I knew, might keep me hospitalized even longer.

By three in the morning, I was beginning to experience moderate to severe pain. The medication given to me by the night nurse didn’t touch the pain. I realized I had no choice. I had to confess my sin -- the incomplete and unsatisfactory way I told them about the kratom -- and plead for mercy.

I called in the night nurse and explained the whole thing. She was very nice about it, let the head nurse know right away, and notified the surgeon as soon as he arrived in the morning.

To make a long story short, arrangements were made for me to be released from the hospital so I could resume my regime of small doses of kratom.

I had lots of minor aches and pains from being worked on so hard and so long during the operation, while in an awkward position. They had raised my legs a considerable angle to the ground, expanded the inner cavities of my body with CO2, and done God knows what to separate my scrotum, testicles and whatever else from the hernia. But with some Aleve, these were now manageable pains. 

Do I have any advice? Not really. The nearest thing I can offer is to say that, should the situation rise again, I would simply tell the medical people about my dependence on kratom. And if they insisted that I get off it before they would do the surgery, I would not have the surgery done.

Jim Hunter lives in Maine. He is a retired social worker.

Do you have a “My Story” to share?

Pain News Network invites other readers to share their experiences about living with pain and treating it.

Send your stories to editor@painnewsnetwork.org.

Should Suboxone Be Used to Treat Kratom Addiction?

By Pat Anson, PNN Editor

A man with a history of substance abuse – including addiction to kratom – has been successfully treated with buprenorphine/naloxone (Suboxone), according to a case study published in the journal Cureus.  Suboxone is a medication that is normally used to treat opioid use disorder.

Kratom is not derived from the opium poppy and is not an opioid. It’s an herbal supplement that comes 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 kratom and use it to self-treat their pain, anxiety, depression and addiction.

The unidentified patient in the case study has a history of using cocaine, marijuana and alcohol, and suffers from anxiety and depression. He was introduced to kratom 12 years ago by his brother for stress relief and as a substitute for oxycodone. Over the years, the patient used more and more kratom, at one point spending up to $600 a week on kratom supplements.

After several failed attempts to wean himself off kratom, which resulted in severe withdrawal symptoms, the patient went to see his primary care physician, Dr. Paul Remick, one of the study’s co-authors. It was Remick who suggested that Suboxone might help him quit kratom.

“He’d been struggling with depression, anxiety, all these various issues. He was pretty reluctant to try therapy like Alcoholics Anonymous or trying to speak to a therapist,” explained lead author Martin Arhin, a medical student at the University of North Carolina at Chapel Hill. “Dr. Remick suggested Suboxone, since kratom has some like opioid-like properties. He felt like it could potentially work. And fortunately, it did.”

After 23 weeks of using Suboxone, the patient’s withdrawal symptoms subsided and he stopped using kratom. He’s also been successfully tapered off Suboxone, a drug that many people wind up taking for life.   

Suboxone is only approved for opioid use disorder and there is no clinical evidence that it can treat kratom addiction. Such a use, while legal, would be considered “off-label” by the FDA. But based on this one anecdotal case, Arhin and his co-authors say Suboxone could be a treatment for kratom dependence.

“Currently, there is no established evidence-based consensus for the treatment of kratom addiction and withdrawal, leaving individual providers to decide on the appropriate course of action,” they wrote. “We recognized the patient's dependency on kratom and subsequently implemented a treatment plan utilizing buprenorphine/naloxone, which effectively alleviated withdrawal symptoms and supported the patient's abstinence from kratom. We suggest that this drug combination may be a potential treatment for kratom addiction.”

‘Kratom Saved My Life’

Ironically, many people use kratom as an alternative to Suboxone. In a 2016 PNN survey of over 6,100 kratom users, nearly ten percent said they used kratom primarily as a treatment for opioid addiction. Most said it was very effective (91%) in easing their withdrawal symptoms and worked better than Suboxone, with fewer side effects.

“Kratom saved my life. I tried every other type of treatment for drug addiction over the past 10 years. Subutex, methadone, total abstinence and the 12 step program. Each time I failed. After 2 years of Suboxone, I stopped treatment and began using kratom,” one respondent told us.

“Because of kratom, I no longer have to worry about heroin (or methadone or Suboxone) making me sick. I've been clean for 2 years. I can hold a job now, and I only use it when I need pain relief or need to relax,” another respondent wrote.

“I became hooked on oxycodone and had to take Suboxone to get off it. The problem is Suboxone withdrawals were nearly as bad, so I used kratom to cure that,” another patient said.

“Kratom truly saved my life. I've always suffered from extreme anxiety, but it has decreased drastically since taking it. Withdrawals from opiates and Suboxone are awful. I would not have been able to get clean without kratom. I'm confident in saying that if you make kratom illegal, the number of overdoses will rise,” wrote another kratom user.

The DEA and FDA have tried to make kratom illegal by having it declared a Schedule I controlled substance. So far, those efforts have failed due to a public backlash.

Kratom is sold legally in most U.S. states, but a handful of states and cities have banned it over concerns about addiction and overdoses.  About 100 deaths nationwide have been linked to kratom use, but in the vast majority of cases other drugs and illicit substances were involved.

About two million Americans use kratom, primarily to treat chronic pain. 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.

Although many people use kratom to self-treat opioid addiction and ease withdrawal symptoms, the FDA won’t allow kratom vendors to advertise or promote kratom for addiction treatment or any other medical purpose. This month, the FDA sent a warning letter to the Sunshine Trading Company in Colorado, warning it to stop promoting its kratom products for “opiate withdrawal.”

“You market kratom products for the treatment or cure of opioid addiction and withdrawal symptoms. However, these products have not been determined by FDA to be safe and effective for these (or any other) uses. Further, the unproven treatments could cause patients to forego or delay FDA-approved treatments for opioid addiction or withdrawal,” the FDA said.

In recent years, several other kratom vendors have received similar warning letters from the agency..

‘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.

Feds Warn Kratom Vendors About Marketing for Addiction Treatment

By Pat Anson, PNN Editor

The Food and Drug Administration and Federal Trade Commission have sent warning letters to four kratom vendors saying they are in violation of federal law for selling “unapproved new drugs.” The letters to Herbsen Botanicals, Klarity Kratom, Kratom Exchange and YoKratom primarily focus on their marketing of kratom as a treatment for opioid addiction.

Kratom is a dietary supplement that 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 their pain, anxiety, depression and addiction. Kratom is sold legally in most U.S. states, but vendors can run into trouble if they claim it can be used to treat medical conditions.

“You market kratom products for the treatment or cure of opioid addiction and withdrawal symptoms. However, these products have not been determined by FDA to be safe and effective for these (or any other) uses,” the agencies said in their letter to Herbsen Botanicals. “Further, the unproven treatments could cause patients to forego or delay FDA-approved treatments for opioid addiction or withdrawal. The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health.”

The letter cites several blog posts on Herbsen’s website, which claim that kratom is a “common recommendation to manage opioid addiction” and “delivers similar effects” as morphine and codeine. Herbsen also has a lengthy disclaimer on its website saying such statements “are not intended to diagnose, treat, cure or prevent any disease or ailment.”

The FDA has tried for years -- unsuccessfully – to schedule kratom as a controlled substance, which would effectively ban its sale and use in the United States. Having failed to achieve that goal, the agency has resorted to occasional warning letters, import alerts and seizures of kratom.   

In a recently updated online fact sheet, the FDA said 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.”

‘Kratom Saved My Life’

Addiction treatment is one of the main reasons that people use kratom. In a large PNN survey of over 6,400 kratom users, about one in ten said they primarily used the plant to treat opioid addiction or alcoholism. Several said it was more effective than methadone or Suboxone in relieving withdrawal symptoms.

“Kratom saved my life. I tried every other type of treatment for drug addiction over the past 10 years,” one respondent wrote. “After 2 years of Suboxone, I stopped treatment & began using kratom. I've made more progress toward my ultimate goal of total sobriety in 2 years of self-administered kratom then 5+ years of suboxone & methadone treatment.”

“Due to 3 surgeries, I became hooked on Oxy and had to take Suboxone to get off it. The problem is Suboxone withdrawals were nearly as bad, so I used Kratom to cure that,” said another.

“Not only is this a wonderful alternative for people with chronic pain. but this also could greatly reduce our heroin epidemic crisis going on in our country. After years of being physically dependent on legally prescribed Suboxone, I was unsuccessful at my attempts to get off of them. Kratom made it possible, and I believe would help others trying to get off any opiates and live full and productive life,” another poster said.

In recent testimony before Congress, FDA commissioner Dr. Robert Califf warned that kratom was a harmful substance that has caused “real adverse events, real negative things that have happened to people.” Califf also said the agency may need new authority from Congress to regulate kratom and other supplements that are not “traditional drugs.”