Ohio Governor Seeks Ban on All Kratom Products

By Pat Anson

Ohio Governor Mike DeWine wants his state to immediately ban the sale and use of all natural and synthetic kratom products by designating them as illegal Schedule One controlled substances, on the same level as heroin and LSD. DeWine is also seeking bans on “all existing and future synthetic kratom compounds.” 

If approved by the Ohio Board of Pharmacy, stores and other businesses in the state would be required to remove all kratom edibles, powders and drinks from their shelves and stop selling them online.

Kratom comes from the leaves of a tree that grows in southeast Asia and has been used 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. The agency recently warned that synthetic kratom products boosted with concentrated forms of the kratom alkaloid 7-hydroxymitragynine (7-OH) could cause addiction and overdoses, and should be classified federally as Schedule One drugs by the DEA.

“These modified kratom products, sold online and in stores, are essentially legal, over-the-counter opiates that anyone – including kids – can buy with just a few bucks,” Gov. DeWine said in a press release.

“There is no accepted medical use for kratom in Ohio, and it is an imminent public health risk. The Ohio Board of Pharmacy should act with urgency to schedule all kratom compounds and future alterations of them as Schedule I illegal drugs.” 

This isn’t the first time the Ohio Board of Pharmacy will consider banning kratom. In 2018, the board voted to classify kratom as a Schedule One drug after receiving a report from the Ohio Substance Abuse Monitoring Network blaming kratom for several deaths and falsely claiming that people were injecting kratom like it was heroin. The board later rescinded its decision after a public outcry.

Another public outcry is likely, judging by the early reaction to DeWine’s proposal on X/Twitter.

“This is not good! Do you want to help patients with uncontrolled pain get their pain medicine doctors back? Because they quit prescribing,” said one poster. “Some have now found relief with Kratom and you want to take this away?”

“Prohibition of both plain-leaf kratom and 7-OH extracts is a bad thing. In both cases, they will lead to people turning to more dangerous opioids,” said another. “Kratom, particularly the pure leaf powder, is incredibly safe, pretty much impossible to have a lethal overdose. Mike DeWine is putting hundreds of thousands of people in his state at risk.”

“Our system has already turned their back on people suffering from chronic pain, disregarding their quality of life. Now the government wants to have us suffer more. This is total bull,” wrote another poster.

Under existing Ohio state law, kratom can only be sold in its natural, dried leaf or powdered form to people 18 years of age and older. Selling adulterated kratom is also illegal.

Despite those safeguards, the Ohio Department of Health says kratom was found to be a cause of death in more than 200 overdose deaths in the state from 2019 to 2024.

Earlier this month, Florida Attorney General James Uthmeier filed an emergency rule classifying concentrated forms of 7-OH as a Schedule One controlled substance in Florida. Gov. DeWine’s proposal would go much further than that, by classifying all kratom products – including natural leaf kratom – as Schedule One drugs.

Alabama, Arkansas, Indiana, Rhode Island, Vermont and Wisconsin have already classified kratom as a controlled substance. Dozens of cities, counties and local jurisdictions have also banned its sale.

While hundreds of deaths in the US have been linked to kratom use, most cases involve other drugs and illicit substances, making it difficult to determine the exact cause of death or any liability.

In a playbook reminiscent of the campaign against opioid pain medication, several law firms are seeking plaintiffs allegedly harmed by kratom to participate in class action lawsuits against kratom vendors and wholesalers.    

A former CDC director recently said that natural leaf kratom caused “no serious adverse events“ to patients involved in an FDA study, but agreed that synthetic kratom should be scheduled as an illegal drug.

“Natural kratom leaf, when used as it has been for centuries, presents a markedly different risk profile than the synthetic products flooding American markets,” said Robert Redfield, MD. “Full spectrum kratom, used responsibly, appears to have acceptable safety margins based on FDA’s own clinical data.”  

(Update 8/27/25: The Ohio Board of Pharmacy cancelled a special meeting scheduled for Wednesday to make an emergency move to ban kratom. No explanation was made as to why the meeting was cancelled.)

Moral Panic Over Herbal Drink Stirs Anti-Kratom Hysteria

By Crystal Lindell 

Last month, a TikTok influencer who goes by the name “YourBestieMisha” posted a video claiming that he was harassed at a Texas gas station by a teenager craving for a drink called “Feel Free.” 

The drink, which is sold in little blue bottles, is made by Oklahoma-based Botanic Tonics. It’s infused with kava root, natural leaf kratom, and other herbs. 

In the video, Michael “Misha” Brown alleges that as he was going into the gas station, he was approached by a "child" who seemed to be about 14 years old.

In Texas, you have to be at least 18 to buy kratom, so when the teen asked Brown to help him get Feel Free, Brown said no. That’s when the teen lunged for his wallet, which Brown says he was able to pull away from the boy. 

Brown then went into the gas station and shared what happened with the clerk, who told him Feel Free is so addictive that people are coming in five or six times a day to purchase a bottle.

“So I get home and look into this and people are literally going to rehab over this drink that is legal in most states in the U.S. and is sold in gas stations,” Brown says in the video. “I don't think we talk enough about things that are legal but are sold next to gum and energy drinks.”

The video has amassed more than 23 million views. However, there does not appear to be any follow-up videos posted by Brown elaborating on his story, or providing any evidence that any of it actually happened. 

MICHAEL “MISHA” BROWN (TIKTOK VIDEO)

In fact, the video has all the classic hallmarks of a “moral panic” story, which is an exaggerated fear or anxiety about something that is fueled by media attention or a video going “viral” online. In this case, there’s the implied harm to a child, no way to verify any of it, and an incentive for the creator to embellish and exaggerate his claims. 

Brown, who is an aspiring actor and singer, has posted thousands of videos online and has over three million followers on TikTok. He also has a podcast and is working on a book. Like other social media influencers, Brown’s income comes from advertising revenue, which is based on the number of views his videos get.

Even if his gas station story actually happened, there’s still a lot to unpack. 

Aside from the fact that children can already purchase excessive amounts of caffeine all on their own, both cigarettes and alcohol are also “things that are legal,” and are sold right next to gum and energy drinks in gas stations across the country. 

The makers of Feel Free have already self-imposed an age restriction for customers to be 21 and older. So if the teen in Brown’s story was hooked on Feel Free, then an adult was helping him get it long before the run-in at the gas station. 

And yes, that is a problem, just like it would be a problem if an adult was buying vodka for a 14-year-old. However, most will agree that doesn’t mean vodka should be illegal for adults.

Videos like Brown’s are concerning because they have the potential to spark real policy debates and hysteria from people who know nothing about kratom, a dietary supplement used by millions for pain relief or as an energy booster. 

The safety of kratom became a hot topic again when the FDA recently announced plans to make the kratom alkaloid 7-hydroxymitragynine (7-OH) an illegal Schedule One controlled substance. 7-OH occurs naturally in kratom in trace amounts, but some kratom vendors sell a concentrated, synthetic version of 7-OH to boost its potency.

Although Feel Free contains very little 7-OH, many media stories have conflated the two, implying the drink has “opioid-like effects” and is “hooking young people.”

In 2023, a class action lawsuit was filed against Botanic Tonics, alleging that Feel Free was misleadingly advertised as a healthy alternative to alcohol. The company settled the case for $8.75 million and agreed to put stronger safety warnings on its products.

Botanic Tonics responded to this latest uproar by trying to differentiate Feel Free from 7-OH, and “applauding” the FDA for its move. 

"Our products contain trace amounts of 7-OH that occur naturally during the traditional drying process — levels that are dramatically different from the concentrated synthetic products now under FDA scrutiny," said Cameron Korehbandi, CEO of Botanic Tonics. "The difference between natural leaf kratom and synthetic 7-OH concentrates represents a night and day distinction in terms of safety and consumer protection."

In my opinion, this was a huge mistake for Botanic Tonics. While it’s tempting to think it can keep Feel Free legal by appeasing the FDA, it’s already become clear that the moral panic around 7-OH is spreading to all kratom products. 

As such, Botanic Tonics should unite with kratom users to ensure that 7-OH continues to be sold the same way nicotine, alcohol, caffeine, and kratom leaf already are: over the counter and with age restrictions. 

If the FDA succeeds in making 7-OH a Schedule One controlled substance, it won’t be long until they come after kratom leaf as well.

FDA’s 7-OH Warning Sparks Sensational Claims About Kratom

By Pat Anson

The FDA’s latest campaign against kratom has reignited a wave of sensational claims in the media about the herbal supplement and its potential for addiction.

“A new emergency is quietly growing in the United States,” warns La Voce di New York, with an ominous but corny headline that calls kratom a new “Hippie Drug” disguised as an alternative to coffee.

“However, the preparation hides a high potential for addiction, with symptoms and withdrawal crises very similar to those caused by the most dangerous opioids.”

USA Today said it spoke with over 20 people who became “severely addicted” to kratom. One of them was Kim Maloney, a 49-year-old Ohio mother, who lost her car, home and marriage when her kratom use spun out of control. She believes it would have killed her, had she not gone into rehab.

"My eyes were rolling in the back of my head. I couldn't walk straight. I didn't leave my couch for months. I had pancreatitis. I had shingles. I was sick. I mean, I was really sick,” Maloney said.

Other news outlets are calling kratom “gas station heroin” and “legal morphine,” taking their cue from FDA Commissioner Marty Makary, MD, who recently announced plans to have a kratom alkaloid called 7-hydroxymitragynine (7-OH) classified as a Schedule One controlled substance --- the same category as heroin and LSD.

“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,” said Makary.

‘Replacing One Addiction with Another’

The FDA’s renewed interest in kratom — and 7-OH in particular — apparently stems from a growing number of social media posts about it being addictive. A Reddit page created last year for people trying to quit 7-OH has over 4,000 members.

“You will have a passionate love affair with 7OH before it shows its true colors,” warns one former user. “Like many, I was a recovered kratom user before trying 7OH. And for the better part of a year, it felt like 7OH was a miracle drug that fixed all the negative side-effects of plain leaf kratom. IT'S NOT.”

Nicholas Campana, a recovering addict and YouTube influencer who goes by the name "Goblin," posted a video a few months ago calling 7-OH the “most dangerous drug in the smoke shop.”

“While kratom is a legitimate step down from opiates, in my opinion this is replacing one addiction with another,” Campana said in the video, which has been viewed over 700,000 times. "7-OH is the latest smoke shop craze. It’s not like the other ones, because this a very, very addictive opioid.”

For the record, neither kratom or 7-OH are opioids. They do not come from poppies. Kratom leaves come from Mitragyna speciosa, a tropical tree native to southeast Asia that belongs to the same botanical family as coffee.

Kratom does have opioid-like effects, however, and 7-OH is one of its active ingredients. In its natural state, only trace amounts of 7-OH are present in kratom. But some kratom vendors are selling gummies, drinks and tablets with concentrated synthetic versions of 7-OH to boost their potency.

‘Works as Well as Oxycodone’

According to one study, as many as two million Americans use kratom. Most take it for pain relief or as an energy booster, and have only been exposed to unadulterated kratom leaf products. Some chronic pain sufferers have tried 7-OH and found it just as effective as prescription opioids.

One of them is Emil, who suffers from chronic pancreatitis. Like many other pain patients, Emil has faced frustrating delays getting his opioid prescriptions filled. He asked that we not use his last name.

“I have had good experiences with 7-OH, using it primarily when I am waiting for a new prescription from my doctor since that can take over a week from the time I request it to getting it filled by the pharmacy, sometimes even longer,” Emil told PNN. ““It does not seem to cause the tiredness and aloofness, for lack of a better word, that prescription painkillers can cause and I feel like I am able to focus better, with less of the unpleasant side effects of painkillers such as nausea, dry mouth, etc. 

“I am prescribed oxycodone for pain and while it is somewhat effective in combination with ibuprofen in treating my pain, it is a constant struggle to keep my pain under control.  I would say that 7-OH works just about as well as oxycodone in controlling the pain, but definitely with less unpleasant side effects and really no so-called withdrawal symptoms or cravings, at least for me, as some people report with prescription painkillers. I truly do not understand why they are trying to ban it outright as a Schedule I substance with no medical use.”

The FDA has offered surprisingly little evidence about the harmful effects of 7-OH or why it is again trying to classify it as a Schedule One controlled substance. The FDA’s Adverse Event Reporting System has recorded only 15 cases involving 7-OH, two of them deaths, but because of “ambiguity about the contributory role of 7-OH” — which suggests other drugs were involved — the agency is downplaying the significance of those cases.

“This raises serious questions about the evidentiary basis for such a significant regulatory action,” Jeff Smith, PhD, national policy director for the Holistic Alternative Recovery Trust, wrote in an op/ed published in Medical Economics. “More research is needed to fully assess 7-OH’s risks, including its potential for misuse, dependence or drug-drug interactions. But they do not support the claim that 7-OH is an imminent threat to public health.

“To be clear, 7-OH is a potent compound. But potency alone does not justify prohibition. Alcohol, benzodiazepines and prescription opioids are far more dangerous and remain legally available under strict regulation. The proper response to uncertainty is research and oversight: not bans.”

‘Embarassing FDA Mistakes’

Kratom supporters and those who want access to 7-OH can take comfort in the FDA’s failure to get kratom banned in previous attempts.

In 2016, the Drug Enforcement Administration – acting at the request of the FDA – tried to classify 7-OH and the kratom alkaloid mitragynine as Schedule One drugs, only to drop those efforts after a public outcry. A top federal health official later said the FDA withdrew its scheduling request because of “embarrassingly poor evidence & data.”

In 2024, the FDA made another preliminary attempt at regulating kratom, publishing a notice in the Federal Register seeking public comment on a proposed survey of kratom users to evaluate 7-OH and mitragynine for potential harms. Ten days later, the FDA abruptly withdrew its study plans, citing unexplained “circumstances necessitating changes.”

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

“The FDA’s few anti-kratom staff are repeatedly undermining the Agency’s credibility on harm reduction strategies,” said Mac Haddow, Senior Fellow on Public Policy at the American Kratom Association (AKA), an association of kratom vendors. “The FDA remains trapped in the web of their own making that unfairly demonizes products like kratom.”

The AKA has since changed its tune, and is now applauding the FDA for its “decisive and science-driven recommendation to classify 7-hydroxymitragynine (7-OH) as a Schedule I substance.”

“These 7-OH products are not kratom. They are chemically altered substances that carry potent opioid-like effects and pose an imminent threat to consumers,” Haddow said in a new statement.

It’s up to the DEA to decide if 7-OH should be classified as a controlled substance. If it does, the DEA must then publish a notice in the Federal Register, take public comments and reevaluate the evidence, a rulemaking process that could take months or even years. Until then, 7-OH can legally remain on the market under federal law as an unregulated dietary supplement, as long as no medical claims are made about it.

(Update 8/13/25: Florida isn’t waiting for the DEA or FDA to act. Florida Attorney General James Uthmeier has filed an emergency rule classifying concentrated forms of 7-OH as a Schedule One controlled substance in Florida. The rule makes it illegal to sell, possess or distribute concentrated forms of 7-OH in the state, calling them “an immediate and imminent hazard to the public health, safety, and welfare.”)

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.

Chronic Pain Is Chronically Expensive

By Crystal Lindell 

My fiancé and I both have chronic pain. Which means we both spend a lot of money trying to manage it. 

Later today, he will drive an hour and a half each way to see his pain doctor so that they can drug test him in person.  He’s the only doctor in the region who will take new pain patients, so he’s the doctor my fiancé goes to, despite the long drive.

The doctor doesn't take my fiancé’s insurance though, so he will have to pay for the appointment the same way he pays for every monthly appointment with this doctor: with $160 cash. 

And when he gets his medication refill in a few days, that will also have to be paid for with cash at the pharmacy, because his insurance won’t cover prescriptions from doctors who don’t take the insurance. So that’s another $53. 

Aside from the direct costs of that whole ordeal, there’s also the in-direct costs like gas in the car, time away from being able to work on our (very) small online business, and the energy he’ll have to spend dealing with the drive and the stress. 

While he doesn’t have to see this doctor in-person every month, he does have to pay the full price for the appointment every 30 days, along with the prescription. So we have to find a way to basically pay for the equivalent of a car payment every month just so he can have the pain medication he needs to function. 

It’s just one of the ways living with chronic pain gets expensive fast, and also stays expensive. 

There’s the obvious stuff people think of, like the cost of both of us seeing doctors and filling prescriptions. But there’s also the less obvious stuff, like the regular purchases of bulk ibuprofen, Excedrin, and of course antacids for the heartburn caused by the other medications. 

And then there’s the more expensive stuff like the closet full of orthopedic braces, crutches, and walking aids.

There's also the $100/month we spend on kratom powder, which is the only over-the-counter substance that actually helps either of us when our very limited supply of prescription pain meds aren’t enough. And with the current swing in temperatures here in northern Illinois, there are a LOT of days when our limited pain meds aren’t enough. 

We also buy Gatorade every week to take the kratom with, because we’ve found it’s the best and cheapest option to use to get the dirt-like powder down. 

It all adds up so fast, especially with seemingly unlimited inflation. And it ends up being money that we can’t use to improve our lives in other ways, like building savings, having a wedding, or paying off debt. 

Speaking of debt, there’s also the added aspect of all the medical debt I’ve racked up over the last decade, despite having insurance for most of that time. It has essentially destroyed my credit, making it that much harder to secure housing and transportation. 

From the outside, it’s easy to assume that our money troubles must be caused by either our inherent laziness or our inability to budget correctly. But when you have health issues, your money is not the same. It is both harder to get and harder to keep. 

All of these costs are non-negotiable. We can’t just skip his doctor appointment because we have unexpected car problems to pay for. We can’t go without kratom as a trade off if we have unexpected veterinary bills for one of our cats. 

There are a lot of ways that society could be set up differently to help people with chronic pain and chronic illness. Things like universal health care, universal basic income, and expanded public transportation options would go a long way.

I would hope the fact that I’m a human being makes me worthy of social supports like that, but if that’s not enough, there are plenty of selfish reasons for other people to support expanded government programs.

While you may assume that because you don’t need some of these support systems yet, then you never will, you’d be wise to reconsider. Because that’s the thing about chronic illness: If you live long enough, eventually you’ll get sick too. 

And when you do, you’ll find out just how chronically expensive chronic illness really is.

6 Things to Try If Your Doctor Won’t Prescribe Opioid Pain Medication

By Crystal Lindell

Many doctors are extremely resistant to prescribing opioid pain medication for any reason these days. Whether it’s for post-operative pain, chronic pain or even pain from terminal cancer, patients are finding that doctors shrug their shoulders and tell them to go home and take ibuprofen.

Unfortunately, over-the-counter pain medication is just not effective in many cases, and that can leave patients in desperate situations. 

As someone who’s been navigating my own chronic illness for more than a decade, as well as helping my loved ones with their health issues, I do have some very realistic advice I can offer.

If you ever find yourself in extreme pain, but your doctor won’t give you pain medication, here are 6 things you can try. 

1. Doctors Expect You To Negotiate

Many doctors now have an unwritten policy where they will only give you opioid medication if you ask a certain number of times, especially when it comes to acute trauma like a broken bone or post-op pain. 

Doctors believe that this helps them to make sure that you really need it. 

So just because your doctor tells you no one time, two times or even three times, that doesn’t mean you should just accept the response. If your pain is severe enough that OTC medication is not working, then ask again. And again. Ideally, they eventually relent and will send in at least a small opioid prescription for you. 

This also helps future patients. Many doctors assume that if patients don’t ask repeatedly for pain medication after a surgery then that means that the surgery doesn’t result in severe pain for anyone. By showing them that you need it, you make it more likely for doctors to believe the next patient.  

2. Tell Your Doctor You’re Unable To Work Due to Pain

Unfortunately, under our current financial structures, much of our worth as humans is still tied to our ability to be productive at our jobs. So telling your doctor that you’re in too much pain to work may inspire them to finally send in an opioid prescription for you. 

They do not want you missing work, which could mean you losing health insurance and being unable to pay them. 

3. Threaten To Go to the ER

Another option when your doctor refuses to give you opioid medication is to tell them that you’re going to go to the emergency room then. This will often spur them to send in a prescription.to your pharmacy.

When it comes to something like post-surgical care, many doctors feel like it makes them look bad when their patients have to go to the ER for after-care. 

I have also seen this work for chronic pain as well, especially if you’re in their office when you bring it up. One time, for example, after explaining that I was going to go to the ER because my pain had spiked, my doctor gave me stronger pain medication in his office.

As an aside: Just make sure that if you get something very strong, like a hydromorphone shot, that you also get medication for nausea, like Zofran. While most ERs do this as a matter of policy, sometimes a doctor will skip it if it’s administered in their office. 

This is something I learned the hard way after an in-office hydromorphone shot left me vomiting for more than 24 hours because I wasn’t used to the strength of the medication. The whole thing could have been prevented with some Zofran.

4. Go to the Emergency Room

If telling your doctor that you want to go to the ER doesn’t motivate them to send in an opioid prescription, then the next step is to actually go to the emergency room. 

In my experience, ER doctors will, at the very least, usually give you a dose of pain medication to take on site. That can help you get the pain down to a level where you can at least think clearly and then figure out next steps and/or get some needed sleep. 

Depending on the situation, sometimes you can also convince ER doctors to give you a small prescription for at-home use too, especially if it’s for something like post-op pain or a severe injury.  

5. Consider a Pain Management Doctor 

If you have chronic pain, many times your best option is getting a referral to a doctor who specializes in pain management. 

This is not ideal because pain management doctors tend to be quite different from primary care doctors. That’s because many pain specialists believe they are being watched by the Drug Enforcement Administration. The DEA has no medical expertise, but has targeted hundreds of doctors for what it calls “unlawful” opioid prescribing.  

Because of that, many pain management doctors act more like probation officers than medical professionals, requiring invasive and expensive monitoring like drug tests and pill counts on a regular basis. This means the patient experience tends to be more like being on probation than getting healthcare. The only thing missing is an ankle monitor.

That said, pain specialists are usually willing to prescribe a low-dose opioid if it doesn’t exceed medical guidelines, which could get them in trouble. For many patients, even a low dose can literally be life saving. 

If you can’t get pain treatment anywhere else, then it can be worth it to put up with the draconian atmosphere. 

6. Try Kratom or Cannabis

The two most effective pain treatments you can get without a prescription are kratom and cannabis, although your mileage may vary and their legal status varies a lot by jurisdiction. 

While I am not sure how effective kratom or cannabis is at treating short-term intense pain, like a broken bone, I have personally found kratom to be the only substance I can get without a prescription that helps my chronic intercostal neuralgia pain. I would describe kratom as having an extremely mild opioid effect. 

Personally, I use it by taking a spoonful of kratom powder with a swig of Gatorade, as I find that to be the most effective delivery method. However, there are many options, ranging from capsules to kratom candy and even kratom seltzer. 

I also know many others who have found relief by using cannabis, which is thankfully legal in many places now. THC gummies seem to be especially helpful to anyone who’s new to cannabis use and doesn’t want to smoke. Cannabis dispensaries are also usually staffed with knowledgeable, friendly employees who are happy to guide you to the best option. 

I always say pain will make you crazy much faster than you expect. Within just three days of severe pain, I have seen people openly saying they were ready to die. 

It’s a true shame that in 2025, when effective and cheap pain medication exists, so many people are still left to suffer simply because of opioid-phobia and an overzealous DEA. 

However, that doesn’t mean you should be forced to suffer through pain just because you may not know how to navigate the healthcare system. You do have options. 

And if you’re in a situation where you’re denied pain care that you need, I hope you’ll use it to inspire more compassion in yourself. Pain treatment is a human right, and the more people who support it, the more likely we are to get it. 

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.

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.