Balancing the Risks and Benefits of Kratom

By David Kroll

David Bregger had never heard of kratom before his son, Daniel, 33, died in Denver in 2021 from using what he thought was a natural and safe remedy for anxiety.

By his father’s account, Daniel didn’t know that the herbal product could kill him. The product listed no ingredients or safe-dosing information on the label. And it had no warning that it should not be combined with other sedating drugs, such as the over-the-counter antihistamine diphenhydramine, which is the active ingredient in Benadryl and other sleep aids.

As the fourth anniversary of Daniel’s death approaches, a recently enacted Colorado law aims to prevent other families from experiencing the heartbreak shared by the Bregger family. Colorado Senate Bill 25-072, known as the Daniel Bregger Act, addresses what the state legislature calls the deceptive trade practices around the sale of concentrated kratom products artificially enriched with a chemical called 7-OH.

7-OH, known as 7-hydroxymitragynine, has also garnered national attention. On July 29, 2025, the U.S. Food and Drug Administration issued a warning that products containing 7-OH are potent opioids that can pose significant health risks and even death.

As kratom and its constituents are studied in greater detail, the Centers for Disease Control and Prevention and university researchers have documented hundreds of deaths where kratom-derived chemicals were present in postmortem blood tests. But rarely is kratom deadly by itself. In a study of 551 kratom-related deaths in Florida, 93.5% involved other substances such as opioids like fentanyl.

I study pharmaceutical sciences, have taught for over 30 years about herbal supplements like kratom, and I’ve written about kratom’s effects and controversy.

One Name, Many Products

Kratom is a broad term used to describe products made from the leaves of a Southeast Asian tree known scientifically as Mitragyna speciosa. The Latin name derives from the shape of its leaves, which resemble a bishop’s miter, the ceremonial, pointed headdress worn by bishops and other church leaders.

Kratom is made from dried and powdered leaves that can be chewed or made into a tea. Used by rice field workers and farmers in Thailand to increase stamina and productivity, kratom initially alleviates fatigue with an effect like that of caffeine. In larger amounts, it imparts a sense of well-being similar to opioids.

In fact, mitragynine, which is found in small amounts in kratom, partially stimulates opioid receptors in the central nervous system. These are the same type of opioid receptors that trigger the effects of drugs such as morphine and oxycodone. They are also the same receptors that can slow or stop breathing when overstimulated.

In the body, the small amount of mitragynine in kratom powder is converted to 7-OH by liver enzymes, hence the opioid-like effects in the body. 7-OH can also be made in a lab and is used to increase the potency of certain kratom products, including the ones found in gas stations or liquor stores.

And therein lies the controversy over the risks and benefits of kratom.

‘No Currently Accepted Medical Use’

Because kratom is a plant-derived product, it has fallen into a murky enforcement area. It is sold as an herbal supplement, normally by the kilogram from online retailers overseas.

In 2016, I wrote a series of articles for Forbes as the Drug Enforcement Administration proposed to list kratom constituents on the most restrictive Schedule 1 of the Controlled Substances Act. This classification is reserved for drugs the DEA determines to possess “no currently accepted medical use and a high potential for abuse,” such as heroin and LSD.

But readers countered the DEA’s stance and sent me more than 200 messages that primarily documented their use of kratom as an alternative to opioids for pain.

Others described how kratom assisted them in recovery from addiction to alcohol or opioids themselves. Similar stories also flooded the official comments requested by the DEA, and the public pressure presumably led the agency to drop its plan to regulate kratom as a controlled substance.

But not all of the stories pointed to kratom’s benefits. Instead, some people pointed out a major risk: becoming addicted to kratom itself. I learned it is a double-edged sword – remedy to some, recreational risk to others. A national survey of kratom users was consistent with my nonscientific sampling, showing more than half were using the supplement to relieve pain, stress, anxiety or a combination of these.

Natural Leaf Powder vs Concentrated Extracts

After the DEA dropped its 2016 plan to ban the leaf powder, marketers in the U.S. began isolating mitragynine and concentrating it into small bottles that could be taken like those energy shots of caffeine often sold in gas stations and convenience stores.

This formula made it easier to ingest more kratom. Slowly, sellers learned they could make the more potent 7-OH from mitragynine and give their products an extra punch. And an extra dose of risk.

People who use kratom in the powder form describe taking 3 to 5 grams, the size of a generous tablespoon. They put the powder in capsules or made it into a tea several times a day to ward off pain, the craving for alcohol or the withdrawal symptoms from long-term prescription opioid use.

Since this form of kratom does not contain very much mitragynine – it is only about 1% of the powdered leaf – overdosing on the powder alone does not typically happen.

That, along with pushback from consumers, is why the Food and Drug Administration is proposing to restrict only the availability of 7-OH and not mitragynine or kratom powder. The new Colorado law limits the concentration of kratom ingredients in products and restricts their sales and marketing to consumers over 21.

Even David Bregger supports this distinction. “I’m not anti-kratom, I’m pro-regulation. What I’m after is getting nothing but leaf product,” he told WPRI in Rhode Island last year while demonstrating at a conference of the education and advocacy trade group the American Kratom Association.

Such lobbying with the trade group last year led the American Kratom Association to concur that 7-OH should be regulated as a Schedule 1 controlled substance. The association acknowledges that such regulation is reasonable and based in science.

Potential Use as Medicine

Despite the local and national debate over 7-OH, scientists are continuing to explore kratom compounds for their legitimate medical use.

A $3.5 million NIH grant is one of several that is increasing understanding of kratom as a source for new drugs.

Researchers have identified numerous other chemicals called alkaloids from kratom leaf specimens and commercial products. These researchers show that some types of kratom trees make unique chemicals, possibly opening the door to other painkillers.

Researchers have also found that compounds from kratom, such as 7-OH, bind to opioid receptors in unique ways. The compounds seem to have an effect more toward pain management and away from potentially deadly suppression of breathing. Of course, this is when the compounds are used alone and not together with other sedating drugs.

Rather than contributing to the opioid crisis, researchers suspect that isolated and safely purified drugs made from kratom could be potential treatments for opioid addiction. In fact, some kratom chemicals such as mitragynine have multiple actions and could potentially replace both medication-assisted therapy, like buprenorphine, in treating opioid addiction and drugs like clonidine for opioid withdrawal symptoms.

Rigorous scientific study has led to this more reasonable juncture in the understanding of kratom and its sensible regulation. Sadly, we cannot bring back Daniel Bregger. But researchers can advance the potential for new and beneficial drugs while legislators help prevent such tragedies from befalling other families.

David Kroll, PhD, is a Professor of Natural Products Pharmacology & Toxicology in the Department of Pharmaceutical Sciences at the University of Colorado Anschutz Medical Campus.

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

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. Selling synthetic or 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.)

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.”