7-OH Is a Breakthrough for Pain Relief and Should Remain Legal

By Crystal Lindell 

This week, in a very disappointing move, Missouri took a step towards banning most 7-OH products, joining a long list of governmental bodies considering similar things. 

If you’re unfamiliar, 7-OH is an alkaloid that occurs naturally in kratom, the full name of which is 7-hydroxymitragynine. When concentrated, it has opioid-like effects that can relieve pain and boost energy levels. 

The interesting part is that 7-OH doesn’t cause respiratory depression the way opioids do, which means it is not deadly the way opioids can be. 

Unfortunately, multiple governmental bodies are attempting to ban it. While the FDA would like to ban it nationwide, states like Florida, Ohio and Kentucky have already banned it, while health officials in California are taking it off store shelves.

The Missouri Senate is considering a bill that would also effectively ban 7-OH. The proposed law would prohibit the sale of all kratom products to people under the age of 21 and specifically limit the 7-OH content in products to 2%.

Since many contain about 50% 7-OH or, in some cases, substantially more, that would essentially prohibit the sale of all 7-OH products. Violators could face felony charges if the bill becomes law.

The Missouri Independent reported that during a committee hearing about the bill, State Sen. Maggie Nurrenbern (D) of Kansas City said several families submitted statements calling 7-OH products “highly addictive, unregulated drugs” that have impacted their loved ones and children.

“I don’t know if there’s any more pressing issue before us than making sure that kids don’t have access to these drugs,” Nurrenbern told the committee. “As well as making sure that we’re not doing further damage to our community right now that’s already grappling with so much in terms of addiction and mental health.” 

A Painkiller That Actually Works

It’s disheartening to see 7-OH framed this way, when I know just how much value it has for the lives of the millions of people suffering from chronic pain. 

For years, we’ve been told that the reason opioid prescriptions had to be greatly restricted was because of overdose deaths. But now that we finally have something that actually treats pain without directly causing OD deaths, officials are still trying to claim it is doing “damage” to the community. 

What about the damage caused by chronic pain?

My life is littered with hellish stories about people I know who couldn’t get pain meds when they needed them. In fact, comment sections on PNN’s social media are often overflowing with the same type of stories.

Readers tell us many doctors dismiss their pain, refuse to prescribe opioid medication, and leave patients to suffer. Some pharmacists also refuse to fill opioid prescriptions and get irate when pushed. 

I have even seen numerous patients lamenting that they have lost the will to live because their severe pain is untreated. I have been there myself. Before I found my current doctor — who prescribes me enough pain medication to function — I still remember talking to my mom about how, if I do kill myself, I want her to understand that death would be a mercy for me.

But now there is an over the counter substance that actually treats pain, and I just have to call it what it feels like to me as a patient: a miracle.

In fact, I would argue that  7-OH is likely the closest we will come in my lifetime to seeing something like hydrocodone being sold OTC – something I have long advocated for.

In a humane society, everyone should have access to effective pain treatment, especially in a country without universal healthcare or insurance coverage.  

I was talking to my fiancé about a surgery he had a few years ago, where the operating surgeon initially refused to give him opioid medication for post-operative pain. The doctor claimed that his other patients had only needed ibuprofen — after he took a scalpel and sliced open their arms to repair a nerve. 

While my partner was still coming out of anesthesia, I had to argue with his surgeon to make sure he was sent home with at least a handful of Norco. 

I had made the mistake in the past of not doing this after my partner’s nose surgery, and then I was left to watch him suffer on the couch for three days while he lamented that every time he tried to breathe, it felt like death.

If either situation happened today, we could save ourselves from so much stress and agony because he could just take 7-OH post-op. Yes, 7-OH is that good of a painkiller.

If doctors were smart they would be jumping all over 7-OH. Finally, something that actually relieves pain and doesn’t kill their patients.  It’s what we have all been looking for! 

But no, doctors are not recommending 7-OH. In fact, most have never heard of it, while state and local governments either ban it or threaten to do so. 

Yes, there are some downsides. The main one being just how expensive it is. One 7-OH chewable tablet, which has 4 servings, will run you around $10. 

It can also be difficult to figure out which brand works best for you, in large part because there’s so little regulation of kratom or 7-OH, making it difficult to know what each brand puts into their tablets and how much is in there.

My circle of people really liked using the brand 7Stax, but you can also browse through the r/7_hydroxymitragynine subreddit for additional recommendations and user experiences. 

You should know that 7-OH can cause dependence and withdrawal symptoms if you abruptly stop taking it. As someone who has used opioids for over a decade to manage pain, I am an expert on tapering down medications to avoid withdrawal. Newcomers may have some trial and error time before they figure out what’s best for their own bodies.

There’s also not much research on how 7-OH interacts with other drugs or health conditions, not to mention the lack of information about long-term side effects.

That is largely why I am still hesitant to recommend it to elderly relatives, as their health tends to be more fragile. Although, paradoxically, they also tend to be much more likely to have chronic pain.  

With everything going on in the news, it does seem like the fight to make 7-OH illegal has taken a backseat to other issues.  

What I would say is that if you have been hesitant to try 7-OH because you don’t want to waste money on another BS supplement that probably won’t work, then I can vouch for the fact that it does work on my pain. 

I’m not a doctor, just a patient who also has a lot of loved ones with chronic pain. And I can tell you that everyone I know who tries 7-OH finds it to be effective.  

If you are among those who have already found 7-OH to be effective, I encourage you to be proactive by reaching out to your local government officials to tell them how important it is for you. I would also encourage you to make yourself available to local reporters when possible, so that they can offer balanced coverage of 7-OH. 

While 7-OH is a breakthrough, it will only stay that way if it remains legal. We all have to fight to keep it that way. 

Federal and State Warnings May Be Increasing 7-OH Sales

By Pat Anson

Federal and state efforts to ban the sale of 7-hydroxymitragynine (7-OH) products may be having the unintended effect of increasing sales of the kratom extract, which is a potent pain reliever.

The owner of Kansas City-based American Shaman, the largest U.S. producer and seller of 7-OH products, says sales have increased since the FDA sent a warning letter to his company in July alleging its 7-OH tablets were being sold illegally as adulterated dietary supplements.

“We’re busier than ever,” says Vince Sanders, who estimates that millions of Americans are using 7-OH for pain relief and as a mood enhancer. “More people are familiar with it now than there were a year ago. All this press just makes more and more people educated about it, and more people go out and try it.”

7-hydroxymitragynine is a naturally occurring alkaloid found in kratom, an herbal supplement used in southeast Asia for centuries as a stimulant and pain reliever. Kratom contains only trace amounts of 7-OH, but Sanders has developed a process that makes it more concentrated and potent. 

Although technically not an opioid, 7-OH has opioid-like effects. Last summer, the FDA asked the DEA to classify 7-OH as an illegal Schedule One controlled substance, claiming it was a dangerous and addictive substance “more potent than morphine.” While the DEA has yet to act on that request, Florida, Ohio, California, and several other states and municipalities have recently moved to ban 7-OH sales.  

‘This Isn’t Some Party Drug’

While there are anecdotal reports that 7-OH is addictive, there is little solid evidence that people are overdosing or being harmed by it. And American Shaman continues to sell it, even though thousands of its tablets have been seized by the FDA.

Sanders believes 7-OH may be at least partially responsible for the recent decline in drug overdoses, because it keeps pain sufferers from turning to more dangerous substances like illicit fentanyl and other street drugs. Some use it as an alternative to Suboxone to treat opioid withdrawal symptoms. 

“There's probably roughly 75,000 people walking the earth today that wouldn't be here, and hundreds of thousands of others that have used 7-OH to completely stop taking a street drug,” Sanders told PNN..

“This isn't some party drug. It's not like, ‘Oh my gosh, I feel so high. This is incredible.’ That's not what 7-OH does. 7-OH is tremendous for pain and it definitely is a mood enhancer. It puts you in a better mood, but it doesn't make you high, like alcohol, marijuana or a traditional opioid. It doesn’t have that effect.”

7-OH is so effective that Sanders advises pain sufferers to use it sparingly in small amounts, and to take a break from it at least once a week to avoid building a tolerance that requires higher doses.  

“If you take it appropriately, you won't build a tolerance. You're not going to build an addiction to it. My 82 year old mother has been using it for nearly two years now. She needed a dual hip replacement, but refused to get it. She was almost to the point of not being mobile, she was in so much pain. But now she gets along like normal. It's amazing. Just takes her pain away.”

Are pain patients using 7-OH? We posed that question to PNN readers on our Facebook page and got some mixed responses.

“It absolutely works! Gets me through an eight hour shift every single day,” said one poster.   

“Best pain relief I ever had,” said another.

“Very effective, but it is addictive. It’s helped a lot of people, but it’s hurt some people as well,” warned one poster.

“Can’t stop taking them. It’s been over a year (and) trying to get down to below 100 mg a day is tough. I cannot have a normal digestion process anymore. Sucks and costs a lot of money,” warned another 7-OH user.

Some drug testing companies have started looking for 7-OH in blood and urine samples. Clinical Reference Laboratory in Kansas tested for it in a random batch of 1,000 samples from across the country. Surprisingly, 7-OH was detected more often than fentanyl and prescription opioids like oxycodone and morphine.

“We found a 1.09% positive rate, which is, depending on the population, higher than all the other opiates we test for combined,” CEO Robert Thompson told the Kansas City Star. “That was pretty concerning to me.”

As perplexing as 7-OH may be to health officials and drug regulators, there’s another kratom extract called pseudoindoxyl that’s even more potent and gaining in popularity. Derived from the alkaloid mitragynine, pseudoindoxyl also has opioid-like effects, but without the respiratory depression and risk of overdose that comes with traditional opioids.  

“For pain relief, it's better than 7-OH. The science would indicate that it's probably five times more potent for pain than 7-OH,” says Sanders, who sells pseudoindoxyl chewable tablets on American Shaman’s website.

He has yet to get any warning letters telling him to stop.

Feds Target Large 7-OH Vendor

By Pat Anson

Federal agents have seized about 73-thousand tablets, gummies, shots and other products containing 7-hydroxymitragynine (7-OH) from a Missouri company that sells 7-OH products nationwide. The seized items have an estimated value of about $1 million.

The seizure is part of a growing effort by federal and state regulators to crackdown on sales of 7-OH, an alkaloid that occurs naturally in kratom. When concentrated, 7-OH has opioid-like effects that can relieve pain and boost energy levels. Health officials say 7-OH can be abused and is addictive, although they have offered little evidence to support those claims.

“This enforcement action is a strong step to protect Americans from the dangers of concentrated 7-OH products, which are potent opioids,” FDA Commissioner Marty Makary, MD, said in a press release.  “We must be proactive and vigilant to address emerging threats to our communities and our kids.”

To be clear, 7-OH and kratom are not opioids. But they act on nerve receptors in the brain that control pain and mood, as do many other non-opioid substances, such as coffee and chocolate. Kratom and its alkaloids also don’t cause respiratory depression, the leading cause of an overdose.

The FDA worked with the Missouri Department of Health in targeting Kansas City-based CBD American Shaman, a company that was the subject of a recent investigative series by the Kansas City Star. American Shaman sells its kratom, CBD and hemp-based Delta-8 products online and in hundreds of smoke shops, gas stations and retail stores around the country.

Missouri’s Health Department released a health advisory in October claiming 7-OH was 13 times more potent than morphine, and could cause poisoning and overdose. The advisory noted the Missouri Poison Center was aware of three cases involving 7-OH, including one person who was “evaluated in a health care facility.”

The FDA’s Adverse Events Reporting System lists 52 “serious cases” associated with 7-OH so far this year, including 6 deaths. Most of the adverse effects were for dependence or withdrawal symptoms.

Warning Letters 

The FDA sent a warning letter to Shaman Botanicals, a subsidiary of American Shaman, last summer accusing it of illegally selling 7-OH in adulterated dietary supplements. Warning letters were also sent to six other companies selling 7-OH products. In response, some removed the 7-OH products from their websites, while others kept right on selling them.   

American Shaman currently still offers 7-OH tablets on its website, saying the tablets provide “relief, relaxation, and focus.” Asked if the tablets are safe, a chat bot gave us this answer:

“Great question! Our Advanced Alkoloids tablets feature precise, lab-tested 7-hydroxymitragynine (7-OH) or mitragynine pseudoindoxyl, depending on the variety. Many customers appreciate their reliable effects and controlled dosing compared to traditional kratom products.

As with any supplement, it’s a good idea to consult with your doctor before starting – especially if you have health concerns or take other medications.”

A disclaimer on the website also warns consumers not to use the tablets if they are taking pain relievers, opioids or other medications, and not to take them daily or for prolonged periods.

CBD AMERICAN SHAMAN

The FDA has recommended to the DEA that it classify 7-OH as a Schedule I controlled substance, which would make it illegal to sell or possess. The FDA says it is not focused on banning natural kratom leaf products, although some state and local governments have already banned kratom sales. 

The DEA has yet to act on the FDA’s request, a process that could take several months once a proposed scheduling is posted in the Federal Register. Kratom and 7-OH are not even mentioned in the DEA’s 2025 National Drug Threat Assessment, an annual report on the production and distribution of illicit drugs in the United States.

A Beginner’s Guide to Using Kratom for Pain Relief

By Crystal Lindell

Whenever I meet someone who’s having trouble managing their chronic pain, I always suggest that they look into kratom. However, many soon realize that there’s not much trustworthy information out there about what kratom is and how to use it. 

I’ve been taking kratom for my own chronic pain since 2018, and I have found that it’s the only thing sold over the counter that actually helps me. 

Below is a look at my experiences with it, and some tips to help if you’re new to the idea of taking kratom for chronic pain. 

Also, I want to make clear that this column is not sponsored, and you’ll notice that there are no links to any specific kratom products or companies. There is a lot of spammy content in articles about kratom, but this isn’t one of them.

What Is Kratom?

The formal name for kratom is “Mitragyna speciosa.” It’s a tropical tree that’s native to southeast Asia, and belongs to the same botanical family as coffee. 

Kratom has been used for centuries in Asia as a natural stimulant and pain reliever, but only in the past decade has it become widely available in the United States

To create the powder that’s usually sold in smoke shops, gas stations and online, kratom leaves are dried and ground up into a fine powder. 

There are three basic strains of kratom, and each one has different effects. 

There is a white strain, which I have found acts as a stimulant or energy booster. The red strain seems more like a mood booster that helps with pain. And then there’s a green strain, which is seen as more of the middle point between the two. 

You’ll also find products labeled as “gold” and “black” and those claim to be stronger versions of kratom, although I haven’t always found that to be the case. 

I personally use a mix of the strains, which is commonly referred to as a "trainwreck" mix. 

Is Kratom Legal?

Laws vary by state, county, and even cities in the United States. So it’s best to check your local laws before purchasing kratom. 

In June, the FDA sent warning letters to 7 kratom vendors about illegally marketing their products as dietary supplements. The letters were specifically in regards to an alkaloid in kratom called 7-hydroxymitragynine -- known as 7-OH -- which relieves pain and increases energy.

The FDA said it would try to get 7-OH classified as an illegal controlled substance, falsely claiming it was an opioid. While 7-OH occurs naturally in kratom, it is present only trace amounts.

To boost its potency, some vendors are selling gummies, tablets and extracts with concentrated levels of 7-OH, which the FDA says “may be dangerous.” For more information about 7-OH, check out this recent column I wrote about that product.

Although some states and cities have already banned 7-OH, the natural leaf powder is widely available (and still legal) in most U.S. states, as long as no medical claims are made about it. 

Is Kratom Dangerous?

It’s rare for someone to have an adverse reaction to natural kratom leaf, which is the form I take. However, people who consumed the concentrated extracts have been hospitalized or experienced overdoses. In most cases, they also consumed alcohol and other substances.

Recently, former CDC Commissioner Robert Redfield, MD, talked about a 2024 FDA-funded study, the final results of which have never been published. He said they found that kratom has low abuse potential.

“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.”

According to the American Kratom Association, FDA researchers were "profoundly disappointed” at the lack of adverse events associated with kratom, as its contradicts the agency’s long-standing opposition to it. That’s supposedly why the study’s findings have not been formally released.

Does Kratom Relieve Pain?

I think kratom really works, at least it does for my chronic pain. I can tell there’s a difference in my pain level shortly after I take a dose. My partner also swears by kratom as an effective treatment for chronic pain.

A 2016 PNN survey of over 6,000 kratom users found that 97% thought it was very or somewhat effective in treating their pain, depression, anxiety and other medical conditions. Over 98% said that kratom wasn’t harmful or dangerous.  

I always say that the best way to know that kratom actually works is when people try to regulate or ban it.

How Do You Take Kratom?

I mostly use the powder form of kratom. It comes in a bag, and it’s usually sold by weight.

I take half a spoonful of the powder, put it under my tongue, and then wash it down with a non-carbonated flavored beverage like juice or Gatorade. The powder is gritty and tastes bad, so you’ll probably need something to wash it down quickly with. To improve the taste, the powder can be mixed into a beverage directly.

You can also buy the powder in capsules, which are easier to consume. I personally find that capsules give me heartburn, so I tend to avoid them. 

There are also edible versions of kratom on the market, such as gummies, chocolates and even seltzers. I find those take longer to kick in, but they tend to offer a more even effect. However, they are more expensive than the raw powder, so I don’t buy them very often. 

If you do try kratom, I recommend using an extremely small dose to start with and, if possible, purchasing it from a smoke shop where employees can help you navigate your options. 

Overall, kratom has the potential to help a lot of people. But everyone is different, so your experience with the substance may vary. My hope is that people who could benefit from using kratom will feel more confident about trying it after learning more about it. 

California Leads Crackdown on Kratom and 7-OH

By Pat Anson

California isn’t waiting for the federal government to classify a potent synthetic form of kratom as an illegal drug. In fact, it’s going a step further.

The California Department of Public Health (CDPH) is warning consumers that products containing kratom or the alkaloid 7-hydroxymitragynine – known as 7-OH -- are illegal to sell or manufacture in the state. In recent months, six fatal overdoses linked to 7-OH have been reported in Los Angeles County, although alcohol, medication and illicit substances were also involved in those deaths.

7-OH occurs naturally in kratom in trace amounts, but some retailers are selling concentrated synthetic versions of 7-OH that boost its potency as a pain reliever and mood enhancer.

In July, the FDA said it would ask the DEA to classify 7-OH as an illegal Schedule One controlled substance, but specifically noted that the move was “not focused on natural kratom leaf products.” 

California health officials are focused on both, claiming natural kratom and 7-OH cannot legally be marketed or sold in the state as drugs, dietary supplements or food additives. In recent weeks they’ve been removing kratom and 7-OH products from retail outlets and manufacturing locations across California.  ​

“We are still finding kratom and 7-OH products for sale in gas stations, smoke shops, online and other retailers. While these products are sometimes marketed as natural remedies, they are dangerous and can result in fatal overdoses,” Dr. Erica Pan, CDPH Director and State Public Health Officer, said in a statement. “The best way to protect yourself is to avoid using 7-OH and kratom-related products.”  

7-HOPE Alliance, a nonprofit that advocates for continued sales of 7-OH, calls the crackdown “unlawful” because there is no California or federal law that bans kratom or 7-OH.

“This is government overreach at its worst,” Jackie Subeck, founder of 7-HOPE Alliance, said in a statement. “When the FDA is already under fire from both Democrats and Republicans for politicizing science, from vaccines to dietary supplements, it’s reckless for California to take cues from them without peer-reviewed evidence and taking action that will put lives at risk.”

Alabama, Arkansas, Indiana, Rhode Island, Vermont and Wisconsin have already classified natural kratom as a controlled substance. Dozens of cities, counties and local jurisdictions have also banned its sale. In August, Florida classified synthetic 7-OH as an illegal controlled substance.

Ohio’s governor recently sought to have all forms of kratom and 7-OH banned in his state, but postponed action after reportedly getting a call from HHS Secretary Robert F. Kennedy Jr.

In 2016, the DEA and FDA tried unsuccessfully to classify 7-OH and the kratom alkaloid mitragynine as illegal 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” about the harms posed by kratom.

“Policymakers across the spectrum have questioned whether the current FDA can be trusted to put science over politics,” said Subeck. “Californians deserve the medical freedoms that they were promised. Not fear campaigns and knee-jerk bans.”

Kratom and 7-OH are not even mentioned in the DEA’s 2025 National Drug Threat Assessment, an annual report that highlights threats to public health posed by illicit drugs.

Kratom products are usually sold as powders, tablets, shots, capsules and gummies. Consumers typically take them to relieve pain, anxiety, depression or withdrawal symptoms from other substances.

Critics call kratom “gas station heroin” and often claim it’s an opioid. But kratom actually comes from a tropical tree native to southeast Asia that belongs in the same botanical family as coffee. Natural opioids are derived from poppy plants, not kratom.

Like coffee, cheese, chocolate and many other food items, kratom acts on nerve receptors in the brain that trigger the release of endorphins and other “feel good” hormones that relieve pain naturally and have other opioid-like effects. Kratom’s effects are usually mild, depending on the amount consumed.

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.

How To Get More Pain Relief From Rx Opioids

By Drs. Forest Tennant, Martin Porcelli and Scott Guess

Due to a multitude of legal restrictions and biases, many persons living with pain who take opioid medication can’t get enough relief to function, be comfortable, and have quality of life.

Summarized below are some of the ways we have found to boost or enhance the pain-relieving effect of prescription opioids.

Take a Booster (Potentiator)

Opioids trigger the endorphin receptor to relieve pain. If you simultaneously take a medicine or supplement that triggers a different receptor or suppresses inflammation, pain relief is enhanced. This boosting effect is the reason opioids are combined with acetaminophen or aspirin in pain medications such as Vicodin or Percocet.

Here is a list of potential non-prescription boosters. You may have to experiment to find one or two that boost the potency of your opioid. You can swallow the booster with your oral opioid or take the booster within 15 minutes after taking the opioid.

• Taurine 1000 mg

• Glutamine 1000 mg

• Lion’s Mane mushrooms

• Quercetin

• Benadryl

• St. John’s wort

• White willow bark

• Cannabidiol (CBD)

• Kava

• Palmitoylethanolamide (PEA) 300 to 600 mg

Under the Tongue vs Swallowing

A medication dissolved under the tongue (sublingually) is always more potent than if you swallow it whole. That’s because digestion in the stomach and intestines may wipe out as much as 50% of an oral opioid’s pain relief capability.

Try dissolving an opioid tablet under your tongue. You may find it much more effective, as it will enter the bloodstream faster. We recommend starting with half your usual dose and increase it as needed, being careful not to exceed your usual dose. Discuss this practice with your medical practitioner.

Don’t Forget Aspirin

Aspirin has been disparaged to the point that people are afraid to take it. It is still one of the very best opioid boosters. Dissolve it under your tongue to avoid stomach upset or bleeding.

Receptor Health

The central nervous system has many receptors (“action points”) that relieve pain. They need to stay healthy and active to provide maximal pain relief. A good nutrition program that consists of daily protein, vitamin D, and magnesium helps keep nerve receptors healthy and maximizes opioid pain relief.

Bedtime Preparation

Some medicinals taken at bedtime have the effect of making the next day’s opioids more effective. Here are some suggestions:

• Metformin 500 mg + L-Theanine 200 mg

• Tryptophan 500 to 1000 mg

• Amitriptyline

• Pentoxifylline

Cannabis

Some persons find that cannabis provides significant pain relief, while others experience little or no relief.

Do not take cannabis products within four hours before or after an opioid dosage to avoid over-sedation, loss of coordination, and mental deficiency.

Kratom

Kratom is the only non-prescription herbal supplement that has opioid-like effects. It comes in a variety of forms, usually natural leaf powder that is sold in capsules, edibles or drinks.

Kratom can be simultaneously taken with opioids, but be wary of synthetic or concentrated kratom as its potency may be unknown or too high.

All persons who take opioids for pain relief should find a kratom form and dosage that relieves pain. Given today’s adverse attitudes and restrictions on opioids, a person relying on prescription opioids alone must face the fact that their medical practitioners may end or reduce their opioid therapy at any time. When this happens, you may have to rely on kratom.

Prescription Boosters

Many physicians prescribe non-opioid medications for pain relief, such as gabapentin (Neurontin), clonidine, tizanidine, baclofen, and pregabalin (Lyrica). These can also be used to boost the potency of opioids. Take these medications within four hours before or after your opioid dose.

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. Readers interested in learning more about his research should visit the Tennant Foundation’s website, Arachnoiditis Hope. You can subscribe to its research bulletins here.

Martin J. Porcelli, DO, is a family medicine doctor in Pomona, CA and is affiliated with Casa Colina Hospital.

Scott Guess, PharmD, operates an independent pharmacy and clinic in Atascadero, CA that specializes in pain management and arachnoiditis.

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section. 

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.)

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.