Thousands of Public Comments Support Keeping 7-OH Legal

By Pat Anson

Over 3,000 additional comments were posted in the Federal Register during the 15-day extension of the public comment period on the Trump administration’s plans to set a legal threshold for the kratom alkaloid 7-OH (7-hydroxymitragynine). 

Almost all of the additional comments oppose the DEA’s plan to set a limit of 1 mg per 7-OH tablet, gummy or shot, saying there is no evidence to support it.

Left unchanged, the DEA order would classify 7-OH products containing more than 1 mg (or more than 0.05% of a product by weight or volume) as illegal Schedule One controlled substances.

Pain sufferers who use 7-OH – often because they can’t get opioid pain medication – say 1 mg is too low of a dose and is far below what they are already taking.

“I currently take 15 mg twice a day every 4-6 hours as needed for my pain,” said April Sikes, a licensed practical nurse. “Please do not take another tool away from people who are simply trying to function, work, and live with dignity.” 

“I am a 31-year-old adult with severe chronic pain and a complex medical history who has used 7-OH for years. My typical amount is approximately 25 to 50 milligrams at a time, generally every 6 to 8 hours as needed,” wrote Veronika Livinska. 

“I currently use approximately 20 mg of 7-OH per day,” said Amy Cullen, who lives with chronic joint pain, anxiety and depression. “7-OH has personally been beneficial to me because it helps me manage my pain and makes it easier for me to function.” 

“I am a responsible member of the 7oh community and found 20mg 3 times a day is an appropriate dosage in maintaining my flare ups of lupus,” wrote Terry Matilda. “Please consider a reasonable threshold for 7oh rather than completely taking the one thing that keeps many pain patients functional.”

‘Little Information’ on 7-OH Safety

Exactly what a “reasonable threshold” is for 7-OH is difficult to determine. The alkaloid occurs naturally in whole leaf kratom – in trace amounts – and many people find those natural levels effective for pain relief, as well as other conditions such as anxiety, depression and withdrawal symptoms.

But manufacturers have developed ways to concentrate 7-OH – turning a mild pain reliever into a potent analgesic that has “opioid-like” side effects, such as withdrawal and addiction. 

Several states and dozens of cities and counties have already banned 7-OH, relying mainly on anecdotal stories about a surge in calls to poison control centers and reports of overdoses and hospitalizations involving 7-OH.

Despite the growing alarm about 7-OH and its characterization as “an imminent threat to public health,” there are no clinical trials or toxicological studies showing that 7-OH is toxic or unsafe in humans. Conversely, no studies have been conducted to establish what a “safe” 7-OH threshold is.

In a 2025 scientific assessment of 7-OH, the FDA acknowledged there is “little information” available on the safety profile of 7-OH. The few studies that exist were done on animals – rodents primarily – which found that 7-OH is a potent analgesic 4 to 6 times stronger than morphine when injected. 

But, when taken orally, researchers say 7-OH did not cause the same respiration depression in animals that causes overdoses in humans.

“If researchers couldn’t kill mice with oral 7OH, how would humans be dying from ingesting the same substance?” asked Joseph Garnella in his public comment. “Millions of 7OH doses have been consumed with zero overdose deaths. The only related deaths had multiple drugs and alcohol in their system.”

“No concentration or quantity of 7-OH has been identified as an imminent hazard,” said Chris O’Donoghue, who like other 7-OH users supports some degree of regulation. “I support age limits and lab testing. Licensed retail so you can get it out of gas stations.”

“It most certainly must be regulated in some way. It absolutely must not be allowed to be sold at gas stations and head-shops," said William Baldwin. “A license (akin to a tobacco or liquor license) should be required by any business involved selling it in the US, and quality control measures amongst the suppliers should be rather stringent.”

“I know people that would be alive today if they had a drug as safe as 7-OH to use, instead of things like heroin or fentanyl. If we ban this compound we are guaranteed to see a massive rise of fentanyl deaths or other dangerous black-market opioids,” said Collin Lomelino.

“I understand that we should probably regulate 7-OH, but the outright banning of this compound is going to leave hundreds of thousands of people no option but to turn to the street, which is filled with highly deadly drugs that will kill so many people.” 

In all, nearly 36-thousand public comments were made in the Federal Register since the Department of Health and Human Services (HHS) made its initial request for information on a 7-OH threshold in early July.

It’s unclear what, if any, impact all those comments will have on the DEA, which reports to U.S. Attorney General Todd Blanche – not HHS. 

DEA could amend its scheduling threshold to allow for more than 1 mg. Or it could implement the scheduling order at any time as it is currently written – making the manufacture, sale and possession of 7-OH illegal – and turning law-abiding 7-OH consumers into felons overnight.  

Why is 7-OH Called ‘Gas Station Heroin’ but Caffeine and Alcohol Are Not?

By Crystal Lindell

I think it’s because I work as a manager at a truck stop that the phrase “gas station heroin” particularly pisses me off.

If you haven’t seen the coverage, “gas station heroin” is the favorite phrase used by the media and anti-7-OH groups to describe kratom and the alkaloid 7-OH (7-hydroxymitragynine).

But it’s not based on anything real, because kratom and 7-OH are not even close to being heroin.

So as the DEA nears a potential nationwide ban on 7-OH, and state and local governments ban kratom, it’s a good time to really look at the ways media and advocacy groups try to justify these bans. Notice how their labeling never extends to other substances like caffeine, nicotine, or alcohol. 

Indeed, calling 7-OH and kratom “gas station heroin” is about as accurate as calling coffee and energy drinks “gas station meth.” Or calling beer “gas station LSD.”

Lots of mind-altering and addictive things are sold at gas stations. But something being a little addictive and a little bit mind-altering does not mean it should be lumped in with more dangerous and more mind-altering substances like heroin.

Take this New York Post article trying to scare readers about 7-OH. Large portions of it focus on the idea that 7-OH is sold at gas stations, as though that’s a reason to ban it in and of itself. 

"People can buy 7-OH at vape shops and truck stops with little guidance on how much they’re actually supposed to take," the Post warned.

Okay, so does that apply to the nicotine products sold at vape shops? Or the alcohol sold at truck stops? I mean, there’s little to no guidance for those substances too. 

The Post also includes a quote from Dr. Oliver Grundmann, a kratom specialist at the University of Florida.

“Even if 7-OH can help people wean themselves off stronger opioids, it has no business being peddled at bodegas,” Grundmann said. “It should be appropriately labeled and also only available in the hands of someone who can provide professional guidance, like a licensed pharmacist. Not a clerk at a gas station.”

Here again, we can easily flip this around to apply to the beer and cigarettes that are readily available at gas stations and “bodegas” – a fancy way of describing a neighborhood convenience store. 

Imagine saying: ““Even if alcohol can help people relax, it has no business being peddled at bodegas.” 

Or this: "Nicotine should be appropriately labeled and also only available in the hands of someone who can provide professional guidance, like a licensed pharmacist. Not a clerk at a gas station.”

In fact, when it comes to things like alcohol and nicotine, we as a society have decided that even if something causes thousands of deaths a year, it can still be sold at gas stations.

The thing is, kratom and 7-OH do not cause thousands of deaths a year. If they did, the DEA would no doubt have thousands of deaths they could point to to justify a ban. Instead, they had to really stretch to find any deaths to share.   

In fact, the DEA could identify only one man in Norway who supposedly died from using 7-OH. The only problem was the death occurred in 2014, long before concentrated 7-OH actually became available in the U.S. in 2022.

By that logic, caffeine should also be turned into a Schedule One drug. After all, a U.S. teen died from cardiac arrhythmia after chugging three caffeinated drinks in 2017. And a young woman died in 2022 after going into cardiac arrest hours after drinking caffeinated lemonade.

Oh, and in regards to the Norway death, that man also had a sedative, antidepressant, and anti-seizure medication in his blood and urine. So it was clearly a case of polysubstance use.

Someone having 7-OH or kratom in their system at the time of death should not be enough reason to classify those substances in the most restrictive DEA drug category.

Imagine if we tracked how many people had caffeine in their blood when they died. Or nicotine. We don’t even bother because when it comes to those drugs, we all understand that simply having a substance in your blood when you die does not mean that it caused your death.

I’m not saying kratom and 7-OH should be sold without any regulations or age restrictions. Rather, just the opposite. I believe the industry should be heavily regulated and nobody under 21 should be able to buy any kratom products.

The good news is that we already have a model for how to implement that: We just need to look to the other drugs already sold at gas stations, like nicotine, alcohol and caffeine. 

California Seizes More Kratom and 7-OH, but Online Orders Continue 

By Pat Anson

With 7-OH consumers still awaiting final word from the DEA on whether the concentrated kratom alkaloid will be classified as an illegal Schedule One controlled substance, individual states are pursuing regulatory action of their own.  

In California, Governor Gavin Newsom announced the state’s enforcement efforts have so far resulted in nearly 8,000 “deadly kratom/7-OH items” being removed from store shelves. 

Trace amounts of 7-OH (7-hydroxymitragynine) alkaloid occur naturally in whole leaf kratom, but manufacturers have developed ways to concentrate 7-OH in tablets, gummies and shots, which are potent pain relievers with opioid-like effects.  

Although the DEA is only considering a ban on 7-OH – leaving natural leaf kratom alone – California says kratom and 7-OH products both pose “serious health risks.” 

California’s crackdown began last October, when state health officials issued a consumer warning claiming that kratom and 7-OH caused several overdose deaths. Enforcement actions stepped up in January, with state agents seizing millions of dollars worth of kratom and 7-OH products. To date, they’ve issued 181 citations. 

The state also warned vendors they could lose their licenses to sell alcohol if they sold kratom and 7-OH. That threat – in effect saying it was safe to sell beer, wine and other intoxicating beverages, but not kratom and 7-OH – has resulted in a 98% compliance rate by Alcoholic Beverage Control licensees.

“If a product is sold in California, people should be able to trust that it follows the law. We’ve made the rules clear, giving businesses the opportunity to comply, and we’re holding accountable those who don’t. That’s how you protect kids and consumers while standing up for responsible businesses doing things the right way,” Gov. Gavin Newsom said in a news release.

But California’s enforcement efforts are uneven because they mainly target brick-and-mortar stores. Some online vendors are still shipping kratom and 7-OH products directly to California consumers, even though the California Department of Public Health (CDPH) said it has taken “significant enforcement action” against out-of-state kratom distributors.  

“CDPH has taken enforcement action on multiple orders of kratom shipped from out-of-state to California distribution facilities,” the agency said in a statement to PNN. "CDPH continues to monitor and enforce compliance with state law, including when products are sold or shipped directly to consumers in California. When CDPH becomes aware of unlawful kratom shipments, CDPH may take appropriate regulatory or enforcement action in coordination with local partners." 

The CDPH says it has the legal authority to ban kratom and 7-OH because they are “adulterated and misbranded” products that violate the California Health & Safety Code.

North Dakota Amends Kratom Ban

Dozens of other states, counties and cities have enacted laws banning or regulating kratom and 7-OH sales.

On Friday, North Dakota Governor Kelly Armstrong signed legislation that bans the sale, possession and use of 7-OH and other synthetic kratom products, and restricts the sale of natural kratom products to adults 21 and older.

Armstrong signed an executive order last month banning all kratom products, but under the new law passed by the North Dakota legislature during an emergency session, it will be legal again to sell natural leaf kratom as long as there are accurate labels and age restrictions.

“This is a victory for public health and safety, keeping dangerous synthetic kratom products off the shelves and protecting our young people from the adverse and unknown long-term effects of natural kratom, which is not regulated by the FDA but will now be subject to strict state regulations,” said Armstrong, who preferred a total ban on kratom.

Meanwhile, the DEA continues to slow walk enforcement action against 7-OH, even though it’s considered “an imminent threat to public health.” It’s been over a year since the FDA asked DEA to classify concentrated 7-OH as an illegal Schedule One substance, explicitly saying such a ban should not include natural kratom leaf.

DEA finally began the formal scheduling process for 7-OH in July, but federal health officials recently extended the public comment period until September 10. It’s not clear when DEA will act once that deadline passes or if it will make any changes in its scheduling order. 

As currently written, the order limits the amount of 7-OH to no more than 0.05% of a product by weight or volume, the equivalent of about 1 mg per tablet or gummie. That is well below the current dosage levels of 7-OH products. 

How I’m Able to Work Again with Chronic Pain

By Crystal Lindell

How do I do it?

On my days off, I sleep for 15 hours, waking up only to eat and pet my cats.

I can’t get out of bed without Norco, morphine, Advil, 7-OH, and Tums.

And I have a super supportive partner who does all the house work, all the grocery shopping, and changes all the litter boxes.  

That’s the short answer for how I manage to work a full-time job outside of the home while living with debilitating chronic pain. It takes a lot of drugs, a lot of sleep, a lot of support, and a lot of luck.

I also eat the same meals nearly every day to make food prep and decision-making easier. And I make zero plans for days off.

I started working again in April – my first full-time job in over four years. 

Despite my years of experience as a professional journalist working in the corporate world, I took a job as a gas station cashier close to home. I was fed up with corporate culture and just wanted to see if I could even handle working full-time again in any capacity with my health issues.

I also needed health insurance and the gas station offered me that after just one month.

Now that it's been a little over three months, it felt like a good time to reflect on how it’s going.

To be honest with you, I absolutely love it!

I love going to work every day. I love interacting with the public and making friends with my co-workers. I love getting out of the house. And I have already been promoted to the first level of management, with hopes of continuing up the ladder.

But it has taken a major toll on my body. 

I wake up in so much pain that walking to the bathroom feels like I’m using muscles for the first time in years. And after my shifts, I only have enough energy to change out of my work clothes and get into bed. 

I really don’t know if I’ll be able to keep it up if 7-OH is officially made into a Schedule One controlled substance.

I really, really want to keep it up though. 

I want to keep working, being good at my job, and forming surprisingly deep connections with my fellow employees. I want to keep feeling productive and living like I have a purpose in this world – even if that purpose is just helping truckers get back on the road.

That’s because, despite all the stereotypes about people with chronic illnesses, I desperately want to work. 

In reality, it’s the people constantly trying to take away my access to opioids and 7-OH who want me to be unemployed and bed bound. 

They may soon get their wish if 7-OH is banned – a policy being pushed in the name of “protecting me.”

Protection I do not want and didn’t ask for.

If it happens, the anti-7-OH advocates and federal health officials won’t take any responsibility. They won’t even offer me health insurance. Instead, I suspect they will tell me to go out and get a job.

$10 Million Worth of 7-OH Products Destroyed

By Pat Anson

The Kansas City-based company that developed and launched the first 7-OH products destroyed $10 million worth of the concentrated kratom alkaloid this week, in anticipation of 7-OH soon being banned nationwide.

7-OH products made by CBD American Shaman have already been taken off the market in its home state, after Missouri’s attorney general sued the company, claiming its 7-OH tablets, gummies and shots are “deadly opioids” that pose significant risks. The company still sells 7-OH tablets online, but won’t ship to Missouri and 13 other states where 7-OH is banned.

The DEA has begun the process of classifying concentrated 7-OH (7-hydroxymitragynine) as an illegal Schedule One controlled substance, which would make the sale and possession of 7-OH a felony. The DEA has already put the kratom alkaloid mitragynine pseudoindoxyl, along with synthetic alkaloids MGM-15 and MGM-16, in that category.

In addition to 7-OH, American Shaman developed the first concentrated mitragynine pseudoindoxyl products, which are more potent pain relievers than 7-OH.

“Unfortunately, of all the things, pseudoindoxyl is probably the very best pain medicine ever to hit earth,” Vince Sanders, Founder and CEO of American Shaman, told the Missouri Independent.

“I mean, very little mind change, very slow addictive properties, and just an incredible painkiller. But it’s gone. I’m sure it’ll show up as a pharmaceutical in five years or so, but as of now, people don’t have it available, which is truly a shame.”

The Department of Justice (DOJ) views pseudoindoxyl differently, calling it an “imminent hazard to public safety.”

“These are potent opioids being manufactured and sold in consumer products, often under labels that obscure their true risks. This action will protect our nation’s children and communities from the dangers of drug addiction and abuse,” Attorney General Todd Blanche said in a news release.

AKA Lawsuit

The DOJ’s news release makes a point of saying the agency has no desire to take natural leaf kratom off the market, and that it will “exercise enforcement discretion” by only targeting products that contain concentrated kratom alkaloids.

The American Kratom Association (AKA), which represents natural leaf kratom vendors, filed a lawsuit against the DEA and DOJ this week, seeking assurances that kratom leaf will be exempted from any federal bans. 

In recent years, kratom vendors have lost a considerable amount of business to 7-OH competitors. The AKA has actively encouraged state and federal governments to ban 7-OH and similar products..      

“The federal government made the right decision to target dangerous chemically manipulated opioid products,” says Mac Haddow, an AKA lobbyist and spokesman. “But that objective is undermined if legitimate natural kratom leaf products are swept into Schedule I because laboratories can now detect trace compounds at levels that do not present the public safety threat DEA sought to address.” 

To be clear, kratom and its alkaloids are not traditional opioids derived from poppy plants. Kratom comes from the leaves of the Mitragyna speciosa tree in Southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. 

Powdered kratom leaf gained in popularity in the United States nearly a decade ago, after many pain sufferers lost access to prescription opioids. The more potent 7-OH products went on the market in 2022 and quickly built up a following. Several million Americans have used kratom leaf or the concentrated kratom alkaloids, which have “opioid-like” effects but do not have the same risk factors as traditional opioids.

Norway 7-OH Death

In its scheduling order for 7-OH, the DEA claimed that “fatal overdoses involving 7-hydroxymitragynine have been reported,” but cited only one death. PNN discovered that lone case involved a middle-aged man in Norway who had a history of drug abuse and mental illness, as well as other health problems. 

In addition to 7-OH and a “high concentration” of mitragynine, toxicologists found a sedative, antidepressant, and anti-seizure medication in the man’s blood and urine. Death was attributed to “intoxication by these substances.”

Most overdoses blamed on 7-OH involve other substances, making the precise cause of death unclear.

Undermining the DEA’s case against 7-OH even further is that the overdose in Norway occurred in 2014, long before 7-OH products appeared on the market.   

7-OH advocates were successful in getting federal health officials to reopen and extend the public comment period on the trace amount of 7-OH that would be allowed after scheduling. That extension until September 10 is not binding on the DEA, but it appears the agency has agreed to postpone any further scheduling action until additional public comments can be made and evaluated. 

The original 30-day comment period received over 32,000 responses, one of the highest number of public comments ever recorded in the Federal Register.      

Extension of Comment Period Buys 7-OH Advocates More Time

By Pat Anson

Pain patients and advocacy groups who support the continued sale of a concentrated kratom alkaloid have apparently been successful in getting the Trump administration to postpone plans to classify 7-OH (7-hydroxymitragynine) as an illegal Schedule One controlled substance.

In a notice soon to be published in the Federal Register, the Office of the Assistant Secretary for Health (OASH) said it was extending for 15 days the public comment period on the threshold of 7-OH that can be legally allowed in commercial products. 

7-OH occurs naturally in whole leaf kratom, but manufacturers have developed ways to concentrate 7-OH into tablets, gummies and shots, which have “opioid-like” effects and are potent pain relievers. 

The earlier 30-day public comment period by HHS ended on July 31 with over 32,000 comments received. The new HHS notice reopens and extends the comment period through September 10.

“Public comments submitted to this docket will be provided by the Secretary for Health and Human Services for consideration by the Attorney General. We are taking this action in response to a request for an extension to allow interested persons additional time to provide comments and input,” wrote Brian Christine, Assistant Secretary for Health at HHS.

“Note that OASH is not soliciting comments on any permanent scheduling decision, the general safety or utility of kratom-derived products, or other policy questions outside the scope of the threshold determination for temporary scheduling.”

In July, the Drug Enforcement Administration published plans to limit the legal threshold of 7-OH to no more than 0.05% of a product by weight or volume, the equivalent of about 1 mg 7-OH per tablet. Virtually all 7-OH products on the market have much higher dosages. 

Although the extension of the HHS public comment period is not binding on the DEA, it seems likely the DEA will also postpone any action on its plan to classify concentrated 7-OH products as Schedule One controlled substances, the same category as heroin and LSD. 

The DEA reports to Attorney General Todd Blanche, who has the ultimate authority to decide how drugs are scheduled under the Controlled Substances Act (CSA). 

“They (DEA) could have a 7-OH ban right now. I think it more likely, given that the Assistant Secretary for Health has requested the 15-day extension, that they’ll give it time to be evaluated,” said Mac Haddow, a lobbyist and spokesman for the American Kratom Association (AKA), which supports the scheduling of rival 7-OH products. 

“So you may see at the earliest, in my opinion, a month before we’ll see the 7-OH schedule come out.”

The extension of the public comment period was sought by 7-HOPE Alliance and other 7-OH advocacy groups, who said they needed more time to respond to the “highly technical and largely unprecedented scientific and regulatory questions” being asked by HHS about a safe threshold for 7-OH.

“Preparing a meaningful response requires consultation with scientific advisors, review of the available literature, coordination with affected stakeholders, and careful analysis of complex pharmacological and analytical issues. These are precisely the types of substantive, evidence-based comments the Agency seeks, yet they cannot reasonably be assembled within the current timeframe.” wrote Jackie Subeck, Executive Director of 7-HOPE Alliance, in a letter to OASH.

“A modest 60-day extension would significantly improve both the quality and breadth of the administrative record before the Agency. It would allow consumers to have their voices heard while providing organizations, researchers, and technical experts sufficient time to develop thoughtful, science-based submissions.”

Doctors for Drug Policy Reform made a similar request for an extension, asking that OASH “coordinate with the Drug Enforcement Administration (DEA) to defer implementation of any temporary scheduling action.”

While 7-OH advocates didn’t get the lengthy extension they asked for, they appear to have accomplished their primary goal, which was to postpone the nationwide banning of 7-OH products.

Anticipating that DEA action was imminent, many vendors have already stopped selling 7-OH products, in some cases slashing their prices to dispose of 7-OH inventory before a ban took effect. Several states and dozens of cities and counties have already banned the sale of 7-OH products in their jurisdictions.

Pseudoindoxyl, MGM-15 and MGM-16 Scheduled

Meanwhile, the DEA is going ahead with plans to classify mitragynine pseudoindoxyl, MGM-15 and MGM-16 as Schedule One controlled substances that pose “an imminent threat to public health.” .

MGM-15 and MGM-16 are synthetic versions of kratom alkaloids, while mitragynine pseudoindoxyl is a concentrated formulation of a natural alkaloid found in whole leaf kratom. The three substances are not as widely used as 7-OH, but are more potent and have more potential for addiction.

“The population likely to abuse mitragynine pseudoindoxyl, MGM-15, and MGM-16 appear to be the same as those abusing Mitragyna speciosa and prescription opioid analgesics,” DEA claimed in its scheduling order.

Because testing methods for mitragynine pseudoindoxyl are limited, there is some concern that scheduling it as an illegal substance — even trace amounts — could lead to an outright ban on kratom itself. The obtuse language used by DEA in scheduling mitragynine pseudoindoxyl seems likely to cause confusion:

“Since nomenclature of this substance is not internationally standardized, compounds of this structure, regardless of numerical designation of atomic positions are covered.”

“Kratom critics, the ones that want everything banned, are going to come out and say, ‘You just banned all natural kratom,’” says Mac Haddow with the AKA.

Haddow believes the DEA will only enforce a ban on concentrated forms of mitragynine pseudoindoxyl, but is worried that trial lawyers and the addiction treatment industry will seek more rigid enforcement.

“(DEA) is never going to enforce against anything naturally occurring. But someone else will, using that language. And that’s why the confusion needs to be clarified,” Haddow told PNN. 

(8/27/26 Update: The AKA filed a lawsuit against the DEA, seeking clarity on how its scheduling of mitragynine pseudoindoxyl as an illegal substance applies to natural kratom leaf. The lawsuit in U.S. federal court does not challenge the DEA's scheduling order, but asks the court to confirm that it does not apply to botanical kratom, which contains trace amounts of the alkaloid.)

DEA Scheduling of 7-OH Could Come Any Day

By Pat Anson

A recent DEA decision to classify the designer drug O-DSMT (O-desmethyltramadol) as an illegal Schedule One controlled substance gives us some insight into how quickly the agency may do the same for concentrated forms of the kratom alkaloid 7-OH (7-hydroxymitragynine). 

It also serves as a reminder of how misleading and inept the DEA and other federal agencies can be about their research and public statements about drugs and other substances.

O-DSMT is a natural metabolite made by the liver when you take the prescription opioid tramadol. Like 7-OH, O-DSMT can have opioid-like effects, and it is significantly more potent than tramadol itself. In recent years, illicit drug labs have been making synthetic versions of O-DSMT, which has led to abuse and overdoses.         

The DEA published its first notice about scheduling O-DSMT on June 24. After a mandatory 30-day waiting period, the agency took another 19 days before officially classifying O-DSMT as a Schedule One substance on August 12.

The entire scheduling process took only 49 days for O-DSMT, which is quick work for the DEA.

Applying that same time frame to 7-OH, which the DEA first moved to schedule on July 6, means the DEA might officially classify concentrated 7-OH as an illegal drug on or about August 24. 

The kratom alkaloid mitragynine pseudoindoxyl and synthetic alkaloids MGM-15 and MGM-16 could also be classified as Schedule One substances that day, putting them in the same category as LSD and heroin.

All of this is projection, since the DEA could schedule 7-OH at any time. In the past, the agency has waited several months or even years before scheduling a drug, but because this is an emergency scheduling based on an “imminent hazard to public health,” the DEA is unlikely to wait long. 

The Trump administration appears eager to take concentrated 7-OH products off the market. President Trump has shown an interest in scheduling 7-OH, and Health and Human Services Secretary Robert. F Kennedy Jr. has called 7-OH manufacturers a “sinister industry” for their marketing efforts to children.

The FDA initially called for 7-OH to be banned over a year ago, but the DEA declined to take action until now.

‘FDA Fairytales’

Which brings us back to O-DSMT, which has an obscure but telling connection to kratom, the DEA and FDA.

In 2016, when the DEA first tried to schedule kratom’s alkaloids as Schedule One controlled substances, it claimed there were numerous deaths associated with kratom, including a “cluster of nine deaths in Sweden from use of the kratom product Krypton.”   

“Krypton” is not a reference to the mythical home planet of Superman, but to an herbal powder that was being sold online as a legal high. Nine young people died in Sweden from respiratory depression after ingesting Krypton in 2010. 

Krypton was then being marketed as a safe and natural kratom product, so the deaths were initially blamed on kratom. But toxicologists soon discovered that Krypton was laced with O-DSMT, which was detected in blood samples from the nine overdose victims. Based on that evidence, Swedish regulators quickly moved to ban O-DSMT as an illegal narcotic in 2011 — fifteen years before the DEA did.     

“We believe that the addition of the potent mu-receptor agonist O-desmethyltramadol to powdered leaves from Kratom contributed to the unintentional death of the nine cases presented and conclude that intake of Krypton is not as harmless as it often is described on internet websites,” Swedish researchers reported.  

Why was the DEA still blaming kratom for the Swedish deaths in 2016? Because that’s what it was told by the FDA, which continued to call the Krypton overdoses “kratom-associated deaths” long after the overdoses were linked to O-DSMT.

“The FDA misrepresented the nine Swedish deaths in its 3-Factor Analysis recommendation to the DEA in 2016 with the express purpose of triggering the emergency scheduling authority of DEA under the Controlled Substances Act (CSA) to schedule kratom as a Schedule I substance,” said Jane Banin, PhD, in a 2018 report sponsored by the the American Kratom Association.    

The DEA wasn’t the only federal agency that was misled by the FDA. The CDC and National Institute on Drug Abuse (NIDA), as well as state and local health officials, also published warnings about kratom, based in part on what Babin called the “FDA’s fairytales.” 

“The FDA’s failure to provide accurate and critically relevant data biased the narrative on the alleged deaths associated with kratom, amounting to a viral event that infected wide ranging opinions, and produced deeply flawed public policy at federal, state, and local levels,” Babin wrote.

The FDA’s sloppy research on kratom was later called "embarrassingly poor evidence” by a top federal health official, when he informed the DEA in 2018 that the agency would no longer seek to have kratom scheduled as an illegal substance. 

Flash forward eight years and the Trump administration is on the verge of banning concentrated forms of 7-OH, but not natural leaf kratom. 

That distinction may be comforting to kratom advocates, but it sparks genuine fear in millions of 7-OH consumers, who have come to rely on 7-OH as a potent and effective pain reliever. 

They can take cold comfort in the fact that the DEA is no longer spreading fairytales about what happened in Sweden. The DEA’s scheduling order for O-DSMT now correctly blames the nine overdoses in 2010 on “intoxication with O-DSMT.” 

Deceptive and Misleading Evidence

That’s not likely to dispel fears the DEA is repeating the same mistakes again with 7-OH. A justified fear, as it turns out.

In its scheduling order for 7-OH, the DEA states that “fatal overdoses involving 7-hydroxymitragynine have been reported,” but briefly cites only one case: a 24-year old man who died in 2014 with a high concentration of 7-OH in his blood. 

PNN discovered the DEA omitted some crucial information about the case and got one detail clearly wrong. For one, according to the researchers who investigated the overdose, the man was not 24-years old, he was middle-aged.

Unmentioned by the DEA is that the man had “a history of drug abuse and mental illness for several years.” In addition to 7-OH, he had a sedative, antidepressant, and anti-seizure medication in his blood and urine – clearly a case of polysubstance use.

Another key detail left out by the DEA is that the overdose happened in Norway – meaning the DEA was again invoking a drug death in Scandinavia and then getting basic facts about it wrong      

But the strangest aspect is when the death occurred. High dose 7-OH products only came on the U.S. market in 2022, so citing a fatal overdose in Norway from 2014 doesn’t make much sense. I’ll go even further and say it’s deceptive.   

In its campaign against 7-OH, the DEA mainly relies on anecdotal information from third-party sources, such as a growing number of calls to poison control centers about 7-OH and user-reported experiences posted online warning of 7-OH addiction and withdrawal.

“The National Drug Early Warning System (NDEWS) conducted web monitoring on reddit mentions of kratom and its derivates. In the report, information provided by reddit discussants surrounding kratom and 7-hydroxymitragynine shows that users often compare 7-hydroxymitragynine effects to prescription opioids, like oxycodone and hydrocodone, with users expressing worry on how such potent products are legally available at smoke shops,” DEA said.

The DEA’s failure to provide credible examples of 7-OH causing a fatal overdose is telling. So is its reliance on the guilt-by-association tactic of equating 7-OH with prescription opioids.

7-OH advocates say the DEA can’t provide evidence about an overdose on 7-OH alone, because the vast majority of reported deaths involve other substances — like the one in Norway. 

“If you talk to medical toxicologists that do postmortems, they don't see it. The experts in the country don't believe that 7-OH is responsible for deaths. If you talk to emergency room physicians, if you talk to addiction scientists, if you talk to leading people at the National Poison Control Center, their data doesn't suggest that this is leading to great harm,” says Jeff Smith, Executive Director of the Holistic Alternative Recovery Trust (HART), an advocacy group funded by 7-OH manufacturers.    

“The data doesn't appear to bear out that there is great harm occurring, or that this is any kind of emergency. If it were, they (DEA) wouldn't have waited a year for the initial recommendation.”

To be clear, concentrated formulations of 7-OH are potent analgesics that can lead to addiction and withdrawal. Even 7-OH advocates say the industry needs more regulation and accurate labeling, and that 7-OH products shouldn’t be marketed and sold to children.

All of this could be moot point though, because 7-OH products appear on the verge of being banned nationwide. Whether the evidence supports it or not. 

When a Pain Flare Steals a Special Day

By Crystal Lindell

Sunday was a boringly normal day for me — as someone who deals with chronic pain on a daily basis. 

When I woke up, it felt like someone had replaced my ligaments with concrete and I was being stabbed in the ribs. I limped to the bathroom. And for breakfast, I had four different pain-relieving drugs and a bottle of water.

After that, I laid back down and slept for another three hours.

I got up just long enough to eat lunch, which of course included a side of more pills. I grabbed my pillow and laid down on the couch in the living room, where I slept for another 2 hours.

It was a pretty routine pre-thunderstorm pain flare for me. Thankfully, I was off work, so I was able to spend the day resting.

The only problem was, Sunday was also my fiancé’s birthday.

He loves me. And he also deals with chronic pain. So he was more than happy to hang out with me on the couch all day while we watched bad 90’s movies.

He was also cool with going to pick up the toilet paper we needed and the Chinese food we got for dinner to celebrate his special day.

But I felt like crap about all of it.

I hate that I spent his entire birthday dealing with a pain flare.

He always does the dishes, and I wanted to do them for him on Sunday to give him a break, but I couldn’t. He also feeds all of the cats first thing every morning, and I wanted to do that for him as well. But again, I couldn’t.

He loves going to play basketball at the court behind our house, but I couldn’t do that with him either.

It sucked. All of it.

Eventually, the thunderstorm came, the pain relieving drugs I was taking started working, and I was able to function a little bit – but by then it was 10 pm and my fiancé was ready for bed.

Part of the issue is that I’m also tapering down on 7-OH in anticipation of the upcoming ban. Before the ban was announced, I was able to take as much 7-OH as I needed on bad pain days.

But these days, I have to use it sparingly, if at all.  The goal is to get off of it before the DEA declares it an illegal Schedule One controlled substance. The only thing worse than losing access to 7-OH would be to also have to go off of it cold turkey.

But that means I’m losing days of my life again to pain. Sometimes, it’s just a random Tuesday that I lose, and it’s no big deal. 

But other times, it’s an “August 9th” that I lose – and then I miss out on a special day.

Study Finds 85% of Kratom-Derived Products Mislabeled

By Pat Anson

A new study at the University of Florida is likely to increase the growing scrutiny of kratom, 7-OH and other kratom alkaloid products.

Researchers found that the vast majority of kratom-derived tablets, edibles and extracts contain alkaloid and chemical compounds that differ substantially from their product labels, potentially putting consumers at risk.

Some have been altered so significantly during the manufacturing process that researchers concluded “these products are definitively not kratom.”

Kratom comes from the leaves of the Mitragyna speciosa tree in southeast Asia, where it has been used for centuries as a natural pain reliever and stimulant. In recent years, demand for kratom products has risen sharply in the United States, reaching an estimated market size of $2.56 billion in 2025.

As the kratom market has grown, so has the variety of products available, including concentrated formulations of 7-hydroxymitragynine (7-OH) and other kratom alkaloids that have “opioid-like” effects and are far more potent than natural leaf kratom.     

Researchers at the University of Florida College of Pharmacy conducted a laboratory analysis of 44 commercially available kratom-derived products purchased online and in stores in several U.S. states.

The study findings, published in the journal of Drug Testing and Analysis, show that 85% of the kratom products had ingredients and concentrations that did not match their labels. In some cases, products were labeled as having a single alkaloid, but multiple alkaloids were detected. Other products contained compounds that were not disclosed on their labels or were listed but not detected.

“The findings are of strong relevance to public health and underscore regulatory actions needed for proper labeling requirements by manufacturers for consumers to know what they are purchasing,” said co-author Christopher McCurdy, PhD, a Professor and Associate Dean for Faculty Development in the UF College of Pharmacy. 

“Right now, consumers are part of a large experiment in which they are taking products that they believe are properly labeled as to the composition of ingredients, yet they are being deceived intentionally or unintentionally by the manufacturers, putting the public at risk.”

McCurdy and his colleagues have spearheaded much of the U.S. research into kratom, with McCurdy serving as an expert witness in kratom litigation cases on both the plaintiff and defendant sides. 

Their research has grown more complicated in recent years, as the kratom market has been flooded by new semi-synthetic products that are often marketed as “natural kratom.” The DEA is currently planning to classify 7-OH and other concentrated kratom products as illegal Schedule One controlled substances, while keeping natural leaf kratom largely unregulated as a dietary supplement..

“Products containing semisynthetic, kratom-derived compounds should be clearly distinguished from natural kratom products,” says lead author Abhisheak Sharma, PhD, an Assistant Professor of Pharmaceutics in the UF College of Pharmacy. “Stronger manufacturing standards, comprehensive testing and transparent labeling are needed to help people make informed decisions and reduce potential safety risks.”

Kratom Litigation

Advocacy organizations for both natural leaf kratom and 7-OH products support stronger labeling, age restrictions and transparent marketing, but there is little effort to enforce those standards at the federal level. That has left most kratom regulation to individual states and local governments.

In a move reminiscent of the opioid litigation cases that cost the pharmaceutical industry over $50 billion dollars, the city of Baltimore recently filed a complaint against several manufacturers and distributors of kratom products, accusing them of “engaging in unfair, abusive, or deceptive trade practices.” 

Maryland has banned the sale of all synthetic or artificially altered kratom products under the state’s Kratom Consumer Protection Act, which also requires product labels to be accurate.

The Baltimore case focuses on several kratom entrepreneurs behind Optimized Plant Mediated Solutions (OPMS), a kratom brand that sells a potent kratom extract called Black Liquid Kratom that’s been linked to several deaths.

“Defendants have employed a web of shell companies and alter egos, and use multiple business names, assumed names, and trade names to hide the scope of their operation and to avoid liability for their actions… while falsely stating or implying in their labeling, packaging, advertising, and marketing of the Kratom Products that the Kratom Products are safe for consumption or offer therapeutic and health benefits that they do not have,” the complaint alleges.

In 2024, the FDA warned consumers not to use Black Liquid Kratom after it was linked to several adverse events. But the OPMS extracts are still available in smoke shops, vape shops and online, where they are often marketed as “all natural” kratom products.

OPMS is one of the “qualified vendors” registered with the American Kratom Association’s good manufacturing standards program, which requires vendors to have labeling that “provides all the information required for consumers to make an informed purchasing decision.”

In their analysis of Black Liquid Kratom, University of Florida researchers found the OPMS extracts “showed variability in their chemical composition, with measured content different from the values stated on the product labels.”  A laboratory analysis found more alkaloids in Black Liquid Kratom than what was indicated on the product label.

‘Enormous Confusion’ as Deadline Nears for 7-OH Kratom Ban  

By Pat Anson

Supporters of a DEA plan to classify 7-OH and other concentrated kratom alkaloids as illegal Schedule One controlled substances are worried an impending ban may affect kratom itself. 

The American Kratom Association (AKA), a group of natural leaf kratom vendors, led the effort to ban what it calls synthetic kratom alkaloids, claiming they are dangerous “opioid products.”  

But now the AKA is worried the DEA scheduling may backfire, saying there is “enormous confusion among some members of Congress and even staff at the DEA” about the differences between natural leaf kratom, 7-OH, and other kratom alkaloids.

At issue is mitragynine pseudoindoxyl, one of many naturally occurring kratom alkaloids. A proposed DEA order would ban all pseudoindoxyl products, which are potent analgesics sold as dietary supplements. 

But because there is no current way to measure pseudoindoxyl levels, the AKA is worried that natural levels of pseudoindoxyl will be banned too – in effect a ban on natural leaf kratom. 

“That’s part of the problem, the confusion,” explained Mac Haddow, an AKA lobbyist who says a “zero tolerance” approach to pseudoindoxyl could theoretically lead to bans on kratom. He wants a “carveout” for pseudoindoxyl and natural leaf kratom, exempting them from any DEA bans.     

“That’s why we made the recommendation to the DEA that they should clarify the distinction. The same kind of carveout for pseudoindoxyl would be appropriate, even though it might not be quantifiable at normal testing levels,” he said.

Haddow blames much of the confusion on 7-OH manufacturers, who say their products are just as natural as kratom. 

“The 7-OH that the body metabolizes from a whole leaf product is really indistinguishable from 7-OH that is in a 7-OH product,” says Jeff Smith, Executive Director of the Holistic Alternative Recovery Trust (HART), an advocacy group funded by 7-OH manufacturers.     

“I frankly don't understand why the traditional kratom people have pushed so hard (for a 7-OH ban) when their products have to be considered a precursor.” 

Kratom comes from the leaves of the Mitragyna speciosa tree in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. In recent years, natural leaf kratom, 7-OH and other kratom alkaloid products have become popular in the United States, where they are used by millions of people to self-treat their pain, anxiety, depression, and substance use problems.  

Fearing they may also lead to addiction and overdoses, several states and dozens of cities and counties have banned 7-OH, and some have included kratom. 

The latest example is North Dakota, where the governor today declared a 30-day public health emergency banning all kratom products. Gov. Kelly Armstrong called for a special session of the legislature next month to make the ban permanent under state law.

“Doing nothing is not an option,” said Armstrong. “Right now, it's the Wild West when it comes to kratom and 7-OH sales in North Dakota: no regulations, no age limits, no accountability.  

“We’re taking emergency action to press pause and get these products off the shelves until the Legislature can address the issue.”   

A nationwide ban on 7-OH may be imminent. The DEA announced last month that it planned an emergency scheduling of 7-OH products as Schedule One controlled substances, the same classification as heroin and LSD. 

The scheduling order could take effect as soon as Wednesday, August 5. That has led to a run on 7-OH products in recent weeks, with 7-OH vendors slashing prices to dispose of as much inventory as possible before the ban takes effect. 

7-OH Retailers Slash Prices as DEA Deadline Looms

By Pat Anson

Online sellers of 7-OH products are offering major discounts on tablets, gummies and shots as a potential August 5 deadline nears for concentrated forms of the kratom alkaloid 7-hydroxymitragynine (7-OH) become illegal Schedule One controlled substances.

“Once they are gone, they are gone for good,” is how Payless Kratom is promoting its 7-OH clearance sale. Other online 7-OH promotions include multi-buy discounts and steep price breaks on bulk purchases.

“This is really the last chance to stock up,” said another 7-OH retailer.

KURES APOTHECARY

The DEA announced on July 6 in the Federal Register that it planned an emergency scheduling of all concentrated forms of 7-OH as illegal Schedule One controlled substances, the same classification as heroin and LSD.  

The scheduling order “will not be issued before August 5,” according to the DEA, and will remain in effect for at least two years, with a possible extension of an additional year.

Stockpiling 7-OH

With the August deadline fast approaching, retailers are getting rid of 7-OH products they will soon be prohibited from selling, and 7-OH consumers are stockpiling products while they can.  

“There is a fire sale going on at the website I get my 7 from,” said one Reddit poster. “They even have a countdown timer that's got the days, hours and seconds until they will no longer be taking orders if/when this goes into effect…. I just placed a massive order a few days ago and it's already on the way. It is probably my last order ever.”

“Prohibition is about to happen and I don’t know that it’s happened with something this popular in a while. We’re gonna see how addictive it is when it becomes a street drug. Turns a lot of otherwise law-abiding citizens into felons,” wrote another Reddit poster. “They’ll be arresting normal folks and destroying their families with drug court for something that was legal to purchase in a gas station 6 months ago.”

“With 7-OH becoming Schedule I in the coming days, I think we're approaching an inflection point. Healthcare workers should be prepared for a spike in both withdrawal presentations and ODs (overdoses),” warned a medical student. “Keep an eye out for both extremes over the next few weeks. Those that stockpiled and unintentionally OD or suddenly lose access and present in severe withdrawal that can resemble heroin or fentanyl withdrawal.”

Whether concentrated 7-OH is an “opioid” like fentanyl is disputed, but most 7-OH consumers acknowledge that it has opioid-like effects and is a good pain reliever.

“The effects of 7-OH on a person's body bear no resemblance to those of heroin or fentanyl,” says Jeff Smith, National Policy Director of the Holistic Alternative Recovery Trust (HART), an advocacy group funded by 7-OH manufacturers.    

Smith has chronic pain from two significant back injuries. The pain was so severe he couldn’t sleep more than 20 minutes at a time, until he started using 7-OH.  

“I've been using it for over a year, and it's helped me immensely with chronic pain and helps me sleep through the pain,” Smith told PNN. “So it has been transformative for me, and I know for tons of other people who I've met when I've gone and testified in different state capitals.  

“No other painkillers have helped. No other sleep medication has helped. I've tried 15 different things probably over the course of a decade or more, and this has really been the first thing that's helped meaningfully.”

HART has produced a documentary to counter what it calls false and misleading narratives about 7-OH. It features 7-OH consumers sharing personal stories of how 7-OH helped them overcome pain, anxiety and PTSD.

Local Bans Already in Effect

In some states, cities and counties, sales of 7-OH and kratom itself are already banned.

In recent months, California has seized nearly 7,000 kratom and 7-OH products, achieving what the state’s Alcoholic Beverage Control (ABC) agency calls a “98% compliance rate.”  

Ironically, many California retailers agreed to stop selling 7-OH and kratom products rather than run the risk of losing their licenses to sell alcohol – a substance that causes substantially more public health and safety problems. 

“After five months of targeted kratom and 7-OH enforcement efforts, nearly 98 percent of ABC-licensed locations are in compliance,” ABC Director Paul Tupy said in a statement. “This is possible through the collaboration of our licensees, who are making sure these harmful products aren’t available on store shelves.” 

Jeff Smith is unsure what will happen after August 5, a date when a window opens 30 days after the DEA’s scheduling order was published.

“The whole process has been so bizarre and herky-jerky that it's difficult to predict,” Smith said. “There is no outer time bound to this process, so 30 days is a minimum, but it's not a maximum. So they could take 60 days, or 90 days, or 180 days, or 365 days. I mean, they could take as long as they want to to address this. We just don't know what they'll do.”

Public Comments Show How 7-OH Ban Would Harm Pain Patients

By Crystal Lindell

Leigh Ann Matthews is a 51 year old woman with chronic pain. She lives alone, makes less than $2,000 per month, and can’t afford health insurance.

She relies on 7-OH for pain relief, and doesn’t know how she’ll be able to work if it’s banned.   

“Please don’t make me suffer with chronic pain by taking away the ONLY thing that has helped me tremendously,” she wrote. “I have no family or friends to lean on or help me. I don’t abuse 7-OH. I’m so afraid.”

Matthews is one of the thousands of people who have shared their stories in the Federal Register in response to the DEA announcing plans to make concentrated forms of the kratom alkaloid 7-hydroxymitragynine (7-OH) an illegal Schedule 1 controlled substance.

As of July 24, more than 20,000 comments had been submitted to the Department of Health and Human Services (HHS).  Reading through them makes some common themes jump out. There are thousands of personal, individual stories that are clearly coming from real people with real fears. 

Many are chronic pain patients, who say that 7-OH has given them their lives back. In fact, a search for the phrase "my life back" turns up 290 comments. A search for "chronic pain" returns 2,608 results.

"I'm a 50-year-old male with multiple sclerosis. I live my life with chronic pain,” wrote Gabriel Duley. “It is so hard to get out of bed to even take a shower. Doctors do not prescribe pain medications. Please do not take 7-OH away. It's the only thing that has given my life back to me."

Tyler Bartone is 30 years old and lives in Ohio. He wrote that he has suffered from chronic pain since he was 22, after a motorcycle accident broke both of his legs.

"Oxycodone, hydrocodone, Suboxone, and tramadol all got tried over those years, and none of them let me function the way I needed to,” Bartone wrote. “When I found 7-OH, that changed. I can walk my dogs now. I can play with my kids. I stopped relying on opioid pain medication because this actually worked for my pain in a way [that] those didn't."

He shared that he takes 30 to 60 mg of 7-OH spread across 4 to 5 doses a day, and that amount has stayed steady for the 1 to 2 years he has used it. 

"What scares me is what happens after a ban like this. People in my situation, and others I know who rely on 7-OH daily just to function, would be left with two options: go back to opioid prescriptions that didn't work as well, or turn to street drugs,” Bartone explained. “I know people would die from that second option. That is the real hazard here, not the milligrams in a tested tablet.”

Bartone said he would support rules that “keep this market honest.” Rules like a 21 and up age requirement, mandatory lab testing with published results, child-resistant packaging, and clear dosage labeling. 

Unrealistic Threshold

The DEA’s scheduling order limits the amount of 7-OH to no more than 0.05% of a product by weight or volume, the equivalent of about 1 mg per tablet or gummie. Virtually all 7-OH products currently on the market have much higher dosages. Bartone thinks it’s an unrealistic threshold.

“I'm asking HHS to set any threshold based on how people actually take this, not a number that erases the product entirely,” Bartone said. 

Katherine Loperena, a 33 year old who works in sales and suffers from chronic pain, also shared her story. She said for the past 1 to 2 years she has used more than 60 mg of 7-OH a day, split across 2 to 3 doses. 

"What scares me most is going back to the days when chronic pain decided whether I could work or not," she wrote. "I lost jobs because the pain became too much to push through, and I spent years choosing between showing up in agony or protecting my income. Before 7-OH, I had tried oxycodone, alcohol, cannabis, and over the counter pain relievers, and none of [them] gave me a real way to manage day to day life."

Lindsay Huffman also shared how 7-OH has helped her manage the chronic pain she’s had for five years.

“Without it, I would have no way to treat my pain,” she writes. “It has been massively beneficial to my quality of life. Banning it would affect thousands of people who just want to be able to function and have finally found some hope."

Kyle Whitman wrote just one sentence: "Please don’t do this."

Lane Reeves said simply, "This (7-OH) should be available for chronic pain patients with no insurance!"

Rolando Smith shared how he uses 25 to 50 mg of 7-OH daily, which he says “has made my life so much more enjoyable through the ability to no longer feel immense pain all day long.”

“I take 7-OH not to feel anything such as a high, but rather to just eliminate the feeling of pain that usually lasts hours each day,” Smith explained. “7-OH is a perfect substance for my pain compared to other painkillers I have received as I am not a fan of overly euphoric or ‘high’ feeling drugs.”

Smith said he’s had no issues with withdrawal or dependence from using 7-OH.

“I've been an on and off user for about a year now, and find it easy to quit when I want to lower my tolerance or run out of supply and feel too lazy to get more. Personally I have not felt negative effects physically or mentally with using this substance and I never feel the need to take any more than what makes my pain disappear,” he wrote.

Patricia Metz shared how she takes 7-OH a few times a week to help with chronic pain from a serious injury. Without it, she doesn’t think she’d be able to work and provide for her child.

"This product has given me back a quality of life I couldn't otherwise have," Metz writes. "I have had six surgeries, countless hours of physical therapy, and spent years working with pain management with no meaningful result. 7-hydroxymitragynine is far safer than prescription pain management and far more accessible.

“There are thousands of people with a similar story who rely on 7-OH, many of whom are scared to death right now because they feel the rug being pulled from under their feet and see a future of pain ahead. I fear that removing access to this valuable resource will drive a good number of those people to dangerous and deadly street drugs."

The American Kratom Association (AKA), which represents natural leaf kratom vendors who have lost market share to 7-OH, is in favor of banning 7-OH products. It recently sent a letter to HHS, claiming many of the public comments in support of 7-OH are ”Coordinated, Duplicate, Fictitious, and Financially Incentivized.”

According to the AKA, many of the comments are anecdotal personal stories that should not be considered as part of the scientific analysis of an appropriate 7-OH threshold. The letter also said some 7-OH vendors are offering discounts to consumers who show that they have left a comment.  

In 2016, the DEA dropped another effort to ban kratom after a public outcry. At the time, the DEA received over 22,000 public comments in the Federal Register, a record number on any issue. It seems likely that record will be broken again.

There’s Still Time to Fight the 7-OH Ban

By Crystal Lindell

It’s a bizarre experience to know that something you take on a daily basis is probably about to become an illegal Schedule 1 controlled substance.

If I take a tablet of the concentrated kratom alkaloid 7-OH on July 31, I’ll just be taking an OTC supplement. 

But assuming the proposed ban goes through, simply possessing the same tablet in August will technically mean I am committing a felony. 

The Drug Enforcement Administration says the 7-OH that I take to manage my chronic pain is so dangerous and medically worthless that it belongs in the same category as LSD and heroin. But they also think it’s fine to leave it legal for one last month.

None of it makes any sense.

Don’t get me wrong, I’m eternally grateful that 7-OH was not instantly made illegal. It gives tens of thousands of people like me time to taper off it.  

But nothing will change about 7-OH in August to suddenly make it more dangerous, other than the way the Trump administration has decided to classify it.

It’s difficult to manage life during such an abrupt transition. I will have to basically teach my brain that one of my supplements is now the kind of thing that could trigger a police raid on my home and get me fired from my job. 

Yes, I have been tapering myself off 7-OH. Of course I have been tapering. Anything less would be irresponsible.

I have successfully tapered from about 80 mg a day down to 25 mg a day. It was not very difficult to drop down my dose that much. I did a little more each day and had almost no withdrawal symptoms. There were a couple days when I was a little more anxious, but that was it.

When I was still living under the impression that 7-OH would remain widely available and legal, I took it whenever I had pain. But now, since I know that it will likely be illegal soon, I only take it when the pain is so severe that I cannot function without it.

Unfortunately, that presents a pretty big problem: What am I going to do when it’s illegal and my pain is so severe that I cannot function without it?

Despite the fact that I have lowered my dose so much – it’s the next 10 days that I’m really scared of. Because that’s when I have to figure out how to live with zero 7-OH. 

I still need it to get through a shift at work, even when using it in combination with opioid medication and  OTC pain relievers. In fact, I still need 7-OH to get through the physical strain of taking a shower.

One thing I love most about 7-OH is that it works immediately whenever I take it. And it’s a chewable tablet, which means I don’t even need a drink of water to swallow a pill.

That makes it an amazing pain reliever for when I’m working. And it makes it super helpful for when I’m on a strict time schedule. Needing to wait 30-40 minutes for a medication to kick in steals so much time out of my day.

There just is no alternative that helps me as much as 7-OH. As such, writing this column genuinely saddens me.

It’s not just grief for myself and what I will have to endure when I can no longer take the most effective pain reliever I’ve ever had. It’s the fact that tens of thousands of other people will also be losing the same thing at the same time. 

Advocacy groups think the total number of Americans who have used 7-OH is as high as one million. That’s a lot of potential felons. Some of them are my loved ones. 

I have seen firsthand how 7-OH has relieved their pain and given them their lives back – in ways I never could have dreamed just two years ago.

I don’t want people to get a false hope that the DEA could backtrack on this, like they did with the kratom ban in 2016. But I also know that doesn’t mean we should just give up.

We have to keep fighting, not just for ourselves, but for all the people who could be helped by this soon-to-be illegal substance.

If you support legal 7-OH, please go leave a public comment on the Federal Registrar. Here are links to the public comment page and the comment portal. Over 17-thousand people have commented already. The deadline is July 31.

Personal comments will have more of an impact. It’s important to remember that they are only asking for a threshold amount of 7-OH that should remain legal. So you should share what dosage you safely take on a daily basis.

We have not lost yet. As such, we can’t stop fighting for this either. 

No One Called Kratom an Opioid Until They Wanted It Banned  

By Pat Anson

The DEA’s recent decision to classify concentrated forms of the kratom alkaloid 7-OH as an illegal controlled substance has resurrected an old argument: Is kratom itself an opioid? 

Kratom comes from the leaves of the Mitragyna speciosa tree in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. Kratom is a botanical cousin of the coffee plant, which relieves pain through a natural alkaloid we all know: caffeine.

No one calls caffeine or coffee an opioid, do they? 

Only in recent years has the “opioid” label been attached to kratom, mainly by government regulators and the addiction treatment industry. Former FDA commissioner Scott Gottlieb, MD, was the first to do so, warning in 2018 that kratom should not be used to treat pain or any other medical condition. 

“Claiming that kratom is benign because it’s ‘just a plant’ is shortsighted and dangerous,” said Gottlieb, who now serves on the board of directors for Pfizer. “It’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated, sold and used recreationally.”  

Gottlieb’s remarks were based on an FDA computer analysis of kratom, which found that 7-hydroxymitragynine (7-OH), mitragynine and other kratom alkaloids share similarities with opioid analgesics.

Like morphine and oxycodone, the alkaloids bind to mu-opioid receptors in the brain and relieve pain. But unlike opioids, they are partial agonists that do not cause respiratory depression. The vast majority of kratom-related “overdoses” occur because people mixed kratom with other substances that depress breathing, such as alcohol or benzodiazepines.  

Nevertheless, Gottlieb insisted on calling kratom an opioid.

“Based on the scientific information in the literature and further supported by our computational modeling and the reports of its adverse effects in humans, we feel confident in calling compounds found in kratom, opioids,” Gottlieb said.

Critics called the FDA analysis “junk science,” citing numerous errors and signs of bias. 

One such critic was Brett Girior, MD, Assistant Secretary for Health and Senior Advisor for Opioid Policy at HHS, who said the FDA analysis of kratom was based on "embarrassingly poor evidence.” It was Girior who put a temporary end to the FDA’s efforts to have the DEA classify kratom’s alkaloids as Schedule One controlled substances.

“While mitragynine and 7-hydroxymitragynine have many properties of an opioid, scheduling these chemicals at this time in light of the underdeveloped state of the science would be premature,” Girior wrote in a 2018 letter to the DEA administrator. “There is significant risk of immediate adverse public health consequences for potentially millions of users if kratom or its components are included in Schedule I.”

‘The DEA Should Control Kratom’

Flash forward 8 years, and the FDA is once again trying to schedule 7-OH and kratom is being called an opioid, although the science behind that claim really hasn’t changed. 

“Like other opioids, kratom is highly addictive: Repeated use leads to tolerance, dependence and the need for progressively higher doses,” wrote Andrew Kolodny, MD, an addiction treatment psychiatrist, in a recent op/ed in the The Washington Post

“The DEA should control kratom in all its forms. Until it does, an opioid will be available for purchase without a prescription, the number of Americans suffering from opioid use disorder will keep rising, and there will be no end to the opioid crisis in sight.”

Kolodny is a familiar name to many pain sufferers. He is the founder and president of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that played an influential role in getting the CDC to draft its controversial 2016 opioid prescribing guideline.

The CDC’s recommendations led to millions of patients being abruptly taken off opioids or reduced to ineffective doses. Some died by suicide or turned to the black market for relief, which helped fuel the fentanyl crisis.

Meanwhile, Kolodny and several other PROP members went on to make millions of dollars testifying as “expert witnesses” in opioid litigation cases. Their demonization of opioid medication is what led many Americans to start using kratom as a pain reliever.

That irony isn’t lost on pain patients, who left some choice comments about Kolodny and his op/ed on PNN’s Facebook page.

“He's a pain grifter making his $$$$ off people suffering from chronic pain,” said one. 

“He'll naturally piss on any treatment for chronic pain that doesn't include Suboxone or a shrink trying to gaslight you into saying nothing is wrong!” said another.

“If kratom hadn't saved my life over 20 years ago, I wouldn't be alive to be able to type this comment and call this article out as blatant misinformation,” wrote another pain sufferer.

Koldony testified in federal court a few years ago that he stopped treating patients when he became Medical Director for Opioid Policy Research at Brandeis University. In his op/ed, Kolodny said he was treating addiction again and that “a growing share” of his patients developed opioid use disorder by consuming kratom. 

At a recent public hearing in Georgia, Kolodny went further, claiming “all of the patients” he was treating had become addicted to kratom. He said a substance doesn’t have to come from the opium plant to be an opioid, citing the skin of the waxy monkey tree frog, which contains “an extremely potent opioid” that is stronger than morphine.

Kolodny also cites a misleading CDC study that found “poisonings and hospitalizations involving kratom have risen 1,200 percent over the past decade.” 

That 1,200% increase sounds horrific, but it is based on fairly small numbers. The total number of “adverse events” involving kratom was 538 in 2025, compared to 43 cases in 2014. That’s where the 1,200% figure comes from. About half of those reports were considered “intentional misuse” or suspected suicide attempts.

The 1,200% spike in cases reflects the simple fact that more Americans are using kratom today than in 2014. Conservative estimates put the number at 2 million, although the kratom industry has a much higher estimate of 20 million. Either way you slice it, 538 cases out of 2 or 20 million kratom users is a very low rate for adverse events. 

Coincidentally, in 2025 the FDA received 538 reports of adverse events involving Suboxone, a medication used to treat opioid use disorder. And there were over 4,800 adverse events involving aspirin that same year. 

No one talks about banning Suboxone or aspirin, or protecting us from waxy monkey tree frogs.  

Kratom Treats Addiction 

Just like the labeling of kratom as an opioid, the term "kratom use disorder" is also a recent invention, first used in 2021 by a group of addiction psychiatrists seeking to establish a clinical consensus for diagnosing and treating kratom addiction with Suboxone. 

One of the ironies in that framing of kratom is that the National Institute of Health recently announced plans to investigate the kratom alkaloid mitragynine as a treatment for addiction.

Many kratom users are already doing so. In a 2016 PNN survey of over 6,000 kratom consumers, about one in ten said they used kratom to reduce their cravings for opioids or alcohol, with over 90% saying it was “very effective.”

“This is an herbal blessing that has kept me from drinking,” said one. “If it becomes illegal, I fear we may never truly be able to study and treat ailments that kratom helps with.”

A more recent survey by 7-Hope Alliance, a 7-OH advocacy group, found that 23% of 7-OH consumers use it to self-treat opioid addiction. The vast majority – 74% – use it to relieve chronic pain.

Mac Haddow, a lobbyist and spokesman for the American Kratom Association (AKA), thinks the effort to frame kratom as an opioid is being driven by the addiction treatment industry.

“I think the more difficult problem is with addiction recovery centers because they’ve become very active in the kratom space, and they're calling it an opioid. They want to say that because they have to be able to qualify a so-called kratom addicted person in order to be reimbursed for the treatments that they provide,” Haddow told PNN.

“To me, that's problematic because that's a profit-centered assessment as opposed to a medical assessment, and clearly they are in the business of calling it an opioid so they can get reimbursement.”

‘7-OH Opioid Products’

One of the weirder ironies in the labeling of kratom is that the AKA, which represents natural leaf kratom vendors, is leading the fight to have concentrated 7-OH products banned. The AKA has even resorted to calling 7-OH an opioid, just like Kolodny and Gottlieb.

In a recent PNN op/ed, Haddow said 7-OH manufacturers have created “7-OH opioid products.” 

“They took a naturally occurring trace alkaloid found in kratom leaf and chemically manipulated it into highly concentrated 7-OH-dominant opioid products, then pushed those products into the marketplace without the guardrails that would apply to any legitimate opioid drug product,” Haddow wrote.

7-OH advocates say the AKA is trying to drive out competitors who have cornered a large share of the kratom market with a superior product. Asked to explain how 7-OH could be an alkaloid in small amounts but an opioid in larger doses, Haddow said 7-OH manufacturers turn it into a “completely different compound.”

“I could be wrong, but I think that the conversion from its trace amounts into a highly concentrated amount, then its activity on the new opioid receptors, is what distinguishes it,” Haddow explained. “It's not natural. There's nothing natural about the 7-OH that's sold in these highly concentrated forms because it's been chemically managed.” 

The DEA disagrees. In its scheduling order for 7-OH products in the Federal Register, the DEA says the 7-OH molecule chemically remains the same – whether in natural leaf kratom or in concentrated versions.

“Despite the different origins of 7-hydroxymitragynine, the chemical structures of synthetic and naturally occurring 7-hydroxymitragynine are identical. Consequently, the intrinsic pharmacological profile, receptor affinity, and mechanism of action of 7-hydroxymitragynine molecule remain unchanged regardless of its source.”   

They may share the same molecule, but the DEA is not seeking to ban natural leaf kratom, only the concentrated 7-OH formulations. It says those products “pose significant safety risk to unsuspecting consumers by exposing them to high doses of opioids.”

There’s that pejorative word again: opioids.

To be clear, 7-OH products are potent analgesics. And like any drug, when used excessively or irresponsibly, they can pose safety risks. 7-OH manufacturers haven’t done themselves any favors by selling their products without warning labels and in child friendly packaging that resembles candy.

7-OH products have been easy to get in gas stations, smoke shops and online, but that era is rapidly coming to a close. Several states and dozens of cities and counties have already banned 7-OH products, and soon there will be a nationwide ban on them.  

Like other attempts at prohibition, whether for alcohol, marijuana or prescription opioids, there will be unintended consequences. 7-OH products seem destined to become hot items on the black market and it’s reasonable to assume that drug cartels will start selling counterfeit 7-OH tablets or exotic new formulations of kratom alkaloids.

The DEA will have new drugs to target and more people to arrest. And the addiction treatment industry will have millions of new patients to prescribe Suboxone to.

No one called kratom an opioid until they wanted it banned. And figured out a way to make money from it. 

“That's a fair assessment. I agree,” says Haddow.

Banning 7-OH Will Make Consumers Less Safe 

By Jeff Smith

The DEA’s rushed proposal to ban 7-OH is a horrendous mistake.

7-hydroxymitragynine, or 7-OH, is an alkaloid from the kratom plant. Many adults use it for serious chronic pain and to help with withdrawal from dangerous opioids. A lot of them say they use 7-OH because whole-leaf kratom was not enough to alleviate their chronic pain. 

Despite initially opposing the scheduling of concentrated 7-OH products, Mac Haddow and his American Kratom Association (AKA), which represent the whole-leaf kratom industry, have spent the last year trying to ban them with fanatical zeal.

In his recent PNN op/ed, Haddow finally acknowledges that these pain patients exist and that their suffering should not be dismissed. But belated sympathy is not enough when the policy he supports, and – indeed – has been spending millions of dollars to lobby, would eliminate access, expose consumers to the consequences of illegal possession, and push people toward products no regulator can inspect. 

This should trouble anyone who cares about ending the opioid crisis. Untreated and undertreated pain are a core reason so many people turn to prescription opioids. When they cannot get adequate pain care, some look for relief wherever they can find it, including the black market – which comes with the risk of illicit fentanyl. 

For some chronic pain patients, 7-OH has been one of the few tools that allow them to work, care for family, avoid withdrawal, and stay away from more dangerous substances.Those consumers deserve transparency, real standards, and the freedom to make informed decisions.

The Holistic Alternative Recovery Trust (HART) has long supported rules around 7-OH, including requiring accurate labels, independent testing, age restrictions, serving limits, contaminant screening, responsible packaging, and enforcement against false medical claims.

Haddow and the AKA have chosen another path. They offer no comparable solution for chronic pain patients. They are trying to make sure adults cannot use 7-OH at all, regardless of the consequences for thousands of people.

Let’s be clear about what classifying 7-OH as a Schedule One controlled substance will mean. Legal access to 7-OH would be cut off for ordinary consumers, potentially for years. The DEA’s own statement says covered 7-OH products would be subject to criminal, civil, and administrative provisions of the Controlled Substances Act, including those for possession.

Haddow has claimed that this prospective ban is mainly about manufacturers, not consumers. But that is disingenuous. Consumers would still face the legal consequences of possession, and many would lose one of the few tools they say has helped them manage pain.

Those who keep using 7-OH anyway will not be safer. Indeed, they will be in much more danger than they are now. Schedule One will not create labels, require testing, set serving limits, punish only bad manufacturers, build a lawful pathway for adult access, or help consumers speak openly with doctors. Instead, it will push consumers toward unregulated supply chains, unknown products, and sellers no regulator can inspect.

Haddow and the AKA have pursued this course by painting 7-OH as a public health emergency. But their evidence does not support the solution they prescribe. They often point to adverse-event reports involving 7-OH or kratom-related products. But many of those reports do not clearly establish what product was used, how much was taken, whether it contained 7-OH, or what other substances were involved. 

Further, many reports involve more than one substance, underlying health conditions, products of unknown strength or composition, or labels that do not identify what the person consumed. It is almost impossible to determine whether whole-leaf kratom was involved in an overdose or a concentrated 7-OH product. 

Regardless, Haddow and the AKA have traveled to one state after another, filling the heads of state legislators and regulators with unprovable scary stories more characteristic of a moral panic than a public health issue.

But the truth is, this was never about safety. As recently as early 2025, Haddow did not call for a  ban on 7-OH. The reason for his 180 degree shift was explored in a recent piece in The New York Times. The article described an influence campaign by kratom companies and their allies to protect their whole-leaf products by urging federal action against 7-OH competitors. 

According to The Times, Secretary of Homeland Security Markwayne Mullin disclosed an investment worth as much as $1 million in Botanic Tonics, the company behind Feel Free, which has consistently urged a 7-OH ban. 

The Times also reported that Botanic Tonics donated $1 million to a political committee associated with Health and Human Services Secretary Robert F. Kennedy Jr., and that company founder Jerry W. Ross used access to Vice President JD Vance to urge a 7-OH crackdown.

That is the context in which consumers should read Haddow’s argument. This is about money, market share, and one part of the kratom industry trying to use federal power against another.

Even opponents of 7-OH should be wary of the ramifications of their strategy. Haddow says banning concentrated 7-OH will protect natural kratom leaf, but history gives consumers little reason to trust that prohibition will stop there. 

In 2016, the DEA tried to place both mitragynine and 7-OH into Schedule One before backing down after public backlash. The arguments now being used against 7-OH are the same arguments used against whole-leaf kratom for years, and there can be little doubt that they will resurface again.

That spillover is already happening. The AKA’s campaign against 7-OH has helped create a political environment in which some legislators now see all kratom as a liability. Kansas recently made kratom and 7-OH Schedule One controlled substances, and Tennessee enacted a new criminal law governing kratom.

There is still time to stop this. The DEA should stand down, Congress should hold hearings, and the Trump administration should replace the ban with a responsible adult-use framework for 7-OH. 

Adults should not be abandoned to withdrawal, untreated pain, lost work, and illicit drug markets because one part of the kratom industry decided that protecting its own products mattered more than protecting the consumers it claims to represent. 

Jeff Smith is National Policy Director of the Holistic Alternative Recovery Trust (HART), an advocacy group funded by 7-OH manufacturers.