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.  

Banning 7-OH Will Save Lives

(Editor’s Note: Last week the DEA said it would classify concentrated versions of the kratom alkaloid 7-hydroxymitragynine (7-OH) as illegal Schedule One controlled substances. In response, PNN’s Crystal Lindell — a 7-OH consumer — wrote an op/ed sharply critical of the DEA’s decision and the role played by the American Kratom Association (AKA), which lobbied for the move. The column below is the AKA’s response.)  

By Mac Haddow

I do not question the sincerity of Ms. Lindell in her Op-Ed describing her personal experience or the seriousness of the pain she describes. No one should minimize the suffering of chronic pain patients, and no one should dismiss the fear that comes when a person believes the product they rely on may no longer be available.

But that does not change the core issue: the Controlled Substances Act was enacted to protect consumers from dangerous drug products — not to punish consumers. When manufacturers create, market, and sell products that present a significant threat to public safety, federal law exists to intervene. 

That is exactly what has happened with chemically manipulated 7-OH opioid products.

The blame for this situation does not rest with the American Kratom Association, natural kratom leaf consumers, regulators, or anyone advocating for responsible consumer protections. The blame lies entirely at the feet of the 7-OH manufacturers who deliberately bypassed federal law and basic safety requirements in pursuit of profits.

These companies did not follow the required pathways for market entry. They did not submit lawful safety data. They did not comply with the federal requirements that exist to protect consumers from dangerous drug 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.

Worse, they deceived hundreds of thousands of natural kratom leaf consumers into believing they were purchasing ordinary kratom products. They traded on the reputation of natural kratom leaf while selling products that are fundamentally different in formulation, potency, pharmacology, and risk. 

That deception has harmed consumers, undermined legitimate kratom regulation, and placed the entire natural kratom community at risk.

The American Kratom Association does not advocate for the purchase of any kratom product. The AKA advocates for consumer protection. That means support for policies requiring safely formulated natural kratom leaf products, proper labeling, age restrictions, contaminant testing, responsible manufacturing standards, and clear limits that prevent dangerous adulteration or chemical manipulation.

The companies you criticize for supporting the AKA are not being defended because they sell products. They are companies willing to support lobbying efforts to protect consumers through rational regulation. That is very different from the 7-OH manufacturers who chose to evade federal requirements, push chemically manipulated opioid products into gas stations and smoke shops, and then claim that enforcement against them is somehow an attack on personal freedom.

It is not.

No responsible public health policy would support allowing consumers to buy opioids from drug dealers on a street corner simply because some adults may want access to them. The same principle applies here. 

Chemically manipulated 7-OH products are opioids. They should not be easily available to anyone through retail channels with no medical supervision, no lawful drug approval, no verified safety profile, no abuse-liability controls, and no meaningful consumer protections.

This is not a debate over bodily autonomy in the abstract. It is a debate over whether manufacturers can bypass the law, create concentrated opioid products, market them as “kratom,” and sell them broadly to consumers without meeting the same safety standards that apply to other opioid products.

Alcohol and tobacco are not a justification for repeating another public health failure. The existence of dangerous legal products does not mean the government should ignore a new class of chemically manipulated opioid products being sold without adequate oversight. It means policymakers should act before the harm becomes larger.

The most important distinction is this: natural kratom leaf products and chemically manipulated 7-OH opioid products are not the same. The AKA has fought for years to protect access to natural kratom leaf for responsible adult consumers. That work is directly threatened by 7-OH manufacturers who blurred the line between kratom and opioids for profit.

Ms. Lindell's anger should be directed at the companies that created this crisis. They put consumers like her in this position. They entered the market unlawfully. They misled consumers. They ignored safety standards. They gambled with public health. And now they want natural kratom advocates to absorb the blame for the consequences of their own conduct.

The AKA will continue to support access to properly regulated natural kratom leaf products. But it will not defend chemically manipulated opioid products masquerading as kratom. Protecting consumers means drawing that line clearly — and enforcing it.

That is not betrayal.

That is responsible advocacy.

Mac Haddow is a Senior Fellow on Public Policy with the American Kratom Association.

Banning 7-OH Will Ruin My Life

 By Crystal Lindell

When I got the news that 7-OH will likely be illegal in the United States within the next month, I was on a break at the new job I was able to get because of 7-OH.

I opened my texts to see a message from PNN editor Pat Anson:

7-OH to be banned nationwide in early August according to DEA filings.”

He’s always been great at breaking news. 

When I saw the words though, I wanted to throw up. I started shaking and was overcome by a cold sweat. Then I fought back tears because I had to get back to work.  

I had to get over the shock and dissociate to get through the rest of my shift at the gas station where I work. I spent the next few hours legally selling customers cigarettes, beer, and lottery tickets. 

Then I went into my car and cried.  

7-OH has truly been a life-changing drug for me and many people I know and love.

I have intercostal neuralgia, which is nerve damage in my ribs. When you have the same thing in your face it’s called trigeminal neuralgia – which is colloquially called the “suicide disease” because so many people who have it kill themselves or want to.

As someone with the intercostal variety, I’m here to tell you that having that kind of pain in your ribs doesn’t make it any less horrible. I have long considered suicide as a potential treatment option.

For many years I was able to find some semblance of stability with a cocktail of opioid and OTC pain medications. I know how lucky I am to be among those who can still get an opioid prescription. But while the opioids have kept the suicidal-level pain at bay, they have never allowed me to actually live.

7-OH does that.

It’s not an exaggeration to say that it has given me my life back. It’s been even more effective than hydrocodone or morphine for me. It instantly treats my pain while also combating fatigue. 

Losing access to 7-OH will be devastating for me. 

I am worried I will no longer be able to work full-time, and that I will then lose the health insurance I only just got. Without work and insurance, I will be back to living below the poverty line, and relying on food pantries. 

But none of that has anything to do with why I think 7-OH should remain legal.

7-OH should remain legal because – as an adult – I should have the legal right to put whatever I want into my own body, and it is no one else’s business how I do that.

That’s it. That’s the only reason needed. Anything else is irrelevant.

This is a bodily autonomy issue. I should be the only one who controls my own body, especially my own medical decisions. 

Not to mention the fact that nicotine and alcohol are legal despite the fact that they are both very addictive and sometimes deadly. Why single 7-OH out? Especially considering how safe it is in comparison to those drugs. 

AKA Betrayal

What’s worse is the outright glee from some leaf kratom advocates, who think banning 7-OH will somehow let them be seen as the golden child.

I feel so betrayed by them. The American Kratom Association in particular pushed for this and they have made a deal with the devil. When 7-OH is banned nationwide, it’s likely that leaf kratom is next. It’s already happened in several states.

I will never again use a single kratom product from any of the companies that support the AKA.

For now, I plan to taper down and hopefully get off 7-OH without going into withdrawal. And I am going to look into different substances that may give me a similar effect. 

I’m also hopeful that the 7-OH manufacturers are working on new formulations of kratom alkaloids that will still be available after the ban. 

And I am clinging to the 1% chance that the DEA backtracks on this, as they did in 2016, after initially announcing plans to make mitragynine and 7-hydroxymitragynine illegal Schedule One drugs. 

I know we cannot count on that though.

Honestly, writing this column feels futile. I know it won’t do anything to stop the ban on 7-OH from coming. But I do feel it’s important to at least create a record of my objections. 

I want it plainly stated that a ban on 7-OH will be detrimental to my life, and to the lives of thousands of others who have found relief from this drug.

But how do I convince people to care about my life? Why do I even have to do so? Shouldn’t caring about other people’s well-being be something that comes naturally?

It’s degrading that I have to beg the world for pain relief. That I have to plead for a medication that allows me to live my life, work a job, care for my cats, love my fiancé, and aid my elderly relatives.

It disgusts and depresses me that we live in a country that would deny me those things.

DEA Will Classify 7-OH as Illegal Drug

By Pat Anson  

The Drug Enforcement Administration is moving to ban all concentrated forms of the kratom alkaloid 7-hydroxymitragynine (7-OH) by classifying it as an illegal Schedule One controlled substance, the same classification as heroin and LSD. 

In a notice pre-published in the Federal Register, the DEA said it would enact a temporary scheduling of 7-OH, which will begin 30 days after the notice is formally published on July 6. That would effectively ban the manufacture, sale and possession of 7-OH products nationwide, potentially in early August.

A separate notice applies the same Schedule One classification to the kratom derivatives mitragynine pseudoindoxyl (MP), dihydro-7-hydroxymitragynine (MGM-15), and the 9-fluoro derivative of 7-hydroxymitragynine (MGM-16).

Kratom comes from the leaves of a tropical tree in Southeast Asia, where it has long been used as a natural stimulant and pain reliever. 7-OH occurs naturally in kratom in trace amounts, but when concentrated it becomes more potent and has “opioid-like” effects.

The DEA’s order limits the amount of 7-OH to no more than 0.05% of a product by weight or volume. Virtually all 7-OH products currently on the market are well above that threshold.

Although many pain patients have found 7-OH to be an effective analgesic, concern has risen that repeated use may lead to addiction and overdose. Several states and dozens of cities and counties have banned 7-OH products, which are currently sold as unregulated dietary supplements.  

“7-Hydroxymitragynine has opioidergic activity, sharing a similar pharmacological profile to schedule II opioids like morphine. Preclinical data indicates that 7-hydroxymitragynine carries a high abuse potential with safety risks, including tolerance, dependence, and respiratory depression, which are comparable to those of classic opioid analgesics,” the DEA said.

“While sellers promote these products for their euphoric and opioidergic effects, evidence demonstrates they may also contain other opioid alkaloids, such as mitragynine pseudoindoxyl. These combinations, coupled with a lack of regulatory oversight, pose significant safety risk to unsuspecting consumers by exposing them to high doses of opioids.”

Under the Controlled Substances Act (CSA), the DEA can “temporarily” place a new substance in Schedule One for two years without a public hearing, as long as the Department of Health and Human Services (HHS) has no objection.  

“I commend the DEA for taking decisive action to address these addictive and harmful substances,” HHS Secretary Robert F. Kennedy, Jr. said in a statement.  “7-OH, MP, MGM-15, and MGM-16 are dangerous opioids that fuel addiction and put American lives at risk. HHS reviewed the science and recommended this action.” 

‘More Than We Were Hoping For’

The DEA action was applauded by the American Kratom Association (AKA), an organization of kratom vendors that promotes the use of unadulterated natural leaf kratom. The AKA has been lobbying local governments to ban 7-OH, but keep kratom legal.

“State officials should be very clear about what happened here,” said Mac Haddow, an AKA lobbyist and spokesman. “The 7-OH industry created this crisis. They manufactured or distributed high-potency opioid products, dressed them up as kratom, and then tried to force natural kratom consumers to pay the price for their recklessness.”

Haddow says the DEA’s action will lend weight to arguments that natural leaf kratom is safer than 7-OH.  

“It's more than we were hoping for, in the sense that we got another clear affirmation from HHS about the distinguishing characteristics, because that's important to state legislatures and to state AGs and to boards of pharmacy,” Haddow told PNN. 

“This was all a great set of announcements that clarifies for every state legislator, every attorney general, and every local county elected body to see exactly that they should be in alignment with the federal policy on these issues.”

7-OH advocacy groups are likely to mount a legal challenge to the DEA’s scheduling of 7-OH.

“We understand that this announcement is causing a lot of confusion, fear, and uncertainty throughout the consumer community. First and most importantly, we want to be clear: 7-OH has not been immediately banned or scheduled,” the 7-HOPE Alliance said in a statement.

“While this development is serious, there is still a process ahead, and there is still an opportunity for science, evidence, and consumer voices to be heard. The 7-HOPE Alliance is actively reviewing the announcement and coordinating with legal, scientific, policy, and advocacy partners to determine the strongest path forward.”

Legal options appear to be limited. Under the CSA, DEA and HHS are given wide discretion to classify a new drug as a Schedule One controlled substance if its poses an “imminent hazard to public safety.” In addition to the two-year temporary scheduling of 7-OH, the U.S. Attorney General has the authority to add an additional third year.

In another notice being published in the Federal Register, HHS is opening a 30-day public comment period on the proposed threshold for 7-OH and the other kratom derivatives.

You can leave a comment by clicking here. Comments must be posted by July 31.

It’s important to note HHS is not asking whether 7-OH should be classified as Schedule One, only if the 0.05% threshold set by DEA is appropriate. It is “not soliciting comment on any permanent scheduling decision, the general safety or utility of kratom-derived products.”

AMA Calls for Complete Ban on Sales of 7-OH

By Pat Anson

The American Medical Association (AMA) is calling for a complete ban on the sale, distribution and marketing of products containing 7-hydroxymitragynine (7-OH), a kratom alkaloid that is of growing concern for its potential to cause dependence and addiction.

7-OH occurs naturally in kratom in trace amounts, but when concentrated acts as a potent pain reliever and stimulant with “opioid-like” effects.

The policy adopted by the AMA at its annual meeting urges the FDA to classify “7-OH kratom products” as adulterated or misbranded. It is particularly concerned about sales to minors and the packaging of 7-OH in colorful, child-friendly forms that could be mistaken for candy.

“We cannot ignore the growing availability of unregulated products marketed in ways that appeal to children and adolescents. Concentrated 7-OH products are being sold in forms that can resemble candy and other treats, creating unnecessary risks for young people,” Dr. Melissa Garretson, a member of the AMA Board of Trustees, said in a statement.

As for kratom itself, the AMA’s House of Delegates passed Resolution 201, which recommends that kratom be evaluated for regulation as a drug under the Controlled Substances Act:

“Our AMA recommends kratom, and its derivatives, should be regulated by the FDA, and its safety and efficacy should be determined through clinical trials before it can be marketed or prescribed as treatment for any condition.”

As dietary supplements, kratom and 7-OH are currently regulated as food — not as drugs — by the FDA, as long as unverified claims are not made about their medical uses. The FDA has repeatedly warned kratom distributors not to make such claims.

Several states and dozens of cities and counties have already banned kratom and 7-OH or put age restrictions on sales. The AMA’s new policy position will likely add weight to further efforts to ban kratom products.

The American Kratom Association (AKA), an association of natural leaf kratom vendors, supports efforts to ban 7-OH products. but is concerned the AMA was not specific enough about its concerns.

“The AMA correctly identifies the danger posed by concentrated 7-OH products, but it stops short of making the most important distinction,” Mac Haddow, an AKA lobbyist, said in a statement. “These chemically manipulated 7-OH opioids are not traditional kratom products. They are highly concentrated opioids manufactured through chemical conversion processes that fundamentally alter the natural composition of kratom.” 

The AKA’s position is at odds with the 7-HOPE Alliance and the Holistic Alternative Recovery Trust (HART), which represent 7-OH consumers and manufacturers. Those groups support age restrictions and regulation of 7-OH, but not outright bans.  

“As discussions surrounding kratom continue, HART urges policymakers, medical organizations, and regulators to engage with the available scientific evidence and work toward regulatory solutions that protect children and consumers while preserving access for responsible adults,” Jeff Smith, HART’s National Policy Director, said in a statement to PNN.

“The fixation and misinformation on 7-OH is a deliberate distraction from far more concerning products that remain widely available to consumers. Instead of pursuing misguided bans on naturally occurring compounds, policymakers and regulators should focus on protecting consumers through consistent, science-based standards that apply equally across all kratom products.”

(Editor’s note: An earlier version of this story incorrectly reported that the AMA only wanted a ban on sales of 7-OH products to minors. PNN regrets the error.)

Kratom and 7-OH Often Confused

The lines between kratom and 7-OH often get blurred. A case in point is a recent news release from the Laguna Treatment Center, an addiction recovery clinic in Southern California, which warned of the “growing threat of kratom and its byproducts.”

In the first 5 months of 2026, the center said it was treating 25 patients “who sought help for kratom dependence.” That represents a 525% increase from the 4 kratom consumers who sought treatment at the center in all of 2025. The center makes no distinction between the different forms of kratom. 

“An alarming number of patients are coming in dependent on and addicted to kratom and its byproducts, such as 7-OH, who were previously unaware of the risks. This is relatively new territory for many providers, and we encourage insurance providers to expand and prioritize coverage for those seeking treatment for kratom misuse,” said Trace Swartzfager, Executive Director of the Laguna Treatment Center. 

Federal policies about kratom and 7-OH are also confusing, if not incoherent. Last month, President Trump said his administration would support the approval of “natural 7-OH,” without clarifying whether he was talking about natural leaf kratom or concentrated 7-OH versions.  

Nearly a year ago, FDA commissioner Marty Makary, MD, called on the DEA to classify 7-OH as an illegal Schedule I controlled substance, but not “natural kratom leaf products.” The DEA has yet to act on the FDA’s request and Makary has since been fired. The Trump administration has yet to replace him.

Claims are often made that 7-OH and kratom are opioids that cause addiction and overdoses. Technically, they are alkaloids and are not derived from poppy plants. Kratom and 7-OH stimulate endorphin nerve receptors in the brain – often called “opioid receptors” – but the same could be said about chocolate and coffee, which stimulate the production of endorphins and other natural “feel good” hormones.

Most of the overdose deaths attributed to kratom and 7-OH involve other substances, so it is not clear if they were the actual causes – much as opioid pain medications were mistakenly blamed for many overdose deaths. The FDA admits there is “ambiguity about the contributory role of 7-OH” in many overdoses.

Further muddying the waters about kratom, the National Institutes of Health (NIH) recently said it would study one of its purported health benefits. The NIH is launching a preliminary study to see if the kratom alkaloid  mitragynine could be used as a treatment for opioid addiction. Many kratom consumers already use the herbal supplement to help reduce their cravings for opioids and alcohol. 

A previous NIH study concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and is “relatively safe” to use.

CDC Study Warns Against Consuming Kava-Kratom Drinks 

By Pat Anson

For the second time in a week, the CDC has released a study warning of “serious medical outcomes” for people who consume kratom, a controversial supplement used by millions of Americans as a stimulant and pain reliever.

This time, the study focuses on the co-use of kratom with kava, a plant in the pepper family used to make a coffee-like drink that promotes relaxation and improves mood. 

Consumption of kava declined after the FDA warned in 2002 that it could cause severe liver injury. But consumption began rising about a decade ago, as drinks containing both kava and kratom rose in popularity among young people.

“These commercial products are commonly marketed as healthy alternatives to alcohol, sold near college campuses, and increasingly being combined with kratom, a psychoactive botanical with opioid-like effects, raising safety concerns,” wrote lead author Christopher Holstege, MD, Professor of Emergency Medicine and Pediatrics at the University of Virginia School of Medicine.

Holstege and his colleagues reported in the CDC’s Morbidity and Mortality Weekly Report (MMWR) that kava-related calls to U.S. poison control centers rose 383% from 2011 to 2025 (from 57 cases to 203). About a third of the kava calls in 2025 also involved kratom. 

“These data indicate a resurgence of overall kava exposure reports to poison centers, as well as an increase in kratom-related kava reports, which has coincided with higher rates of serious clinical outcomes. The findings in this report suggest the need for enhanced surveillance for, clinical awareness of, and public education regarding commercial products containing kava,” Holstege said.

Nearly half (43%) of the kava-related calls involve other substances, including ethanol (alcohol) and benziodiazepines. While most adverse effects were minor, such as nausea and dizziness, about a third resulted in hospitalizations or serious outcomes. Eight kava-related deaths were reported during the study period.

Last week the same group of researchers warned in another MMWR report that kratom-related calls to U.S. poison control centers rose by 1,200% over the past decade. While that appears to be a startling increase, it’s a misleading number that represents only a tiny fraction (0.28%) of the estimated 5 million kratom users.

A MMWR report in 2016 was used by the DEA to justify its efforts to have the kratom alkaloids 7-hydroxymitragynine (7-OH) and mitragynine listed as Schedule One controlled substances, a move that would have effectively banned kratom. That report was also based on calls to poison control centers.

The DEA dropped its proposal after a public outcry. A top federal health official in the first Trump administration later admitted the scheduling request was based on “embarrassingly poor evidence & data” from the FDA and could result in “substantial risk to public health” if kratom were made illegal.

The growing controversy over potent forms of 7-OH recently revived efforts by the FDA to have the DEA list 7-OH as a controlled substance, but not natural leaf kratom. The DEA has yet to act on that request. 

A controversial drink that contains kava and natural leaf kratom is Feel Free Classic, made by Oklahoma-based Botanic Gardens. Media stories claimed the drink is addictive, has “opioid-like effects” and is “hooking young people.”  

A class action lawsuit was filed against Botanic Gardens that alleged it used misleading advertisements to promote Feel Free as a healthy alternative to alcohol. The company settled the case for $8.75 million, and agreed to put stronger safety warnings on Feel Free bottles and limit sales to people 21 and older. 

In 2023, the FDA seized nearly 250,000 bottles of Feel Free, alleging the drink was an adulterated substance with inadequate safety information. Over a year later, the FDA quietly dropped the case.

A small short-term clinical study funded by Botanic Gardens found that Feel Free was “generally safe, with only mild to moderate AEs (adverse events) reported, which were all transient in nature.”

Calls About Kratom to U.S. Poison Control Centers Surge

By Pat Anson

In what could be part of a new federal effort to ban kratom nationwide, the CDC has released a new study pointing to an exponential increase in kratom-related calls to U.S. poison control centers over the past decade.

There was a 1,200% increase in kratom-related reports to the National Poison Data System, from 258 in 2015 to 3,434 in 2025, including a “marked surge” last year. 

There was a similar 1,200% increase in kratom-related reports that resulted in adverse events and hospitalizations, from 43 cases in 2015 to 538 in 2025.

Over that 11-year period, there were a total of 233 kratom-related deaths. Most of the deaths and hospitalizations involved other drugs, such as alcohol, opioids, cannabis, stimulants and benzodiazepines. 

About half of the exposure reports were considered “intentional misuse” or suspected suicide attempts, researchers reported in the CDC’s Morbidity and Mortality Weekly Report (MMWR).

“Kratom-related adverse effects are increasing in number and complexity in the United States. Increasing use, the availability of high-potency kratom, and frequent multiple-substance exposure reports contribute to hospitalizations from physical as well as psychiatric causes,” wrote lead author Christopher Holstege, MD, Professor of Emergency Medicine and Pediatrics at the University of Virginia School of Medicine.

Last summer, the FDA said it would seek to have the kratom alkaloid 7-hydroxymitragynine (7-OH) – but not whole leaf kratom – classified as an illegal Schedule One controlled substance. 

7-OH occurs naturally in kratom in trace amounts, but some kratom vendors are selling concentrated versions of 7-OH that boost its potency as a pain reliever and mood enhancer. The surge in poison control cases in 2025 is mainly attributed to the growing use of 7-OH products. 

“As FDA moves to regulate 7-hydroxymitragynine but not whole-leaf kratom products, surveillance should distinguish product types to assess risks. Building this evidence base is essential to promoting safe kratom use, identifying high-risk combinations of substances, and guiding public health action to prevent future health effects in this rapidly evolving drug landscape,” said Holstege. 

Misleading Numbers

It’s important to note that the surge in kratom-related calls to poison control centers has more to do with kratom’s growing popularity in the United States. 

Kratom comes from the leaves of a tree in Southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. Kratom’s use began growing in the U.S during the 2010’s, as restrictions were placed on opioid analgesics and pain patients sought other ways to get relief. 

According to the MMWR, about 5 million Americans have used kratom, although some estimates are as high as 20 million..

Even using the conservative estimate, the 14,449 kratom-related calls to poison centers over the 11-year period represents only a tiny fraction (0.28%) of the estimated 5 million kratom users.

Critics say calls to poison control centers are “notoriously unreliable” and an imperfect way to measure the risks associated with a substance, since most calls involve minor symptoms such as upset stomachs or dizziness.

The number of calls can also be misleading. For example, a study of poison control data from 2000 to 2017 found there were more calls about exposure to nutmeg than there were about kratom.  

Nevertheless, the poison control data is often used by federal health officials and law enforcement agencies to seek changes in the legal status of a substance.  In 2016, the DEA and FDA cited another MMRW study to justify their efforts to have 7-OH and the alkaloid mitragynine listed as Schedule One controlled substances, in the same category as heroin. Such a move would have effectively banned kratom.

“Evidence from poison control centers in the United States also shows that there is an increase in the number of individuals abusing kratom, which contains the main active alkaloids mitragynine and 7-hydroxymitragynine. As such, there has been a steady increase in the reporting of kratom exposures by poison control centers,” the DEA said in 2016, citing the earlier MMRW study.

The DEA dropped its proposal to schedule mitragynine and 7-hydroxymitragynine after a public outcry, saying a ban on kratom would have “significant risk of immediate adverse public health consequences.” 

A top federal health official later admitted the FDA and the DEA based their scheduling request on “embarrassingly poor evidence & data.”

The growing controversy over 7-OH has revived efforts to restrict or ban sales of kratom and 7-OH at the state and local level. It may only be a matter of time before the DEA joins that movement, by renewing its effort to schedule 7-OH, mitragynine, and perhaps kratom itself.

California Expands Crackdown on Kratom and 7-OH

By Pat Anson

California is expanding a statewide crackdown on kratom and 7-OH products, with Gov. Gavin Newsom boasting of a “95% compliance rate” in removing the products from store shelves.

“California will not stand by while dangerous, illegal products are sold in our communities. We’ve shown with illegal hemp products that when the state sets clear expectations and partners with businesses, compliance follows. This effort builds on that model — education first, enforcement where necessary — to protect Californians,” Newsom said in a statement.

California’s crackdown began last October, when state health officials issued a consumer warning claiming that kratom and 7-OH are dangerous and illegal to sell. State agents also began visiting over 4,500 licensed retailers, urging them to voluntarily remove the products from their shelves.

Enforcement actions stepped up in January, with most retailers complying. To date, 61 violations have been reported, with over $5 million worth of kratom and 7-OH products seized.  The state has warned non-compliant vendors that they could lose their licenses to operate.

To be clear, the enforcement action is uneven. It’s still relatively easy to order kratom or 7-OH products from out-of-state and have them shipped to California, where I live.  

I visited a retail outlet in the San Gabriel Valley this morning that was still selling kratom, but not 7-OH. A clerk at the store told me they knew 7-OH “would be a problem” due to its potency and, as a result, had never sold 7-OH products. 

7-OH (7-hydroxymitragynine) is an alkaloid that occurs naturally in kratom in trace amounts. When concentrated, it has opioid-like effects that can relieve pain and boost energy levels. Natural leaf kratom has similar, but milder effects, and has been used for centuries in Southeast Asia as a natural pain reliever and stimulant.

While hundreds of fatal overdoses in the U.S. have been blamed on kratom, the evidence supporting that claim is thin. Other drugs and substances are usually involved, making it difficult to attribute the deaths to a specific cause.

Federal Efforts Foiled

In recent years, several states and dozens of local municipalities have banned kratom and/or 7-OH sales, but federal efforts have been stymied by lack of evidence they are harmful. 

In 2016, the DEA and FDA tried unsuccessfully to classify 7-OH and the kratom alkaloid mitragynine as illegal Schedule One controlled substances, 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.” 

Last summer, the FDA said it would ask the DEA once again to schedule 7-OH as a controlled substance, but the DEA has yet to act on that request.

Even when the FDA has acted on its own, it has run into difficulty. In 2023, the agency seized nearly 250,000 bottles of “Feel Free,” an herbal drink containing kratom, from Oklahoma-based Botanic Gardens. The FDA alleged the drink was an adulterated substance and there was inadequate information that it was safe to consume.

Over a year later, the FDA quietly dropped the case. Botanic Gardens has continued to manufacture and sell Feel Free, because the FDA never obtained a permanent injunction telling them to stop. 

Some of the agency’s own research, recently published in the journal Therapeutic Drug Monitoring, supports the safety of kratom.  

When natural leaf kratom was given to 116 healthy volunteers for 47 days in a placebo-controlled clinical trial, including some at very high doses, researchers reported kratom was “well tolerated,” with no serious adverse events and “no evidence of meaningful abuse potential or withdrawal.”

The FDA now says it “not focused on natural kratom leaf products” and only wants concentrated 7-OH extracts banned.

Critics say ham-handed efforts by federal, state and local governments to ban either kratom or 7-OH could backfire by fueling demand for a new illicit drug. 

“Moving 7-OH into Schedule I would not eliminate demand; it would displace it, shifting sales from regulated retail settings into illicit markets where potency is unverified, adulteration is common, and risks are far greater,” Jeffrey Singer, MD, a senior fellow at the Cato Institute, wrote in an op/ed in the Washington Examiner.

“Such a step could also provide transnational criminal organizations with yet another product to layer onto a portfolio already dominated by fentanyl and its analogues. In striving to prevent harm, lawmakers risk repeating a familiar policy pattern — one that inadvertently amplifies danger while removing a lower-risk alternative from the legal marketplace.”

DEA Cuts Oxycodone Supply, But Raises Production of Morphine in Surprise Move

By Pat Anson

The Drug Enforcement Administration is moving ahead with its plan to reduce the supply of oxycodone by over 6% in 2026, while at the same time significantly raising its production quota for morphine. There will be small reductions in the supply of hydrocodone, codeine and other Schedule II opioids this year.

The move to increase the supply of morphine by 10.5% is surprising, as the agency proposed cutting morphine production by over half a percent a little over a month ago. 

The DEA officially announced its plans January 5 in the Federal Register, 35 days after a December 1 deadline set for the agency in the Controlled Substances Act (CSA). Under the CSA, the DEA has broad legal authority to set annual aggregate production quotas (APQs) for opioids and other controlled substances. 

The December 1 deadline is important because it gives the pharmaceutical industry time to prepare for the coming year by adjusting drug manufacturing and distribution schedules. The DEA’s chronic failure to meet that deadline in previous years has contributed to shortages, according to drug makers.

Over 5,000 public comments were received by the DEA in response to the agency’s initial APQs for 2026. Most comments pleaded with the agency not to make any further cuts in the supply of opioids, many of which are already in short supply at pharmacies and hospitals. 

“I oppose cutting production for controlled medications at this time as there is already a shortage for many of these medications and patients are often not able to obtain their prescriptions. Cutting production during a shortage will only exacerbate the problem and increase patient suffering,” Hannah Khalil wrote in a public comment echoed by many others. 

The DEA, however, was dismissive of claims about opioid shortages, saying it was not responsible for them.

“Drug shortages may occur due to factors outside of DEA's control such as manufacturing and quality problems, processing delays, supply chain disruptions, or discontinuations,” the DEA said. “Currently, FDA has not listed on its Drug Shortage website any nationwide shortages of oxycodone and hydrocodone products.”

While it is true the FDA does not currently have oxycodone or hydrocodone on its shortage list, the American Society of Health-System Pharmacists (ASHP) has listed both opioids on its shortage list since 2023. Limited supplies of oxycodone and hydrocodone are available from some manufacturers, according to the ASHP, while others have the medications on back order.

The difference between the FDA and ASHP shortage lists is that the FDA relies on drug manufacturers to report shortages, while the ASHP proactively surveys both pharmacies and drug makers about their inventories. That arguably makes it superior to the FDA’s methodology.

Ironically, the DEA itself has challenged the reliability of the FDA’s drug shortage list.

“DEA has made it clear it does not trust FDA’s information, as it does not consider many of the shortages that FDA verifies to be legitimate,” the General Accountability Office (GAO) said in a 2015 audit report. “They do not believe FDA appropriately validates or investigates the shortages.”

Increased Morphine Production

The DEA offered no explanation for the increase in morphine production. The production quota for morphine is 10.55% higher than last year's quota and the highest amount since 2021.

One likely reason for the DEA’s decision is that the FDA recently added morphine tablets and injectable morphine solutions to its shortage list, due to discontinuations and short supplies. The ASHP has listed morphine in shortage for several months. 

Morphine solutions and other injectable opioids are an important resource in hospitals, emergency rooms and surgery centers, where they are used in post-op care, sedation and anesthesia.

Morphine tablets are most often used to treat severe chronic pain.

I fear there will be continued shortages resulting in many patients suffering from the DEA’s quota decisions.
— Dr. Lynn Webster, pain management expert

“In 2025, there were major shortages of morphine immediate release (15-mg, 30-mg tablets) and morphine extended release (mostly 30-mg tablets) that lasted 3-4 months and were disruptive to care. I mentioned morphine in my personal, submitted comments (to the Federal Register),” said Chad Kollas, MD, a palliative care physician in Florida.

“I suspect that others also complained about last year’s morphine shortages, which may have led to the increase in production of morphine in 2026. It is also the cheapest of the traditional opioids, which may have played a role in the decision. I’m disappointed that they held the line on the oxycodone reduction.”

“I don't know why the DEA would reduce oxycodone while increasing the morphine quota. It seems illogical since there are reports that both are in shortage at the clinical level,” says Lynn Webster, MD, a pain management expert and former president of the American Academy of Pain Medicine. “I fear there will be continued shortages resulting in many patients suffering from the DEAs quota decisions.  

“They know patients are struggling to get access to both medications but they may think oxycodone is more likely to be abused than morphine. It appears they are trying to tell providers what they should prescribe. Yet they are not supposed to be involved in determining how medicine is practiced. Whether intentional or not, that is exactly what they are doing.”

Even with this year’s increase in morphine production, DEA has reduced the supply of morphine by over 63% since 2015. Steep declines have also been made in quotas for hydrocodone (-73%), oxycodone (-71%), and codeine (-70%) over the past decade.  

The DEA began cutting the opioid supply in response to pressure from Congress and anti-opioid activists, who claimed that prescription opioids were responsible for soaring overdose rates. While that claim has been largely debunked, opioid prescribing has continued to fall, as doctors became fearful of being accused of “overprescribing.”

The DEA says the “medical usage” of opioids fell by 10.5% in 2024 alone. The agency expects  that trend to continue, while dismissing claims that its shrinking opioid production quotas have interfered with the practice of medicine. 

“DEA's regulations do not impose restrictions on the amount and the type of medication that licensed practitioners can prescribe. DEA has consistently emphasized and supported the authority of individual practitioners under the CSA to administer, dispense, and prescribe controlled substances for the legitimate treatment of pain within acceptable medical standards,” DEA said. 

The 5 Most Popular PNN Stories of 2025

By Crystal Lindell

Looking back at 2025, there was a lot of news to cover when it came to chronic pain and illness. Access to opioids was again a major concern for our readers, but there was also a lot of interest in the potentially harmful effects of gabapentin.

Below is a look at the top 5 most widely read articles that PNN published in 2025.

We truly appreciate every time you read, comment and share our articles. And we can’t wait to bring you more great coverage in 2026! 

1) Over 15 Million Americans Prescribed Gabapentin Despite Warnings

In September, we covered an analysis by CDC researchers that showed that the use of gabapentin (Neurontin) continued to soar in the United States — usually for chronic pain and other health conditions the drug is not approved to treat. 

Gabapentin is the fifth most prescribed drug in the United States, with prescriptions nearly tripling since 2010, according to findings published in the Annals of Internal Medicine. The number of patients prescribed gabapentin reached 15.5 million in 2024, up from 5.8 million in 2010.

Read the full article here.  

2) Cannabis Use by Older Adults Linked to ‘Younger Brains’ and Improved Cognition

In August, we covered a study that showed that cannabis use by older adults slowed the aging of their brains and may even improve cognitive function.  

An international research team analyzed health data on more than 25,000 adults in the UK, looking at the relationship between cannabis use, aging, and cognitive function. They found that cannabis users had brain characteristics “typically associated with younger brains” and “enhanced cognitive abilities.” 

Read the full article here

3) 6 Things to Try If Your Doctor Won’t Prescribe Opioid Pain Medication

A lot of pain patients find that their doctors are reluctant to prescribe opioids. So in February, I shared six things to try if your physician tells you to go home and take ibuprofen.

The first tip is not to give up. Tell your doctor what poorly treated pain is doing to your life – that you’re unable to work or that you may have to go to the emergency room. Tell the truth and don’t exaggerate, and you just might get them to change their mind.

Another option is to try kratom and/or cannabis. They don’t work for everyone, but many patients say they provide some level of pain relief.  

Read the full article here. 

4) DEA Plans Further Cuts in Oxycodone Supply

In November, we covered the DEA’s plan to cut the supply of oxycodone by more than 6% in 2026, along with marginal reductions in the supply of hydrocodone, morphine and other Schedule II opioids. 

From year-to-year, the cuts may not appear significant. But over the past decade, there has been an historic decline in the nation’s opioid supply. If its current plan is adopted, DEA will have cut the supply of hydrocodone and oxycodone by over 70% since 2014.

The DEA says the “medical usage” of prescription opioids is declining, when in fact the “medical need” for them is actually increasing.

Read the full article here

5) Study Links Gabapentin to Increased Dementia Risk 

In July, we covered how gabapentin (Neurontin) may significantly increase the risk of dementia and cognitive impairment, even for middle-aged patients who only took the nerve medication for six months.

That was according to research published in the Regional Anesthesia & Pain Medicine journal, which looked at health records for more than 26,000 U.S. patients with chronic low back pain.

Researchers found that patients with six months or more of gabapentin use had a 29% higher risk of developing dementia and an 85% higher risk of developing mild cognitive impairment 

Read the full article here.

We hope you enjoyed reading PNN in 2025 and that you found our stories informative and helpful. We look forward to continuing our coverage of chronic pain and other health issues in 2026. 

Unlike many other online news outlets, we don’t hide behind a paywall or charge for subscriptions. PNN depends on reader donations to continue publishing, so please consider making a donation today.

Happy New Year everyone!

‘Stop This Insanity’: Pain Patients Plead with DEA Not to Cut Opioid Supply Again

By Pat Anson

Thousands of people have left public comments in the Federal Register, most of them sharply critical of the Drug Enforcement Administration’s plan to reduce the supply of opioids and other Schedule II controlled substances in 2026.

If enacted without any changes, the DEA’s proposal would be the 10th consecutive year the agency has reduced aggregate production quotas (APQs) for manufacturers of opioid pain medication. 

The biggest cut next year would be in the supply of oxycodone – a reduction of 6.24% – a pain medication that is already in short supply, according to the American Society of Health-System Pharmacists.

“When cutting the production of this medication, you are harming millions of innocent victims, whose life has been taken from injury/illness and rely on pain medication daily to survive and have a quality of life,” wrote Charl Revelo. “We are not criminals. We are innocent pain patients.”

Revelo is one of over 5,000 people who left comments in the Federal Register – a hefty turnout, given that the DEA only allowed 15 days for public comments, about half the usual comment period for quota proposals. December 15 was the last day comments were accepted.

Over the past decade, DEA has reduced the supply of oxycodone and hydrocodone by over 70 percent –  citing a decline in “medical usage” and fewer requests from drug manufacturers. 

But “medical usage” does not reflect a decline in medical need. Chronic pain has actually risen in the U.S. and now affects about 60 million people, including 21 million with high-impact pain – pain strong enough to limit daily life and work activity, which is often treated with opioids.

Despite the increase in medical need, doctors are not writing as many prescriptions for opioids as they used to, in part because they fear investigations for “overprescribing” by the DEA and other law enforcement agencies. 

“Declining prescribing does not reflect declining need. It reflects restricted access, pharmacy shortages, and policies that have pushed patients off medically necessary treatment. These quota reductions will increase harm, not reduce it,” wrote a poster who preferred to be anonymous. 

“The current atmosphere of fear around prescribing of opioids is very likely to account for the apparent reduction in use. If doctors are afraid to prescribe these medications, that leads to a decrease in prescriptions,” wrote Jonathan Rogers. “This situation has led to chronic pain patients seeking other treatment, including kratom, methadone from clinics that are set up for addiction treatment and not pain management, and adulterated street opioids.”

“Please STOP reducing the amount of opioids. Pain patients are suffering & your actions - continuing to reduce opioid production year after year - is fueling the dangerous black market & putting Americans who are desperate for pain relief at great risk. It’s irresponsible & speaks to your motives,” wrote an anonymous poster.

“Do not reduce the production of opioids. They are a necessary medication to treat patients. The previous reductions, laws, lawsuits by anti-opioid persons, and incarcerations of medical providers is already causing so much suffering and death of pain patients,” said another anonymous poster. 

“This insanity with cutting back and ultimately doing away with opioids is criminal,” wrote Brooke Moon. “Please allow doctors to practice medicine and prescribe what they deem is necessary for the treatment of pain. The suffering of millions of innocent pain patients doesn't need to continue. Please stop this insanity!”

Missed Deadlines

Several posters pointed out the DEA has repeatedly missed a December 1 deadline in the Controlled Substances Act for setting annual production quotas. That puts a strain on drug manufacturers and contributes to shortages. 

“My mother recently died of cancer and was unable to get her pain medication and died in agony. That is on you,” wrote Peter Wilson, who suffers from chronic back pain.

“You need to get your annual quotas for medications before the deadlines expire. You need to do your job and make sure there are adequate quotas of legitimate pain medication for patients who desperately need it. Don't blame this on the pharmaceutical companies whose hands are tied by your inability to come up with reasonable quotas in the allotted time.”

Other posters support a proposal for the DEA to hire a Chief Pharmacy Officer (CPO) and put that person in charge of quota allotments. A CPO would be more familiar with the drug supply system and manufacturing deadlines.

“They should have a CPO because the DEA and DOJ can't seem to stay on track by themselves. They are allowed to miss the deadline, but in a normal person's world, you would be reprimanded for missing the deadline,” said an anonymous poster.

“The DEA definitely needs to hire a Chief Pharmacy Officer to take control of the quota disaster. DEA cites lack of staffing as one of the reasons it can not get the next year's quota in by December 1. Hiring a CPO would assure that the quotas are in by the deadline and that someone knowledgeable would make an informed, reasonable decision on the amounts,” wrote another anonymous poster. 

Even with a shortened public comment period, the production quotas for 2026 will likely not be finalized until after January 1. The last time production quotas were that late was in 2024, when the quotas were not published until January 3. Drug shortages spiked to record levels in the first few months of that year, including opioid pain medications covered under the quota system.

DEA Missed Deadline for Opioid Production Quotas. Will It Worsen Shortages?

By Pat Anson

In recent years, hundreds of physicians have been prosecuted by the U.S. Justice Department for violations of the Controlled Substances Act (CSA).

In many cases, the doctors were accused of prescribing opioid pain medication without “a legitimate medical purpose” – a vague term in the CSA that was meant to prevent drug abuse, but in practice put the DOJ in charge of deciding whether healthcare decisions involving controlled substances are legal. 

The CSA is rigidly enforced when federal prosecutors believe opioids are prescribed excessively. But when it comes to enforcing another provision in the CSA, the DOJ and Drug Enforcement Administration have routinely ignored deadlines for setting aggregate production quotas (APQs) for opioids and other Schedule I and II controlled substances:

“On or before December 1 of each year, upon application therefor by a registered manufacturer, the Attorney General shall fix a manufacturing quota for the basic classes of controlled substances in schedules I and II.”

The December 1 deadline is important because it gives the pharmaceutical industry a small window to prepare for the coming year by acquiring raw materials for drugs, setting manufacturing schedules, and distributing medications to hospitals and pharmacies – a process that can take as long as six months. . 

But Attorney General Pam Bondi and acting DEA Administrator Terry Cole didn't publish their proposed quotas for 2026 in the Federal Register until November 28, which call for a 6% cut in the supply of oxycodone.

Allowing for a shortened public comment period that ends December 15, and time to review thousands of comments and make changes in the quota allotments, that means the final APQs for next year will likely not be ready until after January 1.

The last time production quotas were that late was in 2024, when the final APQs were not published until January 3. Drug shortages spiked to record levels in the first few months of that year, including many medications that are covered under the quota system. 

Missing the deadline again this year threatens to worsen chronic shortages of oxycodone, hydrocodone, fentanyl, hydromorphone, morphine and amphetamine-based stimulants that are vital to millions of patients who live with pain or attention deficit disorder (ADHD).

The DOJ and DEA did not respond to multiple requests from PNN to explain why the CSA deadline was missed again.

This is not a new problem. Late quotas and drug shortages have persisted for years, as the DOJ and DEA have focused on going after doctors who prescribe opioids – at times using “flimsy evidence” – rather than ensuring that essential medications are available on time. 

That mindset of being a law enforcement agency first – with maintaining the drug supply an afterthought – may have cost some patients their lives. 

“We talk a lot about opioid misuse, but almost never about the quiet suffering caused when essential pain medicines simply aren't available,” says Lynn Webster, MD, a pain management expert and former president of the American Academy of Pain Medicine. “Chronic delay and rigidity in quota decisions make patients with serious illness feel like collateral damage in a war on drugs that has lost sight of its humanitarian obligations.

“Quotas were meant to curb diversion, not to create a permanent state of scarcity for people in pain. By keeping quotas tight and decisions late, the DEA has turned an already fragile supply chain into a game of musical chairs where patients lose their seats.”

Late Quotas Worsened Drug Shortages

As far back as 2015, the General Accountability Office (GAO) warned in an audit report that the DEA “has not effectively administered the quota process.” Although a decade old, many of the problems cited by the GAO still exist today.

“Each year, manufacturers apply to DEA for quota needed to make their drugs. DEA, however, has not responded to them within the time frames required by its regulations for any year from 2001 through 2014,” the GAO said.

“Manufacturers who reported quota-related shortages cited late quota decisions as causing or exacerbating shortages of their drugs.”

The report found that drugs containing Schedule II controlled substances accounted for over half the shortages between 2001 and 2013. Several manufacturers complained to the FDA the shortages were caused by the DEA’s mishandling of the quota system.

But the DEA denied any responsibility for the shortages, while blaming the missed deadlines on  “inadequate staffing” and an “increasing workload” in its Quota Unit.

“DEA is confident that its administration of the quota process did not affect a shortage during the period of review because drug product shortages are not limited to products that contain Schedule II controlled. substances,” Joseph Rannazzisi, then-DEA Deputy Assistant Administrator, wrote in the agency’s response to the GAO report.

Rannazzisi would later emerge as a “whistleblower” on 60 Minutes, who blamed the opioid crisis on lax policies at the FDA that favored that drug industry.

The relationship between DEA and FDA, at least in 2015, was not one of trust. The FDA advised the DEA about medical demand for Schedule II drugs and any shortages that may exist, but the DEA didn’t always listen.

“DEA and FDA are not able to effectively collaborate due to fundamental disagreement over whether any given shortage exists. DEA has made it clear it does not trust FDA’s information, as it does not consider many of the shortages that FDA verifies to be legitimate,” the GAO said. “They do not believe FDA appropriately validates or investigates the shortages.” 

The GAO concluded that problems in DEA’s Quota Unit run deeper than any petty rivalries with the FDA. 

“Our work shows that DEA’s lack of internal controls, such as controls to ensure data reliability, performance measures, and monitoring of performance, may hinder the agency’s ability to ensure an adequate and uninterrupted supply of controlled substances,” the 2015 report found. “This approach to the management of an important process is untenable and poses a risk to public health.”

New Deadline

The GAO’s critique came at a time when the DEA’s deadline for final APQs was October 1 – a deadline the agency consistently failed to meet. 

To buy itself more time to work on quotas, the DEA lobbied Congress to change the annual deadline to December 1 in the 2018 Support Act, a bill intended to reduce opioid diversion. The DEA also reduced the amount of inventory drug manufacturers are allowed to keep of controlled substances, and agreed to base its quotas on dosages, not the raw supply of drugs.

How has that worked out? Poorly.

The DEA has not only been unable to meet the December 1 deadline, but the smaller inventories have worsened the ability of drug manufacturers to respond to late quotas and emerging drug shortages. 

The pharmaceutical industry warned the DEA that reducing inventories would only worsen shortages and do little to prevent diversion.

“We believe that risks associated with this proposal, including the increased likelihood for drug shortages and market outages, greatly outweigh the negligible benefit this provision will provide,” Larry Cote, an attorney representing a drug manufacturer, wrote to the agency in 2019.

“Given the timing of procurement quota issuance, it will become more imperative to carry increased levels of inventory at year end in order to ensure continued drug supply, as opposed to decreased levels.”

The DEA ignored those warnings and reduced inventories anyway. As a result, analgesic medications needed for surgery and post-op care, such as injectable fentanyl and hydromorphone, have been on the FDA shortage list for years, in part due to low inventories. The two drugs are rarely diverted.

‘Vulnerable to Supply Shocks’

Two pharmacists recently criticized the DEA for its “outdated system” for APQs.

“The current one-size-fits-all system for setting APQs is ineffective and Congress recognized this back in 2018, passing the SUPPORT Act to modernize the APQ setting process and require quota allocations based on dosage form. Yet seven years later, the DEA has failed to implement this law, leaving manufacturers constrained, patients underserved, and the nation vulnerable to supply shocks,” Soumi Saha, PharmD, and Justin Schneider, PharmD, wrote in a recent op/ed published in the Pharmacy Times.   

Saha and Schneider believe many of the quota problems could be addressed if the DEA were to hire a Chief Pharmacy Officer who is familiar with the drug supply system and is put in charge of the quota system.

“It is time to elevate the agency’s clinical responsibility by establishing a Chief Pharmacy Officer (CPO) within the DEA - a role dedicated to ensuring that patient access is not an afterthought, but a core priority,” they said. “A strong CPO would not only modernize quota systems but also bring agility, accountability and patient advocacy to the heart of DEA decision-making.”

To be clear, the DEA is not solely at fault for persistent shortages of opioids and other controlled substances. A 2021 opioid litigation settlement with three drug distributors essentially rationed the supply of opioids at many pharmacies and made pharmacists even more wary of filling new prescriptions. 

In a 2023 PNN survey of over 2,800 patients, 90% said they experienced delays or problems getting their opioid prescriptions filled, mostly because their pharmacy was out of stock. Nearly one in five were unable to get their pain medication, even after contacting multiple pharmacies.

Some generic drug manufacturers have stopped making opioids because of low profit margins and because of concerns they could be targeted by plaintiff law firms in opioid lawsuits that could cost them billions of dollars. 

Bad weather and a heavy reliance on foreign drug manufacturers have also made the supply chain less reliable and contributed to shortages.  

But the DEA’s chronic failure to meet quota deadlines – a problem dating back decades – and its slow-walking of efforts at reforming the quota system, have made a fragile drug supply chain even more vulnerable to disruptions. And it is patients who pay the ultimate price for the DEA’s negligence.

“When DEA repeatedly misses its own deadlines for setting opioid production quotas, that uncertainty reverberates all the way to the bedside,” says Dr. Webster. “Manufacturers pull back, pharmacies ration, and it's the patients – people with cancer, sickle cell disease, or severe chronic pain – who are left wondering if their next prescription will even be filled.” 

Should the DEA hire a Chief Pharmacy Officer? Should deciding what is or isn’t “a legitimate medical purpose” be left to the DEA and DOJ? Only a few days are left to comment on the DEA’s proposed APQs for 2026. You can leave a public comment by clicking here.

DEA Plans Further Cuts in Oxycodone Supply  

By Pat Anson

The Drug Enforcement Administration is planning to cut the supply of oxycodone by over 6% in 2026, along with marginal reductions in the supply of hydrocodone, morphine and other Schedule II opioids. 

If the DEA’s plans are finalized after a short public comment period, it would be the 10th consecutive year the opioid supply has been reduced in the United States.

The DEA announced its plans Friday in the Federal Register. Under the Controlled Substances Act (CSA), the agency has broad legal authority to set annual aggregate production quotas (APQs) for drug makers – in effect telling them the amount of Schedule I and Schedule II chemicals and medications they can produce. 

The DEA is planning another round of cuts in the Schedule II opioid supply because it continues to see declines in the “medical usage” of opioids – an average decrease of 10.5% in 2024 alone. 

It’s important to note that medical usage is different from “medical need.” Doctors simply aren’t prescribing as many opioids as they used to, so while the need for pain relief hasn’t changed and may have even increased due a spike in rates of chronic pain, the number of prescriptions written for opioids has declined. 

DEA expects that trend to continue, based in part on data from IQVIA, a private company that tracks prescription drug use. The agency is also seeing fewer requests from drug manufacturers to make oxycodone.

“DEA projects that the medical usage of these controlled substances will continue to decline in 2026 based on a review of domestic usage data from IQVIA,” DEA said in its Federal Register notice. “Additionally, DEA has observed a significant decline in requests for product development quotas to support manufacturing towards FDA approval of drug products containing oxycodone.” 

DEA Opioid Production Cuts Planned for 2026

  • Oxycodone          6.24% decrease

  • Morphine             0.559% decrease

  • Hydrocodone       0.529% decrease

  • Hydromorphone  0.109% decrease

  • Fentanyl              0.014% decrease

  • Codeine               0.002% decrease

From year-to-year, the cuts may not appear significant. But over the past decade, there has been an historic decline in the nation’s opioid supply. If its current plan is adopted, DEA will have cut the supply of hydrocodone by 72.9% and oxycodone by 70.6% since 2014.

Some of the decline in “medical usage” is driven by scarcity. For example, Endo Pharmaceuticals recently informed the FDA it discontinued production of 2.5, 5, 7.5 and 10 mg Percocet (oxycodone/acetaminophen) tablets. Major Pharmaceuticals stopped making oxycodone/acetaminophen tablets a few months ago. And Teva Pharmaceuticals, a large generic drug maker, stopped making immediate-release oxycodone in 2023.  

The FDA does not currently list oxycodone products on its drug shortage database, but the American Society of Health-System Pharmacists (ASHP) has since 2023. Limited supplies of oxycodone are available from some manufacturers, according to ASHP, while others have the medications on back order.

Hydrocodone/acetaminophen tablets have also been on the ASHP’s shortage list (but not on the FDA’s) since 2023. Major and Camber Pharmaceuticals have both stopped making them.

Health Canada reported a nationwide shortage of oxycodone/acetaminophen combinations over the summer, a shortage that persists today but is expected to resolve soon.

Why would the DEA be reducing production quotas for opioids that are already in short supply?

DEA sets its APQs after consulting with states willing to share their prescription drug data, as well as federal agencies like Health and Human Services and the Food and Drug Administration. 

DEA also asked for input from the Centers for Disease Control and Prevention, an agency in turmoil after several months of layoffs, budget cuts and leadership changes. A response to that request “was inadvertently delayed” at CDC, but DEA says it will take it under consideration when or if it ever arrives. 

“DEA remains committed to monitoring drug shortages, limiting their impact, and resolving them as quickly as possible. DEA continues to seek additional information that will assist in accurately forecasting domestic medical usage and export requirements of schedule I or II substances,” DEA said.

Unlike previous years, when there was a 30-day period for public comments on the DEA’s quota proposal, the agency is only allowing about two weeks. You can leave a comment here, but it must be posted no later than December 15. DEA did not explain why it was reducing the amount of time the public can comment.