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.

Because testing methods for mitragynine pseudoindoxyl are limited, there is some concern that scheduling it as an illegal substance 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. 

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.