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

By Crystal Lindell

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

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

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

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

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

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

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

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

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

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

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

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

Unrealistic Threshold

The DEA’s scheduling order limits the amount of 7-OH to no more than 0.05% of a product by weight or volume, the equivalent of about 0.5 mg 7-OH per tablet. Virtually all 7-OH products currently on the market have much higher dosages. Bartone thinks it’s an unrealistic threshold.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

There is still time to leave a public comment on the scheduling of 7-OH before the July 31 deadline. 

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

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.

‘Super High Concentration’ of Kratom Involved in Georgia Man’s Death

By Pat Anson, PNN Editor

The family of a 23-year-old Georgia man who died last year after ingesting a potent kratom extract has filed a wrongful death lawsuit against a kratom manufacturer and a trade association that promotes the company for following good manufacturing standards.

Ethan Pope was found dead on the kitchen floor of his apartment on December 3, with his dog by his side. Pope had recently purchased bottles of Black Liquid Kratom made by Optimized Plant Mediated Solutions (OPMS).

An autopsy concluded that Pope died as a result of cardiac arrest due to mitragynine intoxication, and his death was ruled an accident by the Georgia Bureau of Investigation.

Mitragynine is an alkaloid and one of the active ingredients in kratom, which comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever.

ETHAN POPE

In recent years, kratom has become a popular supplement in the United States, where it is used by millions of people to self-treat their pain, anxiety, depression and substance use problems. It is sold legally in most states, including Georgia, where it can be purchased at gas stations and smoke shops.

Kratom is normally consumed as a dry unadulterated powder, but the Black Liquid Kratom allegedly consumed by Pope is a highly concentrated 50:1 extract, with up to 375mg mitragynine per bottle.

“This super high concentration can be felt with just a drop or two of the extract added to your tea or coffee. Even veteran users of kratom should start slow with this liquid extract because it is so different from other liquid extracts on the market,” is how one kratom vendor markets Black Liquid Kratom.

Another kratom vendor specifically cautions that OPMS extracts are “too strong for use on a daily basis.”

It’s not clear how long, how often or why Pope had been taking kratom, but at a news conference this week his parents said they found a to-do list in his apartment that included the words “Stop taking kratom.”

The family’s lawsuit was originally filed in May and an amended complaint was filed this week, naming over a dozen different individuals, vendors and organizations, including OPMS and the American Kratom Association (AKA).    

“You don’t expect to go into a store and find something similar to heroin between energy drinks and breath mints. We intend to hold every single person and entity involved in the distribution and sale of these products responsible,” attorney Matt Wetherington said in a statement.

The lawsuit drafted by Wetherington makes frequent references to kratom as a heroin-like substance, but there is no relationship between the two. Heroin is derived from opium plants, while kratom comes from mitragynine speciosa trees. Both act on opioid receptors in the brain, however, which has led to claims that kratom is an opioid.

OPMS has not commented publicly on the lawsuit, and the AKA issued a short statement saying it rejected the lawsuit’s claims and filed a motion to be dismissed from the case.

‘100% Natural and Never Adulterated’

OPMS is featured on the AKA’s website as one of the first kratom vendors to comply with its Good Manufacturing Practice Standards Program (GMP), an effort to enhance the safety of kratom products. To get “GMP Qualified” status, vendors have to agree to annual audits, inspections and testing of every production lot of kratom.    

“Optimized Plant Mediated Solutions has been the leader in the Kratom and Kava extract industry since 2010 due to its unique cold water extraction process. All O.P.M.S. products are 100 percent natural and never adulterated,” the AKA says on its website, which includes a link where OPMS products can be purchased directly from the company.

OPMS did not immediately respond to a request for comment from PNN. The company’s website cautions consumers that “several companies illegally counterfeit” its products, adding “dangerous ingredients” that pose a “serious health threat.” It urges consumers to report any suspicious products.

Taken in low doses, kratom acts as a mild analgesic and stimulant. Consumers generally take higher doses to combat severe pain and cravings caused by substance addiction. Most users do not experience a “high” or euphoria after taking kratom.

The Food and Drug Administration has not approved kratom for any medical use and vendors can run into trouble with the agency if they claim kratom can be used to treat health conditions. The FDA tried for years -- unsuccessfully – to schedule kratom as a controlled substance, which would effectively ban its sale and use in the United States. The FDA says kratom’s effects on the brain are similar to morphine and that kratom has “properties that expose users to the risks of addiction, abuse, and dependence.”

Not all federal agencies take such a dim view of kratom. A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

About 100 deaths have been linked to kratom use, but in the vast majority of cases other drugs and illicit substances were involved.  A toxicology test on Ethan Pope found antihistamine and antidepressant medications in his system, but no illegal drugs or alcohol were detected.

FDA Finds Unsafe Levels of Heavy Metals in Kratom

By Pat Anson, PNN Editor

The American Kratom Association’s new certified vendor program has gotten off to an inauspicious start. Kraken Kratom, the first vendor to qualify under the AKA’s Good Manufacturing Standards (GMP) program, has been flagged by the Food and Drug Administration for having dangerous levels of heavy metals in some of its products.

The FDA this week released the final test results on 30 kratom products found to contain levels of lead and nickel considered unsafe for daily human consumption. Five of the 30 samples that tested positive came from Kraken Kratom or one of its affiliated vendors.

“The analysis found significant levels of lead and nickel at concentrations that exceed safe exposure for oral daily drug intake,” the FDA said in a statement. “Based on these test results, the typical long-term kratom user could potentially develop heavy metal poisoning, which could include nervous system or kidney damage, anemia, high blood pressure, and/or increased risk of certain cancers.”

Ironically, last month Kraken Kraken became the first company to receive the AKA’s seal of approval as a certified GMP vendor. To qualify, participants must undergo a third-party audit and inspection of their manufacturing and packaging facilities.   

The company said in a statement posted online that it was never contacted by the FDA about the heavy metal findings or told to take its kratom products off the market.

“Kraken has no information regarding the samples the FDA used in their tests, including when or how the FDA acquired our products or when they tested the samples they obtained,” the statement said.

This isn’t the first time Kraken Kratom has come under FDA scrutiny. Its parent company, PDX Aromatics of Portland, Oregon, recalled thousands of kratom packages last year after samples tested positive for Salmonella bacteria. The company believes the samples that tested positive for heavy metals may have come from an FDA inspection in March, 2018.

“If these samples are from that investigation, their product lots were pulled from the market over 12 months ago as part of the extensive recall we did in cooperation with the FDA. Further, it would indicate that the FDA was rehashing old information, not in an attempt to protect the public, but as a way to target and further stigmatize kratom,” the company said.

In recent years, millions of Americans have discovered kratom, an herb grown and used in southeast Asia for centuries as a natural stimulant and pain reliever. Kratom is widely available online and in smoke shops, but the quality of what’s being sold and what country it came from are often unknown. Like other dietary supplements, kratom products are essentially unregulated and there are little or no quality controls.

That’s one of the reasons the AKA launched its GMP certification program. The organization said it wanted to protect kratom consumers from “unscrupulous vendors using sloppy manufacturing procedures” and those who adulterate kratom to boost its potency by adding substances like fentanyl or morphine.

But under the AKA’s certification program, no kratom products are actually tested for Salmonella bacteria, heavy metals, fentanyl or any other foreign substances.

“No, absolutely not. That is not our function,” AKA President Dave Herman told PNN. “The audit does not inspect the products. The audit inspects the procedures in place to manage the facility.”

Herman says third party auditors hired by the vendor and approved by the AKA only inspect manufacturing procedures — not the kratom itself. He declined to comment on the FDA’s discovery of heavy metals in Kraken Kratom products.

“I have no way of knowing when samples were taken or under what conditions they were taken,” he said. “Was it prior to an inspection? After an inspection? And without that knowledge I’m not sure I can say anything intelligent,” Herman said.

A handful of states have banned kratom and there is speculation the Drug Enforcement Administration will try again to schedule it as a controlled substance, something the agency backed away from in 2016 after a public outcry. FDA commissioner Scott Gottlieb, MD – who leaves office today -- has also mounted an extended public relations campaign against kratom.

"Over the last year, the FDA has issued numerous warnings about the serious risks associated with the use of kratom, including novel risks due to the variability in how kratom products are formulated, sold and used both recreationally and by those who are seeking to self-medicate for pain or to treat opioid withdrawal symptoms,” Gottlieb said in a statement.

“Data suggest that certain substances in kratom have opioid properties and that one or more have the potential for abuse. The findings of identifying heavy metals in kratom only strengthen our public health warnings around this substance and concern for the health and safety of Americans using it."