$10 Million Worth of 7-OH Products Destroyed

By Pat Anson

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

7-OH products made by CBD American Shaman have already been taken off the market in its home state, after Missouri’s attorney general sued the company, claiming its 7-OH tablets, gummies and shots are “deadly opioids” that pose significant risks. Several other states and dozens of cities and counties have also banned sales of 7-OH.

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

In addition to 7-OH, American Shaman makes concentrated mitragynine pseudoindoxyl products, which are even more effective pain relievers than 7-OH.

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

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

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

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

AKA Lawsuit

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

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

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

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

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

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

Norway 7-OH Death

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

In addition to 7-OH and a “high concentration” of mitragynine, investigators found a sedative, antidepressant, and anti-seizure medication in the man’s blood and urine. Death was attributed to “intoxication by these substances.” Most overdoses blamed on 7-OH also involve other substances, making the cause of death unclear.

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

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

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

Federal and State Warnings May Be Increasing 7-OH Sales

By Pat Anson

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

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

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

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

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

‘This Isn’t Some Party Drug’

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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