Vince Sanders of CBD American Shaman defends 7-OH products

In the U.S., tens of millions of products of 7-hydroxymitragynine (7-OH) have been sold since being introduced this year to the market, according to Vince Sanders, the founder and president of CBD American Shaman.

Sanders described the positive effects of 7-OH products as “mood-enhancing,” “anti-anxiety,” and “mood-stabilizers,” and he asserted 7-OH represents a safe alternative for people who suffer from opioid addiction.

In an interview this past summer, Sanders said he is not aware of any adverse event or poison control reports associated with 7-OH products. He said he has a little under 300 CBD American Shaman stores across the U.S. that sell 7-OH under the brand Advanced Alkaloids. His company also manufactures 7-OH white-label products for other businesses.

“All the reports that we hear back are positive and life-changing,” Sanders said, “and how, ‘I no longer live in pain,’ or how, ‘I’m off my mood-stabilizing drugs or my antidepressants.’ On and on and on that ‘This is a life saver. Please make sure this product [is] available. Thank you so much.’”

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In June, a group of prominent kratom researchers sounded the alarm over 7-OH, cautioning that 7-OH and another compound (mitragynine pseudoindoxyl) are not present in native kratom leaf material. Kratom researcher Christopher McCurdy, Ph.D., of the University of Florida College of Pharmacy, previously told SupplySide Supplement Journal (formerly known as Natural Products Insider) that 7-OH “is more selective for opioid receptors than many of the traditional opioids.”

Related:Kratom groups, researchers sound alarm over 7-hydroxymitragynine products

“It has shown to substitute for morphine in rats that have been trained to self-administer morphine, and it also shows a ‘denovo’ ability to become self-administered by rats, where mitragynine did not show this ability,” said McCurdy, a medicinal chemist, behavioral pharmacologist and pharmacist. “Therefore, it is extremely likely that 7-OH is physically and psychologically addictive with high potential for abuse. In short, when isolated or heavily concentrated, it should be a controlled substance.”

In July, one month after McCurdy and three other kratom researchers issued a joint statement on 7-OH, the head of the Global Kratom Coalition delivered letters to state attorneys general in Arizona, Oklahoma, Tennessee and Texas.

In a July 16 letter to Tennessee Attorney General Jonathan Skrmetti, GKC Executive Director Matthew Lowe attached a report detailing proof of purchase receipts and testing results, with a link to a joint statement from the kratom scientists. According to Lowe, the products tested contained excessive amounts of 7-OH and synthetic alkaloids, had inadequate labeling and were adulterated in violation of the Tennessee Kratom Consumer Protection Act.

“We urge your office to thoroughly review the enclosed report and supporting documentation,” Lowe wrote to Skrmetti. “The evidence clearly demonstrates the widespread availability of illegal kratom products in Tennessee and the potential harm they pose to consumers.”

Tennessee law limits 7-OH content to no more than 2% of the total alkaloid composition of the product, Lowe’s executive summary indicated, yet independent lab testing of tablets purchased at retail locations in the state found that 7-OH levels were 92% of the total alkaloid fraction of the 7-OH tablet.

(After this article was published, several kratom sources — including Mac Haddow of the American Kratom Association — pointed out there is no KCPA in law today in Tennessee. A 2023 bill died in the legislature, Haddow said. However, Tennessee does have certain restrictions on kratom sales.)

Similar letters were sent to attorneys general in Arizona, Oklahoma and Texas. None of the offices responded to requests for comment.

“These [7-OH] products are nowhere even close to what kratom is,” Lowe said in an interview. “I would argue that they’re not kratom, but they’re using kratom’s safety profile and history of use to sell what is effectively an opioid as a dietary supplement.”

In Missouri, one of Sanders’ companies has been facing an investigation by the attorney general, though it is presumably related to cannabinoids, including CBD, delta-8 THC and delta-9 THC. In April, the state AG issued civil investigation demands to four companies, including American Shaman Manufacturing Inc.

A spokesperson for Missouri Attorney General Andrew Bailey did not respond to requests for comment on whether the probe into American Shaman would expand to 7-OH products.

Asked in the July interview whether such products are part of the state’s investigation, Sanders responded, “I have no idea … we complied with their request.”

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Sanders described CBD American Shaman as a “science-based company” and observed he was manufacturing kratom shots for other businesses when he read a research paper that examined mitragynine — one of the main compounds in kratom — as a potential opioid substitute. In that paper, he explained, he learned that mice were converting mitragynine to 7-OH.

“Then I’m like, ‘Well, if this is really the active ingredient, why deal with … mitragynine,” Sanders said. “Let’s go to actually what is responsible for the therapeutic. “That’s when [Patrick Kampmeyer] and I began our relationship. We already had a relationship on cannabinoids. I said, ‘Look, I think this is much, much bigger than cannabinoids. Let’s focus solely on this,' and that’s how it all started.”

Philip Gao, Ph.D., is president and founder of KanPro Research Inc., a contract research organization based in the Bioscience & Technology Business Center at the University of Kansas. According to Gao, 7-OH has made a huge difference in his personal life.

On the last day of June 2023, as he was lifting a box while clearing out his belongings at the University of Kansas’s Protein Production Core Lab, the scientist “felt a sharp pain radiate from my back to my right heel.”

“Initially, I didn’t think much of it, but within two weeks, the pain had escalated to an unbearable level if I stood or walked for more than 10 minutes,” Gao said in an email for this story. “The following two months were sheer torment.”

A visit to his physician revealed he had a lumbar spine injury. Gao said he decided not to take “pain medication to avoid potential dependency and commenced physical therapy, which offered minimal relief.” One day, Sanders provided him with 7-OH after Gao had commenced a project in August 2023 with CBD American Shaman.

“One afternoon, while engrossed in the lab work, I noticed that I had been moving around pain-free for nearly three hours,” Gao recalled. “I realized then that I had accidentally transferred some 7-OH onto my skin and into my bloodstream. This serendipitous discovery led to the development of a pain relief medical patch, which was subsequently tested in a pilot study on the battlefield in Ukraine.”

He said he’s intermittently used a 7-OH patch to decrease his pain and experimented with oral dissolvable strips that have mitigated his pain and improved the quality of his sleep.

According to Gao, one of his senior staff scientists conducted a cell-based toxicity study to measure the median lethal dose of 7-OH — or in science jargon LD50, which is the amount of a toxic agent sufficient to kill half of a population of animals.

He said researchers found that cells did not die at 106 milligrams per kilogram of body weight, which is equivalent to 1,000 times of normal usage. He added cells were killed when using a dosage of 1,606 mg per kilogram.

“No one consumes this much of anything at one time, let alone 7-OH,” Gao remarked. “The lethal doses are somewhere between those two very high numbers that no one in practice would even use. It is like saying you will die if you eat 100-1,000 kilos of sugar.”

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According to Sanders, the 7-OH market didn’t get off the ground until March of this year, and he said it “took off at a rate” that he cannot describe.

“Anyone [who] takes kratom, once they try this product, they won’t take kratom again,” he stated, suggesting that critics of 7-OH are seeking to protect the traditional market for kratom leaf and kratom extracts.

“Traditional kratom people see a technological advancement that they can’t achieve, and they’re terrified this is going to end their business,” proclaimed Sanders, who described 7-OH as a “superior product.”

“This is buggy manufacturers trying to stop cars,” he added. “This is traditional telephone providers that don’t want to give up the phone plugged into the wall against a cell phone provider. Technology moves and industries go away.”

Asked whether the criticism of 7-OH is tied to competitive worries from kratom businesses, GKC’s Lowe responded, “It’s like saying that tianeptine should be allowed to be sold” and the only reason people object to its sales is because it’s “cutting into the market share and profits of the pharmaceutical companies or any other health care product companies.” Tianeptine, which has alarmed health officials, has earned the nickname “gas station heroin” and was the subject of an article published in January in the New York Times.

“The long and short of it is the pharmacological profile of [7-OH] is deeply concerning,” Lowe added. “It’s as close to an opioid as you can get. It acts in the exact same way as an opioid, and it’s being sold illegally in my view as a dietary supplement.”

7-OH does not appear in the kratom leaf material at an amount that can be quantified, according to Kirsten Smith, an assistant professor in the Department of Psychiatry and Behavioral Sciences at Johns Hopkins University. In a previous article on 7-OH published by SupplySide Supplement Journal, she described the compound as an “active metabolite” that may be detected at extremely low levels in the plant material after it is harvested and, for example, exposed to sunlight.

Jay McLaughlin, Ph.D., another kratom researcher and a professor in the College of Pharmacy at the University of Florida, said he agreed with the assessment of 7-OH by his colleague, McCurdy.

“We find it a mu-opioid receptor agonist and reinforcing in our mouse studies,” he said in an email. As Dr. Smith noted, “research shows it has much higher (~30 fold greater) affinity for the mu opioid receptor vs. mitragynine itself,” McLaughlin added, “and it is selective for the opioid receptors, whereas mitragynine itself binds at a plethora of other targets (alpha-adrenergic and serotonin receptors, notably).”

McLaughlin and Susruta Majumdar, Ph.D., a professor in the Department of Anesthesiology at Washington University School of Medicine (WUSM), co-led a research paper (published in the peer-reviewed journal Cellular and Molecular Neurobiology) focused on natural and semi-synthetic kratom alkaloids.

Majumdar described 7-OH as a “typical opioid” that shares the same properties as heroin and morphine and is shown to cause respiratory depression.

“I still think kratom has huge utility and advantages,” Majumdar said, “but when it comes to the bad player, the bad guy, it is 7-hydroxymitragynine."

Later in the interview, he expressed his opposition to kratom being scheduled as a controlled substance due to the potential to hamper research of the botanical, though he expressed support for regulation of 7-OH products.

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Sanders maintained his company is devoted to producing safe 7-OH products. His own brand of 7-OH products, Advanced Alkaloids, features a disclaimer on the label associated with a dietary supplement product: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”

Sanders provided SupplySide Supplement Journal a written response to questions regarding measures taken by his company to comply with the Federal Food, Drug & Cosmetic Act (FDCA), which the U.S. Food and Drug Administration is charged with administering and enforcing.

“Our company takes compliance seriously, and this begins with the manufacturing process to ensure the products are produced in accordance with FDA’s current good manufacturing practices for dietary supplements,” he said.

Sanders noted his business conducted its own safety studies a year before releasing 7-OH products into the market. And he said he’s working on additional research, including a toxicity study, a study to show 7-OH products are not addictive, and a third human study to demonstrate the health benefits of the products, including impacts on mood and stress relief.

He further asserted his products comply with state and federal labeling regulations and requirements.

“All labeling makes clear the products are intended for adult consumers only, and we avoid making any drug or disease claims and make sure the label does not contain any false, misleading or unsupported claims,” said Sanders.

He added the label includes contact information so consumers can contact the company with complaints, questions or safety concerns, or report any adverse events associated with the products.

Lowe countered that 7-OH doesn’t belong in a product marketed as a dietary supplement, and that “nothing is known about” 7-OH in its isolated form.

“Should you be able to sell an opioid replacement as a dietary supplement in a gas station?” Lowe asked. “Is that in the best interest of consumer safety and consumer health? I don’t believe so.”

He went on to describe 7-OH as a “novel substance … that is not kratom.”

“Anything that’s used to support kratom’s safety or kratom’s reason for being in the United States is thrown out the door when you look at a 7-OH isolate,” Lowe said. “And I would argue it’s no longer even a dietary ingredient.”

Editor's corrections: Philip Gao, Ph.D., was incorrectly referred to as Patrick Gao in the initial publication of this story. Also, this article was clarified to reflect that the state of Tennessee does not have a Kratom Consumer Protection Act in law.