A Kansas City company is illegally marketing pills that have opioid-like effects and could face possible action, the U.S. Food and Drug Administration wrote in a warning letter sent Tuesday.
Shaman Botanicals LLC is a leading supplier of a substance called 7-OH being sold in pill form and as an ingredient in drinks. The name, 7-OH, is short for 7-hydroxymitragynine, and it’s made by chemically converting the main opioid-inducing element in kratom.
The letter sent to Shaman was also sent to six other companies, all but one of which have their products manufactured at Shaman Botanical using its patented 7-OH formula, said Vince Sanders, Shaman’s owner.
Shaman was the first company to make 7-OH products, he said.
The FDA posted the letters publicly on its website Tuesday and issued a press release.
“This action reflects the agency’s growing concern around novel potent opioid products being marketed to U.S. consumers and sold online and in smoke shops, gas stations, and corner stores,” the FDA’s press release states. “While 7-OH occurs naturally in trace amounts in kratom, the agency’s letters focus on concentrated 7-OH products such as tablets, gummies, drink mixes, and shots, which may be dangerous.”
Shaman’s own products are called 7-OH White Vein and Green Vein chewable tablets. It white labels EDP 7OH shots made in Kansas City by Relax Relief Rejuvenate Trading, LLC, and the owners Dustin Robinson and Ajaykumar Patel also received a warning letter as well.
“7-OH is not lawful in dietary supplements and cannot be lawfully added to conventional foods,” the agency’s release states. “Consumers who use 7-OH products are exposing themselves to products that have not been proven safe or effective for any use.”
Sanders told The Independent Tuesday that the company conducted three research studies on the products, including using rodents and beagles, which he believes shows the products are safe.
“We’ve spent an enormous amount of money and time on this,” he said, regarding the scientific studies. “My 82-year-old mother takes it twice a day. She was in so much pain… and it changed her life.”
Aside from pain relief, Sanders has advocated in Washington D.C. and in a recent column in the Kansas City Star that the product can also be a harm reduction tool for people addicted to opioids.
“There’s some addiction specialists that are just like, ‘Hey, this is too important,’” Sanders said. “The public needs this product. We can’t lose it, so we’re going to have some big voices on our side.”
However, several experts, including one from Johns Hopkins University School of Medicine, wrote a “letter to the editor” in December, arguing that 7-OH has the potential to create an addiction problem for individuals.
“…chronic 7-hydroxymitragynine product use could result in opioid-like physical dependence and possibly addiction,” the letter published in The Society for the Study of Addiction journal.
Missouri lawmakers attempted to ban 7-OH products this spring, but some contended the amended version of the bill would have only regulated kratom products and not 7-OH. The bill died after the Senate failed to take it up for a committee hearing.
What is 7-OH?
Understanding what 7-OH is requires a bit of chemistry.
Kratom leaves come from a tropical tree found in Southeast Asia, and they can be crushed and then smoked, brewed with tea, or placed into gel capsules.
The leaves contain an alkaloid called mitragynine. During digestion, the body converts it into 7-hydroxymytragynine, or 7-OH, in small amounts. It’s what gives people the opioid-like effect.
The 7-OH products the FDA is targeting contain a highly concentrated amount of 90% to 100%. To make it, companies take mitragynine and chemically oxidize it to make a concentrate.
Eating apple seeds is a good way to explain the difference between 7-OH products and regular kratom products, said Charles White, chair of the department of pharmacy practice at the UConn School of Pharmacy.
Apple seeds contain a small amount of natural amygdalin, he said. If you chew the seeds and swallow them, the amygdalin converts into a trace amount of the natural ingredient cyanide in the body. The amount of cyanide produced, he said, is too low to hurt anyone because people couldn’t eat enough apples.
“What if a company extracted the amygdalin out of the seeds and put it through a chemical process to produce cyanide and only put the cyanide in a tablet in a dose that can kill people,” he said. “Then when people express concern, you tell them that it is safe and refer to data on the healthy effects of apples to sell it.”
The way that 7-OH is being marketed as kratom is what has the FDA and some medical experts concerned.
“The 7-OH only stimulates opioid receptors and does so 30 times stronger than mitragynine, and produces an effect similarly as strong as morphine,” White said.
Christopher McCurdy, a professor of medicinal chemistry and associate dean of the University of Florida College of Pharmacy, has conducted studies on rodents that have shown 7-OH to be as highly addictive as prescription opioids.
The way they’re being marketed reminds him of the overprescribing of opioid medications for pain relief that began in the 1990s, which led to a national opioid crisis.
“The narrative is so incorrect that’s being spread about these products,” he said. “It harkens back to the days when OxyContin was first being marketed. It’s deja vu, and it’s unfortunately another potential crisis in the making.”
McCurdy said the “hallmark sign” that it’s an opioid is that the respiratory depressive effects and the abuse potential in animals can be reversed with Narcan, a life-saving medicine used to reverse an opioid overdose.
Kirsten Smith, an assistant professor at the John Hopkins Department of Psychiatry and Behavioral Sciences, recently completed a study on 7-OH, which examined use motivations and addiction potential. Papers are currently under peer-review.
“I’m seeing a signal of 7-OH that implies that while there are many reported benefits,” she said, “there is a substance use disorder quality to this that does not seem to be the case with caffeine or kratom.”
Smith said the effects of 7-OH may wear off quickly, meaning people may want to take it again sooner, and that’s important when understanding addiction potential.
She questions why FDA action did not occur two years ago when the products first came on the market.
“Where has the FDA been?” she said. “I find it to be remarkable that this has been going on for two years without proper regulation.”
Michele Ross, a drug addiction neuroscientist and a scientific advisor with the 7-OH advocacy group 7-HOPE Alliance, said she doesn’t dispute that 7-OH is more potent than kratom.
“That doesn’t necessarily mean it’s bad or more addictive,” she said. “It just means you need a smaller amount of 7-hydroxymytragynine to get some relief effects.”
Ross works with chronic pain patients, she said, and she believes 7-OH can be less toxic than taking kratom products because less of it is metabolized through the liver and kidneys.
“I’ve heard estimates of 20 million doses [of 7-OH] per month have been sold for the last two years, and there’s no deaths,” she said. “So if this was this terrible, dangerous, highly-addictive substance, there’d be deaths.”
The FDA has rejected kratom as a new dietary ingredient several times, she said, despite the amount of research done to prove its safety.
“CBD has been as well,” she said. “They keep rejecting it. So the problem isn’t that these aren’t FDA approved. The problem is how the FDA approves substances.”
