Missouri Attorney General Catherine Hanaway on Thursday joined a growing number of government agencies investigating the makers and sellers of a product called 7-OH for engaging in what she called “unlawful” practices.
The name, 7-OH, is short for 7-hydroxymitragynine, and it’s made by chemically converting the main opioid-inducing element in kratom. 7-OH is sold as gummies, candies, imitation ice cream cones, liquid shots, tablets and powders. People can buy 7-OH products in Missouri smoke shops, gas stations, convenience stores and online shops.
Hanaway on Thursday announced her office had issued “civil investigative demand” letters, which are essentially subpoenas, to six companies that represent the “major points of sale” for both 7-OH and regular kratom products. The letters mandate the company to hand over multiple types of documents, including lab test results, research on health risks and safety label information.
Consumers, Hanaway said in a press release, “may be exposed to unapproved, unsafe and deceptively marketed opioid-like drugs.”
According to the letters sent to each company, the attorney general’s investigation targets the distribution of products containing 7-OH or “any part of the plant Mitragyna speciosa,” which is the kratom plant.
“We are deeply concerned,” she said, “that Missourians are being sold drug-like substances under the guise of harmless supplements, with no FDA approval, no safety testing, and in some cases no meaningful disclosure of what these products actually contain.”
The Missouri Department of Health and Senior Services issued a health advisory last month warning consumers of potential health risks it says are associated with 7-OH.
The U.S. Food and Drug Administration sent warning letters in June to six manufacturers of 7-OH, and federal action is still pending. The companies the FDA targeted are different from the ones Hanaway is investigating, except for one.
Kansas-City-based Shaman Botanicals LLC — the leading supplier of 7-OH in Missouri — received letters from both the FDA and Hanaway.
The company’s owner, Vince Sanders, has said Shaman was the first company to make 7-OH products.
Sanders replied to the FDA’s questions about the company’s products in August, told The Independent Friday, and has not yet heard back from the federal agency. The FDA warning has not stopped the company’s production, which he said is higher than ever.
The company’s response to the FDA warning letter included 300 pages of expert testimony and 200 pages of legal opinion, he said.
“I’ve got seven of the world’s experts on there that wrote letters that are saying, ‘Listen, you guys are completely wrong. Here’s the science, here’s the facts,’” Sanders said.
He plans on providing the same information to Hanaway, he said. Sanders’ other Kansas City company, CBD American Shaman LLC, also received a letter from Hanaway.
CBD Kratom, the largest kratom retailer in the country, was also among the recipients, along with St. Louis-area companies Green Dragon CBD, Emporium Smoke Shop and Moonlight Smoke Shop.
CBD Kratom issued a statement Friday saying the company plans on taking the attorney general’s process seriously and “welcome any opportunity to demonstrate the strength of our safety standards, compliance practices, and long-standing commitment to consumer education.”
CBD Kratom does not manufacture or sell 7-OH products, according to the company’s statement, and its leaders believe the investigation’s scope is “unusually broad.”
The company pointed to the FDA’s distinction this summer between natural kratom and 7-OH.
In a July press release announcing the FDA’s warning letters, the agency stated: “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.”
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-OH in small amounts. It’s what gives people the opioid-like effect.
The products the FDA is targeting contain a highly concentrated amount of 7-OH by taking mitragynine and chemically oxidizing it.
The way that 7-OH is being marketed as kratom is what has the FDA and some medical experts concerned.
Sanders argues his product is superior to most kratom products and shouldn’t be taken off the market.
“We clearly have a better product,” he said. “Consumers voted with their dollar.”
This story was originally published by the Missouri Independent.
