Florida Attorney General James Uthmeier has used an emergency rule to classify concentrated 7-OH as a Schedule I controlled substance in Florida. The move comes as the federal drug enforcement administration is pursuing a national ban.
7-0H, or 7-Hydroxymitragynine, is a semi-synthetic compound extracted from Kratom leaves. Kratom historically comes from Southeast Asia. In Thailand, it’s common to chew leaves from the tree, and in Malaysia, many brew it into a tea.
Christopher McCurdy, a behavioral pharmacologist at the University of Florida that has been studying Kratom for years, believes consumption patterns in the United State are different than the plant’s original use.
“Consumption patterns, to me, in the traditional sense, more resemble the way that we drink coffee in the mornings,” he said.
Kratom has increased in popularity in both leaf and extract forms around the U.S. He said options are now available for customers looking for energizing effects at low doses, and those who want more opioid-like effects at higher doses.
The leaf may have potential medical uses. According to animal studies conducted by McCurdy and other UF researchers, certain compounds in Kratom may also be useful for treating opioid addiction, though no human trials have been performed.
“Mitragynin the main alkaloid in the plant, and we've looked at that as a potential treatment for opioid use disorder and opioid withdrawals, and it works very well also to reduce withdrawal symptoms, much better than buprenorphine or methadone,” he said.
Kratom products are found in smoke shops around the state. Extracts containing Mitragynin and other alkaloids put into drinks, shots, and gummies are legally purchasable. But those products aren’t being targeted by the government bans, just 7-0H products. McCurdy said those products are fundamentally different.
Over the past several years, the 7-0H marketed products have been produced with much higher 7-0H contents than Kratom leaves, often without the other alkaloids in it, all pressed into a pill form. And McCurdy said those factors lead to some significant safety concerns.
“The 7-0H products become a very different beast from two safety standpoints. One, is that we don't really understand what's all in that product, because it's been synthetically manipulated. And then two, we do know that 7-hydroxy material is a pure opioid, and it's actually more similar to prescription opioids like morphine or oxycodone or hydrocodone than it is to being kratom,” he said.
The similarity to opioids is what Florida Attorney General James Uthmeier focused on when announcing the ban last week.
“It is chemically manipulated in a way where it's very dense, and actually, I'm told by medical experts, can be up to up to 13 times more potent than morphine. So, it is a significant pain killer. It has been proven to be highly addictive and easily can be overdosed,” he said during the press conference announcing the ban.
The supporters of 7-0H have resisted that characterization.
Paula Savchenko, an attorney representing 7-0H companies, says that there is not enough evidence of harmful effects to support scheduling it.
“They have no science to back that, that 70H is more addictive than opioids, right?” she said.
An assessment by the FDA released this year concluded 7-0H has potential for abuse and some animal studies have found it has some physical risks similar to taking opiods, but no human studies have been performed using isolated or purified 7-OH.
Savchenko points out that reporting on deaths or adverse events from 7-0H have not been separated from Kratom reporting, and says most negative outcomes have occurred when other substances were also in the person’s system. She argues 7-0H is being used by people looking to kick opioid addiction.
“It's kind of like you need to look at the numbers and the data and decide, is this really a threat to imminent harm because it's addictive, or is this helping people?” she said.
She said she does not think 7-0H should be scheduled, but instead regulated like other emerging products, like hemp.
“There should be requirements on what type of packaging, and you should have to have certificate, you know, COAs, and all the same requirements to keep the public safe in the way the products are manufactured and distributed,” she said.
Savchenko claims the push to ban the product at the state and federal level is being lobbied for by larger Kratom companies .
“When 7-hydroxy came into the market like one to two years ago, and started taking up that market share from the Kratom industry, the Kratom industry did not like that, and they started lobbying the government to basically make 7-hydroxy look bad. And now you're seeing the results of that, because the Kratom industry wants to take their market share back,” she said.
McCurdy does support the emergency ban for now, but he wants to see further study into 7-0H, which could be banned nationally if it is federally scheduled as a Schedule 1 drug.
“It could be a very good painkiller. It could be a very good pharmaceutical down the road, if it's tested and studied in the appropriate manner. But right now, it really is no different than having morphine available in smoke shops and gas stations. And we would not, I think anyone say that morphine should be available at smoke shops or gas stations,” he said.
Other states are pursuing their own actions, but Florida is one of just two states that give their attorney general the power issue an emergency to schedule a drug.