Science Or Hysteria? The Fight Over 7-OH

Forbes

14 hours ago

Drug policy is an easy thing to get wrong and a difficult thing to get right. Most drug policy experts agree that total prohibition has failed, but there is little consensus on what might actually work. Drug policy often happens in the ivory towers of government and academia, which can lead to a gap between official rules and street reality—the best example being alcohol remaining legal while less harmful drugs are banned.
Why ban a less harmful compound like cannabis when booze is cheap and widely available to adults? And, yet, cannabis is banned at the federal level despite hundreds of human trials showing medical value—a decision rooted more in 'reefer madness' hysteria than science. Now a similar fight may be brewing over a newer compound: 7-hydroxymitragynine (7-OH).
7-OH is a naturally occurring alkaloid found in trace amounts in the kratom plant. Both kratom and 7-OH are mildly psychoactive and sold in smoke shops across much of the U.S. The effects can be either stimulative or sedative, depending on dose and individual metabolism.
Why people turn to these products varies greatly but many report doing so for medicinal reasons. In the last couple of years, labs have begun extracting and concentrating 7-OH for sale as a standalone product. Both of these compounds have experienced their share of controversy, which seems to be growing.
On July 29th, the Food and Drug Administration (FDA) issued an emergency request to the Drug Enforcement Administration (DEA) to place 7-OH into the most restrictive class in the Controlled Substances Act (CSA)—the same category as heroin. The FDA cited increased risks of dependency given the way 7-OH binds with mu opioid receptors and anecdotal reports of misuse from social media.
The FDA has concerns about the potential of 7-OH to be abused and cause harm. 'Today, we're taking action on 7-OH as a critical step in the fight against opioid addiction,' said U.S. Health and Human Services Secretary Robert F. Kennedy, Jr. 'We will protect the health of our nation's youth as we advance our mission to Make America Healthy Again.' The FDA did not request a ban on kratom in its natural form, but because 7-OH is part of kratom's chemistry, any action could have legal spillover effects on kratom itself.
Louisiana recently banned both in one move.
The DEA can either grant the FDA's emergency scheduling request, removing 7-OH from store shelves immediately, or they may start the normal rulemaking process, which takes 12–18 months. It's an exhaustive process that examines both the scientific data of a compound and citizens' personal experiences with it.
There are also public comments and hearings designed to maximize due diligence before the DEA schedules any compound. Congress can also act, but most scheduling decisions are made within the agencies. The DEA may be reluctant to do so this time, given the recent past.
The DEA and the FDA already tried to ban the kratom plant in 2016 but withdrew during the process after receiving over 20,000 public comments from advocates, patients, and scientists. Kratom (and 7-OH) may be used by tens of thousands of patients for pain relief and harm reduction. The outcry from these patients was significant enough to cause the FDA to rescind their recommendation to ban both 7-OH and kratom.
The FDA Assistant Secretary of Health at the time, Dr. Brett Giroir, concluded more scientific studies were needed before kratom could be credibly banned. He sent a letter to the acting DEA Administrator rescinding the FDA recommendation to place kratom in Schedule 1 of the CSA. While the letter is wonky to read, Girori listed several important scheduling considerations in his letter:
'Further analysis and public input regarding kratom and its chemical components are needed before any scheduling should be undertaken. It is important that we have additional information to justify scheduling, such as:
While some of the studies and data that Giroir wanted on kratom and 7-OH may be underway, most of the items he listed are still unknown and no credible data exists to meet the standards cited in his rescinding letter. In the years since, even more people have turned to these compounds for relief, making banning them more complicated than in 2016.
One patient I spoke with who uses 7-OH is Zach L., who did not want his last name used for this article. He's struggled with opioid dependency for a long time. 'For the past 10 years, I battled opioid addiction. Fake pills. Xanax. Anything to quiet the storm in my head,' Zach said. 'I overdosed four times. I went to rehab twice.' Then he found 7-OH and things began to improve for him.
'The first time I took it, something changed,' said Zach. 'I didn't feel high. I felt normal. Present. The cravings quieted. The bottomless pit of anxiety and depression eased. For the first time in a decade, I could see a future that didn't end in relapse or worse.' For Zach, 7-OH is a life saver and he believes it's much safer than hard drugs and alcohol.
The most recent data available may indicate that kratom and 7-OH are relatively safe compared to legal drugs like alcohol. This data from the 2023 National Poison Data System (NPDS) may be informative to policymakers:
Compare this to alcohol:
While none of the PhDs I spoke with about 7-OH advocate banning alcohol in this country again, some were troubled by the lack of data the FDA cited in the press release. 'There is not sufficient scientific information or data to meet the criteria for scheduling,' said Dr. Kirsten Smith of John Hopkins University.
Dr. Smith works with people with drug-use disorders and takes a real world view of drug policy. She's concerned about what some addicts or chronic pain patients might do if a ban of 7-OH happens. 'People will find something else to use if this is banned and those alternatives may be more harmful than 7-OH.'
Dr. Edwin Boyer, Professor of Emergency Medicine at Ohio State University, shared Dr. Smith's concerns about the FDA analysis. 'The problem with the Food and Drug Administration analysis is that it relies heavily on the strength of binding at the mu opioid receptor,' said Dr. Boyer. 'In reality, toxicity is driven by exposure, not strength of binding. The FDA did not consider the degree of exposure following oral administration of 7-hydroxymitragynine in their analysis.'
According to a recent article in Reuters, The Marwood Group, a health industry advisory firm, recently completed an independent analysis of data from the FDA, CDC, and other federal agencies that confirms 7-OH's strong real-world safety profile. According to the FDA's Adverse Event Reporting System, there have been no confirmed deaths from 7-OH alone despite more than half a billion estimated doses consumed nationwide.
While the Marwood Group may harbor their own biases, one element of the report was striking. Opioid deaths were down significantly across the country in 2023 and 2024. While the availability of Narcan, a drug that reverses overdoses if administered quickly enough, has grown since 2022, it's not at the same rate as the drop in overdose deaths.
The report suggested that the increased availability of 7-OH may be contributing to saving lives. The charts, graphs, and patient testimonials in the report are compelling. While the drop in overdose deaths is unquestionably good news, no one really knows why it's happening. While the availability of 7-OH cannot be dismissed as a root cause, like most things regarding 7-OH, its impact on overdose deaths has not yet been measured or studied.
In a world where prohibition has failed and legal drugs like alcohol cause massive harm, should a compound with no confirmed fatalities—and potential public health benefits—be banned without more research?
Wouldn't science, not panic, lead to better policy?