Written by Tanya Terry
Featured photo: Jim O’Neill, deputy secretary of health and human services
The U.S. Food and Drug Administration (FDA) has taken significant action against concentrated hydroxymitragynine, also known as 7-OH.
Between June and July of this year, the FDA issued warning letters to seven companies for illegally distributing products such as tablets, gummies or drink mixes with high concentrations of 7-OH, which were marketed as dietary supplements or conventional foods.
Additionally, the FDA has issued alerts to health care professionals and consumers warning them of the risks of 7-OH products, such as causing seizures or addiction.
In July 2025, the FDA recommended the Drug Enforcement Administration (DEA) classify 7-OH as a Schedule I controlled substance because of 7-OH’s effects on the body, which are similar to the effects of opioids.
“What you’ve seen, is you’ve seen ‘bad actors’ come into the space, take a natural plant in kratom leaf-they have figured out how to synthesize that plant and turn it into something that is highly potent,” said Matthew Lowe, executive director of the Global Kratom Coalition.
He added: “…Unfortunately, they’re calling them kratom. They’re calling them natural. They are not either of those things. They are an unapproved new drug.”
According to the Global Kratom Coalition, “7-OH is an opioid by definition, with a potency up to 13 times that of morphine.”
Lowe also stated many people who have used natural kratom for 15 years without any problems are encountering issues with 7-OH.
“Within 2-3 months, their life is turned upside down,” he added. “They’ve got a terrible addiction. They’re spending hundreds of dollars a day on these product, and there’s significant health consequences. People having seizure, etcetera.
“I spoke to someone at an addiction center three days ago, and they said 90% of the calls they are getting are for concentrated, synthetic 7-OH. They don’t see that same issue with kratom leaf.”
According to FDA.gov, kratom is a tropical tree, native to Southeast Asia used to self treat pain, coughing, diarrhea, anxiety and depression, opioid use disorder and opioid withdrawal.
“Kratom has been in the United States for over 50 years,” said Lowe. “It’s been consumed safely for centuries, and these products are just completely novel. They have only been around for two years, and we’ve seen significant damage being caused by it….It can cause respiratory depression….That’s where you see people die from traditional opioid use. Overconsumption compresses breathing, and they die.”
Florida Attorney General James Uthmeier filed an emergency rule on August 13, 2025, classifying isolated and concentrated 7-hydroxymitragynine (7-OH) as a Schedule I controlled substance, with the rule taking effect immediately.
On a national level, the DEA is able to emergency schedule 7-OH, or permanently schedule it.
“If they emergency schedule it, it happens a lot quicker. If it’s permanent scheduling it can take anywhere between 18 months to 24 months. The process has started. Once it’s scheduled, we will understand what the limitations are.”
Products containing amounts of 7-OH above the level the DEA decides upon may become illegal.
But, since 7-OH is still fairly new it’s effects are still being studied.
Some proponents of concentrated, synthetic 7-OH argue it is superior to morphine when used for chronic pain, but with milder side effects. They also state that 7-OH is superior to natural kratom for because of its more powerful impact of the brain’s opioid receptors. They have suggested it could be used to help reduce opioid tolerance or alleviate withdrawal symptoms, which some health professionals are currently disputing.
The DEA rulemaking process will include public comment opportunities before any final scheduling is enacted.
