The U.S. Food and Drug Administration has launched a high-stakes effort to crack down on a dangerous new substance spreading across America: 7-hydroxymitragynine, or 7-OH. This chemical, a highly concentrated synthetic byproduct of the kratom plant, is being sold widely as gummies, tablets, and drink mixes in gas stations and vape shops. Now, the FDA wants it classified as a Schedule I substance — the same category as heroin and LSD — and is warning the public that the opioid crisis may be repeating itself, just with a different name.
What Is Kratom and Why Is It Called “Legal Morphine”?
Kratom is a tropical tree native to Southeast Asia. For centuries, its leaves have been used for pain relief, increased energy, and mood enhancement. The two main active compounds in kratom are mitragynine and 7-hydroxymitragynine (7-OH), both of which bind to opioid receptors in the brain. These compounds produce effects similar to opioids like codeine and morphine.
Because of these properties, some users have nicknamed it “legal morphine” or “gas-station heroin.” But the FDA has made it clear: 7-OH is not just opioid-like. “Scientifically, by definition, it is an opioid,” said FDA Commissioner Dr. Marty Makary. “And yet it’s being sold in gas stations and smoke shops across America, with nobody realizing what they’re buying.”
What Does Schedule I Mean?
If the Drug Enforcement Administration follows through with the FDA’s recommendation, 7-OH will be placed in Schedule I under the Controlled Substances Act. Schedule I substances are considered to have:
- No accepted medical use in the U.S.
- A high potential for abuse
- A lack of accepted safety under medical supervision
This is the same classification as heroin, LSD, and ecstasy. The new classification would make it illegal to possess, sell, or manufacture 7-OH for any reason other than approved scientific research.
What Are the Effects and Dangers?
Kratom and its components can have both stimulating and sedating effects depending on the dosage. Low doses may increase energy or alertness, while high doses can result in euphoria, sedation, and pain relief. But the risks grow with concentration. While kratom leaves contain less than 1% 7-OH, some manufactured products contain dangerously high levels.
“Studies suggest concentrated 7-OH is up to 13 times more potent than morphine,” said Jim O’Neill, deputy secretary of Health and Human Services. “It carries a high risk for addiction — on purpose.”
Users have experienced seizures, liver toxicity, difficulty breathing, and even death. Between 2020 and 2022, kratom was linked to at least 4,100 deaths, according to a Washington Post analysis. In Florida alone, more than 580 people have died from kratom-related overdoses since 2013.
Adding to the danger is the lack of quality control. Some kratom products have been found to contain heavy metals like lead and arsenic or have been contaminated with salmonella. Others come with no dosing instructions at all. As one grieving mother put it after her son died from a kratom overdose, “Just because it’s sold at the convenience store doesn’t mean it’s not dangerous.”
Is Kratom Addictive?
Yes. Kratom and especially 7-OH have been shown to cause physical dependence and withdrawal symptoms. According to the FDA, people who develop a substance use disorder from kratom often exhibit cravings, increased tolerance, and continued use despite harmful consequences.
There are also cases of neonatal abstinence syndrome, where newborns go into withdrawal because their mothers used kratom during pregnancy.
As Dr. Lief Fenno, chair of the American Psychiatric Association’s Council on Addiction Psychiatry, explained: “The experience patients have with kratom is very similar to addiction to any other opioid.”
Where and How Is It Sold?
Kratom products are sold legally across much of the U.S., often in powder, capsule, tablet, or drink form. It is a booming $1.5 billion industry, with products available online, in vape shops, convenience stores, and gas stations. These items are often fruit-flavored or disguised as supplements, with labels that may leave out key information or intentionally mislead buyers.
But with no FDA-approved uses and no safety assurances, the entire market exists in a legal gray zone. Some sellers have even falsely labeled their kratom shipments as “potpourri” to avoid detection.
The FDA has issued numerous warnings about kratom since 2016 and has seized or blocked shipments of illegal kratom products. The agency recently sent warning letters to seven companies for selling 7-OH in forms like gummies, drink mixes, and shots.
In June, the FDA released public education materials and a “Dear Colleague” letter to physicians, alerting them to the dangers. It also added new codes to the National Poison Data System in February to track 7-OH exposures more accurately.
Still, enforcement has been slow and limited by gaps in regulation. “We cannot get caught flat-footed again,” said Dr. Makary. “7-OH is an opioid that can be more potent than morphine. We need regulation and public education to prevent another wave of the opioid epidemic.”
Patchwork Crackdowns at the State Level
In the absence of federal regulation, several states and cities have taken action on their own. Six states — Alabama, Arkansas, Indiana, Rhode Island, Vermont, and Wisconsin — have banned kratom entirely. Others, like Kentucky and Georgia, have raised the minimum age to purchase kratom to 21 and introduced strict labeling requirements.
In Oklahoma, Representative Daniel Pae emphasized the urgency: “Given the political reality of Congress, I don’t anticipate them taking any action anytime soon.” As a result, local governments have stepped in to fill the void.
A Divided Debate
While the FDA’s move to schedule 7-OH is widely supported by public health officials, the broader conversation around kratom remains divided.
Some, like the American Kratom Association, support the FDA’s move on 7-OH but warn against banning natural kratom. “These 7-OH products are not kratom,” said Mac Haddow of the association. “They are chemically altered substances that pose an imminent threat to consumers.”
Others argue that kratom, when used responsibly, may help people with opioid withdrawal or chronic pain. Oliver Grundmann, a professor at the University of Florida who has studied kratom since 2016, said, “There are legitimate uses for it, but it needs to be in a controlled environment.”
What’s Next?
The DEA must now review the FDA’s recommendation and begin a public rulemaking process. That includes collecting public comments and weighing the evidence before making a final decision on scheduling 7-OH.
Meanwhile, the FDA says it will continue to support scientific research on kratom and 7-OH. A clinical study is planned to explore the safety and psychological effects of the compounds in humans. But until that data is available, officials say their top priority is prevention.
“Public health is supposed to prevent disasters, not just clean them up after they’ve killed thousands and thousands of people,” said Dr. Makary.
The fight over kratom is far from over. But if the FDA has its way, the days of “legal morphine” being sold next to slushies and cigarette lighters may finally be coming to an end.
HNZ Editor: I’ve known people who have had severe problems with addictions to these products, to the point where they needed a 6 week rehab program to get clean. Kratom is dangerous.
