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Understanding kratom: FDA focuses on harmful 7-OH items in nationwide enforcement

Understanding kratom: FDA focuses on harmful 7-OH items in nationwide enforcement

U.S. health agencies are addressing the dangers posed by substances that are widely accessible across the country. One such substance is 7-hydroxymitraginine, commonly referred to as 7-OH. This plant-derived compound is often used for pain relief but has also been linked to potential abuse and various adverse drug reactions.

Health officials have categorized this substance as a “synthetic opioid.” It appears in various products—including drinks, powders, and tablets—found in smoke shops, gas stations, and other retail outlets nationwide. Recently, there has been a noticeable uptick in medical incidents associated with 7-OH, which has prompted the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) to take action against vendors of these items.

On Tuesday, HHS issued a press release indicating that the FDA plans to recommend regulatory measures under the Controlled Substances Act (CSA) to manage these products. FDA Commissioner Marty McCurry noted in a statement that places selling addictive products like concentrated 7-OH have emerged across the country.

In light of the previous opioid crisis, he expressed concern, stating, “After the last wave of the opioid epidemic, we can’t catch flat again.” He added that 7-OH is more potent than morphine and called for regulations and public education to deter another potential wave of opioid-related issues.

Interestingly, there are currently no FDA-approved medications containing 7-OH. It’s important to note that dietary supplements involving this compound are illegal and cannot be incorporated into standard food products.

What is Kratom?

Kratom, derived from the leaves of the Mitragyna speciosa tree found in Southeast Asia (like Malaysia and Thailand), contains over 40 active compounds. The most notable among these are mitraginine, 7-hydroxymitraginine, and specific foline. Kratom is thought to have dual properties—offering stimulating effects at low doses while also possessing opioid-like analgesic qualities.

According to Dr. Richard Clark, medical director of the California Poison Control System in San Diego, Kratom is often used as an alternative to opioid analgesics or to alleviate opioid withdrawal symptoms. Many Americans turn to it for chronic pain management.

How is Kratom different from 7-OH?

When isolated in a concentrated form, 7-OH—an active metabolite of Kratom—can act as a very effective painkiller. HHS has identified that 7-OH is notably more potent than morphine, making it susceptible to misuse and addiction-related issues.

Though vendors might market Kratom as a safe, all-natural product, the actual composition can vary significantly from what’s indicated on the label, which raises concerns among experts. While serious toxic effects from Kratom are uncommon, high consumption or combining it with other drugs can lead to severe reactions, including hallucinations and even death in rare instances.

Dependence and withdrawal are also potential risks associated with its use, and side effects might include nausea, dizziness, confusion, and trembling.

During a recent press conference, the FDA and HHS reiterated the urgency of addressing the availability of 7-OH products. Robert F. Kennedy Jr. emphasized that these substances are readily found near schools and in economically disadvantaged neighborhoods. He remarked, “They are sold for kids; they come in gummy bears, brightly colored and candy-flavored.”

McCurry further clarified that the agency currently does not deem pure kratom as “safe” for consumption.

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