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On July 29, the U.S. Food and Drug Administration (FDA) suggested action to control and target certain 7-hydroxymitragynine products, such as kratom. They are targeting the byproducts of the kratom plant, not the natural kratom plant itself. The action is intended to protect Americans from dangerous opioids.
“We’re taking action on 7-OH as a critical step in the fight against opioid addiction,” said HHS 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.”
“Vape stores are popping up in every neighborhood in America, and many are selling addictive products like concentrated 7-OH. After the last wave of the opioid epidemic, we cannot get caught flat-footed again,” said FDA Commissioner Marty 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.”
During the 2025 Regular Legislative Session, Sen. Jay Morris pushed to criminalize the production, distribution, and possession of kratom. Lawmakers agreed to remove the drug from establishments as it had potential side effects, including liver damage, seizures, and even death. Anyone in possession of the drug can face either five years in prison or a fine up to $50,000, or both.
What is Kratom?
According to the FDA, kratom is a tropical tree native to Southeast Asia. The herb was used to self-treat conditions such as pain, coughing, anxiety, and opioid withdrawal. Statistics show that about 1.7 million Americans over the age of 12 used Kratom in 2021.
Kratom was sold in numerous forms, including powder, capsules, or tea.
There aren’t any drug products containing kratom or its two main chemical components, mitragynine and 7-hydroxymitragynine, that are legally sold in the U.S. The FDA has not approved any prescription or over-the-counter drugs containing kratom.
According to the National Library of Medicine, kratom is a dietary supplement whose active ingredients are opioid receptor agonists, meaning they attach to certain parts of the brain similar to the parts opioids attach to. Those spots control pain, mood, and energy.
At low doses, kratom gives the user energy, and at high doses, it gives the user pain relief. When used at higher doses, your brain could start to depend on it, potentially leading to addiction.
The FDA will continue to review scientific data to determine if a drug containing kratom is safe, but until then, the agency will warn the public against the use of kratom for medical treatment.
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