Exposing the hidden danger in some kratom products.
The FDA issued warning letters to several companies for illegally selling products containing 7-hydroxymitragynine, also known as 7-OH.
According to the U.S. Food and Drug Administration (FDA), there is no evidence that kratom is safe or effective for treating any condition.
Kratom is a tropical tree native to Southeast Asia. Kratom leaves contain two major psychoactive ingredients (mitragynine and 7-hydroxymytragynine). These leaves are crushed and then smoked, brewed with tea, or placed into gel capsules. Kratom has a long history of use in Southeast Asia, where it is commonly known as thang, kakuam, thom, ketum, and biak.
In the United States, the abuse of kratom has increased markedly in recent years.
Consumption of its leaves produces both stimulant effects (in low doses) and sedative effects (in high doses), and can lead to psychotic symptoms including hallucinations, delusion, and confusion, or psychological and physiological dependence. Kratom’s effects on the body include nausea, itching, sweating, dry mouth, constipation, increased urination, tachycardia, vomiting, drowsiness, and loss of appetite. Users of kratom have also experienced anorexia, weight loss, insomnia, hepatotoxicity, and seizure.
What’s the big deal?
7-OH is a super-concentrated byproduct of the kratom plant, and it’s showing up in gummies, tablets, drink mixes, and energy shots. Some people take it for managing chronic pain, for treating opioid withdrawal symptoms, or for recreational purposes. These products may not be clearly or accurately labeled as to their 7-OH content, and are sometimes disguised or marketed as kratom.
The agency is even warning health care professionals to be on alert. The FDA is particularly concerned with the growing market of 7-OH products that may be especially appealing to children and teenagers. 7-OH is increasingly recognized as having potential for abuse, because of its ability to bind to opioid receptors.
In Alabama, Arkansas, D.C., Indiana, Rhode Island, Vermont and Wisconsin it is a controlled substance. About 18 states regulate its possession, sale, or manufacture and 26 states do not control or regulate it at all.
When federal health regulators announced plans to control a compound found in the kratom plant, they made one big distinction. They are not targeting the kratom leaf or ground up kratom, but only the concentrated synthetic byproduct that is an opioid.
Why it matters?
Unlike smoke shops or gas stations advertising kratom-derived concentrates, coffee shop-style retailers serve drinks often in the form of tea brewed from the kratom plant. Kava is a separate plant also typically sold as a beverage. In its native Southeast Asia, the kratom plant has long been used as a remedy for pain and opioid withdrawal symptoms as well as for its euphoric and energizing effects.
The FDA is taking a bold step to protect Americans from dangerous, illegal opioids by recommending a scheduling action to control certain 7-OH products under the Controlled Substances Act (CSA), based upon their medical use, potential for abuse and safety or dependence liability. The Drug Enforcement Administration (DEA) is reviewing the recommendation and has the final authority on scheduling, which requires a rulemaking process that includes a period for the public to provide comments before any scheduling action is finalized.