Out of Control
In July, my wife and I trekked to Omaha to drop our daughter off at grad school at the University of Nebraska Medical College. It’s an 8-hour journey, so we made a few pit stops along the way. We love to fill up the gas tank at Kwik Trips, because they are very clean and have a plethora of fresh food options.
When we got to Iowa, however, the Kwik Trips morphed into Kwik Stars. They’re owned by the same parent company, but the convenience stores are named Kwik Star in Illinois, Iowa, South Dakota, and North Dakota to avoid confusion with another chain called QuikTrip, which was already established in those states.
When we stop, I like to grab a Sprite Zero, while my wife will typically grab an Arnold Palmer. Some convenience store customers, however, stop in to buy products containing 7-OH.
The chemical, formally known as 7-hydroxymitragynine, can be found in tablets, gummies and drink mixes typically sold in gas stations and convenience stores. It is often marketed as a way to help people relax, relieve pain or improve their mood or focus. Approximately 1.9 million people ages 12 and up in the U.S. reported using kratom in 2022, according to the National Survey on Drug Use and Health.
The alkaloid has opioid-like effects and studies suggest that it’s more potent than morphine. The U.S. Food and Drug Administration has warned that 7-OH can lead to substance abuse disorder, as well as having serious side effects, including damage to the heart or liver, seizures, digestive issues, shallow breathing, withdrawal symptoms or even death.
As a result, the FDA recently recommended classifying 7-OH as an illicit substance. “We’ve seen a disturbing rise in reports of overdoses, poisonings and emergency room visits linked to products containing 7-OH,” Jim O’Neill, deputy secretary of the U.S. Department of Health and Human Services, said at a news conference announcing the recommendation. He said that because 7-OH products are often sold without warnings or control over the quality or dosage, “This is a recipe for public health disaster.”
7-OH is found naturally in the leaves of the Mitragyna speciosa tree, which is native to Southeast Asia. An herbal extract made from those leaves, known as kratom, is also sold as an unregulated dietary supplement. While kratom products contain trace amounts of 7-OH, the products sold in convenience stores contain a synthetic, concentrated version of the chemical, which are sometimes misleadingly marketed as kratom.
Based on the FDA’s recommendation, the Drug Enforcement Administration, the branch of the Justice Department responsible for classifying drugs as controlled substances, will review 7-OH products. There DEA could give the compound one of five potential classifications, which correspond to varying degrees of regulation. The classifications are based on a substance’s medical use, public health risks and potential for abuse.
According to Commissioner Martin Makary, the FDA is recommending that the DEA classify 7-OH as a Schedule I substance, meaning it has no accepted medical use and a high potential for abuse. Other drugs in that category include heroin, marijuana and ecstasy.
In June, the FDA issued warning letters to seven companies it said were illegally marketing products containing 7-OH. According to the agency, the chemical cannot be lawfully added to conventional foods or dietary supplements because there is not enough information to demonstrate its safety.
The American Kratom Association does not oppose the FDA regulating kratom products, but it maintains that kratom does not have a high potential for abuse or warrant classification as a controlled substance.
A group of 7-OH users held a parade to protest its classification as a controlled substance. The turnout was staggering.
Reg P. Wydeven
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