WASHINGTON – You can buy the powerful, unregulated products at gas stations, vape shops, and convenience stores across the country, and now the U.S. Food and Drug Administration (FDA) is recommending that 7-hydroxymitragynine, also known as 7-OH, be classified as a controlled substance under the Controlled Substances Act. The FDA is specifically targeting 7-OH, a concentrated byproduct of the kratom plant; it is not focused on natural kratom leaf products.
A national kratom advocacy group is supporting the move. Matthew Lowe, executive director of the Global Kratom Coalition, warned during a media briefing that failure to act could contribute to the next wave of the opioid epidemic.
“They’re being sold as natural. They’re not. They’re being sold as kratom. They’re not,” said Lowe.
Some of the synthetic products are 13 times more potent than morphine and are being sold without regulation or prescription, according to Lowe.
“So if you don’t think oxycodone should be sold in gas stations, you shouldn’t think these should be without a prescription,” said Dr. C. Michael White, who joined Lowe in the briefing.
FDA officials note that while 7-OH occurs naturally in kratom leaves, it makes up less than 2% of the plant’s alkaloid content. Manufacturers, however, are now synthetically producing concentrated versions with levels the FDA says pose opioid-like risks.
“Critically, 7-OH produces respiratory depression, physical dependence, and withdrawal symptoms characteristic of classical opioids, such as morphine, fentanyl, oxycodone, and hydrocodone,” the FDA wrote.
Dr. White compared the difference between natural kratom and synthetic 7-OH to apple seeds and cyanide. Amygdalin, a compound in apple seeds, releases hydrogen cyanide when chewed or digested, but the amount in seeds is too small to pose a risk. If a manufacturer synthetically created concentrated amygdalin, however, it could be dangerous.
“Is that still an apple?” White asked.
The Drug Enforcement Administration will now review the FDA’s recommendation and decide whether to classify 7-OH as a controlled substance, a process that will include a public comment period.
