The Food and Drug Administration is recommending that 7-hydroxymitragynine, commonly referred to as 7-OH, be federally scheduled under the Controlled Substances Act. The agency announced July 29 that it had initiated the review process with the Drug Enforcement Administration, and FDA Commissioner Marty Makary has suggested that 7-OH should be classified as Schedule I.
7-OH is an active byproduct of mitragynine, which is the main psychoactive compound in the Mitragyna speciosa plant—similar to how delta-9-tetrahydrocannabinol (THC) is the primary psychoactive compound in Cannabis sativa. The Mitragyna speciosa plant is better known as kratom. Essentially, 7-OH is a more potent version of kratom.
“The FDA is specifically targeting 7-OH … it is not focused on natural kratom leaf products,” the agency stated. “7-OH is increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors.”
Both mitragynine and 7-OH are considered partial opioid agonists, like buprenorphine. In its accompanying report on 7-OH, however, the FDA stated that “observations suggest 7-OH has pharmacological properties representative of a full mu opioid agonist and an associated high potential for abuse.” It also stated that “[c]linical presentations include euphoria, sedation, respiratory depression and opioid-like withdrawal syndromes, with users acknowledging its significant addiction potential.”
It should be noted that all of these observations and clinical presentations refer to either lab testing involving petri dishes or mice, or posts on Reddit and other online forums like Erowid.
The FDA’s analysis did include human post-mortem toxicology data, but the agency cautioned that it “generally cannot be discerned” whether 7-OH specifically contributed to any deaths, so there are “significant limitations in making inferences from these data.”
What we do know is that both supply and demand for 7-OH, or similar higher-potency kratom products, have been growing at a faster rate since 2023 compared to previous years.
7-OH is not regulated, and so various products like chewable tablets or gummies can be legally sold at vape shops, gas stations, convenience stores and so forth.
The Centers for Forensic Science Research & Education has described mitragynine, AKA plant-based kratom products, in a manner that recalls synthetic cannabinoids: “a pharmacologically complex drug, exhibiting stimulant-like effects at low doses and sedative effects at higher doses.”
At a July 29 press conference, United States Secretary of Health and Human Services Robert F. Kennedy Jr. stated that CSA scheduling was necessary to prevent 7-OH from becoming the fourth wave of the opioid-involved overdose crisis. It’s widely established among drug-policy researchers that after prescription analgesics, then heroin, then fentanyl, the fourth wave already began around 2018 with opioid-stimulant polysubstance use. But the FDA has been using this “fourth wave” framing for 7-OH, too.
Also on July 29, FDA Commissioner Marty Makary published an op-ed in the New York Post warning that 7-OH could be the next wave to follow “prescription opioids, heroin and fentanyl.” He also leaned on tropes borrowed from the FDA’s anti-vaping agenda, which the agency has been featuring heavily throughout its new 7-OH public awareness materials as well.
“Vape shops are popping up in every neighborhood in America, but few people—even doctors—know that many of these shops are selling a dangerous new opioid,” Makary wrote in the Post. “Perhaps most alarming is that 7-OH products are often disguised as attractive candies, gummies and even ice cream cones that parents might never see as a risk … this synthetic opioid [is not] a safer alternative—and store owners, too, should be aware.”
Images (cropped) via Food and Drug Administration