The Food and Drug Administration is recommending restrictions on a synthetic opioid-like substance sold at gas stations and corner stores nationwide — but with a special carveout for the “natural” herbal supplement the substance is derived from.
The distinction could be a sign of how the FDA will regulate other dietary supplements moving forward. When asked if the agency was considering such a tactic for other products, commissioner Marty Makary said: “I think it’s a good idea.”
The carveout has another clear winner, too: The kratom companies and lobbyists whose products compete with 7-OH, and who have pushed the federal government for this result.
Tuesday’s announcement concerned 7-hydroxymitragynine, or 7-OH, a concentrated byproduct of the kratom leaf. At low concentrations, like those found in kratom, 7-OH can have stimulant-like effects; at higher concentrations, its effects are more similar to opioids. Kratom and 7-OH products are not approved by the FDA, but both are sold nationwide. Advocates for both substances claim that they treat chronic pain or can be used as an alternative to opioids.
The FDA disagrees — for high-dose, synthetic 7-OH products. The agency said on Tuesday that it will recommend the Drug Enforcement Administration add 7-OH to its list of scheduled drugs. Earlier this month, the FDA also sent seven warning letters to companies manufacturing 7-OH products, writing that “while 7-OH occurs naturally in trace amounts in kratom, the Agency’s letters focus on concentrated 7-OH products such as tablets, gummies, drink mixes, and shots, which may be dangerous.”
Kratom and 7-OH can be addictive due to the substances’ opioid-like properties. A very small number of deaths have been linked to kratom use.
But the FDA took special care this week to note that it is not targeting kratom products, going so far as to release a new report that it says will “educate the public about the health concerns of 7-OH and its distinction from the kratom plant leaf.”
Tuesday’s press conference with HHS leadership also featured a testimonial from Melody Woolf, who told reporters kratom treated her chronic pain.
“It was kratom only, the powdered leaf, that saved my life,” Woolf said. “And now I’m seeing something very dangerous happen. 7-OH is being sold over the counter, and it is not the plant, it’s the concentrated substance.”
She added, “7-OH is not what helped me get out of bed and get a quality of life again that I enjoy.”
Soren Shade, the owner of a company that sells kratom teas, told NOTUS after the press conference he believed kratom industry lobbying groups were involved in the FDA’s announcement to seek scheduling for 7-OH specifically.
“It’s an exceptionally powerful lobbying arm,” Shade said. “I think that’s why they were so clinical in their discerning between kratom and 7-OH, because the kratom lobby has been very effective.”
Shade said he believed Kratom lobbying groups had been the “leading advocate” in the FDA’s decision to recommend the DEA review its scheduling designation for 7-OH.
“It is taking a lot of money away from the industry,” Shade said.
Two leading kratom lobbying groups, the American Kratom Association and the Global Kratom Coalition, did not respond to requests for comment.
This is not the first time the federal government has taken steps to regulate kratom and 7-OH — nor is it the first time the kratom lobby has played a role in determining what, exactly, those steps are. In 2016, the DEA attempted to add kratom to its list of scheduled substances. A 2023 Tampa Bay Times investigation found that kratom lobbying groups were instrumental in getting the DEA to reverse its decision.
Tuesday’s press conference had dual purposes, with speakers focusing on both the harm synthetic 7-OH products cause to the “natural” kratom industry and the role 7-OH could play in the opioid crisis. Sen. Markwayne Mullin, who has introduced legislation to combat the drug epidemic, joined the conference and called particular attention to Health Secretary Robert F. Kennedy Jr.’s own history of addiction.
“For the first time, we have a secretary that not only has a backbone to do something about it, but he does it because he has personal experience,” Mullin said about Kennedy’s role in targeting unapproved supplements like 7-OH. “It takes somebody like that that understands the danger that this causes to stand up and push against this, I say, illegal industry because they’re using every loophole they possibly can.”