Federal officials promised on Tuesday to crack down on a potent semisynthetic opioid found in convenience store gummies, drinks and dietary supplements by putting the substance in the most restricted class of drugs.
The action by the US Department of Health and Human Services and the Justice Department targets a compound called 7-hydroxymitragynine, or 7-OH, that is drawn from the opioid-like herb kratom. Taken in small doses, kratom and that component can act as a stimulant, and some people use it to manage opioid withdrawal symptoms.
Although 7-OH occurs naturally in “trace amounts” in kratom, some consumer products on the market have concentrated amounts of 7-OH, the US Food and Drug Administration has said.
“We are not targeting the kratom leaf or ground-up kratom. We are targeting the concentrated synthetic byproduct that is an opioid,” FDA Commissioner Dr. Marty Makary said Tuesday during an HHS event.
Federal health agencies have seen a “disturbing rise in reports of overdoses, poisonings and emergency room visits” with products containing 7-OH, HHS Deputy Secretary Jim O’Neill said. The substance carries risks of addiction but is often sold without dosage controls or warnings, he added.
Yet there are “terrible statistics” on how many people have actually overdosed from 7-OH products, Makary said, because few doctors are familiar with the substance. Health officials are also working on education campaigns and research on 7-OH, he said.
Makary said the FDA is recommending that 7-OH be listed as Schedule I, the most restrictive class of controlled substances. The government defines drugs in that class — including heroin, cocaine, cannabis, LSD and psilocybin — as having no currently accepted medical use and a high risk of addiction.
Other opioids, such as fentanyl and morphine, are in a lower schedule because they are used medically. It is unclear where health officials would recommend that the Drug Enforcement Administration place leaf or ground kratom, which contain less 7-OH than synthetic products but are also virtually unregulated.
Asked about the potential for future natural kratom regulations, Makary said some physicians have expressed concerns about its risks and addiction potential.
But, he added, “We have to prioritize what we work on, so we are going after the killer first, which is the synthetic, concentrated kratom, and then we can look into that other question. But we think it’s night and day in terms of the public health risk.”
On July 15, the FDA sent warning letters to seven companies marketing 7-OH products including gummies, tablets and drink mixes. The agency reiterated in those letters that it is illegal to add the substance to any dietary supplements or food products — though that has proved difficult to regulate, as kratom regularly appears in products at smoke shops and gas stations.
Several former health officials from the first Trump administration have publicly urged the government to step up regulation of kratom and 7-OH in particular. Former US Centers for Disease Control and Prevention Director Dr. Robert Redfield penned a June op-ed in The Hill arguing that health agencies would not need to “reinvent the wheel” but adopt a standard set forth in recent legislation.
“Natural kratom leaf, when used as it has been for centuries, presents a markedly different risk profile than the synthetic products flooding American markets,” Redfield wrote.
But that leaves the open question of how to regulate natural kratom. In 2018, the FDA declared the herb, derived from an Asian evergreen tree, an opioid.
“There is no evidence to indicate that kratom is safe or effective for any medical use,” then-FDA Commissioner Dr. Scott Gottlieb said in a February 2018 statement. “And claiming that kratom is benign because it’s ‘just a plant’ is shortsighted and dangerous.”
That statement is no longer available on the FDA website. The agency now states that “until the agency scientists can evaluate the safety and effectiveness of kratom (or its components) in the treatment of any medical conditions, FDA will continue to warn the public against the use of kratom for medical treatment.”
Melody Woolf, an advocate for people with chronic pain, championed the benefits of natural kratom at Tuesday’s HHS event. “I was so grateful I found a botanical called kratom,” she said. “It was kratom only, the powdered leaf, that saved my life. And now I’m seeing something very dangerous happen: 7-OH is being sold over the counter.”
The Holistic Alternative Recovery Trust, an advocacy organization focused on opioid addiction, pushed back on the claims after Tuesday’s event and noted that officials weren’t able to point to any deaths attributed to 7-OH.
“Since today’s announcement did not reference any concrete public health data, we can only conclude that instead of public health being paramount, other interests may be driving policy decisions,” Jeff Smith, the group’s national policy director, said in a statement. “The FDA needs to hear from researchers, toxicologists, and addiction science experts — and from the American people. Cutting off access helps no one, but it will hurt many.”
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