FDA Proposes Ban on Kratom-Related Substance

The FDA’s Decision to Schedule 7-OH as a Controlled Substance

The U.S. Food and Drug Administration (FDA) has taken a significant step by proposing to classify the opioid-like compound 7-hydroxymitragynine, commonly referred to as 7-OH, as a Schedule I controlled substance under the Controlled Substances Act. This decision means that the compound is considered to have a high potential for abuse and no accepted medical use in the United States.

7-OH is a psychoactive compound found in the kratom plant, which is native to Southeast Asia. It has been studied extensively by the National Institutes of Health (NIH), which notes that the compound binds to opioid receptors in the brain. This interaction raises concerns about its potential for misuse and addiction, prompting the FDA to take action.

The move specifically targets high concentrations of 7-OH, which can naturally occur in certain strains of the kratom plant. Kratom itself has a long history of use in traditional herbal medicine and remains unregulated in the U.S. However, the FDA is not targeting the whole plant or its ground form. Instead, it is focusing on concentrated synthetic derivatives of the plant that mimic the effects of opioids.

FDA Commissioner Marty Makary emphasized that the decision is aimed at preventing the spread of products containing 7-OH, which are increasingly being sold in vape shops, smoke shops, and grocery stores. He described the action as a preventative measure to avoid another public health crisis similar to the opioid epidemic.

“We have a history in public health of being asleep at the wheel,” Makary said. “For the sake of our nation’s children, let’s not get flat-footed again.” He added, “Public health is supposed to prevent disasters, not just clean them up after they killed thousands and thousands of people.”

The FDA’s classification will now be forwarded to the Drug Enforcement Administration (DEA), which will issue a proposal to schedule the substance and allow for public comments. In 2016, the DEA had previously shelved plans to regulate kratom compounds due to strong public opposition.

Makary also highlighted the administration's commitment to preventing another wave of the opioid epidemic. “The Trump administration is deeply committed to preventing another wave of the opioid epidemic,” he stated.

Perspectives from Industry and Advocates

Not everyone agrees with the FDA’s approach. Paula Savchenko, an attorney and consultant at Cannacore group, argues that targeting 7-OH could restrict access to medicines like kratom that many individuals rely on for relief. She pointed out that kratom has helped countless people manage chronic pain, anxiety, and opioid withdrawal symptoms.

Savchenko criticized the FDA’s research linking kratom to a new opioid epidemic, stating, “There is no link to overdose deaths directly from 7-OH. That’s why this is so ridiculous.” She believes that the pharmaceutical industry may be behind the push to regulate kratom because it offers an alternative to opioids that is less addictive and more affordable.

“This is a direct target from Big Pharma to the kratom industry because kratom is taking up part of the market share from opioids and that’s a problem for big pharma,” she said.

Personal Experiences and Concerns

Melody Woolf, a supporter of the FDA’s scheduling policy, shared her personal experience with kratom. She described how she was bedridden for eight years due to a chronic pain condition until she began using kratom. “Right away my life improved, I was out of bed, I was doing activities with my kids, and I lost a lot of weight,” Woolf said. “I got my life back.”

However, Woolf made a clear distinction between the kratom she uses and products containing 7-OH. She noted that the substance itself is “very dangerous” and that it was not the component that helped her recover.

Savchenko also expressed concerns about the FDA’s recommendations, calling them misleading. She said she will work with industry partners to oppose the classification during the DEA’s process. “Our government is not well educated on this topic or they're purposefully spreading this information,” she said. “We’ll be actively involved in the rule making and public comments.”