The 7-OH Scheduling Announcement: A Turning Point for Kratom and Future Research

From our vantage point in the ibogaine community, we've witnessed a rise in individuals seeking assistance for dependency on concentrated kratom alkaloids—specifically, 7-hydroxymitragynine (7-OH). It is for this reason that the July 29th announcement from the FDA is so significant. The agency is advocating for the classification of products containing 7-OH as a controlled substance, and the level of scheduling will have profound implications for the kratom community and the future of research.

The 7-OH Focus

At a press conference on July 29th, U.S. Health and Human Services Secretary Robert F. Kennedy, Jr. and other health officials made it clear that this action is aimed directly at 7-OH, a concentrated and often synthetically produced alkaloid. As Kennedy stated, their goal is to take action against "the dangerous opioid 7-OH to protect the American people." The focus is not on the natural kratom leaf powder but on unregulated products found in places like gas stations and vape shops. Officials cited its potency—reportedly many times stronger than morphine—as a key reason for concern.

The Spectrum of Scheduling: Schedule I vs. Schedule II

The proposed scheduling level is critical. In the U.S., controlled substances are categorized based on their potential for abuse and accepted medical use:

• Schedule I: Defined by a high potential for abuse and no currently accepted medical use. Research is severely restricted, and prescriptions are prohibited.

  
  

• Schedule II: Defined by a high potential for abuse but with a currently accepted medical use. These substances can be prescribed under strict regulations, and research is more accessible than with Schedule I substances.

Implications of Schedule I vs. Schedule II for 7-OH

If 7-OH products are classified as Schedule I:

• Research Hindrance: Scientific study would be exceptionally difficult, potentially preventing a deeper understanding of 7-OH's properties and its relationship to other kratom alkaloids.

• Federal Criminalization: Possession and distribution would become federal offenses, with potential ramifications for the broader kratom market, even though the target is specific products.

• No Medical Recognition: It would officially deny any potential medical utility of 7-OH, conflicting with anecdotal evidence and preliminary research.

  
  

However, if 7-OH were classified as Schedule II:

• Recognition of Medical Potential: This would acknowledge that 7-OH may have some medical application, a significant difference from the Schedule I designation.

• Facilitated Research: While still regulated, research would be more feasible, allowing scientists to investigate its effects and potential therapeutic uses.

• Controlled Access: In theory, 7-OH could be prescribed under strict medical supervision for specific conditions, although this is unlikely to translate to widespread availability of current 7-OH products. More importantly, it would allow for a regulated supply chain, potentially displacing the unregulated market.

A More Balanced Approach?

Many believe that a Schedule II classification would strike a better balance between public safety and the need for scientific inquiry. This approach could allow the government to:

• Control Manufacturing and Distribution: Implementing strict regulations on the production and sale of isolated 7-OH, ensuring it's not readily available in unregulated channels.

• Enable Legitimate Research: Providing a framework for scientists to study 7-OH's properties, benefits, and risks under controlled conditions.

The Path Forward

The FDA's recommendation now moves to the DEA, which will initiate a formal rulemaking process. This includes a scientific review and a crucial public comment period. The kratom community and its advocates will undoubtedly use this opportunity to emphasize the distinction between natural kratom and concentrated 7-OH. They may argue against a Schedule I classification that could have far-reaching negative consequences and instead advocate for a Schedule II designation as a more targeted and scientifically defensible approach. As one official noted, the goal is to "prevent disasters" rather than just clean them up after the fact.

The ibogaine community, seeing firsthand the complexities of 7-OH dependency, will be watching this process with keen interest, hoping for an outcome that prioritizes both safety and a deeper understanding of these powerful plant-derived compounds. Watch the full conference here.