Statement on DEA's Revised Scheduling Action for 7-OH and Related Substances

"The marketplace for kratom-related products has changed dramatically in recent years, with increasingly potent products often reaching consumers through a patchwork of regulations that can be difficult to enforce. We are encouraged that HHS refined its scientific recommendations and that DEA has incorporated them into a revised scheduling framework that is better designed to target highly concentrated, opioid-like products. While we ultimately believe products containing potent psychoactive compounds should be subject to rigorous FDA review, DEA should now move quickly to finalize temporary scheduling consistent with these updated recommendations." Shatterproof CEO Pam Jenkins 

Shatterproof welcomes the Drug Enforcement Administration's (DEA) revised emergency scheduling action for 7-hydroxymitragynine (7-OH) and mitragynine pseudoindoxyl (MGPI), which incorporates updated scientific recommendations from the U.S. Department of Health and Human Services (HHS). 

Preventing substance use disorder and protecting young people from unnecessary risk must remain the guiding priorities as federal and state policymakers respond to the rapidly evolving marketplace for kratom-related products. In recent years, products containing concentrated forms of kratom alkaloids have proliferated, making it increasingly difficult for consumers, policymakers, and retailers to distinguish between traditional "natural leaf" kratom products and products specifically manufactured to deliver much stronger opioid-like effects. 

Shatterproof is encouraged that HHS revisited its initial recommendation and developed a more refined scientific framework. The revised approach, which focuses on concentration thresholds and alkaloid ratios rather than relying primarily on total quantity, is better designed to identify products that have been intentionally concentrated or enhanced. It also appears responsive to concerns raised in formal comments submitted by Shatterproof and other stakeholders regarding the need to differentiate products containing naturally occurring trace amounts of these substances from products engineered to deliver substantially greater potency. 

This change is important because regulatory frameworks should focus on the characteristics most closely associated with addiction risk and consumer harm. As manufacturers continue to develop increasingly potent products, regulators need approaches that are grounded in science and capable of addressing attempts to exploit loopholes or circumvent public health protections. 

DEA's revised scheduling action is also an important acknowledgment that the marketplace for kratom-related products has become increasingly complex. Across the country, states have adopted a patchwork of laws governing kratom and related products, resulting in inconsistent youth and consumer protections and significant enforcement challenges. At the same time, novel products continue to emerge that may bear little resemblance to what consumers commonly understand as "natural leaf" kratom. 

While Shatterproof believes products containing potent psychoactive substances should ultimately be subject to rigorous FDA review to establish their safety, efficacy, quality, and appropriate labeling, stronger federal action is needed now. In the absence of a comprehensive federal regulatory framework, science-based safeguards that reduce addiction risk and protect youth are critical. 

For that reason, Shatterproof supports DEA's revised scheduling approach and urges the agency to move forward expeditiously with temporary Schedule I controls consistent with the updated HHS recommendations. Prompt action is necessary to help prevent the continued proliferation of highly concentrated opioid-like products while providing greater clarity for consumers, regulators, and state policymakers. 

This action represents meaningful progress toward a more risk-based and evidence-driven approach. We are encouraged to see federal agencies refining their response based on scientific evidence and stakeholder input, while maintaining focus on the products that pose the greatest threat to public health.