Comment from Chatburn, Shawn, HHS-OASH-2026-0232, HHS-OASH-2026-0232-0001, 2026-13608

I respectfully urge the Department of Health and Human Services and the Drug Enforcement Administration to reject the proposed temporary scheduling threshold for 7-hydroxymitragynine (7-OH) and instead pursue a science-based regulatory approach that protects public safety while preserving consumer access. 7-OH is a naturally occurring alkaloid present in the kratom leaf. It is not a novel synthetic drug. For many individuals, access to kratom-derived compounds has been life-changing — particularly for those failed by conventional pain and substance-use treatment systems. Consumers across the country rely on 7-OH to manage chronic pain, improve their quality of life, reduce reliance on prescription opioids, and as a harm reduction tool. Many have also used it to leave fentanyl, heroin, alcohol, and other more dangerous substances. At a time when millions of Americans continue to struggle with chronic pain, substance use disorder, and limited access to affordable healthcare, removing another potential tool is not sound public policy — and that is exactly what the DEA’s proposed Schedule I placement would do. 7-OH does not belong in Schedule I of the Controlled Substances Act. Serious adverse events involving 7-OH alone are rare, there have been no overdose deaths involving 7-OH alone, and researchers continue to study its potential medical benefits. Notably, placing these products into Schedule I will make future scientific research significantly more difficult at precisely the time when more research, not less, is needed to better understand 7-OH and its full public health potential. I support reasonable regulation and accurate labeling of 7-OH and other kratom products. However, the proposed threshold of 0.050% or approximately 1 milligram per article is simply too low. It would effectively eliminate the vast majority of 7-OH products currently available. That is not regulation. It is prohibition. History has shown that prohibition does not eliminate demand. It pushes consumers into unregulated markets, increases the risk of unsafe products, and criminalizes ordinary Americans who are simply trying to improve their quality of life. The people who will be negatively impacted are parents, veterans, caregivers, workers, and individuals who often turned to 7-OH because traditional pain treatment or healthcare was unavailable or unaffordable. Any threshold should reflect how these products are actually used by responsible adults. A 1 milligram limit does not accomplish that. If limits are established, they should be based on real-world consumer use and scientific evidence, not an arbitrary level that effectively bans an entire category of products. I respectfully ask the DEA to reject the proposed threshold and instead adopt a practical, evidence-based regulatory framework that protects consumers, supports continued research, and preserves legal access for responsible adults. Thank you for your consideration. Sincerely, Shawn chatburn