Key Points
- HHS recommended science-based thresholds to the DEA to target kratom products containing 7-hydroxymitragynine (7-OH) and mitragynine pseudoindoxyl (MGPI)
- The thresholds aim to distinguish natural kratom from enhanced or concentrated products with potent opioid compounds
- The DEA will temporarily schedule 7-OH and MGPI in Schedule I of the Controlled Substances Act if they exceed the recommended thresholds
What HHS' Recommendation Means for Kratom Users
The US Department of Health and Human Services (HHS) has recommended science-based thresholds to the Drug Enforcement Administration (DEA) to target kratom products containing potent opioid compounds. The thresholds aim to distinguish natural kratom from enhanced or concentrated products with potent opioid compounds.
According to HHS, 7-hydroxymitragynine (7-OH) and mitragynine pseudoindoxyl (MGPI) are potent opioid compounds associated with kratom products. The recommended thresholds are designed to temporarily schedule 7-OH and MGPI in Schedule I of the Controlled Substances Act if they exceed the recommended levels.
The new HHS recommendation responds to concerns about how scheduling could affect natural botanical kratom products potentially containing trace amounts of MGPI. HHS and FDA will continue working with DEA to protect Americans from dangerous concentrated and synthetic opioid products while ensuring federal policy is grounded in the best available science.
At a Glance
| 7-Hydroxymitragynine (7-OH) | a potent opioid compound associated with kratom products |
| Mitragynine Pseudoindoxyl (MGPI) | a potent opioid compound associated with kratom products |
| Schedule I | a temporary scheduling designation for controlled substances with high potential for abuse |
Where the Sides Stand
HHS and DEA
Position: supporting science-based thresholds for kratom regulation
Role in the story: regulatory agencies
Motivation: protect public health
Kratom industry advocates
Position: opposing strict regulation of kratom products
Role in the story: industry stakeholders
Motivation: concerns about over-regulation and impact on business (our reading)
Behind the Science: Understanding the Risks of Enhanced Kratom
Behind the Science: Understanding the Risks of Enhanced Kratom
The HHS recommendation is based on a review of available scientific data, including preclinical studies that found 7-OH to be substantially more potent than morphine. The FDA also identified evidence supporting a meaningful risk of opioid-like physical dependence and withdrawal from MGPI.
The recommended thresholds are designed to reflect the alkaloid composition of natural kratom products and provide a way to identify products intentionally enhanced or concentrated with 7-OH or MGPI. This approach allows HHS and DEA to focus on the products that pose the greatest threat to public health.
What to Expect Next for Kratom Regulation
What to Expect Next for Kratom Regulation
The DEA will temporarily schedule 7-OH and MGPI in Schedule I of the Controlled Substances Act if they exceed the recommended thresholds. This means that kratom products containing these compounds in excess of the recommended levels will be subject to stricter regulation and control.
Kratom users can expect increased scrutiny of kratom products and potentially stricter regulations in the future. It is recommended that users carefully review product labels and consult with healthcare professionals before using kratom products.
Risk & Opportunity Assessment
| Commercial Risk | Medium | Stricter regulation and control of kratom products may impact the commercial availability and pricing of kratom products |
| Regulatory Risk | High | The DEA's temporary scheduling of 7-OH and MGPI in Schedule I may lead to increased regulatory scrutiny and potential fines or penalties for non-compliance |
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