FDA Commissioner on Kratom Safety: Focus on Synthetic Concentrates

FDA's Stance on Kratom Safety

• ⚠️ The FDA is not prepared to say anything is 100% safe, especially substances with psychoactive properties.
• 🎯 The agency's current focus is on synthetic concentrated kratom products, distinguishing them from trace amounts naturally found in kratom leaves.

Kratom and Public Health Risks

• ❓ There is a lack of clear data on kratom as a sole cause of fatal overdoses, as doctors are often unfamiliar with the substance.
• 💡 The situation is compared to the early days of opioid prescription, where the addictive nature was not fully recognized.
• 🔬 The NIH is committed to research to better understand kratom's effects and risks.

Regulatory Actions and Future Plans

• 📢 The FDA is issuing a report explaining kratom, recommending the scheduling of concentrated kratom as a controlled substance to the DEA, and sending a dear doctor letter to physicians nationwide.
• 🤝 Letters have been sent to distributors of synthetic concentrated kratom, with some distributors showing positive feedback.
• 🗣️ The FDA aims to create a national conversation about the risks of these substances, encouraging parents, school boards, and places of worship to discuss them.

Kratom vs. Other Substances

• ⚖️ The FDA's framework for distinguishing between trace and concentrated kratom may be applicable to other dietary supplements.
• 📈 The FDA is prioritizing action against synthetic concentrated kratom due to its perceived night and day difference in public health risk compared to natural kratom.
• ❓ Regarding high-potency cannabis products, the FDA acknowledges serious concerns and ongoing public health campaigns, but these are treated as separate issues from kratom.

Classification and Next Steps

• 💊 The FDA is recommending that concentrated kratom be classified as an opioid.
• ⏳ The ultimate decision on scheduling rests with the DEA, and the FDA is awaiting their action.