This is a lengthy study of the CSA Eight Factors and scheduling recommendation of Kratom, one that was submitted to the DEA/FDA. The 8 factors are used to determine the public risk. Because this is such an important study, we have decided to break this down into a series of posts, to be able to summarize the most important parts of the study.
The 8-Factor analysis is not a formal petition, rather it is a guide for addressing the government’s requirements for rescheduling and regulating Kratom as a safe and effective medicine. The analysis presents the CSA and FDA requirements for demonstrating the medical value of legitimizing Kratom as well as the major public health impact it can have towards the many patients it helps. Within the analysis is a critical review of the abuse, dependence, medical use, and standards being implemented to regulate kratom programs in the United States.
Part of the introduction:
The analysis presents the CSA and FDA requirements for demonstrating the medical value of legitimizing Kratom as well as the major public health impact it can have towards the many patients it helps. Within the analysis is a critical review of the abuse, dependence, medical use, and standards being implemented to regulate medical cannabis programs in the United States.
This is part one of series of articles breaking down this very important study performed. This should and ultimately will, be the basis of how the DEA should move forward with our beloved plant called kratom, or Mitragyna speciosa.
The eight factors is a common format that the DEA requires when a substance is thought to be a risk, or at least a “perceived” risk. Medical cannabis went through the same process.
Here is a breakdown of the 8 factors:
- Factor 1: Kratoms’ Actual or Relative Potential for Abuse
- Factor 2: Scientific Evidence of the Pharmacological Effects and General Pharmacology of Kratom
- Factor 3: The State of Current Scientific Knowledge Regarding the Drug or Other Substance
- Factor 4: Its History and Current Pattern of Abuse
- Factor 5: The Scope, Duration, and Significance of Abuse
- Factor 6: What, if any, Risk there is to the Public Health
- Factor 7: Its Psychic or Physiological Dependence Liability
- Factor 8: Whether the Substance is an Immediate Precursor of a Substance Already Controlled
Kratom leaves and extracts have been used for centuries in Southeast Asia and elsewhere to manage pain and other disorders and, by mid-twentieth century, to manage opioid withdrawal. Kratom has some opioid effects but low respiratory depression and abuse potential compared to opioids of abuse.
Note the specifying of kratom as a “low respiratory depression” characteristic, a very important component of the study. This is the major differentiation between kratom and opioids.
The present 8-factor analysis has been developed to determine the appropriateness of CSA scheduling of kratom and/or its alkaloids and derivative products, and if so, the most appropriate schedule for kratom.
Although MG and 7-OH-MG have sometimes been referred to as “opioids,” in this document the term “opioid” will only be used to refer to molecules and products that are opioids as defined by the CSA, which identifies opioids as substances with addiction forming or addiction-sustaining liability similar to morphine, or substances capable of conversion into drugs with such liability.
It’s obvious already that the study makes an important distinction of kratom and opioids. We will discover later why there is a clear difference.
We will provide an insight and simplified breakdown of each one of these factors, and more importantly, what that means to to kratom. Please keep this bookmarked for future posts!