The following excerpt has been taken directly from Dr. Henningfield et. al response to the FDA’s 8-Factor Analysis.
(Jack E. Henningfield, Ph.D)
1. FDA’s 8-Factor Analysis does not constitute a reliable and valid scheduling decision guiding document.
2. FDA clearly did not involve NIDA or kratom science experts, as revealed by its major deficiencies.
3. The FDA analysis is incomplete, omitting key data sources routinely relied upon for identifying trends in abuse (e.g., the major federal surveys) and key scientific studies, AND is out-of-date as it does not refer to critical studies including those by NIDA (Yue et al., 2018) and Hemby et al., 2018.
4. The evidence is sufficient to conclude that placement of kratom in Schedule I or any other approach that would ban kratom, would lead many kratom consumers to seek black market kratom and some to relapse to opioids and thus pose a serious risk of death.
1. DEA should ask FDA to reexamine the abuse potential of kratom and potential alternative regulatory approaches to kratom with involvement of NIDA and kratom experts, and stakeholders that have additional data and will be affected, namely kratom vendors and kratom consumers. This should be done transparently and include public meetings.
2. Federal agencies should conduct a nationally representative survey to better understand how many people use kratom, use it in place of opioids and would be put at risk of relapse to opioids if kratom was banned, where they live geographically, and other information critical to understanding the nature and magnitude of a ban, as well as regulatory alternatives to a ban.
3. We recommend that FDA propose a regulatory framework that will ensure that safely manufactured kratom products remain continuously available to consumers in natural leaf forms and manufactured extractions that are widely used by consumers, with regulations to ensure quality and appropriate standards for contents, labeling, and marketing…
What Should You Do with this Knowledge?
Firstly, share it with your kratom friends and family!
Secondly, as Kratom Advocates (yes, that’s you!), preparing yourself with factual knowledge that’s in favor of kratom is the key to changing the minds of a nation. With each growing member of the kratom community that is educated and can cite a fact, our pro-kratom movement grows stronger.
Please take 15min to read the whole paper and prepare yourself for that critical moment where you’ll need to tell a friend, healthcare professional or legislator a fact about kratom from this paper, for example:
“reports of adverse effects and effects in which people sought medical attention are apparently rare as evidenced by emergency room reports, poison control center data, surveys (e.g., Grundman et al., 2017; Garcia et al., 2018; Henningfield et al., 2018),”