Kratom Ban Update: What the FDA has been Hiding

Introduction

Recently, the American Kratom Association held a press conference to talk about the U.S. Department for Health and Human Services (HHS) rescinding its scheduling recommendation for Kratom. Although this action was taken, the U.S. Food and Drug Administration (FDA) failed to make this information available to the public and policy makers. Unfortunately, this withholding of information left states with inaccurate information about Kratom that influenced policy. In several states this even resulted in a Kratom ban.

This blog will cover a little bit of the FDA’s history with Kratom, as well as the importance of the new information from HHS.

FDA & Kratom Ban History

If you’re familiar with Kratom and public policy, you might know that the FDA does not look at it favorably. In fact, on August 31, 2016, the DEA issued a notice of intent to place Kratom as a Schedule 1 substance. Basically, starting a Kratom ban and labeling it as belonging to the class of most dangerous and severe drugs. Drugs like heroin, LSD, and ecstasy.

This intent to schedule was based on a recommendation the FDA received from the HHS. Following the FDA’s announcement on scheduling Kratom, there was a large public backlash. YouTube campaigns were started, people gathered to protest outside of their local government buildings, and thousands of testimonials were sent to representatives. Finally, the FDA pulled their intent to schedule. The public and policymakers assumed this was due to the backlash. As we now know, that’s not quite the whole story.

HHS Rescinds Scheduling Recommendation

So, what is the full story? Well, it turns out that the recommendation letter from the HHS was rescinded. They took it back. There are criteria that a substance must meet in order to be on schedule 1. Kratom does not even nearly meet these requirements.

Kratom ban update text. Reads: Pursuant to the Controlled Substances Act (CSA), I am rescinding our prior recommendation dated October 17, 2017, that the substances mitragynine and 7-hydroxymitragynine be permanently controlled in Schedule 1 of the CSA. HHS is instead recommending that mitragyning and 7-hydroxymitragynine not be controlled at this time, either temporarily or permanently, until scientific research can sufficiently support such an action. Mitragyning and 7-OH-mitragyning are two of the constituents of the plant Mitragyna speciosa (M. speciosa), commonly referred to as kratom. This decision is based on many factors, in part on new data, and in part on the relative lack of evidence, combined with an unknown and potentially substantial risk to public health if these chemicals were scheduled at this time. Further research, which I am proposing be undertaken, should provide additional data to better inform any subsequent scheduling decision.
The introductory text from the HHS letter to the DEA, informing them of the decision to rescind the scheduling recommendation about Kratom.

The full letter details what the requirements for scheduling are, and precisely how Kratom does not meet them. Further, they highlight the “significant risk of immediate adverse public health consequences for potentially millions of users” if Kratom were to be banned. Read the full text of this letter here.

FDA Hides Information; Influences Kratom Bans

Unfortunately, this information from the HHS was not made available to he public or policymakers for over two and a half years. Even though the scheduling decision was halted by the FDA, decisions about Kratom bans were made in cities and states across the country based on HHS’s first letter of scheduling recommendation.

We think this quote from an American Kratom Association spokesman pretty much sums it up:

“Despite this formal action by HHS, the FDA has failed to make this action public and continued to
allow the public; policy makers at the federal, state, and local levels; and the media to believe its
recommendation for schedule kratom was actively being considered by DEA despite the fact the
science did not support that action,” stated Mac Haddow, Senior Fellow on Public Policy for the
American Kratom Assocation (AKA). “The FDA abandoned its mandate to protect the public health
and instead stood silent for more than 2 ½ years while the opioid overdose crisis deepened,
particulary in the midst of the spike in overdose deaths related on the ongoing COVID-19 pandemic,
all while HHS had concluded kratom could have helped those using highly lethal opioids.”
Mac Haddow’s response to the FDA’s information withholding.

Read the full statement by Mac Haddow here. Further, read the AKA’s official press release on the whole issue here.

AKA Press Conference

Below we’ve included the full video press conference by the AKA about this news.

Conclusion

Unfortunately, the FDA failing to disclose this information from the HHS had a significant impact. States and policymakers went with the information that they had, that Kratom had been recommended as a very dangerous drug. As a result, 5 states have entire Kratom bans, and individual cities in some states have banned the plant also. This was an unfortunate example of government not serving their people. Even the HHS states the possible harm in banning Kratom, and expresses the importance of further research into its positive uses.

A look on the bright side, however, is that this information is out there now. There are representatives like Congressman Mark Pocan fighting for Kratom research, safety, and availability. Hopefully, Kratom research will be fueled by this incentive, and places with Kratom bans will revisit those regulations.


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