Future of Kratom, DEA, and FDA
It wasn’t that long ago in Washington, D.C. at the kratom rally in front of the White House that hundreds of people from the atom community were united together and requesting fundamental rights from our government. There was one “ask” that stood out among the rest, and that was “DUE PROCESS.”
Here we are now a month later and our voices were heard. On October 6, 2016 the DEA withdrew its original notice of intent and is now soliciting comments from the public regarding the scheduling of mitragynine and 7-hydroxymitragynine under the Controlled Substances Act. The Comment period will be open until December 1, 2016.
The Botanical Education Alliance will provide a link on our website providing educational videos and insight into this new chapter of our journey and how we can make our time count!
Apart from our BEA Educational Series to come, the BEA has amassed the most comprehensive scientific dossier on kratom that the world has ever seen. This document and more was made possible by your generous donations along with the cooperation of private companies as well as professional researchers.
Without you (The Kratom Community) none of this would be possible for the last 3 years that the BEA has fought for this community, kratom, and its use at the local, state, and now federal level.
When we presented the DEA with this document they were overwhelmed with the data we submitted to show that kratom is safe, no more addictive than coffee, and has no negative side effects on short or long term human health. We are now looking to receive more donations to hire the finest professionals in the field of addiction, toxicology, and safety to make our final push of the year.
This is what we have all been waiting for and the BEA already has the majority of this work done. All we need is your support for the final fight.
Progress with Congress, DEA, and AKA
With your help we have made several trips to Washington D.C. to personally speak at the White House rally, and with Congressmen and Senators that have been instrumental in removing the original emergency ban.
We have also met with our legal team at Venable LLC several times now to discuss the most effective legal strategy to success without breaking the bank. This strategy wielding such powerful scientific data has forced the DEA to seek the help of the FDA now.
In one of the most critical meetings to date, right before the DEA announcement to withdraw its notice, the BEA’s Travis Lowin and Angela Watson invited AKA management, N.S. Kevin Matthews, Lobbyist Mac Haddow (In Person), as well as the AKA introducing Steve Curtis of ZAG Global and Ms. Susan Ash (VIA Phone) to participate in the final joint planning to free ourselves from the emergency ban.
We continue to foster a collaborative environment for organizations and individuals to come together and work for the community that we serve, as well as taking the lead in education and science of the plant we all love.
Looking Deeper into the DEA’s Withdrawal of Notice of Intent
The DEA’s new 7-page document submitted to the Federal Registrar on October 6 https://www.federalregister.gov/documents/2016/10/13/2016-24659/withdrawal-of-notice-of-intent-to-temporarily-place-mitragynine-and-7-hydroxymitragynine-into
This letter of intent describes the FDA’s involvement on Page 1 stating, “In addition, DEA will receive from the Food and Drug Administration (FDA) a scientific and medical evaluation and scheduling recommendation for these substances, which DEA previously requested.” The previous notice of intent to emergency schedule kratom on Aug. 25, 2016 https://www.federalregister.gov/documents/2016/08/31/2016-20803/schedules-of-controlled-substances-temporary-placement-of-mitragynine-and-7-hydroxymitragynine-into
It states on Page 4 that “The Assistant Secretary (Karen DeSalvo) also stated that the HHS (FDA) has no objection to the temporary placement of mitragynine and 7-hydroxymitragynine into schedule I of the CSA.”
Page 5 of the Oct. 6th letter states at the bottom, “2 Section 811(b) provides that the scientific and medical evaluation and scheduling recommendation shall be conducted by the Secretary of Health and Human Services (HHS). This function has been delegated to the Assistant Secretary for Health (Karen DeSalvo) 58 FR 35460 (1993). Within HHS, the FDA has primary responsibility for conducting the evaluation and making the recommendation.
Commenting on Kratom
What this means is that ALL our public comments from Aug. 25th and any submitted between now and Dec. 1st is going to be fully considered by the DEA.
Specifically on Page 5 the DEA states, “In response to the notice of intent, DEA received numerous comments from the public on mitragynine and 7-hydroxymitragynine, including comments offering their opinions regarding the pharmacological effects of these substances.” This is where we MUST pay attention! We must be very careful how we describe these two alkaloids of Kratom in our opinions that we submit.
We DO NOT want to give the DEA opinions that suggest the pharmacological effects of these two alkaloids are that of drugs. Because Kratom is NOT a drug, it is a regulated dietary ingredient.
There are certain opinions that can be said of drugs and certain opinions that can be said of dietary supplements. The BEA will go over this key point and more in our educational videos.
The Asst. Secretary Karen DeSalvo has already stated that the FDA “has no objection to the temporary placement of mitragynine and 7-hydroxymitragynine into Schedule I of the CSA.”
We are to assume they have not changed their minds and since the same organization and individual (DeSalvo) will be conducting the evaluations and recommendation to come, then it is imperative that the BEA continue its hard work to produce the community’s own evaluation and recommendation to show that kratom does not need to be scheduled at all!
DEA’s and FDA’s Plan for Scheduling
During our conversations with the DEA, the agency indicated it is expected that the FDA will have its analysis done by Dec. 1st. It is important to note that we have moved on from the original 3 Factor Analysis to an 8 Factor Analysis. Here is what was being considered, and what is being considered now:
The DEA considered these 3 Factors out of the 8 Factors first go around:
- Its history and current pattern of abuse.
- The scope, duration, and significance of abuse.
- What, if any, risk there is to the public health.
Now it will consider the following factors:
- Its actual or relative potential for abuse.
- Scientific evidence of its pharmacological effect, if known.
- The state of current scientific knowledge regarding the drug or other substance.
- Its psychic or physiological dependence liability.
- Whether the substance is an immediate precursor of a substance already controlled under this subchapter.
What We Must Do
Rounding things up here are a few keys points we need to educate ourselves about plus we will have a BEA Educational Series about all this in the weeks to come. Be Patient and make informed decisions! The DEA and FDA sure are.
1. Public comments
Kratom is primarily used as an alternative to opiates for pain management or to help with addiction only reinforces this position in FDA’s mind and will be used by FDA to support its position that:
- The only intended use of Kratom is as a drug
- It has a high potential foe addiction because individuals cannot appear to live without it
- It should be scheduled
2. Ethical Marketing
Companies that have product names related to drugs must cease and desist immediately as it plays directly into FDA’s position on Kratom. The industry is only as good as its least ethical product. Otherwise the FDA will focus in on those examples.
We Still Have Lots of Work Ahead
We are in the process of preparing an analysis of the information that is needed to address the 8-factor analysis. In our conversation with DEA yesterday, the agency indicated that it expected FDA to have that analysis done by December 1st. DEA will then evaluate it and decide whether to move forward with full scheduling.
The DEA did indicate, while not likely, that it is not taking emergency scheduling off the table if the agency felt FDA’s analysis is sufficiently compelling to issue a new 30-day notice.
It would be shame if we win the battle with DEA to lose the war with FDA. We need to harness our resources to show there are legitimate dietary supplement uses for Kratom and that any safety and addiction concerns are misplaced. This approach is different than how we dealt with the DEA. The gamechanger will come down to use of language, so let’s be vigilant with our efforts and make it count!