What Happens Next?

Due to the volume of questions we anticipate, we had this prepared by our law firm:

The DEA docket for comments closed on December 1st at 11:59pm. The docket will continue to be updated with the comments that were filed before the docket was closed, so we should expect to see additional comments added. Note, it is likely that the number of total comments submitted is not likely to be the same as the number of comments actually posted. Comments that are duplicative, contain personal privacy information or proprietary information or inappropriate language are typically not posted.

As noted in the DEA’s Federal Register notice, DEA has 2 main questions before it: Should kratom be scheduled? If so, under what process: the permanent scheduling process or the emergency scheduling process, concurrent with or followed by the permanent scheduling process. To reach a conclusion on those questions, DEA will do the following:

DEA will review all comments in the docket, review the HHS (Health and Human Services) 8 Factor analysis and scheduling recommendation, once it receives the document, and depending on the recommendation in the HHS 8 factor analysis, do it’s own analysis.

· The HHS 8 factor analysis will be completed by FDA in consultation with NIDA for review and transmission to DEA from the HHS Assistant Secretary for Health

· The Controlled Substances Act provides that if HHS recommends that a substance not be scheduled, DEA cannot control the substance.

· If HHS recommends that kratom be controlled, DEA will do it’s own analysis of the 8 factors and determine if there is substantial evidence supporting scheduling.

If DEA concludes that kratom should be scheduled, it will have to also decide what process it will follow:

· If DEA determines that it meets the criteria for emergency scheduling, it will post a new notice of emergency scheduling, announcing control of kratom in schedule I in 30 days

· If DEA determines that kratom should be controlled through the process for permanent scheduling, it will draft and publish in the Federal Register a proposal for the control of kratom in a particular schedule (I-V). That proposal will address the evidence supporting the need for control and will provide for a comment period and an opportunity to request a hearing. After the comment period closes, DEA will evaluate the comments and determine whether to grant any hearing requests. If a hearing is granted, the process for a hearing before a DEA administrative law judge will proceed – this is typically a lengthy process. If a hearing is not granted and DEA concludes that nothing in the comments has altered its proposal to control kratom, it will draft and publish a final order scheduling kratom. The order will likely provide for a 30 day period after it is published for the scheduling order to be effective.

The timing of any decision is difficult to predict at this point. Some factors that will influence the timing of any decision:

· When DEA gets the HHS recommendation and what it says (as noted above, if HHS recommends no scheduling, DEA cannot schedule the substance)

· The time it takes DEA to review all the comments. DEA has to decide what resources to put to this process – is it one person or a team of people?

· The transition to the new administration. In general, federal government agencies have been asked to delay significant regulatory actions until the new administration is in place and able to review. That being said, my sense is that some agencies are not heeding that request for certain decisions. Given the difficulty of this decision and the volume of comments, it seems that DEA will not be able to get its work done before the next administration is in place, even if it wanted to. How quickly DEA will work on this decision after the inauguration is also difficult to predict and will depend on the leadership at DOJ and DEA and the priorities for the agency.

Next thing to look for:

· The news that HHS has forwarded its analysis and recommendation. HHS is not always willing to publicly acknowledge that it has sent a recommendation to DEA. HHS and FDA typically decline to comment on whether they have finished their work and transmitted it to DEA. However, DEA has publicly acknowledged receipt of the HHS – particularly when pressed on the matter from members of Congress.

Note – Even if HHS recommends no control and DEA is barred from controlling kratom or DEA decides on its own not to schedule kratom, such a decision doesn’t close the door forever on scheduling – HHS/FDA/DEA can gather additional data and start the process all over. Or an interested party could submit a petition to DEA requesting scheduling and trigger a new review. This would be something to look out for down the road as additional data and experience on the use of kratom are developed.

Showing 13 reactions

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  • commented 2017-04-12 12:17:06 -0400
    This herbal supplements has given me my quality of life back. After 6 failed neck and back surgical procedures to treat my neck and spine. I was heading to be wheelchair bound for life. This is a miracle herb for me. I also have a very long list of other medical diagnosis. Which, everyone has improved with this herb.
  • followed this page 2017-04-12 12:12:12 -0400
  • followed this page 2017-03-29 17:41:02 -0400
  • followed this page 2017-03-28 02:20:26 -0400
  • commented 2017-02-22 13:30:02 -0500
    Kratom has helped me in so many ways it shouldnt be banned i have cancer and its helped wit so much and my withdrawal from the pain meds the doc had me on so please dont ban it or take it away its a plant that is natural wouldnt this world want us living off the earth properties then paying thousands of dollars on meds and rehab and everything else no we dont this earth is filled wit things that can help us dont take that away from us
  • followed this page 2017-02-01 00:23:22 -0500
  • commented 2017-01-19 20:31:45 -0500
    Thank you SO much for fighting for all of us who are trying to keep this lifesaving plant legal! It means the world. You did an awesome job on the show " the doctors", but I wish they would have dedicated a whole hour to this very topic! Maybe someday!!! Thank you for all you do!!! Keep it up 👍🏼
  • commented 2017-01-06 02:52:09 -0500
    I have a chronic pain condition and I live in Alabama, where kratom and marijuana are illegal and the CDC and the FDA have scared doctors away from prescribing any kind of opioid medication. I have nowhere to turn for any kind of relief. People are turning to street drugs which are dangerous and unreliable, and it breaks my ♥ to say that people are killing themselves because a life of pain isn’t a life at all. You live your everyday life in pain which causes depression, anger issues, the inability to hold a job or lead any kind of a normal life. Every relationship suffers because your in to much pain or your to exhausted to do normal every day activities like going to visit your parents or meeting up with friends. I want a small government, one that can protect it’s people and help the less fortunate but I want them OUT OF MY DICTORS OFFICE!!! I believe my doctor knows better than our government what is best for me. And making plants like marijuana and kratom illegal is negligent, they are harmless and help people in pain. The only reason to make these plants illegal is because big pharma told them to. We are not a free people anymore, the government is to big and has it’s fingers in way to many aspects of our lives. This must stop.
  • followed this page 2016-12-23 05:27:15 -0500
  • commented 2016-12-21 21:20:10 -0500
    Dear President Trump, we are about the same age. Do not fall for making this illegal to me. Not only is it none of anyone’s business what I do to myself to get by, but I’d hate to see you used by the Drug Rehab Industry to maximize their already obscenely inflated profit margins. This tree leaf got me off the horrible industrial-strength opiates some 10 years back, and now regulates my days into something manageable, as my shoulder is permanently destroyed beyond any hope of having a peaceful, pain-free existence. Just tell these busy-body so-called healer bureaucrats to go to hell, where they belong. This is how the Art of Healing has been turned into a poorly run Industry. Hey doctors! It is your industry! Fix it!
  • commented 2016-12-13 23:31:53 -0500
    DEA knows the right decision is to leave the harmless plant alone. Obviously they can not do such a thing. They need their raises every year. They need extra funding every year. Guess what, marijuana is getting legalized across the country. Know what that means? You guessed it – less money to fight the cause. Now their probably looking to make water a schedule one drug. So they can get extra funding to fight off ocean waves from our beaches. What I say doesn’t matter, but I will say it anyways. The DEA is a joke. Our prisons and jails are FULL of productive members of society. All because they had their personal use drugs on them? Now I believe getting a dealer or an operation is one thing. Getting a user and incarcerating them and ruining their record is another. Getting users is a failure and a big one at that. once a user has his drugs you have failed. Your job is to stop people from getting drugs. Anything else is a waste of our tax dollars. Like making herbs like Kratom illegal.
  • commented 2016-12-12 11:50:06 -0500
    Thank you for keeping us updated, and for all that you are doing in this fight.
  • commented 2016-12-05 13:49:47 -0500
    Thank you for the post!

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