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.