How to comment on the federal register

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

(4) Its history and current pattern of abuse.

(5) The scope, duration, and significance of abuse.

(6) What, if any, risk there is to the public health.

Now it will consider the following factors:

(1) Its actual or relative potential for abuse.

(2) Scientific evidence of its pharmacological effect, if known.

(3) The state of current scientific knowledge regarding the drug or other substance.

(7) Its psychic or physiological dependence liability.

(8) Whether the substance is an immediate precursor of a substance already controlled under this subchapter.

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

A) The only intended use of Kratom is as a drug

B) It has a high potential foe addiction because individuals cannot appear to live without it

C) 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 To Do
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!

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