N. B. One Half Century of Centralized Regulatory Review.
October 2016
In that CRE is no longer working on the kratom issue please note that CRE will no longer be making posts on this website but is keeping it live for use by the kratom community.
Comments of Americans for Safe Access on the impact of CRE’s intervention in the DEA regulatory proceeding for Kratom.
See nearly 1,000 comments sent to CRE from the public.
Please note that CRE is making the following recommendation to the Kratom community if it is to head off a product ban by the federal government:
More specifically, the kratom community should present a Petition for Rulemaking to the FDA which would request that kratom be regulated as a dietary supplement. The resultant regulation would be subject to notice and comment and would address a range of topics, including dosage, adulteration, health claims, misuse, labeling and misbranding.
The kratom community must either make an explicit decision as to whether they will submit to federal regulation of dosage and purity or in the alternative take no position and hope for the best from federal regulators.
For additional details and support for the aforementioned proposal from some elements of the kratom community, see this post. CRE has laid the foundation for the professional associations dealing with kratom to carry the ball forward. The aforementioned petition should be filed immediately in order to exploit the current momentum behind kratom. In so doing, legal and scientific analyses are important but they must be first preceded by the development of a sound regulatory strategy.
In any event the moving party acting on behalf of the kratom community should have a proven track record comparable to that of CRE; meaning that a distinction must be made between activity and accomplishment—simply preparing scientific papers without any accomplishments directly related to their preparation is an irrelevant action.
======== Termination of CRE Postings on Kratom (Oct. 2016) ========
Editor’s Note: Comments by our readers which are posted on this Roundtable will be routinely read by regulators, the press and Congressional staff based upon prior CRE sponsorship of roundtables on public policy issues.
Comments are accepted here.
Nov. 18 Will a strategy devoid of regulation prevail?
With exactly two weeks to go before the December 1st end to the U.S. Drug Enforcement Administration Agency (DEA) comment period on kratom, the American Kratom Association (AKA) is seeking today to rally the kratom community to double the number of comments on file from the current level of about 5400 to at least 10,000.
See post
Nov. 15 Controversy erupts over ban of hot new drug
A pending federal ban on an ancient Asian herb called kratom is
drawing pushback from some researchers and alternative-medicine advocates.
The federal Drug Enforcement Agency’s proposed restrictions on
kratom’s painkilling properties could take effect after a 30-day notice period
ends Friday. DEA spokesman Russ Baer couldn’t give the exact
date that possession, manufacture and distribution of kratom is likely to
become illegal.
See post
Nov. 5 The DEA looks to crack down on Kratom
The bottom line said Winegar, “We just don’t know enough about Kratom and it’s risky to take.”
See post.
Nov. 2 Kratom: Health Risk or Harm Reduction
“Or they might decide it should be regulated like alcohol, a substance with its own risks and benefits. Says Martins, “There is room for middle ground.”
Nov. 1 AKA and BEA New Website
Kratomcomments.org Generates 1300 Comments In Boosting Public Feedback To DEA On Coffee-like Herb Kratom See post.
Oct. 27 Kratom: Country Wide Recognition
See USA Today on kratom.
Oct. 24 The Power of a Recorded Comment
CRE is often asked why we place an emphasis on recorded comments–particularly those which are expressed in complete sentences and have in excess of one hundred forty characters. Here is one example of their effectiveness.
Recently CRE was asked by a regulator why CRE would become involved in such an esoteric issue such as kratom when CRE generally deals with macro issues such as the governance of the regulatory state.
We referred the regulator to this comment we received which was rated by our readers as one of the best posted on our website
Oct. 22 Dosage and Purity
Reader Comment (Oct. 21 below)
“The exception to this, would be so called “gas station kratom” and “energy shots” containing mitragynine. The vast majority of kratom consumers dislike these products and these points of sales and support regulating that aspect of the marketplace.”
CRE Response
Gas station kratom and select energy shots are a substantial part of the problem. In both cases the product could be contaminated; in addition there is no indication of a safe dosage.
The kratom community must either make an explicit decision as to whether they will submit to federal regulation of dosage and purity or in the alternative take no position and hope for the best from federal regulators.
With the December 1 deadline looming our readers are encouraged to express their opinion here.
Oct. 20 This article deserves a hard look.
The kratom community should give a hard look at the New York Times article: Regulate Quality, Dosage and Purity of Kratom. We appreciate the difficulty in reaching consensus on a contentious issue which affects a wide and diverse group. Nonetheless the clock is clicking on the public comment period and honeymoons only last so long.
Oct. 19 Three Articles in New York Times on Kratom
Regulate Quality, Dosage and Purity of Kratom
Benefits of Kratom Are More Legitimate Than the Fears
Is Kratom the Plant That Heals, or Kills?
Oct. 19 Public Participation At Its Best
The academic landscape is filled with studies on how to improve public participation in the regulatory process, in particular the treatises on e-rulemaking.
Some of the studies involve case studies on what motivates individuals to participate in the opaque and somewhat esoteric regulatory process. However few, if any, of the studies provide any data on whether the said procedures actually change anything.
The kratom Interactive Public Docket sets the gold standard.
Oct. 18 Comment
Reader Comment
It is difficult to be enthusiastic about the DEA punting this to the FDA, as the FDA has appeared to have kratom in its crosshairs for several years.
CRE Response
Please note that the FDA does not have unfettered discrestion in its conclusions because it must comply with the Data Quality Act. See the following statement from our Oct. 17 response.
It should be noted that the findings of both agencies (DEA and FDA) must comply with the Data Quality Act. Additional information on the Data Quality Act is here.
Oct. 18 Scientific American on Kratom.
The withdrawal of an emergency substance restriction is something the DEA “has never been done before. It’s an unprecedented action,” Baer says. “[While] the DEA still believes kratom is a dangerous, harmful substance,” he says the agency wants to send the message that it is listening to citizens: “We don’t want the public to believe we are simply a group of government bureaucrats who don’t care about their safety and health.”
Oct. 17 Comment
Reader Comment:
Regarding the October 14th entry, why is the DEA pretending to withdraw the Notice of intent, but still intending to ultimately ban this tree? They are referring to the FDA/HHS now for nails in the coffin, and we all know they’ve been wanting to rid us of this tree for many years.
CRE Response:
We have no information that would suggest the DEA is not extremely committed to an unbiased review of the issue. It should be noted that the findings of both agencies (DEA and FDA) must comply with the Data Quality Act. Additional information on the Data Quality Act is here.
October 17 Comment
Reader Comment
“Is it true that the DEA in its ego trip of authority can change with the rest of us.”
CRE Response
DEA is run by a cadre of dedicated civil servants vested with an awesome responsibility. The bottom line is that DEA changed its course–that is what is important.
October 14 Comment
CRE appreciates all of your comments. CRE most certainly opened the door for a scientific debate but the real credit goes to DEA, an agency not wed to the past. The Guardian, an international publication, agrees with our assessment.
The kratom community should respond, during the public comment period, with an equally responsible action by delineating an acceptable regulatory regime.
From the Guardian:
“This is an unprecedented action. It’s never happened before,” said agency spokesman Russ Bayer. “We’ve never withdrawn a notice to temporarily schedule any substance but we want to move through this process in a transparent manner.”
The DEA seems to admit that an emergency scheduling was not necessary after all. This is important. In future discussions, I hope we all will continue to hear each other clearly. I think we all want responsible use of kratom, whereby nobody becomes “addicted”. Maybe age restrictions will work with kratom. But, we have seen cases where age restrictions do not work well, aka alcohol. Age restrictions do not necessarily keep teens from drinking, unfortunately. Yet, we use age restrictions anyway. To me setting the legal age for kratom use to 18 would be excellent.
It is difficult to be enthusiastic about the DEA punting this to the FDA, as the FDA has appeared to have kratom in its crosshairs for several years. What is encouraging is that the grim descriptions of kratom that FDA continually cites in its import bans are the very same data DEA cited in their Aug. 30 emergency schedulihg announcement. Such data has been largely debunked as inaccurate, invalid, or otherwise compromised. to the point of now being toothless.
It’s time to get the politics and ideologies and bureaucratic chest-thumping out of the process and allow real scientists to do their work. This is a rare opportunity for the DEA and FDA to show they are willing to listen to science., and not twist or spin fearful data to support conclusions they’ve already made. Such bureaucratic restraint is rare, but could usher in a new era where these two agencies start to shift public perception of them as brownshirts and Big Pharma shills to agencies that indeed try to protect the public they serve.
Protecting the public in this instance does not include scheduling a harmless supplement — thereby effectively stripping its availability from millions of Americans who use it responsibly — but offering ways to monitor it through the supply chain and ensure it arrives at consumers safely.
Thank you for the reminder that this unprecedented move by DEA to withdraw emergency scheduling is a huge positive. There is reason to have hope, but there is also reason to be cautious. Regarding the NYT’s article “Regulate Quality, Dosage, and Purity of Kratom,” I don’t understand why kratom is any more likely to be contaminated than any other supplement or product. It seems that anything has the potential to be adulterated or contaminated. I remember reading about poisoned Tylenol years ago, which killed several people. Perhaps I am misunderstanding this particular point. Thank you so much, CRE, for the continued support and wealth of information.
As I posted on the NYT’s article “Regulate Quality, Dosage, and Purity of Kratom,” comments section: “It is extremely important to acknowledge that these “loose regulatory parameters established by the Dietary Supplement Health and Education Act of 1994” apply to ALL dietary supplements, therefore they all share this “caveat emptor”. Historically consumer advocate groups have taken the initiative having dietary supplements individually tested and rated. Please note that the kratom community has been doing just that for decades. The exception to this, would be so called “gas station kratom” and “energy shots” containing mitragynine. The vast majority of kratom consumers dislike these products and these points of sales and support regulating that aspect of the marketplace.”
hi friends