FDA has always been the elephant in the kratom room

Learn about the elephant and provide your views to your colleagues in the kratom community.





Kratom Roundtable

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.

Related Comments

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:


Publisher’s Note: The Guardian reports:

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 “We’ve never withdrawn a notice to temporarily schedule any substance but we want to move through this process in a transparent manner.”

CRE most certainly served as a catalyst in its initial communication with the DEA, however it was the DEA—not CRE—that gave all the affected individuals the relief they sought. Kudos to the DEA.

Kudos also to our many readers who made nearly one thousand informative comments which were reviewed by Administration officials as authenticated by our traffic counts on this website.

Medscape: DEA Delays Kratom

The US Drug Enforcement Administration (DEA) has not taken action to make the herbal supplement kratom as schedule I drug, despite previously announcing its intention to do so by September 30.

The delay comes as some members of Congress, as well as kratom users and researchers, have grown increasingly vociferous over the notion that the DEA would make kratom a schedule I substance, in the same class as heroin and marijuana, without allowing any public input.

Read article.

Reason Magazine: “Confused? You’re are not alone”

Editor’s Note: In part the confusion is a result of the fact that DEA has not released a copy of its letter to HHS as so requested by CRE within days of DEA’s Notice of Intent to ban kratom. [There must be some reader interest in this topic in that CRE received nearly 1,000 comments on the post.]

After the Drug Enforcement Administration (DEA) announced an “emergency” ban on kratom at the end of August, a spokesman for the agency said “our goal is to make sure this is available.” The spokesman, Melvin Patterson, also told The Washington Post kratom does not belong in Schedule I of the Controlled Substances Act, the law’s most restrictive category, even though that is where the DEA had just put it.

Forbes: “It appears the DEA will instead open up a modified comment process before a final decision will be made”

Forbes made the above quote based upon a conversation that Congressman Pocan had with Administrator Rosenberg.

In another interview, a DEA spokesman stated it is not a question as to if kratom is banned, but only when.

It is important that the “modified comment process” take place before any  action on a ban is announced, however tentative.   To this end those  commenting  should give consideration to regulating kratom as dietary supplement, see

cre-position-statement-on-kratom and


One of the Many Informed Reactions to the CRE Proposal to Regulate Kratom as a Dietary Supplement

Editor’s Note:  We appreciate all the emails our  readers have sent us through the “contact” link on the CRE website. But please note that to ensure the privacy of the sender our software eliminates all email addresses which make it impossible for us to respond.

CRE appreciates the many positive responses to its proposal to regulate kratom as dietary supplement; see cre-position-statement-on-kratom. CRE’s position is similar to the program in place in Canada where kratom is classified as a natural health product.

Please see an excellent response which follows. Also see the 9/28 post in the Of Note Blog in the preceding post which solicits public comment on the CRE proposal.

Of Note!

 Week of September 25


9/28   Comment on cre-position-statement-on-kratom

CRE has conducted an in-depth review of the kratom issue and has read and benefited from the numerous comments posted on this website. Based on the said information, CRE has developed a proposal for addressing the issue.

We welcome public comments prior to arriving at a final position. Please note that the CRE position is contingent on the DEA not taking any additional action on its intent to ban kratom.

The Ultimate Scientific Verdict on Kratom: WebMD?

Publisher’s Note: One implication of this article is that kratom should be regulated as a dietary supplement. The resultant regulation would address labeling, adulteration, health claims and related issues of product integrity. If this end is pursued, the kratom industry should examine the use of voluntary-consenus-standards-kratom.

What Is Kratom? Why Does the DEA Want to Ban It?
By Jennifer Clopton
WebMD Health News
Sept. 19, 2016 — Advocates say the herb kratom offers relief from pain, depression, and anxiety. Scientists say it may hold the key to treating chronic pain and may even be a tool to combat addiction to opioid medications.

But the Drug Enforcement Administration (DEA) is moving to ban its sale as of Sept. 30, citing an “imminent hazard to public safety.” The DEA last month announced it would make kratom a Schedule 1 drug — the same as heroin, LSD, marijuana, and ecstasy.

Quebec Chapter of the Hell’s Angels Motorcycle Club is Poised to Dominate the Post-Prohibition Kratom Black Market

The face of organized crime is changing and becoming vastly more dangerous as it merges with terrorist organizations and extends its economic tentacles. Professor Louise Shelley of George Mason University described the evolving nature of crime, “At the end of the 20th century, a new phenomenon appeared—the simultaneous globalization of crime, terror, and corruption, an “unholy trinity” that manifests itself all over the world.  . . . it is a distinct phenomenon in which globalized crime networks work with terrorists and both are able to carry out their activities successfully, aided by endemic corruption.”[1]