February 8, 2018
Kellyanne Conway
Counselor to the President
The White House
1600 Pennsylvania Avenue, NW
Washington, DC 20500
Robert W. Patterson
Acting Administrator
Drug Enforcement Administration
Lincoln Place-West
700 Army Navy Drive
Arlington, VA 22202
Dear Ms. Conway and Mr. Patterson:
It is our understanding that the Drug Enforcement Administration (DEA) has received a
recommendation from the US Food and Drug Administration (FDA) to place mitragynine and 7-
hydroxymitagynine, compounds found in the plant known as kratom, into Schedule I of the
Controlled Substances Act (CSA). We believe strongly that the current body of credible research
on the actual effects of kratom demonstrates that it is not dangerously addictive, nor is it
similar to “narcotics like opioids” with respect to “addiction” and “death” as stated by the FDA
in its November 14th Kratom Advisory. Equally important, four surveys indicate that kratom is
presently serving as a lifeline away from strong, often dangerous opioids for many of the
several million Americans who use kratom. A ban on kratom that would be imposed by CSA
Scheduling would put them at risk of relapse to opioid use with the potential consequence of
overdose death. Similar unintended consequences are to be expected in some who would be
forced to use opioids to manage acute or chronic pain.
In the report issued on November 1, 2017 by the President’s Commission on Combating Drug
Addiction and the Opioid Crisis, where the Commission strongly supported research and
development of alternatives to opioids for pain management, the powerful conclusion offered
was that “[F]irst, individuals with acute or chronic pain must have access to non-opioid pain
management options.”1 The available science is clear that kratom, although having effects on
opioid receptors in the brain, is distinct from classical opioids (e.g. morphine, heroin,
oxycodone, etc.) in its chemistry, biological effects, and origin (kratom is a tree in the coffee
family, not the opium poppy family). Importantly, as commonly used in raw plant form, it does
not appear to produce the highly addictive euphoria or lethal respiratory depressing effects of
classical opioids.
It is our collective judgment that placing kratom into Schedule I will potentially increase the
number of deaths of Americans caused by opioids because many people who have found
kratom to be their lifeline away from strong opioids will be vulnerable to resumption of that
opioid use, whether their prior opioid use was for relief of pain or due to opioid addiction. This
opinion is supported by four national surveys conducted in the past two years, as well as
decades of studies in the US and in Southeast Asia, where kratom has been used as a safer
alternative to opioids for more than a century. Failure to evaluate this potential outcome of
1 The President’s Commission on Combating Drug Addiction and the Opioid Crisis, November 1, 2017, page 8.
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any proposed scheduling of kratom would directly contradict the expressed purpose of the
enactment of the CSA by the U.S. Congress, to protect the safety of consumers. Perversely, it is
foreseeable that such an action may lead to the deaths of people and worsen the opioid crisis,
not mitigate it.
In fact, publicly available research documents that kratom has a long history of acceptably safe
consumer use, and, when used as an alternative pain management therapy, kratom provides a
far more favorable safety profile for consumers compared to more dangerously addictive and
potentially deadly classical opioid medications. Current scientific research suggests that kratom
provides some pain relief activity on the pain centers in the brain without the dangerous and
potentially deadly respiratory suppression induced by classical opioid medications. The federal
government should be encouraging additional research into the potential benefits of kratom, as
well as the possibility that extracts of kratom and/or new medicines that are similar to kratom’s
active ingredients might serve as breakthroughs in pain relieving medicines that are so
desperately needed. However, this latter path will not be a rapid one, since the average time
and cost of new drug development is more than 10 years and 2.5 billion dollars. Placing kratom
into Schedule I of the CSA will also have a profound and pervasive chilling effect on this needed
additional research.
Finally, it is our strongly held belief that the claims that kratom has caused the deaths of all or
even most of the 36 individuals cited by the FDA in a November 14, 2017 Public Health Advisory
on kratom cannot be supported by any reasonable scientific or medical standard. Unlike
overdose deaths that are rightly attributed to classical opioids, which reliably cause respiratory
depression and death at high doses, the fatalities that the FDA lists as having been associated
with kratom include deaths with a wide variety of apparent causes in people suffering from
various diseases and/or taking other substances that also likely contributed to their deaths. For
example, it includes 9 fatalities in Sweden that resulted from an adulterated product that
included the active substance of the prescription opioid tramadol (leading Swedish authorities
to conclude that those deaths were caused by O-desmethyltramadol, not kratom). The
assertion that a scheduling recommendation can be based on a claim of deaths “associated
with kratom” rather than deaths “caused by kratom” is not, in our judgment, either
scientifically valid nor the standard that was contemplated by the U.S. Congress for the
scheduling of any substance under the CSA. Applying such a broad standard for scheduling
substances would appear to be a significant overreach of the regulatory powers of the FDA and
DEA beyond the currently established, rigorous, and clearly limited eight factors set forth in the
CSA for scheduling of any substance.
The practical application of such a broad standard for scheduling would erode the foundational
premise for the CSA that currently requires rigorous scientific standards to be applied to any
analysis of a substance proposed for scheduling, and would open a Pandora’s box of politically
motivated scheduling decisions driven by arbitrary philosophical or partisan viewpoints without
regard to any reliable scientific standards. We believe that any such public policy constitutes a
clear abuse of the regulatory powers entrusted to the FDA and DEA under the CSA. Similarly,
any actions taken by local or state governments to schedule or ban kratom at this time are
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likewise misguided and could result in many people who use kratom for health and well-being
to turn to opioids and potentially adulterated kratom products from the illicit market that
would quickly replace the lawful market.
Rather than foster an illicit and dangerous kratom market, the FDA could protect the American
public by appropriate regulation of kratom, as the FDA’s Office of Dietary Supplements has
been working toward. This could provide consumers and health professionals with the
information to help guide safe use, and ensure that lawfully marketed products meet the same
standards as other natural and dietary products relied upon by American consumers. The
attached summary of regulatory principles from the American Kratom Association is an
example of some of the regulatory actions that the FDA could take that would address concerns
of the FDA and others, and serve to protect kratom consumers and public health.
We affirm our belief that the existing science on kratom does not justify its placement into
Schedule I of the CSA, nor for kratom to be added to any local or state Controlled Substances
list that would effectively remove it from consumer access. For reference, we have attached
five recent peer-reviewed, published scientific articles addressing the addiction and safety
profile for use of kratom by consumers supporting our position expressed herein. One of them
is a major survey relevant to understanding the benefits and low risks of kratom use in America,
as well as the risks of banning kratom (Grundmann, 2017). Another is an example of the sort of
8-factor analysis that is generally used by the FDA for Controlled Substances regulatory decision
making (Henningfield et al. 2017). It relies on laboratory, clinical, and epidemiological studies
including four national surveys of kratom use and other federal survey data and not the
unvalidated computer model referenced by the FDA in its February 6th Advisory. These studies
and other independent peer reviewed evaluations published in scientific and medical journals
provide the profile of a substance that is largely used safely to the benefit of several million
Americans (e.g., Kruegel and Grundmann, 2017; Swogger and Walsh, 2018).
We encourage you to support efforts to ensure continued lawful access to kratom, guide
balanced regulation by the FDA, and facilitate research, thereby protecting and not harming
public health.
Respectfully submitted,
Jack E. Henningfield, Ph.D.
Vice-President, Research, Health Policy, and Abuse
Liability
Pinney Associates, Bethesda, Maryland, and
The Johns Hopkins University School of Medicine
Baltimore, Maryland
Marc T. Swogger, Ph.D.
Department of Psychiatry
University of Rochester Medical Center
Rochester, New York
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Zach Walsh, Ph.D.Science Letter on Kratom
Department of Psychology
University of British Columbia
Kelowna, BC Canada
Oliver Grundmann, Ph.D.
College of Pharmacy
Department of Medicinal Chemistry
University of Florida
Gainesville, Florida
Robert B. Raffa, Ph.D.
Professor of Pharmacology
Temple University School of Pharmacy
Research Professor
Temple University School of Medicine
Philadelphia, Pennsylvania
Paula Brown, Ph.D.
Director of Applied Research
Natural Health & Food Products
British Columbia Institute of Technology
Vancouver, British Columbia
Andrew C. Kruegel, Ph.D.
Department of Chemistry
Columbia University
New York, New York
Albert Garcia-Romeu, Ph.D.
Psychiatry and Behavioral Sciences
Johns Hopkins University School of Medicine
Baltimore, Maryland
Roland R. Griffiths, Ph.D.
Professor of Behavioral Biology
Professor of Neuroscience
Johns Hopkins University
Baltimore, Maryland
