FOUR LEADING KRATOM RESEARCHERS URGE FDA TO FOCUS ON SCIENCE RATHER THAN RHETORIC
Top Experts Reject FDA Statements that Compounds in Natural Botanical Are Dangerously Addictive, Similar to “Narcotics Like Opioids” or Pose Claimed Death Risk
WASHINGTON, D.C. – March 7, 2018 – Four of the world’s leading kratom researchers today called on the U.S. Food and Drug Administration (FDA) to cease the agency’s scientifically unsupported attacks on the coffee-like herb kratom. The scientists strongly believe 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 public advisories and subsequent warnings. It is the scientists’ position that a ban on kratom could result in a “serious public health threat” as consumers are pushed to dangerous alternatives in the black market, while at the same time halting much needed scientific research on the risks and benefits of kratom and its alkaloids.
The four kratom experts organized today’s news conference and were not paid to participate in it. The scientists are: Marc T. Swogger, Ph.D., associate professor of psychiatry, University of Rochester Medical Center; Oliver Grundmann, Ph.D., clinical associate professor, College of Pharmacy, University of Florida; Paula N. Brown, Ph.D., director of applied research, BC Institute of Technology, Canada Research chair, Phytoanalytics and adjunct professor of biology, University of British Columbia; and Dr. Jack Henningfield, vice president of research, Health Policy and Abuse Liability, at PinneyAssociates, and adjunct professor of Behavioral Biology, Johns Hopkins University School of Medicine.
Instead of a de facto ban on kratom, the scientists urged the promotion of good manufacturing practices (GMP) complying to FDA standards, as is the case with other widely available supplements in the United States.
The following are the statements of the four experts:
Science suggests removing kratom from the market would be a risk, not benefit, to public health – Marc T. Swogger, Ph.D., associate professor of psychiatry, University of Rochester Medical Center
Risks associated with scheduling and loss of access
Contrary to the President’s Commission on Combating Drug Addiction and the Opioid Crisis
“We have science-based objections to the scheduling of kratom under the Controlled Substances Act.
The existing science indicates that many of the millions of people in the U.S. who use kratom rely on it as a lifeline away from potentially deadly opioids. People use kratom to ease opioid withdrawal and to manage acute and chronic pain. Scheduling kratom would remove a valuable pain treatment option for millions, leading to greater opioid use with the likely consequences of increasing dangerous opioid dependence and overdose deaths.”
“Our objection to the scheduling of kratom is supported by data from four national scientific surveys conducted in the past two years, as well as decades of information from Southeast Asia, where this plant has been widely used as a safer alternative to opioids for more than a century. We cannot say that kratom is harmless for everyone, nor can we say that we know everything there is to know about the plant; rigorous, well-controlled studies are necessary. At this juncture, however, there is no high-quality evidence to indicate that kratom is a serious public health threat, and much evidence to suggest that banning it would be.”
“If the government fails to seriously consider the unintended consequences of banning kratom, they will be abdicating their duty to protect the safety of consumers – the expressed purpose of the enactment of the CSA by the U.S. Congress. Neglecting the available science and scheduling kratom are exactly what one would do if their aim was to worsen the opioid crisis.”
The FDA has pointed to 44 deaths over the last decade in the U.S. as their basis for concern, while the actual role of kratom in these deaths is speculative – Oliver Grundmann, Ph.D., clinical associate professor, College of Pharmacy, University of Florida
- Speculative; lack of causality for deaths involving kratom
- Differentiation of mode of action for kratom alkaloids from opioids; do not cause respiratory depression upon binding the same opioid receptors
“It is our strongly held belief that the claims that kratom has caused the deaths of all or even most of the 44 individuals cited by the FDA 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, thus allowing for no conclusive determination of the causative agent(s) responsible for deaths.”
“The FDA used a computer simulation, the PHASE model, to justify classifying Kratom and its major alkaloids, mitragynine and 7-OH mitragynine as opioids. Using a computational model alone is not sound science and fails to consider the additional scientific literature that has reported a distinct difference in how the alkaloids in kratom interact with the same opioid receptors in the brain. In isolated receptors and animals alike, the alkaloids presented with different effects from that of classical opioids like morphine or heroin, primarily not presenting with potentially fatal respiratory depression at higher doses.”
Publicly available research documents illustrate kratom has a long history of acceptably safe consumer use – Paula N. Brown, Ph.D., director of applied research, BC Institute of Technology, Canada Research chair, Phytoanalytics and adjunct professor of biology, University of British Columbia
Import advisory of February 2014 by FDA identifies kratom as a dietary ingredient
History of safety for traditional use and modern use for pain relief
Regulation as a dietary ingredient means compliance with Good Manufacturing Practices
“The FDA issued an import alert in February 2016 that stated, ‘Kratom is a botanical that qualifies as a dietary ingredient under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(ff)(1)].’ When marketed as a dietary ingredient, FDA also considers kratom to be a new dietary ingredient under section 413(d) of the Act [21 U.S.C. 350b(d)] because, to the best of the agency's knowledge, there is no information demonstrating that this substance was marketed as a dietary ingredient in the United States before October 15, 1994.”
“So while we can argue whether FDA’s consideration of kratom as a New Dietary Ingredient is substantiated or not, the focus should be on compliance with Good Manufacturing Practices (GMP) to ensure the public has access to products that are not adulterated with opioids (e.g., fentanyl, carfentanil, and other morphine-derived products), spiked with concentrated amounts of mitragynine and 7-OH mitragynine that are not consistent with levels in historical products and are tested for microbial to meet purity specifications. We agree that these concerns should be eliminated with a single kratom-based product regulatory standard that would protect both kratom manufacturers and consumers.”
“Documented literature demonstrates widespread use of kratom leaves for centuries; traditionally used as an energizer, relaxant, and to relieve stress and/or minor aches and pain (Suwanlert 1975; Watanebe et al., 1997; Vicknasingam et al., 2010, Adkins, 2011; Stolt et al., 2014; Brown et al. 2017). Kratom has also been increasingly used as a natural remedy to improve mood and quality of life and as substitutes for prescription and illicit opioids for managing pain, as shown in the recent four published surveys. The current scientific research suggests that kratom provides some pain relief without the dangerous and potentially deadly respiratory suppression induced by classical opioid medications. Risk assessments must rely on laboratory, clinical, and epidemiological evidence including the four national surveys of kratom use and other federal survey data and not the non-validated computer model referenced by the FDA in its February 6th Advisory.”
“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 federal government should be encouraging additional research into the potential therapeutic benefits of kratom while ensuring that the products available are not adulterated – Dr.Jack Henningfield, vice president of research, Health Policy, and Abuse Liability, at PinneyAssociates, and adjunct professor of Behavioral Biology, Johns Hopkins University School of Medicine
Scheduling would stymie research
The possibility of a breakthrough in pain and addiction treatment
Need alternate regulatory pathways – drug model too costly for non-patentable plant
“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.’ 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).”
“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, should not be ignored. 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.”
“The assertion that scheduling recommendations can be based on claims of deaths ‘associated with kratom’ rather than deaths ‘caused by Kratom’ is not, in our judgement, either scientifically valid nor the standard that was contemplated by the U.S. Congress for scheduling of any substances, and 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 by CSA for scheduling a substance.”
“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.”
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EDITOR’S NOTE: Limited and unrestricted support for this news event is being provided by the nonprofit People Plants Health.