AKA Files Formal Demand For FDA To "Rescind" False Advisory About Kratom

Wednesday, November 15, 2017 General News
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Association Says Misleading and Unsubstantiated FDA Advisory on Coffee-Like Herb Kratom Should be Corrected; Agency Ignored Extensive Evidence Kratom Is Not a Cause of Death, Not an Opiate and Not Addictive; Potential for Worsening Opioid Epidemic Feared.

WASHINGTON, Nov. 15, 2017 /PRNewswire-USNewswire/ -- The Food and Drug Administration (FDA) advisory published this week

about the coffee-like herb kratom is based on "discredited, incomplete, and mischaracterized scientific claims" and should be rescinded, according to the American Kratom Association (AKA), which represents more than three million responsible adult consumers of kratom.   In response, AKA is initiating a formal dispute resolution (FDR) petition with the U.S. Department of Health and Human Services (HHS) challenging the weak scientific basis of the FDA advisory and seeking to have it overturned.  The AKA filing is available online at https://www.americankratom.org/.

AKA's statement reads in part: "For years, the FDA has published scientifically inaccurate information on the health effects of consuming kratom, directly influencing regulatory actions by the DEA, states, and various local government entities.  AKA believes the FDA health advisory on kratom will lead to more state and local bans, all based on discredited, incomplete, and mischaracterized scientific claims …"

AKA President and Board Chair Dave Herman said: "We care very much about the health and well-being of the kratom community and that is why we welcome a full-scale review and the eventual rescinding of the FDA's latest attack on kratom.  We know from surveys that kratom consumers are concerned about being forced to seek relief by using illegal opioids in the event that kratom is banned.  It would be an outrageous and unacceptable public health outcome if the effect of the FDA assault on kratom backfires and leads to more opioid addiction and death.  The very real possibility of this kind of unintended consequence happening in the wake of FDA-inspired restrictions on kratom should give any responsible legislator or regulator real pause."

According to the AKA, several points in the FDA advisory are at odds with the facts and these are facts that FDA staff have at their disposal and should have acknowledged. For example, contrary to the statement that kratom has "narcotic opioid like" abuse potential and other effects, kratom is primarily used for benefit by millions of Americans and not to get "high". In fact, kratom is a poor substitute for opioids for getting high.

FDA staff also know, as has been well documented, that kratom does not cause the lethal respiratory depressing effects that are a hallmark of narcotic-like opioids which is why more than 90 people die every day from narcotic like opioids. In stark contrast, among millions of users of kratom in America, probably dating back to the 1990s and earlier, there has not been a single documented actual kratom-caused overdose death.  The handful of possible kratom-associated deaths in the US involved people taking multiple drugs, with apparent causes of death varying widely, quite unlike what is seen with narcotic-like opioids.

In fact, a review of decades of data from South East Asia where kratom use is common, and of all data from the US, including four recent independent surveys involving thousands of kratom consumers, indicates that "kratom is more likely a path away from opioids than a path to opioids," said Jack Henningfield, Ph.D. He is one of the world's leading experts on addiction, and the behavioral, cognitive, and central nervous system effects of drugs, and lead author of an assessment of kratom abuse potential that was delivered to the Drug Enforcement Administration (DEA) and the FDA on November 29, 2016.

Dr. Henningfield's 2016 8-factor analysis of kratom's abuse potential included the following conclusions:

  • Placement of kratom on a restricted classification is not warranted from a public health perspective and is more likely to cause public health problems that do not presently exist.
  • Kratom consumption has not emerged as a public health or medical problem for adults or children despite more than two decades of rapidly increasing consumption by millions of Americans served by approximately 10,000 vendors.  Specifically, among the three-four publicly documented deaths that have ever been suspected to possibly have involved the consumption of kratom, none have been shown to merit designation as a kratom overdose death and all have involved either other substances or physical or mental health conditions that may have been the primary causes of, or significant contributors to, the death.
  • Kratom consumption appears to be primarily motivated by its perceived effects that enhance well-being, occupational performance, and social interactions, as well as serving as a natural "home remedy" that is preferred by millions of Americans to conventional medicines.
  • The foregoing is consistent with the pharmacology of kratom and more specifically its alkaloids (MG and 7-OH-MG), which produce mixed pharmacological effects that are generally mild and caffeine stimulant-like at lower dosages.  Consumption does not typically interfere with work or social activities and commitments, and in fact kratom is widely reported in the US, as in Southeast Asia, to contribute to work productivity, quality of life, and social relationships.
  • Although the primary alkaloids of kratom, MG and 7-OH-MG, may demonstrate some characteristics considered for controlled substance scheduling, as do many other products including caffeine, nicotine, some antihistamines, and alcohol, despite decades of wide-spread consumption, there does not appear to be a public health risk that would warrant their scheduling.
  • MG and kratom have very low toxicity, and thus a favorable safety profile.  There have been few reports of serious adverse events or deaths associated with kratom and for most, the contribution of kratom is not clear.  For example, in Sweden in about 2008-2009, a blend of herbals including kratom along with the opioid analgesic O-desmethyltramadol, and possibly co-administration of other drug substances was associated with nine deaths.  Tramadol (including O-desmethyltramadol), in contrast to kratom, has been documented to carry a risk of severe respiratory depression and overdose death.  To date, in the US, there have been no confirmed reports of death that can be considered "causatively" due to kratom overdose.
  • There appear to be remarkably low risk of serious adverse effects from kratom consumption as compared to opioids and other common drugs of abuse.  Further, there is little evidence that kratom products are used by routes other than oral beverage or food consumption.  In contrast, opioids and many other drugs of abuse are frequently used by high impact routes such as nasal insufflation, smoking, and injecting.  Graduation from oral consumption to such other routes is common for opioids and other substances of abuse but not for kratom.
  • Consumption of kratom products appears to provide positive benefits such as relief of pain and fatigue without the adverse consequences produced by other products that are used for similar purposes.  For example, liver disease caused deaths associated with the use of acetaminophen is a serious problem in the US, and there are problems of serious GI side effects and cardiovascular problems associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDS).  At the far extreme, there is the inherent risk of overdose and serious addiction associated with the use of opioids. For those who manage various ailments with kratom instead of such products, the benefit to risk ratio appears favorable.

The AKA statement notes that the FDA statements about kratom are also contradicted by scientific literature.  "The published research of prominent scientists at Columbia University, Johns Hopkins University, the University of Mississippi School of Pharmacy, University of Florida College of Pharmacy, and Rutgers Robert Woods Johnson Medical School stand in stark contrast to the poorly articulated FDA staff recommendations on the hazards of kratom use."

The AKA statement issued today also notes: "… AKA has commissioned a survey of kratom consumers that was recently completed of those who are seeking pain relief from pain, anxiety, and depression, and the preliminary results confirm two earlier surveys that many consumers would turn to prescription drugs if kratom were no longer available.  The survey results document a perverse and unintended consequence resulting from Dr. Gottlieb's public health advisory on kratom where the threat to public health, adverse events, and deaths would occur because of the kratom ban contemplated by the FDA.  It is inconceivable that the FDA would favor a policy that would foreseeably force a patient who have been weaned off of opioid addition back to dangerously addictive and potentially deadly opioid prescription medications."

ABOUT AKA

The America Kratom Association, a consumer-based non-profit organization, is here to set the record straight, giving voice to those suffering and protecting our rights to possess and consume kratom. AKA represents tens of thousands of Americans, each of whom have a unique story to tell about the virtues of kratom and its positive effects on their lives. www.americankratom.org

 

View original content:http://www.prnewswire.com/news-releases/aka-files-formal-demand-for-fda-to-rescind-false-advisory-about-kratom-300556786.html

SOURCE American Kratom Association, Washington, D.C.



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