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