10 - 2019 | KratomSpace

Whether kratom will be banned remains an open question. After it initially appeared the U.S. Drug Enforcement Agency (“DEA”) would designate kratom a Schedule I substance, it quickly reversed course and it has now been more than three years with no action. Meanwhile, kratom has continued to be demonized by regulatory agencies like the U.S. Food and Drug Administration (“FDA”), while an increasing number of studies have suggested that kratom may have legitimate uses, and may be safer and less addictive than traditional opioids. Where things go from here is unclear, but there is increasing optimism that kratom will find mainstream support over the next several years.What Is Kratom?Kratom is a tropical tree native to Southeast Asian countries like Indonesia and Malaysia. Its leaves have been used by locals for centuries to treat pain and other conditions. See our in-depth guide on the best kratom for pain for greater details.At lower doses, kratom acts as a stimulant similar to coffee. At higher doses, kratom acts as a sedative and has opiate-like effects.Kratom use is sharply on the rise, with an estimated 10 times as many users today as compared to just five years ago.Kratom’s Regulatory HistoryThe U.S. Drug Enforcement Agency’s Position on KratomIn 2016, the DEA announced its intention to designate kratom a Schedule I substance pursuant to the Controlled Substances Act due to its potential for abuse and because it had no recognized medical use. This would have placed kratom in the same category as illicit street drugs like LSD, heroin and ecstasy.The DEA’s announcement spurred large-scale protest from both citizens and members of Congress, and in an unprecedented move, the DEA placed its decision on hold pending a public comment period. Given strong advocacy from both pro-kratom and anti-kratom groups, as well as a lack of research on kratom, it has now been more than three years with no action by the DEA.The U.S. Department of Health and Human Services’ Position on KratomMeanwhile, in October 2017, the U.S. Department of Health and Human Services (“DHHS”) issued a controversial report recommending that kratom’s two primary alkaloids – mitragynine and 7-hydroxymitragynine – be designated Schedule I substances. In February 2018, the FDA (a division of the DHHS) issued another report claiming that kratom is an opioid and should be regulated as such. The FDA’s assessment was based on a novel approach they called “Public Health Assessment via Structural Evaluation” (“PHASE”). PHASE was described as a “3-D computer technology” that predicts how chemical molecules may behave in the body, and the FDA was heavily criticized for basing their recommendation on a computer model rather than tests on physical kratom.The FDA’s Crackdown on Kratom Marketing PracticesWhile the FDA has not been able to persuade the DEA to place kratom on Schedule I, it has nevertheless been active in pursuing kratom vendors for allegedly misleading marketing practices. In particular, the FDA has issued several rounds of warning letters “for illegally selling unapproved, misbranded kratom-containing products with unproven claims about their ability to treat or cure opioid withdrawal symptoms.”What’s Next for Kratom?What’s next for kratom is unclear. Many commentators believe that the DEA’s lengthy period of inaction, coupled with increasingly effective lobbying by pro-kratom groups, means that kratom is unlikely to be banned at the federal level any time soon. But anti-kratom crusaders (including the DHHS and FDA) remain vocal, and there continues to be a real risk that kratom could be banned at some point in the future. Locations Where Kratom is Already BannedWhile kratom is legal at the federal level, it has been banned in six states, including Alabama; Arkansas; Indiana; Rhode Island; Vermont; and Wisconsin. Several counties and cities have also banned kratom, including San Diego, California; Denver, Colorado; Sarasota County, Florida; Alton, Illinois; and at least 10 counties and 23 cities in Mississippi.Several states have also instituted various restrictions on purchasing kratom, including age restrictions (Illinois, New Hampshire, North Carolina and Tennessee) and bans on synthetic versions (Tennessee).Risks of KratomThe Shadowy Kratom MarketHistorically, kratom has been available at places like gas stations, liquor stores and headshops. These types of retailers offered little transparency into sourcing and harvesting methods, manufacturing standards or the purity of their products.While more reputable vendors committed to higher standards and self-regulation are beginning to appear (particularly online), many people still source untested kratom at local outlets. Kratom Contamination IssuesSalmonella OutbreakIn 2018, there was a salmonella outbreak in kratom products that affected nearly 200 people in 41 states. Of course, this was the result of poor manufacturing and handling processes, rather than an inherent risk of kratom.Presence of Heavy Metals in Kratom ProductsIn April 2019, the FDA released results of heavy metals testing on 30 kratom products, revealing that it had found significant levels of lead and nickel. The FDA warned that prolonged use of these products could lead to heavy metals poisoning, including nervous system or kidney damage, high blood pressure, anemia and/or increased risk of certain cancers.The FDA did not disclose, however, which kratom brand(s) or products it tested. And of course, heavy metals do not occur naturally in kratom, so the presence of these compounds is again a manufacturing issue rather than an inherent risk of kratom. Without more information from the FDA, no real conclusions about the magnitude of danger from heavy metals in kratom can be drawn.Risks of Kratom OverdoseIn 2017, the U.S. Center for Disease Control (“CDC”) issued a report claiming that during an 18-month period between 2016 and 2017, it found 91 deaths relating to kratom. The CDC conceded, however, that virtually all of the deaths involved the presence of other illegal drugs or prescription medicines. The CDC also included several deaths that clearly resulted from other causes (including a person who was shot and person who fell out of a window) simply because there was kratom in the person’s system.Also in 2017, the University of Colorado completed a study that found only 15 kratom-related deaths between 1997 and 2017, and similarly found that other drugs likely played a role in at least 14 of those cases.Kratom Overdose Risks Compared to Other OpioidsWhile any deaths involving kratom are concerning and should be investigated fully, it’s important to remember that the 91 deaths cited by the CDC in 2016 and 2017 compares to nearly 100,000 deaths from opioids in the U.S. alone during that same period.Reconciling Alleged Risks of Kratom with Lengthy History of Safe Use in Southeast AsiaThe FDA claims kratom is a dangerous plant with serious side effects including seizures, hallucinations and psychosis, yet kratom has a centuries-long history of use in Southeast Asia, virtually without incident. How can the FDA’s views be reconciled with kratom’s history?One possibility is that at least some of the kratom reaching the U.S. is adulterated in one way or another, and those impurities are responsible for any negative effects. Another is that U.S. users are using kratom in quantities and at frequencies that far exceed historical averages, and higher doses are responsible for the dangers the FDA cites. At this point we simply don’t know, and further research is warranted.Kratom ResearchHow Does Kratom Work?Research into the exact mechanisms of kratom is incomplete, but several studies have found that kratom appears to target opioid receptors – the same part of the brain that responds to drugs like morphine, codeine and fentanyl.But several studies have also found that, unlike opioids, kratom does not appear to result in respiratory depression (i.e., slowed breathing) – the primary culprit in fatal opioid overdoses. Those studies have also suggested that kratom may result in far lower physical dependence than prescription opioids.Is Kratom Addictive?Kratom’s two primary alkaloids – mitragynine and 7-hydroxymitragynine – may cause dependency, but most researchers have described withdrawals as manageable, with dull pain and trouble sleeping cited as typical symptoms. One recent study in the Journal of Psychoactive Drugs noted, “these effects appeared to be relatively mild, since the majority of participants did not seek treatment for their pain and sleep problems and, in fact, the withdrawal effects only lasted between one and three days.”Similarly, Christopher R. McCurdy, PhD, and a chemistry professor at the University of Florida at Gainesville has said, “It is probably addictive, but its addictive equivalent is something like coffee, which isn’t surprising because the leaf is in the coffee family.”Lobbying EffortsThe American Kratom Association (“AKA”) has proven to be a strong lobbyist, and in August 2018 submitted a petition to keep kratom legal that was signed by more than 40,000 Americans.Shortly thereafter, in December 2019, the AKA issued a 27-page report arguing that the FDA has failed to provide any reliable data or science supporting that kratom should be a Schedule I drug.The AKA continues to move the industry forward, including by promulgating its Good Manufacturing Practice standards to help the industry better police itself.Big Pharma’s Influence on a Kratom BanSome argue that the FDA’s seemingly irrational hostility to kratom, especially in the face of the serious consequences of the opioid epidemic, is driven by the influence of Big Pharma over key individuals within the agency.But the tide does appear to be turning, and many scientists and politicians want kratom to remain legal – at the very least to ease research into potential benefits given the strong anecdotal evidence of its effectiveness.In fact, nine senators – including Bernie Sanders – specifically urged the DEA not to ban kratom, citing “the long reported history of kratom use, coupled with the public’s sentiment that it is a safe alternative to prescription opioids.” Whether their voices are heard remains to be seen.

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