Introduction
Humans have used Kratom for centuries since its discovery in Southeast Asia. Its medicinal purpose has been recognized socially and scientifically since its first recorded use. Ketumssaw we powder is typically made from the leaves of Mitragyna Speciosa, a tree in the coffee family.
This herb is traditionally made into tea, chewed (mixed with betel nut), or smoked in cigarettes. It contains two psychoactive compounds known as Mitragynine and 7- Hydroxymitragynine that binds to the soothing receptors of the brain.
Nowadays, in addition to its native countries, Kratom users in America have also increased exponentially along with other nations worldwide. Mitragyna was traditionally used by workers and manual laborers in Thailand and Bali for various recreational and remedial reasons.
Kratom Users In America
Ketum users in America are estimated to be around 16 million people using this plant as a medicinal herb. This makes ketum one of the emerging industries of remedial botanicals. The Botanical Education Alliance determined the net worth of the speciosa industry as 1.13 billion dollars.
A Swedish botanist introduced this botanical plant in the 1800s. He brought the plant to the U.S. to study its properties after the East India company left the Indian continent. However, this beneficial tree in America started after the Vietnamese war.
The immigrants from Southeast Asian countries and soldiers that returned from the war brought this herb to the United States. Still, Korth was not that famous until the last decade. This was when people mainly started recognizing this herbal plant and its benefits.
Most Mitragyna users in America are adult men with an average age range of 30-31 years.
Different consumers use this herbal plant for various personal reasons.
In the U.S., you can find Ketum easily near you. It is economical and readily available online and vaping centers, local stores, gas stations, head shops.
Numerous forms of Speciosa are present in the market, including kratom powders, kratom capsules, tablets, kratom extracts, shots, tinctures, and resins.
Why Kratom Came Under The Radar Of DEA?
As the product rose to popularity in 2011 and the number of Ketum users in America increased, so did the number of calls to poison control centers about mitragyna poisoning, which reached 13 calls countrywide. The number of calls increased to 682 in 2017.
Between 2011 and 2017, 32 percent of adult speciosa exposure instances resulted in admission to a medical facility, and 52 percent of cases resulted in a severe medical consequence, such as seizure, respiratory distress, or a slow heart rate.
Whatever might cause these adverse reactions, we know for sure that there is only a minimal amount of research studies that explain this botanical’s mechanism of action and drug interactions.
The Efforts Of Legislating Kratom By DEA
Because of the increasing number of Kratom users in America since the mid-’90s, some local Ketum stores and head shop owners tried to adulterate this botanical with chemicals like heroin or morphine to highly enhance the effects of the product, which caused adverse health effects in many people. This resulted in the warning against mitragyna speciosa issued by the Drug Enforcement Administration (DEA) in 2005.
In 2009, as a result of 9 deaths in 12 months due to consuming a product named “Krypton,” the agency reissued a warning. The outcomes of the chemical analysis of Krypton by the FDA showed that the product contained toxic levels of soothing named tramadol, causing those deaths.
After that, the U.S.’s Food and Drug Administration (FDA) issued three import alerts for Korth products over five years and seized speciosa products worth 5 million dollars that weighed more than twenty-five thousand pounds in California and 90,000 bottles of Mitragyna containing dietary supplements in Illinois, respectively in 2014 and 2016.
Subsequent Attempts To Ban Mitragyna Speciosa By DEA After 2016
2016 is marked as the worst year in the history of the American Kratom industry. Because after 2016, DEA and FDA tightened their belts to ban Ketum federally. In August 2016, DEA issued a notification to list Mitragynine and 7- Hydroxymitragynine, the two psychoactive compounds present in the speciosa plant, as Schedule I substances under emergency scheduling provisions controlled substances.
However, the decision could not be enforced and was delayed indefinitely because of overwhelming backlash from various Kratom users in America. Since the decision to ban, DEA and FDA are at odds with Ketum users in America as many of them found relief with this beneficial herb from their chronic ailments.
Position Of FDA Regarding Kratom Ban
The FDA rekindled its interest in scheduling Ketum’s two psychotropic components in October 2017, submitting an 8-factor analysis to the Drug Enforcement Administration. A month later, the FDA issued a public health advisory on Mitragyna, claiming that the substance has been linked to 36 deaths and has effects and risks similar to soothings. The number of mitragyna-related deaths has now risen to 44, according to a statement made by the FDA on February 6, 2018.
The FDA developed the Public Health Assessment via Structural Evaluation (PHASE) model to simulate how the chemical constituents are structured at a molecular level, their behavior inside the body, and the effects they could produce on the brain using 3D computer technology. Furthermore, the FDA claimed that based on the results from the phase model, they could confidently call both psychoactive compounds soothings.
More issues around speciosa arose as FDA concluded in July 2018 that several products included exceptionally high levels of salmonella. As of the end of May 2018, 199 cases of salmonellosis had been linked to Korth intake in 41 states.
Due to the crisis, multiple items were voluntarily recalled. Still, the FDA issued its first mandated recall order against one supplier who refused to cooperate with the voluntary recall. The FDA detected 30 different Kratom products containing nickel and lead in concentrations that exceed the safe exposure limit for oral daily medication intake in April 2019, adding to the concerns with Ketum products.
The FDA issued warning letters to two dealers and distributors, Cali Botanicals and Kratom NC, in June 2019, on account of false claims. The distributors were charged with marketing mitragyna products containing medicinal items making unverified claims.
The company claimed about their product’s ability to treat or cure sedative weakness and withdrawal symptoms.” These companies allegedly also claimed that “Kratom can protect you from cancer” and that it can be used to cure migraines, ADHD/ADD, and other ailments.
The Stance Of The American Kratom Association (AKA) Following Kratom Ban
American Kratom Association is a Virginia-based non-profit organization established in 2014 by some Kratom users in America to protect users’ right to buy and consume unadulterated ketum. Since the start, the American Kratom Association was never against the legislative measures to make mitragyna a safe and effective product.
However, after the DEA and FDA tried to ban the plant entirely in the United States of America instead of regulating it, AKA had to come out to protect it. In September 2016, after the decision of DEA to temporarily ban this valuable plant until further research, AKA organized “Kratom March” in front of the White House in which a lot of Mitragyna users in America took part and managed to convince 60 Congress members to oppose DEA’s suggestion of banning the herb.
AKA’s stance is clear regarding the speciosa plant. They advocate that this herbal product should not be banned because its use and effects are more similar to unscheduled substances like caffeine rather than soothings. Furthermore, AKA insists that there is no death related to consumption or overdosing of refined products.
After DEA and FDA’s persistent stubbornness to not regulate Ketum, AKA devised the Good Manufacturing Practices program (GMP) on its own to control manufacturing practices in the industry. The vendors and manufacturers need to follow strict production, testing, and packaging rules to make it to the GMP qualified list of the American Kratom Association.
Current Advancements On The Issue
For many Kratom users in America, it is not understandable why FDA is adamant about banning it without sufficient evidence against deaths. Many reports show that the causes of deaths caused by consuming contaminated products were not Kratom but the other added chemicals like soothings or alcohol.
Many experts argue that the FDA is making a mistake by relying on PHASE’s simplistic approach. The rate at which cures are absorbed in the gastrointestinal tract, how quickly they pass the blood-brain barrier, and what occurs inside cells once drugs attach to receptors on their surfaces are all ignored by PHASE.
This system also ignores the mu-soothing receptor’s skewed agonism and Mitragynine’s inability to activate beta-arrestin. These factors impact mitragyna’s physical effects, but the PHASE model does not account for them, and the FDA ignores the model’s limitations.
Bottom Line
Kratom users in America are increasing day by day, which requires the regulation of this botanical rather than prohibiting it entirely because banning any substance without proper research is as dangerous as approving them without it.
Moreover, Ketum seems to be quite helpful in regulated high-quality doses, and it’s pretty hard to overdose on it or get sick from it. The very low toxicity of k in overdose should indicate that smart regulation could make it a very desirable option as an alternative to addictive pharmaceutical drugs.
