What Are Kratom Products?
Kratom, or Mitragyna speciosa, is a tropical tree native to Southeast Asia, and the consumption of its leaves has been commonplace for centuries. In Southeast Asian tradition, manual laborers ingested the substance to combat fatigue and improve work productivity. By chopping the fresh or dried leaves, the laborers either chewed or made kratom into tea. Additionally, in a ceremonious preparation, kratom leaves were used to treat various medical conditions, such as morphine dependence in Thailand, and as an opium substitute in Malaya (Cinosi et al.).
Today, in Western culture, Kratom is an unregulated enhancer that produces an opioid-like stimulant. The herb is ingested orally in pill form or drank as a tea; it also can be smoked (Great Bend Post). Kratom is also marketed as a dietary supplement, with users reporting multiple reasons for their use of the substance, such as to alleviate pain, to address symptoms of mental health conditions like anxiety and depression, to help stop or reduce opioid or other substance use, and to manage withdrawal symptoms and cravings related to opioids and other drugs (National Institute on Drug Abuse).
From its traditional use to increase work and productivity in Southeast Asia to now as a recreational psychoactive drug in Western countries, this enhancer is a topic of debate among users and researchers. While some users swear by its benefits, the substance is too complex for federal regulators to approve its use. This is because kratom is a natural product — the raw leaves from Mitragyna speciosa. Natural products are exceptionally complex regarding their chemistry. If a product has a complex chemical makeup, it is difficult to standardize. For a drug to become studied, tested and federally approved, a standard is required by researchers. The level of complexity, variability, and unknown nature of kratom samples “offers risks of ill health with potentially life-threatening consequences” (Cinosi et al.).
What are the effects?
At low doses, kratom produces stimulant effects comparable to medications commonly used to treat ADHD — users report increased alertness, physical energy, and talkativeness. At high doses, users experience sedative effects, and the substance functions as an opioid (Child Mind Institute). The European Monitoring Center for Drugs and Drug Addiction describes small-dose effects as “cocaine-like” and larger-dose effects as “morphine-like.”
After ingesting a few grams of dried leaves, the energetic and euphoric effects are felt in ten minutes and last for sixty to ninety minutes. Users report increased work capacity, alertness, sociability, and sometimes heightened sexual desire. Very little clinical research has been conducted on kratom’s effect on humans, but in one of the few human clinical experiments, a 50 mg dosage of mitragynine, one of Kratom’s ingredients, produced motor excitement, then giddiness, then loss of motor coordination, and tremors of the extremities and face.
In larger doses meant for the sedating effect, ten to 25 grams of dried leaves may produce sweating, dizziness, nausea, and dysphoria. However, these effects dissipate and are replaced with calmness, euphoria, and a dreamlike state that lasts up to six hours (European Monitoring Center for Drugs and Drug Addiction).
For regular users, kratom’s effects on the body include nausea, itching, sweating, dry mouth, constipation, increased urination, tachycardia, vomiting, drowsiness, and loss of appetite. Users of kratom have also experienced anorexia, weight loss, insomnia, hepatotoxicity, seizure, and hallucinations (Drug Enforcement Administration).
For regular kratom users who experience dependence, the withdrawal symptoms include craving, weakness and lethargy, anxiety, restlessness, rhinorrhea, myalgia, nausea, sweating, muscle pain, jerky movements of the limbs, tremor as well as sleep disturbances and hallucination. Treatment, if needed, may include dihydrocodeine-lofexidine combination, non-steroidal anti-inflammatory agents, antidepressants, and/or anxiolytics (European Monitoring Center for Drugs and Drug Addiction).
Consuming kratom with other drugs can provoke serious side effects, according to the European Monitoring Center for Drug and Drug Addiction. In fact, adverse drug interactions involving kratom tea taken with carisoprodol, modafinil, propylhexedrine, or Datura stramonium have been reported. A fatal case in the United States involved a blend of kratom, fentanyl, diphenhydramine, caffeine, and morphine sold as an herbal drug.
Opioid addiction
According to the Drug & Chemical Evaluation Section of the DEA’s Diversion Control Division, Kratom consumption can lead to addiction. The DEA’s fact sheet released in March 2023 mentions a study of Thai kratom addicts, in which it was observed that some addicts chewed kratom daily for 3 to 30 years (mean of 18.6 years). Withdrawal symptoms were observed, such as hostility, aggression, emotional lability, wet nose, achy muscles and bones, and jerky movement of the limbs. Furthermore, several cases of kratom psychosis were observed, where kratom addicts exhibited psychotic symptoms that included hallucinations, delusion, and confusion (DEA).
Although kratom is being advertised as a healthier alternative to overcome opioid addiction, kratom itself may have the potential to be addictive. Regular kratom users may experience withdrawal symptoms if they stop using it. Its potential for dependence and addiction has long been apparent and led to its categorization as a banned substance in both Malaysia and Thailand in the mid-twentieth century (Cinosi et al.).
Kratom leaves contain two major psychoactive ingredients (mitragynine and 7-hydroxymitragynine). These ingredients interact with opioid receptors in the brain, producing the pleasurable, pain-reducing effects of opioids, especially when users consume large amounts of the plant. The danger, according to David Seitz, MD and medical director of a New York-based rehab program, is the perception of kratom. Young people believe the drug is harmless because it’s touted as a natural herbal (Child Mind Institute).
Concern over kratom’s addiction potential has led to preclinical trials, but there is little conclusive evidence done on humans. However, in a rat-modeled study to discover abuse liability in kratom’s main alkaloids (mitragynine and 7-hydroxymitragynine), researchers found that 7-hydroxymitragynine “should be considered a kratom constituent with high abuse potential that may also increase the intake of other opiates” (Hemby et al.).
Not only did mice and rat models demonstrate addiction potential, but also a cognitive impairment, particularly in the setting of chronic mitragynine ingestion; mitragynine being a main ingredient of kratom. Conclusions in a study that administered mitragynine to rats in a maze found that high and consistent use of the substance caused memory deficits and spatial learning (Hassan et al.).
Kratom poses a number of risks to patients due to its status as an unregulated supplement. Without regulation and the oversight that comes with it, there is little to ensure the authenticity, purity, quality, potency, and safety of commercially available kratom preparations. It is difficult to know what really is in commercial Kratom, and the concentration of mitragynine can vary significantly. For these reasons, researchers purchased several commercially available Kratom products to analyze the potential adulteration of the “highly potent and addictive plant alkaloid, 7-hydroxymitragynine” (Lydecker et al.).
The study found multiple packed kratom products with enhanced levels of 7-hydroxymitragynine to increase potency. The artificial increase in commercial products showed a substantially higher level found in raw M. speciosa leaves. As previously concluded, the development of addiction and toxicity is specifically dependent on 7-hydroxymitragynine. The authors conclude their research by expressing the importance of oversight of commercial kratom products (Lydecker et al.).
Scot Yarnell, a psychiatric mental health nurse practitioner at The Center for Counseling & Consultation in Great Bend, KS, says kratom is quickly becoming part of the opioid crisis while it is sold legally over the counter. Yarnell says the drug should not be legal and hopes Kansas will follow the lead of the six states that have made kratom illegal.
“I have helped detoxify patients from kratom in other parts of Kansas,” he recalled. “When the case is severe enough, we use the same protocol as detoxing from heroin or fentanyl” (Great Bend Post).
Regulation
The U.S. Food and Drug Administration is warning consumers not to use Mitragyna speciosa — kratom. According to the agency, kratom appears to have properties that expose users to the risks of addiction, abuse, and dependence, as the plant affects the same opioid receptors as morphine. For these reasons, there are no FDA-approved uses for kratom. (FDA and Kratom). The FDA and CDC have also investigated a multistate Salmonella outbreak linked to kratom powder, identifying Salmonella strains in kratom powder products, which led to mandatory and voluntary recalls by various companies.
In addition to the FDA’s concern over kratom’s addiction potential, the agency has conducted laboratory testing to determine if the drug contains heavy metals. In analyzing 30 kratom products, the test found significant levels of lead and nickel at concentrations that exceed safe exposure for oral daily drug intake. Long-term kratom users could potentially develop heavy metal poisoning, which could include nervous system or kidney damage, anemia, high blood pressure, and/or increased risk of certain cancers (Laboratory Analysis of Kratom Products for Heavy Metals). The investigation also resulted in mandatory recall orders and voluntary recalls for powdered kratom manufactured by different companies found to be contaminated with Salmonella.
In April 2023, US Marshals seized over 250,000 units and $3 million worth of dietary supplements and bulk dietary ingredients containing kratom. These dietary supplements are manufactured by Botanic Tonics LLC in Oklahoma for the brand “Feel Free Plant Based Herbal Supplement” (FDA Roundup).
The U.S. Department of Justice, on behalf of the FDA, filed a complaint in the U.S. District Court for the Northern District of Oklahoma, alleging that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury. Therefore, dietary supplements and bulk dietary ingredients that are or contain kratom are adulterated under the Federal Food, Drug, and Cosmetic Act (FDA Roundup).
In 2018, the FDA issued a warning letter to Revibe, Inc., of Kansas City, Missouri – for illegally selling unapproved kratom-containing drug products with unproven claims about their ability to help in the treatment of opioid addiction and withdrawal (FDA News Release).
Despite the regulation and stance of the FDA, passionate users of kratom have organized associations and even laws to protect the sale of the substance. The Kratom Consumer Protection Act (KCPA) is a bill created to regulate the manufacture and sale of kratom to protect consumers.
The law sets guidelines on kratom’s manufacturing, distribution, sale, possession, age limits, fines, and testing and labeling requirements. If a state passes the Kratom Consumer Protection Act, it will likely modify the original text to best fit the state’s needs and laws. Georgia, Arizona, Nevada, Utah, and as of June 2, Florida, have passed the KCPA (Kratom.org).
Gov. Ron DeSantis authorized the Florida Kratom Consumer Protection Act, among other legislation, on June 2. Beginning July 1, kratom sales to anyone under 21 will be illegal in Florida. Those who do sell below the age restriction will face a second-degree misdemeanor charge, punishable by a fine of up to $500 and up to 60 days in jail (Florida Politics).
Though the finer details of the law vary from state to state, some standard provisions within the KCPA bill include the following:
- Prohibits the sale of kratom to minors ages 18+ only
- Disclosing if any food items contain kratom
- Banning the sale of adulterated or contaminated kratom products
- Disallowing kratom products that are packed with or contain harmful substances that alter the strength or quality of the kratom in a way that could harm or injure the customer
- Prohibiting kratom products that may be mixed or packed with substances scheduled in the respective state
- Forbidding the sale of kratom products containing more than 2% of 7-hydroxymitragynine
- Prohibiting the sale of any products that contain synthetic kratom alkaloids or a synthetic version of any other natural compounds found in kratom
- Labeling kratom products and stating the ingredients and origin of kratom
- Disclosing the amount of mitragynine and 7-hydroxymitragynine that each product contains
Although kratom is technically legal at the federal level, some states and municipalities have chosen to regulate it on their own — either banning the substance or making it illegal to sell, possess, grow, or use it. Others have imposed age restrictions.
Kratom is illegal to buy, sell, possess, or use in Alabama, Arkansas, Indiana, Rhode Island, Vermont, and Wisconsin. But these six states are the only states that have completely banned the substance. States that passed KCPA, detailed above, include Arizona, Georgia, Nevada, Utah, and now Florida. Kratom is legal in Tennessee for those over the age of 21 and in New Hampshire and Illinois (save the city of Jerseyville) for those over the age of 18 (Sprout Health Group).
Outside San Diego, which banned it, kratom is legal in California. Outside Denver, where it’s considered illegal for human consumption, kratom is legal in Colorado. Aside from being banned in Sarasota County, kratom is legal in Florida. Outside Union County, which has banned the substance, kratom is legal in Mississippi. In the remaining 33 states, kratom is completely legal (Sprout Health Group).
Other countries, according to the DEA, are reporting emerging new trends in the use of kratom. In the United Kingdom, kratom is promoted as an “herbal speedball.” In Malaysia, kratom (known as ketum) juice preparations are illegally available. Kratom is banned in Malaysia and has been illegal in Thailand since 1943. In Malaysia, the cultivation of kratom trees is not illegal, but people caught distributing kratom or processing the leaves, however, can be fined, jailed, or both (DEA).
According to the American Botanical Council, an attempt by the Malaysian government to reschedule kratom from the Poisons Act of 1952 to the Dangerous Drugs Act of 1952 was halted by legislators who were not convinced of its health dangers. In Thailand, kratom was first regulated under the 1943 Kratom Act and then rescheduled under the Thai Narcotics Act in 1979, which is less punitive than the Kratom Act (ABC).
Further, Australia fully bans Kratom, placing it on the most restrictive level of the Australian National Drugs and Poisons Schedule. In New Zealand, however, kratom can be legally sold and consumed upon presentation of a medical prescription. In Southeast Asia, the region where it originates, kratom remains illegal in Singapore, Vietnam, and Malaysia, but also in Myanmar. In fact, the 1993 Narcotic Drugs and Psychotropic Substances Law prescribes that the cultivation, possession, distribution, and transportation of kratom are criminal offenses punishable with long-term prison penalties (Transnational Institute).
Harm to Kids
Kratom has gained more popularity amongst young people over the last few years. Since it is available on the internet for purchase, it is now widely used as a drug of abuse, namely as a new psychoactive substance, being a cheaper alternative to opioids that do not require medical prescription in the US (National Library of Medicine).
According to Mike Milham, MD, PhD, a child and adolescent psychiatrist at the Child Mind Institute, high school and college students are surrounded by kratom, the drug easily available in smoke shops and on the internet. Students report kratom helps them study and treats anxiety. Dr. Milham states the problem is that kratom might initially help with stress, but then kids become stuck.
“For students especially, you can imagine the allure of the stimulant effects, but once you start experiencing the euphoria of the opioid aspect, you’re at risk for addiction,” Dr. Wilhelm said.
To date, there have been no well-controlled scientific studies showing that kratom is effective for opioid abuse withdrawal or any other conditions in humans. And since it is not regulated by the FDA, there’s no way to know how potent any given amount is or if a batch contains other substances as well, creating an especially dangerous gamble for kids (Child Mind Institute).
Parents Dana and John Pope filed a wrongful death lawsuit against about a dozen people, companies, and organizations connected to the manufacturing, marketing, and sale of kratom after their 23-year-old son Ethan was found dead in his apartment in December 2021. They hadn’t known how long their son was using the drug or even what it was, but Ethan must have been experiencing adverse effects because a to-do list was found in his apartment with the task: Stop taking kratom. The lawsuit was filed in May 2022 and expanded in October (AP News).
Who are kratom users?
An analysis of the 2019 National Survey on Drug Use and Health estimated that the proportion of Americans over the age of 11 who used kratom in the past year is about two million people. The target audience includes middle-income, young-to-middle-aged adults seeking out remedies for pain or mental health conditions like anxiety (Nationwide Children’s). As more people in the United States consume kratom, its popularity as a dietary supplement and recreational product continues to grow, drawing attention from government authorities like the FDA and DEA.
A study conducted by the Center for Injury Research and Policy and the Central Ohio Poison Center at Nationwide Children’s Hospital found that most reported kratom exposures occurred among males (71 percent), age 20 years and older (89 percent), at a residence (86 percent), and were intentional abuse or misuse (60 percent), suspected suicide (9 percent) or adverse reaction (8 percent) (Nationwide Children’s).
Overall, nearly one-third (32 percent) of the calls resulted in admission to a healthcare facility, and more than half (52 percent) resulted in serious medical outcomes, especially among teenagers and adults. Among the 48 kratom exposures that involved children aged 12 years and younger, 69 percent were children younger than two years, including seven newborns, five of whom were experiencing withdrawal (Nationwide Children’s).
“As physicians, we need to educate pregnant women on the risks of kratom use during pregnancy and while breastfeeding. Kratom can cause neonatal abstinence syndrome, also known as NAS, in which newborns suffer withdrawal from drugs they were exposed to in utero,” says Henry Spiller, MS, DABAT (Nationwide Children’s).
Why hasn’t it been approved by the Food and Drug Administration?
Dr. Christopher McCurdy of the University of Florida delivered a lecture on kratom, “Can a Controversial Tree End the Opioid Crisis?” Dr. McCurdy believes kratom has the potential to do good: that if the appropriate controlled dosage is taken, it could replace medications used during opioid detox. However, Dr. McCurdy admits that there are too many gaps in science to be definitive. Research has been conducted surrounding the effects of kratom and its chemical makeup, but human clinical studies are scarce.
Dr. Christopher McCurdy believes a lack of conclusive research can be blamed on the fact that kratom is not a standard product. Kratom trees have different chemotypes, in which strands contain different amounts of alkaloids. The processed kratom products in the US don’t mirror the same composition as the kratom tea prepared traditionally in Southeast Asia. Because there is no reliable makeup of the substance, there’s no foundation upon which to build experimental models and clinical trials. Dr. McCurdy states that adverse effects of kratom in the Western world can be blamed on the differences among products — when there was a seemingly long history of safe use (National Center for Complementary and Integrative Health).
But ultimately, the substance is too new and unstudied to definitively declare its safety. The long-term effects of kratom use are not well understood. There have been reports that long-term use of large doses of kratom may cause serious liver problems in some people.
Harmful contaminants such as heavy metals and disease-causing bacteria have been found in some kratom products (National Center for Complementary and Integrative Health).
Despite the FDA’s precautions or scientific research that shows kratom’s habit-forming tendencies, passionate kratom users have created protection organizations, such as the American Kratom Association. In their writing, the AKA has five goals: support consumers, educate, speak the truth on kratom, global awareness, and protect natural resources. Their mission is that the FDA’s war on kratom interferes with consumers’ rights to make informed choices while misleading consumers and policymakers with disinformation (American Kratom Association).
The AKA is not wrong in that users who have found success with Kratom exist. Dr. Milham acknowledges that there are challenges in determining how exactly kratom should be regulated or classified.
“Making it completely illegal isn’t necessarily a good idea because, at this point, you do have portions of the community that actually are using it to help with opioid withdrawal, and to just make it illegal and take it completely off schedule doesn’t really make sense.”
Instead, Dr. Milham suggests kratom be made a Schedule II drug. The Drug Enforcement Administration classifies Schedule II drugs with “a high potential for abuse, with use potentially leading to severe psychological or physical dependence.”
This classification effectively translates the potential danger that kratom carries while still allowing its use in a controlled fashion, both in distribution and quality of ingredients.
“Drugs with addictive potential,” he argues, “should be in the hands of the healthcare providers to prescribe.”
Manufacturers
According to the Drug & Chemical Evaluation Section of the DEA’s Diversion Control Division, Kratom is widely available on the Internet and also sold in ethnobotanical retail stores. There are numerous vendors within and outside of the U.S. selling kratom. Forms of kratom available through the Internet include leaves (whole or crushed), powder, extract, encapsulated powder, and extract resin “pies” (40g pellets made from reduced extract). Seeds and whole trees are also available from some vendors through the Internet, suggesting the possibility of domestic cultivation.
In February of this year, News Direct published the seven best kratom vendors according to quality and efficacy. The best overall vendor, according to the list, was Kats Botanical for its wide range of products and strict quality control. Kats Botanical is AKA certified, meaning the American Kratom Association approves the method of production and sale. The association approves vendors that adhere to the AKA GMP Standards Program, a set of safety regulations following the manufacturing process. To become an AKA GMP Qualified Vendor, according to the AKA’s website, participants must complete an annual independent 3rd party audit to ensure their compliance with the program standards.
As an AKA-certified vendor, Kats Botanical subjects its products through third-party lab testing. While competitors test strictly for purity, Kats Botanical tests for everything, including pesticides, heavy metals, contaminants, pathogens, and more. Further, Kats Botanicals gets its leaves from small farms in Indonesia, as opposed to mass-produced kratom farms domestically. For kratom users, this all-natural, organic element is a bonus. The blog notes Kats’s “surprisingly” affordable products, considering their quality. Sixty capsules go for around $19.99, or a half pound (250g) of powder for $39.99 (News Direct).
The best kratom to buy in bulk, according to News Direct, is Golden Monk. Also, an AKA-certified vendor, Golden Monk kratom, undergoes six lab tests for possible unwanted ingredients such as microbes (mold, yeast, bacteria, and pathogens) or heavy metals (arsenic, cadmium, mercury, and lead). The list includes an additional plus: Golden Monk offers a discreet packaging option, so as to not gain unwanted attention. The remaining vendors on the list include Kraken Kratom, Kratom Spot, Just Kratom, Top Extracts, and Organic Kratom USA (News Direct).
Process
The kratom vendor “Dakind Kratom” details its production process from Southeast Asia to US shelves. Typically grown in either pockets of cleared forest or in home gardens, kratom leaves are harvested based on criteria such as the tree’s age, the size of the leaves, and the veins’ color, the blog reads.
Once picked, the leaves are dried and fermented in a process that prevents the growth of mold and bacteria while also activating the alkaloids. Fermentation, according to Dakind Kratom, helps break down the cell structure of the leaves and enhance their aroma and taste. The blog post then details Step 3: Processing and Testing:
“After fermentation, the kratom leaves are processed into various Kratom products. Some kratom manufacturers powder the kratom leaves, while others extract their alkaloids and add them to capsules or tinctures. The purity, freshness, and potency of the raw material used determine the quality of kratom products, which are tested for safety before human consumption. Such tests screen for contaminants and adulterants like heavy metals, salmonella, and fungi.”
The FDA and CDC have investigated a multistate Salmonella outbreak linked to powdered kratom, resulting in recalls and voluntary recalls of these products due to contamination concerns.
From there, kratom is packaged into capsules and powders that can be mixed into teas and juices or added to smoothies and food. Kratom extracts are more potent and concentrated with a faster-acting effect (Daking Botanicals).
