FDA Flip Flops (Again) on Kratom

By Pat Anson

The Food and Drug Administration can’t seem to make up its mind about kratom.

Just 10 days after publishing an initial notice in the Federal Register seeking public comment on a study about the risk and safety of kratom and psychedelic substances, the agency abruptly withdrew its request.

“FDA no longer intends to proceed with the proposed study as described because circumstances occurred necessitating changes to the scope of the study,” the FDA said in a brief statement, without explaining what “circumstances” changed.

Kratom is an herbal supplement made from the leaves of a tree in southeast Asia, where it has been used for centuries as a stimulant and pain reliever. In recent years, millions of Americans have discovered that kratom can be used to treat pain, anxiety, depression and addiction. The FDA takes a dim view of that, because it has not approved kratom for any medical condition.

“Notably, kratom's unapproved status does not appear to have diminished its growing popularity, with people using kratom to reportedly ‘treat’ certain health conditions. Its chemical affinity with opioid and use among patients with opioids use disorder as a ‘treatment’ is of public health concern for the Agency,” the FDA said in its August 2 notice. “The use of this substance, that has yet to be tested and determined safe for use in human population by the Agency, is a significant concern.”

The FDA seems particularly interested in studying how consumers buy kratom or psychedelic substances, what benefits they get from them, and whether “marketing strategies nudge purchase and affect use demand.” The FDA hired a market research firm, the Brightfield Group, to conduct an “Exploratory Behavioral Economics Study” to see what motivates kratom and psychedelic users.

The agency could have saved itself some time and money by looking at the findings from a PNN survey of 6,150 kratom users. Over 90% said kratom was “very effective” at treating pain and other medical conditions, and 98% didn’t believe kratom was harmful or dangerous.

‘Embarassing Mistake’

Kratom advocates say the FDA’s withdrawal of the study notice was the “latest embarrassing mistake” the agency has made about kratom.

In 2016, the FDA joined with the DEA in proposing that kratom be classified as an illegal Schedule I controlled substance, a request that was later withdrawn due to the “significant risk of immediate adverse public health consequences” if kratom was banned nationwide. A top federal health official said FDA staff based their scheduling request on “embarrassingly poor evidence & data.”

“The FDA’s few anti-kratom staff are repeatedly undermining the Agency’s credibility on harm reduction strategies,” Mac Haddow, Senior Fellow on Public Policy at the American Kratom Association (AKA), said in a statement. “The FDA remains trapped in the web of their own making that unfairly demonizes products like kratom and psychedelics that, when properly used, are helping people who struggle with addictions and mental health issues and that are saving lives.”

Others disagree about kratom’s safety. The Brightfield Group is tracking social media posts about kratom and is reportedly seeing more online discussions about its risks and addictive properties. While hundreds of deaths have been linked to kratom use, most cases involve other drugs and illicit substances, making it difficult to determine the exact cause of death.  

“Describing kratom as a ‘benign botanical supplement’ is dangerously misleading. Kratom has documented risks, including addiction potential. Downplaying these risks does a disservice to consumers,” says attorney Matt Wetherington, who represents the family of Ethan Pope, a Georgia man who died after consuming a potent kratom extract called Black Liquid Kratom, made by Optimized Plant Mediated Solutions (OPMS).  

Pope’s family has filed a wrongful death lawsuit against OPMS, as well as the AKA and other kratom vendors. The FDA issued a recent alert urging people not to ingest Black Liquid Kratom, a warning the AKA has characterized as a “coordinated effort” by trial lawyers to drum up more clients for a class action lawsuit.  

“The AKA's overall combative tone towards the FDA and trial lawyers is counterproductive. Constantly framing regulators as enemies undermines opportunities for constructive dialogue that could actually benefit kratom users,” says Wetherington. “No one but the FDA actually knows why they withdrew the request to study. Speculating beyond their stated reason is a fool’s errand.”

FDA Warning About Kratom Death Challenged by Critics

By Pat Anson

The FDA is warning consumers not to ingest a liquid kratom extract after the death of one person and “many reports” by users of other serious adverse events, including withdrawal, addiction, anxiety and aggressive behavior.

The FDA’s July 26th alert about Black Liquid Kratom, which is made by Optimized Plant Mediated Solutions (OPMS), contained no details about the death or any of the adverse events. It was soon challenged by the American Kratom Association (AKA), which said the “mistaken and misguided safety alert” should be withdrawn until the FDA independently verified claims about the death.   

In recent years, kratom has become a popular supplement in the United States, where it is used by millions of people to self-treat their pain, anxiety, depression and substance use problems. Although legal in most states, kratom has never been approved for medical use by the FDA.

“Products containing kratom have been marketed as foods, including dietary supplements, or drugs with claims of therapeutic benefits. However, the FDA has not approved any prescription or over-the-counter drug products containing kratom or associated compounds, mitragynine and the more potent metabolite, 7-OH mitragynine,” the alert warned.

“The FDA recently received an adverse event report of a person who died after using OPMS Black Liquid Kratom. This is one of many reports of serious adverse events individuals have reported experiencing after consuming OPMS Black Liquid Kratom.”

The agency released no other information about where or when the death occurred. Only one death involving 7-OH mitragynine is recorded on the FDA’s Adverse Events Reporting System. That case was reported in 2023, but the death may have occurred earlier.

In 2021, a Georgia man died after consuming Black Liquid Kratom. An autopsy concluded that 23-year old Ethan Pope died from cardiac arrest due to mitragynine intoxication. Pope’s family has filed a wrongful death lawsuit against OPMS, the AKA and other kratom vendors.

Kratom is normally sold as a dry unadulterated powder, but Black Liquid Kratom is a highly concentrated 50:1 extract containing up to 375mg of mitragynine — an alkaloid that acts on the same receptors in the brain as opioids.

A kratom vendor that sells Black Liquid Kratom warns the extract is “too strong for use on a daily basis.”

If the 2021 Georgia death is the one FDA is referring to in its safety alert, it raises questions about why the agency waited so long to warn consumers about the extract or why it was never recalled. Black Liquid Kratom can still be purchased from a number of kratom vendors.

"The consistently unreliable and often false statements about kratom issued by the FDA over the past decade, which is a part of its relentless and misguided pursuit of banning kratom products that is not supported by reliable science, are wrong and Commissioner Califf should hold his agency fully accountable," Mac Haddow, Senior Fellow on Public Policy at the AKA, said in a statement.

"The various autopsy reports that have claimed that kratom is the sole cause of deaths have been thoroughly refuted as incomplete, poorly documented, hastily concluded, or demonstrably incorrect."

Alert ‘Coordinated’ by Trial Attorneys

In 2016, the FDA and DEA tried unsuccessfully to ban kratom products nationwide by listing it as a Schedule I controlled substance. An Assistant Secretary for Health in the Trump administration withdrew the FDA’s scheduling request in 2018, saying it was based on “embarrassingly poor evidence & data.”

The AKA characterized the FDA’s alert as another effort to demonize kratom that was being “coordinated” by trial attorneys seeking to cash-in on product liability lawsuits. A New York law firm even cites the alert on its website, telling kratom users that it was “ready to represent you in your injury case.”

“Plaintiff’s trial attorneys have been openly encouraging clients and other anti-kratom advocates to submit complaints to the FDA on alleged deaths over the past few months and have taken to social media platforms to solicit others to do so. The FDA ‘safety alert on kratom’ appears to be the result of a coordinated effort by those trial attorneys who have a financial interest in litigation against the very company the FDA’s safety alert identifies,” the AKA said.

A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps reduce the use of opioids, and has a low risk of adverse effects. Hundreds of deaths have been linked to kratom use, but in the vast majority of cases other drugs and illicit substances were involved.  

A toxicology test on Ethan Pope found antihistamines and antidepressants in his system, but no illegal drugs or alcohol. The Georgia Bureau of Investigation classified his death as an accident.

‘Super High Concentration’ of Kratom Involved in Georgia Man’s Death

By Pat Anson, PNN Editor

The family of a 23-year-old Georgia man who died last year after ingesting a potent kratom extract has filed a wrongful death lawsuit against a kratom manufacturer and a trade association that promotes the company for following good manufacturing standards.

Ethan Pope was found dead on the kitchen floor of his apartment on December 3, with his dog by his side. Pope had recently purchased bottles of Black Liquid Kratom made by Optimized Plant Mediated Solutions (OPMS).

An autopsy concluded that Pope died as a result of cardiac arrest due to mitragynine intoxication, and his death was ruled an accident by the Georgia Bureau of Investigation.

Mitragynine is an alkaloid and one of the active ingredients in kratom, which comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever.

ETHAN POPE

In recent years, kratom has become a popular supplement in the United States, where it is used by millions of people to self-treat their pain, anxiety, depression and substance use problems. It is sold legally in most states, including Georgia, where it can be purchased at gas stations and smoke shops.

Kratom is normally consumed as a dry unadulterated powder, but the Black Liquid Kratom allegedly consumed by Pope is a highly concentrated 50:1 extract, with up to 375mg mitragynine per bottle.

“This super high concentration can be felt with just a drop or two of the extract added to your tea or coffee. Even veteran users of kratom should start slow with this liquid extract because it is so different from other liquid extracts on the market,” is how one kratom vendor markets Black Liquid Kratom.

Another kratom vendor specifically cautions that OPMS extracts are “too strong for use on a daily basis.”

It’s not clear how long, how often or why Pope had been taking kratom, but at a news conference this week his parents said they found a to-do list in his apartment that included the words “Stop taking kratom.”

The family’s lawsuit was originally filed in May and an amended complaint was filed this week, naming over a dozen different individuals, vendors and organizations, including OPMS and the American Kratom Association (AKA).    

“You don’t expect to go into a store and find something similar to heroin between energy drinks and breath mints. We intend to hold every single person and entity involved in the distribution and sale of these products responsible,” attorney Matt Wetherington said in a statement.

The lawsuit drafted by Wetherington makes frequent references to kratom as a heroin-like substance, but there is no relationship between the two. Heroin is derived from opium plants, while kratom comes from mitragynine speciosa trees. Both act on opioid receptors in the brain, however, which has led to claims that kratom is an opioid.

OPMS has not commented publicly on the lawsuit, and the AKA issued a short statement saying it rejected the lawsuit’s claims and filed a motion to be dismissed from the case.

‘100% Natural and Never Adulterated’

OPMS is featured on the AKA’s website as one of the first kratom vendors to comply with its Good Manufacturing Practice Standards Program (GMP), an effort to enhance the safety of kratom products. To get “GMP Qualified” status, vendors have to agree to annual audits, inspections and testing of every production lot of kratom.    

“Optimized Plant Mediated Solutions has been the leader in the Kratom and Kava extract industry since 2010 due to its unique cold water extraction process. All O.P.M.S. products are 100 percent natural and never adulterated,” the AKA says on its website, which includes a link where OPMS products can be purchased directly from the company.

OPMS did not immediately respond to a request for comment from PNN. The company’s website cautions consumers that “several companies illegally counterfeit” its products, adding “dangerous ingredients” that pose a “serious health threat.” It urges consumers to report any suspicious products.

Taken in low doses, kratom acts as a mild analgesic and stimulant. Consumers generally take higher doses to combat severe pain and cravings caused by substance addiction. Most users do not experience a “high” or euphoria after taking kratom.

The Food and Drug Administration has not approved kratom for any medical use and vendors can run into trouble with the agency if they claim kratom can be used to treat health conditions. The FDA tried for years -- unsuccessfully – to schedule kratom as a controlled substance, which would effectively ban its sale and use in the United States. The FDA says kratom’s effects on the brain are similar to morphine and that kratom has “properties that expose users to the risks of addiction, abuse, and dependence.”

Not all federal agencies take such a dim view of kratom. A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

About 100 deaths have been linked to kratom use, but in the vast majority of cases other drugs and illicit substances were involved.  A toxicology test on Ethan Pope found antihistamine and antidepressant medications in his system, but no illegal drugs or alcohol were detected.

FDA Seeking Public Comments on Kratom

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is seeking public comments on the medical use and abuse of kratom. In a notice published Friday in the Federal Register, the FDA said the comments will be reviewed as it prepares a response to the World Health Organization (WHO), which is considering whether to place international restrictions on kratom and six other psychoactive substances.   

Kratom comes from the leaves of the mitragyna speciosa tree in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have discovered kratom and use it to self-treat pain, anxiety, depression and addiction. The FDA has tried -- unsuccessfully so far – to schedule kratom as a controlled substance, which would effectively ban its sale and use in the United States.

Under international treaties, WHO is required to assess the use of psychoactive substances and advise the United Nations on whether they pose a public health risk and should be controlled. The annual assessment will begin in October and U.N. members have been invited to submit their recommendations.

Although the FDA said the U.S. will defer from making any immediate recommendations to WHO, the notice in the Federal Register makes plain that the agency still has a dim view of kratom. It makes no mention of the medical benefits many kratom users get from the herbal supplement.

“Kratom has a history of being used as an opium substitute in Southeast Asia. In the United States, kratom is misused to self-treat chronic pain and opioid withdrawal symptoms.”

— FDA

“Kratom is an increasingly popular drug of abuse and readily available on the recreational drug market in the United States. Evidence suggests that kratom is abused individually and with other psychoactive substances,” the FDA said.

“Kratom has a history of being used as an opium substitute in Southeast Asia. In the United States, kratom is misused to self-treat chronic pain and opioid withdrawal symptoms. Consumption of kratom can lead to a number of health impacts, including, among others, respiratory depression, vomiting, nervousness, weight loss, and constipation. Kratom has been reported to have both narcotic and stimulant-like effects.”

The American Kratom Association (AKA), a group of kratom vendors and consumers, said FDA instigated WHO’s review of kratom as a way to bypass the drug scheduling process in the U.S. The AKA is urging kratom consumers to submit positive comments about the herbal supplement.  

“The comments should be focused on the experiences that kratom consumers have had with kratom and how it has benefited them in terms of improving their quality of life, to reduce pain, to reduce anxiety and depression, to wean off of opioids, and how kratom has saved their lives,” Mac Haddow, an AKA lobbyist, said in a video. “We want the WHO to know the powerful experiences that people have had. We want to protect kratom, not only here in the United States, but also around the world.”

There’s an August 9 deadline for comments, which can be submitted here.

Asked if the FDA requested WHO to review kratom, a spokesperson told PNN the agency “does not determine for the U.S. government which substances shall be proposed” for review. WHO reviews can be requested by any member countries that are signatories to international drug control treaties.

Kratom’s legal status varies around the world. Thailand recently decriminalized kratom and will make the plants legal to grow and export in August. Kratom use is banned domestically in Indonesia, but kratom farming is still permitted. Most kratom exports come from Indonesia, where it is considered an important cash crop.

Kratom sales are legal in most U.S. states, although some states and communities have banned it. The FDA recently seized 37 tons of kratom from a vendor in Florida for alleged violations of a federal law that prohibits the sale of adulterated dietary supplements.

A federal effort in 2016 to ban kratom nationwide failed due to a public outcry. Two years later, the Department of Health and Human Services (HHS) withdrew a request to classify kratom as a Schedule I controlled substance, citing lack of evidence it can be abused or posed a public health threat. A top HHS official later said the FDA request to schedule kratom was rejected because of “embarrassingly poor evidence & data.”

Study Estimates Two Million Americans Use Kratom

By Pat Anson, PNN Editor

A new study estimates that less than one percent of Americans -- about two million people --- use kratom, an herbal supplement that’s growing in popularity as a treatment for pain, depression, anxiety and addiction.

The study, one of the first to look at kratom use in the general population, is based on data from the 2019 National Survey on Drug Use and Health – the first year the annual survey asked respondents about kratom.

Researchers at New York University’s Grossman School of Medicine looked at data from over 56,000 people who participated in the survey and estimated that 0.7 percent of adults and adolescents in the U.S. used kratom in the past year.

Kratom use was more likely by people who also use cannabis, stimulants and cocaine, and was particularly common among those who misuse prescription opioids. About 10 percent of people diagnosed with opioid use disorder reported kratom use.

“It was not surprising at all that such a large portion of people with opioid use disorder use kratom. What I didn’t expect was to find kratom use to be independently linked to cannabis use disorder,” said study author Joseph Palamar, PhD, an associate professor of population health at NYU Grossman School of Medicine.

“A lot of people who use substances to get high also use other substances to get high — alone or in combination. If anything, I hope that results of this paper demonstrate not only that a lot of people with opioid use disorder use kratom, but also a lot of people who use other drugs have been adding this substance to their drug repertoires for whatever reason.”

Men, white people, and those with depression and serious mental illness were also more likely to report using kratom. Teenagers and adults over 50 were less likely to use it.

The findings are similar to those in a 2016 PNN survey of over 6,000 kratom users. A little over half said they primarily used kratom for pain relief, while others used it as a treatment for anxiety (14%), opioid withdrawal (9%), depression (9%) and alcoholism (3%).  Over 90% said kratom was “very effective” in treating their medical condition.   

“A lot of people who use kratom rave about its ability to decrease opioid withdrawal, but kratom itself can be addicting so people need to be aware and be careful. Kratom might indeed be able to serve as a useful tool for people seeking to get off opioids, but I think more research is needed to determine exactly how it should be used and how to use it safely,” Palamar said in an email to PNN.

The study, published in the American Journal of Preventive Medicine, notes that over 150 overdose deaths linked to kratom have been reported. But most of those overdoses also involved other drugs such as illicit fentanyl, heroin and cocaine, or prescription drugs such as benzodiazepines and psychiatric medications.    

“Given the high number of poisonings involving kratom combined with other drugs, I hope that at least people who decide to use it try to avoid combining it with other substances,” Palamar said.

Kratom comes from the leaves of a tree that grows in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever. Kratom can be sold legally in most U.S. states, but vendors can run into trouble if they claim it can be used to treat medical conditions. The FDA says it has “serious concerns” about kratom because of its opioid-like properties.

A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

The American Kratom Association, an advocacy group for kratom consumers and vendors, claims that 10 to 16 million Americans use kratom. That estimate is based on exports to the U.S. reported by kratom growers in Indonesia.

FDA Updates Import Alert for Kratom

By Pat Anson, PNN Editor

Federal health officials may have dropped plans to schedule kratom as a controlled substance, but that’s not stopping the Food and Drug Administration from updating an import alert that gives the agency broad powers to seize shipments of the herbal supplement.

The alert targets dozens of kratom exporters and importers in the United States, Canada, Indonesia, Malaysia and the Philippines, and allows FDA inspectors to detain “without physical examination” dietary supplements and ingredients that contain kratom.  In an email, an FDA spokesperson told PNN the alert was updated for “minor changes” involved with one firm’s listing  

Kratom is an herbal supplement that comes from the leaves of a tree that grows in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have discovered kratom, using it to self-treat their chronic pain, anxiety, depression and addiction.

The FDA says it has “serious concerns” about kratom because of its opioid-like properties.

“Consumption of kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms,” the alert warns.

The FDA issued its first import alert for kratom in 2012, just as kratom was gaining in popularity in the U.S. Since then, several large shipments of raw kratom or kratom supplements have been seized. One of the largest seizures was in 2018, when 28 tons of kratom were confiscated at a South Carolina warehouse operated by Earth Kratom, a kratom wholesaler and vendor. The kratom was later incinerated.   

Kratom can be sold legally in most U.S. states, but vendors can run into trouble if they claim it can be used to treat medical conditions or market it as a dietary supplement.

A lobbyist for the American Kratom Association, an association of kratom vendors and consumers, said the updated alert is part of the FDA’s “disinformation campaign” against kratom.

“The FDA routinely uses the import alerts in discussions with various stakeholders to highlight their claims that kratom is not ‘legally marketed’ in the United States, and by adding a recent date by way of an update makes it appear to be a recent action,” said Mac Haddow. “The import alert is an abuse of that authority that is supposed to apply to contaminated and adulterated products.

“In fact, the objections listed in the import alerts issued by the FDA technically only apply to importers who are subsequently making illegal therapeutic claims or as a dietary supplement on marketing materials. A bulk kratom importer is not subject to FDA's authority. Kratom processors who make no claims and sell kratom as a food are not subject to any pre-market approval by the FDA.”

Federal efforts to ban kratom in 2016 failed due to a public outcry. Two years later, federal health officials quietly withdrew their request to classify kratom as a Schedule I controlled substance because of “lack of evidence” it can be abused or posed a public health threat. The FDA, however, still maintains “significant potential safety concerns” about kratom. 

A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

Feds Withdrew Request to Ban Kratom in 2018

By Pat Anson, PNN Editor

Federal health officials quietly withdrew their request for kratom to be classified as a Schedule I controlled substance in August 2018, according to a previously undisclosed letter to the U.S. Drug Enforcement Administration.

The letter from Brett Girior, MD, Assistant Secretary for Health & Human Services (HHS), to the DEA’s acting administrator cited concerns that “there is a significant risk of immediate adverse public health consequences to potentially millions of users if kratom or its components are included in Schedule I.”

Kratom is an herbal supplement comes from the leaves of a tree that grows in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have discovered kratom, using it to self-treat their chronic pain, anxiety, depression and addiction. Classifying kratom’s two active ingredients, the alkaloids mitragynine and 7-hydroxymitragynine, as Schedule I substances would effectively ban kratom by making its sale and possession illegal.  

The 2018 letter from HHS was made public this week by the American Kratom Association (AKA), an advocacy group for kratom consumers and vendors, which said it obtained the letter from Rep. Mark Pocan (D-WI).

“The decision by the FDA to not disclose the recission of their recommendation for scheduling of kratom that took place more than 2 ½ years ago has significantly misled policy makers, the media, and kratom consumers in the belief a scheduling decision was imminent,” Mac Haddow, Senior Fellow on Public Policy for the AKA, said in a statement. “Six states were duped by this messaging to pass bans on kratom sales, and a number of local county and city governments also based their bans on the FDA’s claims.

“Through all of this the FDA has remained silent and has failed to disclose that HHS reviewed their scheduling recommendation and took the unprecedented action to rescind the recommendation because the FDA had failed to meet its burden under the CSA (Controlled Substance Act).”

An FDA spokesperson said it was not up the agency to disclose the letter’s existence.

“While the FDA is an agency within HHS, the letter at issue was not the FDA’s to publicly disclose and any announcement regarding a decision to schedule or not schedule a potential controlled substance is made by the Drug Enforcement Administration, not the FDA,” the spokesperson said in an email to PNN.

‘Lack of Evidence’ Kratom is Harmful

Girior’s letter to DEA said there was a “relative lack of evidence” that kratom can be abused and posed a public health threat.

“Although there remains cause for concern for 7-hydroxymitragynine and potentially mitragynine, the level of scientific data and analysis presented by the FDA and available in the literature do not meet the criteria for inclusion of kratom or its chemical components in Schedule I of the CSA at this time,” Girior wrote. 

“There is still debate among reputable scientists over whether kratom by itself is associated with fatal overdoses. Further analysis and public input regarding kratom and its chemical components are needed before any scheduling should be undertaken.”  

The DEA tried unsuccessfully to list kratom as a Schedule I substance in 2016, calling it an “imminent hazard to public safety,” a decision that was reversed after a public outcry from kratom supporters. 

But federal efforts to demonize kratom continue to this day, led for a time by FDA Commissioner Scott Gottlieb, who claimed kratom was an opioid and should not be used to treat any medical condition. Gottlieb resigned as FDA Commissioner in 2019, eight months after Girior’s letter. The agency he led remains opposed to kratom.   

“Kratom products have been associated with significant potential safety concerns. While it is important to gather more evidence, data suggest that certain substances in kratom have opioid properties that expose users to the risks of addiction, abuse and dependence,” the FDA spokesperson said.

“There is no FDA-approved drug containing, or derived from kratom, and the agency has received concerning reports about the safety of kratom. The FDA is actively evaluating available scientific information on this issue. In addition, FDA has sent numerous letters to firms that have marketed kratom products with unsubstantiated claims that their products can treat opioid withdrawal and addiction and other serious medical conditions.”

Kratom use has been growing in the U.S. as people seek alternatives to opioid pain relievers and other pharmaceutical drugs. Most kratom users say the leaves have a mild analgesic and stimulative effect, similar to coffee.  

A recent study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and is “relatively safe” to use.

Kratom Advocates Call for End to ‘Leafer Madness’

By Pat Anson, PNN Editor

If you are curious about the herbal supplement kratom and did some research online to learn more about it, chances are you’ve come across some of the scary headlines:

“Warnings Issued on Kratom Use”

“The Herbal Supplement That Could Poison You”

“Kratom Is Unsafe for People’s Health”

“Kratom: Deadly Supplement or Supplementing Death?”

With news coverage like that, you might wonder why anyone would try kratom. But according to the American Kratom Association, there are 16 million kratom users in the United States, most taking it to treat chronic pain, addiction, withdrawal or anxiety.

Why is a popular supplement being demonized in the media? Kratom advocacy groups say many news organizations in the U.S. have succumbed to a collective case of ‘Leafer Madness’ – similar to the ‘Reefer Madness’ over marijuana.

In a media analysis released in May, the industry-funded Kratom Information and Resource Center (KIRC) concluded there was a “tsunami of unfair and unbalanced” reports on kratom.

Ninety-two percent of the nearly 2,500 media stories analyzed by KIRC were found to be negative or unbalanced. Most of the negative coverage was by local media, which was heavily influenced by FDA and CDC reports linking kratom to overdose deaths or comparing kratom to opioids. Those reports were rarely questioned by reporters who didn’t seek another opinion.

This week KIRC followed up on its media analysis by sending a petition to nine media trade organizations asking that kratom be covered more fairly.

“You are in a position to encourage your members to start reporting on the coffee-like herb kratom in a fair and balanced way. Please urge them to tell both sides of the story, seek out the reputable scientists who dispute claims made against kratom, and stop depicting kratom consumers as unsavory characters.

“To date, most ‘reporting’ about the kratom consumed today by millions of American adults without ill effect has been sensationalistic and one-sided, the modern-day equivalent of the irresponsible and inaccurate ‘Reefer Madness’ media depictions that once were used to justify keeping in place restrictions on marijuana and to stigmatize those choosing to consume it.”

The nine media trade groups receiving the KIRC petition are: The American Society of News Editors, National Association of Science Writers, Association of Health Care Journalists, News Media Alliance, Investigative Reporters and Editors, National Newspaper Association, The Association of Magazine Media, Society of Professional Journalists and The National Association of Broadcasters.

“Stop treating kratom like some kind of pinata that you can whack away at as though the rules of journalism don’t apply,” KIRC spokesperson Max Karlin said in a statement.

“Our message to the media is very simple: Get your facts straight about kratom and listen to all voices, not just those with the biggest megaphones. There is a great deal of scientific disagreement about kratom when it comes to such issues as pain management and dependency. All experts should be heard, not just a cherry-picked few who have been lined up by proponents of prohibition.”

The “scientific disagreement” over kratom stems from the fact that so little is known about it – even though it’s been used for centuries in southeast Asia as a natural pain reliever and stimulant.  There have been few clinical studies of kratom to document its risks and benefits — leaving mostly anecdotal reports to rely on.

Still Interested in Learning About Kratom?  

One can find a lengthy and balanced review of kratom that was recently published in the journal Substance Abuse and Rehabilitation.  The authors — two pharmacy professors at the University of Florida and Midwestern University in Arizona — question the claims about kratom causing overdoses, because “causality could not be established in almost all cases because of poly-drug exposures.”

And while reports of kratom addiction “are of serious concern” given the opioid crisis, Oliver Grundmann, PhD, and Charles Veltri, PhD, found no solid evidence that kratom causes dependency.

At the same time, however, they urge kratom consumers to be cautious about be exposed to kratom products that could interact with medications they are already taking.

“The labeling of Kratom products available to consumers needs to follow appropriate regulatory standards as well as quality good manufacturing practices to ensure that consumers who seek out Kratom are not exposed to adulterated or contaminated products,” Grundmann and Veltri wrote. “Health care providers should be trained on the science of Kratom and its clinical implications to assist consumers in making the right choice and avoid herb–drug interactions.”

Indonesia May Ban Kratom Exports

By Pat Anson, PNN Editor

A possible ban on the growth and export of kratom in Indonesia is raising alarm among kratom users in the U.S. and around the world.  About 95% of the world’s supply of kratom comes from Indonesia, where the herbal supplement has become a lucrative cash crop.

Kratom leaves are harvested from a tree that grows in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have started using kratom to treat pain, addiction, anxiety and depression.

Kratom advocates say the U.S. Food and Drug Administration – which opposes the use of kratom for any medical condition – has been lobbying the Indonesian government to ban kratom farming. Current plans by the Indonesian Ministry of Health call for a 5-year transition period to allow kratom growers to shift to other crops.

“If this ban is allowed to go into effect, it will effectively end consumer access to kratom in the United States, and the FDA won’t have to do anything more to declare victory in the War on Kratom,” said C. M. “Mac” Haddow, a lobbyist for the American Kratom Association (AKA), a group of kratom vendors and consumers.

“Even if some black-market kratom gets into the United States after the Indonesian ban goes into effect, it will be so expensive that only the uber-rich will be able to afford it. And it will likely be extremely dangerous to consume because there will be no standards on growing, harvesting, and shipping.”

FDA Denies Involvement

An FDA spokesman said the agency has “inquired” about kratom in Indonesia, but denied making any effort to have it banned.

“The FDA has inquired to understand the current status of kratom under Indonesian law. However, the FDA has not advocated either formally or informally about a change in law in Indonesia or any other country relative to kratom,” the spokesman said in an email to PNN.

The AKA sent a delegation to Indonesia last month to meet with the Ministry of Health and other government officials. Among the attendees was Duncan Macrae, the founder of Kratom.com and one of the first commercial growers of kratom in Indonesia. Macrae told PNN the initial meeting went well.

“When we left Jakarta we were given the green light that there would always be a legitimate path to export kratom even though the Indonesian government will almost definitely regulate and make kratom illegal for domestic use in Indonesia,” Macrae wrote in an email. “Unfortunately, since there was some (in my opinion) unnecessary outreaching to other departments such as the Agriculture & Quarantine department and also the department of trade, this has stirred up another hornet’s nest.” 

According to the AKA, the Ministry of Agriculture sent a memo in the past week to various agencies in the Indonesian government recommending the ban on kratom be formalized at all levels of government.  

Macrae fears that kratom will also be classified as an illegal controlled substance in Indonesia, which would effectively ban its growth and export.  

“Was the FDA involved? For sure yes! Unfortunately, this went through the U.S. embassy in Jakarta as well.”

— Duncan Macrae, Kratom Supplier

“This means it has no scientific or medicinal use and will even prevent further research from being done on the plant in Indonesia,” said Macrae. “Was the FDA involved? For sure yes! Unfortunately, this went through the U.S. embassy in Jakarta as well.” 

A leading Indonesian politician called on the government to ignore the “world health mafia” and conduct research on the risks and benefits of kratom before banning it.

"Once again the government does not play a ban without doing deep professional research. It is tantamount to throwing away the nation's own assets. In the end Indonesia will only be an importer of finished products from kratom leaves," Daniel Johan, Deputy Chairperson of the House of Representatives, told a local news agency. "Indonesia must master its downstream products so that it is truly beneficial for the people of Indonesia and the world, so that we do not even enter the format of world health mafia war."

Kratom is already banned for domestic use in Indonesia, although the export of raw kratom product is allowed. In 2016, about 400 tons of kratom were shipped every month from Indonesia’s top growing region -- worth about $130 million annually, according to a report from Agence France-Presse. Most of those exports went to the U.S.

The FDA has linked kratom to dozens of fatal overdoses -- although multiple substances were involved in nearly all of those deaths. The FDA has also found salmonella bacteria and heavy metals in a relatively small number of kratom products. 

Last year, the Department of Health and Human Services (HHS) recommended to the DEA that kratom be classified as a Schedule I substance – which would effectively ban it nationwide. Currently, the DEA doesn't even list kratom in its annual report on drug threats. 

The AKA is planning to send another delegation to Indonesia this month to lobby against a kratom ban.

More Overdoses Blamed on Kratom

By Pat Anson, PNN Editor

A new analysis by the Centers for Disease Control and Prevention lists the herbal supplement kratom as the cause of death in at least 91 overdoses in the U.S. from 2016 to 2017.  Multiple substances were involved in the vast majority of those cases, with over half of the deaths also linked to fentanyl, a synthetic and potent opioid that has become a scourge on the black market.

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. In recent years kratom has grown in popularity in the U.S. as a treatment for chronic pain, addiction, depression and anxiety.  

Although kratom is not an opioid, public health officials have warned that it has “opioid-like” qualities, can be addictive and is not approved for any medical condition.

In the new study, CDC researchers analyzed over 27,000 fatal overdoses in 27 states between July 2016 and December 2017. Kratom was determined to be the cause of death by a medical examiner or coroner in 91 overdoses, with multiple substances detected in all but seven of them.

Heavy Drug Use

Most of those who died were apparently heavy drug users. In nearly 80 percent of the kratom-involved deaths, the decedents had a prior history of substance misuse and 11% had survived a previous overdose.  Fentanyl or fentanyl analogs were co-listed as a cause of death in 56% of the kratom-involved deaths. Heroin was co-listed in about a third of the kratom cases, followed by benzodiazepines (22%), a class of anti-anxiety medication, prescription opioids (20%) and cocaine (18%).

“I’m actually pleased that they are recognizing that when kratom is present in a decedent, it is usually with other substances. Instead of blaming kratom as the cause of death, it points to polysubstance use,” said Jane Babin, PhD, a molecular biologist and patent attorney. “If someone takes a lethal dose of fentanyl plus kratom, it is unreasonable to conclude that kratom was the cause of death.  The same could be said of a lethal dose of fentanyl plus anything else – cannabis, coffee, Tylenol, etc.  This is the same situation in many ‘opioid related’ deaths, where multiple substances are present.”

Babin has worked as a consultant to the American Kratom Association, an advocacy group of kratom vendors and consumers. She has disputed previous reports of kratom overdoses – attributing them to faulty lab tests and inexperienced coroners.

“When a coroner can’t find an obvious physical cause of death, they pin the death on kratom even though they don’t have a link between the cause and manner of death and what is known about kratom pharmacology,” Babin wrote in an email to PNN. “I think the bigger question that CDC and FDA need to address is why do these people take so many different substances, including prescription medications?  

“The answer is not simple and there is no quick fix.  It is easier to blame kratom or opioids and focus on those instead of addressing the complex problems of pain, mental illness and the circumstances of life that lead people to take multiple substances.  At least they ‘look’ like they are doing something.”

It was another CDC report in July 2016 that laid the groundwork for an attempted ban on kratom. The report called kratom "an emerging public health threat" due to a modest increase in the number of kratom-related calls to poison control centers. The following month, the Drug Enforcement Administration tried to schedule kratom as a controlled substance, something the agency backed away from after a public outcry.

Last week the Food and Drug Administration released a laboratory analysis that found dangerous levels of heavy metals in over two dozen kratom products. However, the agency did not consider the finding significant enough to order a recall. Kratom has never been listed as dangerous substance in the DEA’s annual National Drug Threat Assessment.

FDA Finds Unsafe Levels of Heavy Metals in Kratom

By Pat Anson, PNN Editor

The American Kratom Association’s new certified vendor program has gotten off to an inauspicious start. Kraken Kratom, the first vendor to qualify under the AKA’s Good Manufacturing Standards (GMP) program, has been flagged by the Food and Drug Administration for having dangerous levels of heavy metals in some of its products.

The FDA this week released the final test results on 30 kratom products found to contain levels of lead and nickel considered unsafe for daily human consumption. Five of the 30 samples that tested positive came from Kraken Kratom or one of its affiliated vendors.

“The analysis found significant levels of lead and nickel at concentrations that exceed safe exposure for oral daily drug intake,” the FDA said in a statement. “Based on these test results, the typical long-term kratom user 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.”

Ironically, last month Kraken Kraken became the first company to receive the AKA’s seal of approval as a certified GMP vendor. To qualify, participants must undergo a third-party audit and inspection of their manufacturing and packaging facilities.   

The company said in a statement posted online that it was never contacted by the FDA about the heavy metal findings or told to take its kratom products off the market.

“Kraken has no information regarding the samples the FDA used in their tests, including when or how the FDA acquired our products or when they tested the samples they obtained,” the statement said.

This isn’t the first time Kraken Kratom has come under FDA scrutiny. Its parent company, PDX Aromatics of Portland, Oregon, recalled thousands of kratom packages last year after samples tested positive for Salmonella bacteria. The company believes the samples that tested positive for heavy metals may have come from an FDA inspection in March, 2018.

“If these samples are from that investigation, their product lots were pulled from the market over 12 months ago as part of the extensive recall we did in cooperation with the FDA. Further, it would indicate that the FDA was rehashing old information, not in an attempt to protect the public, but as a way to target and further stigmatize kratom,” the company said.

In recent years, millions of Americans have discovered kratom, an herb grown and used in southeast Asia for centuries as a natural stimulant and pain reliever. Kratom is widely available online and in smoke shops, but the quality of what’s being sold and what country it came from are often unknown. Like other dietary supplements, kratom products are essentially unregulated and there are little or no quality controls.

That’s one of the reasons the AKA launched its GMP certification program. The organization said it wanted to protect kratom consumers from “unscrupulous vendors using sloppy manufacturing procedures” and those who adulterate kratom to boost its potency by adding substances like fentanyl or morphine.

But under the AKA’s certification program, no kratom products are actually tested for Salmonella bacteria, heavy metals, fentanyl or any other foreign substances.

“No, absolutely not. That is not our function,” AKA President Dave Herman told PNN. “The audit does not inspect the products. The audit inspects the procedures in place to manage the facility.”

Herman says third party auditors hired by the vendor and approved by the AKA only inspect manufacturing procedures — not the kratom itself. He declined to comment on the FDA’s discovery of heavy metals in Kraken Kratom products.

“I have no way of knowing when samples were taken or under what conditions they were taken,” he said. “Was it prior to an inspection? After an inspection? And without that knowledge I’m not sure I can say anything intelligent,” Herman said.

A handful of states have banned kratom and there is speculation the Drug Enforcement Administration will try again to schedule it as a controlled substance, something the agency backed away from in 2016 after a public outcry. FDA commissioner Scott Gottlieb, MD – who leaves office today -- has also mounted an extended public relations campaign against kratom.

"Over the last year, the FDA has issued numerous warnings about the serious risks associated with the use of kratom, including novel risks due to the variability in how kratom products are formulated, sold and used both recreationally and by those who are seeking to self-medicate for pain or to treat opioid withdrawal symptoms,” Gottlieb said in a statement.

“Data suggest that certain substances in kratom have opioid properties and that one or more have the potential for abuse. The findings of identifying heavy metals in kratom only strengthen our public health warnings around this substance and concern for the health and safety of Americans using it."

Is Kratom Being Spiked With Other Drugs?

By Pat Anson, PNN Editor

It’s no secret that illicit fentanyl has become a scourge on the black market. The potent synthetic opioid – about 100 times stronger than morphine --  is now involved in over half of U.S. overdoses. Fentanyl is being found in a wide variety of street drugs, including heroin, meth, cocaine and marijuana, and it is increasingly used in the manufacture of counterfeit painkillers and other fake medications.  

“As traffickers have expanded into the sale of fentanyl-containing counterfeit pills, the scope of users who were exposed to fentanyl increased significantly; the prescription pain reliever misuser population is almost ten times that of the heroin user population,” a recent DEA report warns. “The presence of fentanyl-containing counterfeit pills in an area is increasingly associated with spikes in overdose deaths.”

Although there is no hard evidence that drug dealers are mixing fentanyl with kratom to boost its potency, some in the kratom community think it is inevitable that someone will try. There have already been cases of kratom products being adulterated with hydrocodone and other opioids.

“I don’t know that there’s been a case of fentanyl in kratom, but since that’s what they are finding in everything else and that is the most dangerous drug out there now, it stands to reason that someone who would spike kratom with hydrocodone would now spike it with fentanyl either wittingly or unwittingly,” said Jane Babin, PhD, a molecular biologist and consultant to the American Kratom Association (AKA), an advocacy group for kratom vendors and consumers.

Like other dietary supplements, kratom products are essentially unregulated and there are little or no quality controls.

In an effort to change that, this week the AKA officially launched a good manufacturing practice (GMP) program, which will require producers of kratom products to meet strict manufacturing standards verified by a third-party auditor if they want to be certified by the AKA.  

"The AKA GMP Standards Program will help reassure the public and demonstrate to the FDA, DEA, lawmakers, and others that the kratom industry is acting responsibly," AKA president Dave Herman said in a statement. 

"The AKA GMP Standards Program will also protect kratom consumers from unscrupulous vendors who produce kratom products using sloppy manufacturing procedures that allow for contamination, and equally important the standards program will exclude vendors who deliberately adulterate kratom products to boost their effect by adding dangerous and sometimes deadly substances like fentanyl or morphine." 

In recent years, millions of Americans have discovered kratom, which has been used in southeast Asia for centuries as a natural stimulant and pain reliever. Kratom is widely available online and in smoke shops, but the quality of what’s being sold and where it comes from is often unknown – even by the people selling it.

“The stuff that’s sold as kratom in the United States cannot be reliably proven to be kratom,” Edward Boyer, MD, a Professor of Emergency Medicine at Harvard Medical School, recently told PNN.  “There is evidence to suggest that some of the kratom sold in the United States is adulterated to make it more potent, to make it more powerful.”

Boyer says some kratom products have been found to contain artificially high levels of 7-hydroxymitragynine, one of the naturally occurring alkaloids that make kratom act on opioid receptors in the brain. Manufacturers may also be lacing kratom with opioids and other drugs.

“One theory is that some unscrupulous vendors may be spiking kratom with something more potent to drive business. It may be even more prevalent than we know, which could account for some of the reports on Reddit and Blue Light (online message boards) that say kratom is addictive and it does lead to euphoria,” Babin said in an email.

A handful of states have already banned kratom and there is speculation that the DEA will soon try again to schedule it as a controlled substance, something the agency backed away from in 2016 after a public outcry. The FDA has recently mounted a public relations campaign against kratom, what the AKA calls a “shadow ban” that has led to kratom shortages.

Could the AKA’s effort to improve the quality of kratom products backfire by giving ammunition to federal regulators who want a nationwide ban?

“That kratom may be adulterated is not a reason to ban it.  There are reports all the time of dietary supplements, even ones sold by reputable companies like GNC and Vitamin Shoppe, are adulterated with prescription drugs, banned substances and who knows what else,” says Babin.

“The other thing to consider is that if kratom is banned, demand may lead to a black market.  It will likely be smuggled in and/or products not containing kratom will be sold as kratom and those may be spiked with other substances, including fentanyl.”

Is FDA ‘Shadow Ban’ Causing Kratom Shortages?

By Pat Anson, PNN Editor

The American Kratom Association (AKA), an advocacy group for kratom vendors and consumers, came out with an alarming bulletin this week.

“BREAKING: FDA Commissioner Scott Gottlieb is shutting down kratom supplies shipments to the United States. The AKA is running out of time and resources to make sure we can secure the supply chain for you to purchase kratom,” read the post on the AKA’s Facebook page.

The bulletin claimed the FDA was trying to “criminalize kratom users” and then launched into a fundraising appeal asking supporters to “dig deep and send a contribution right now” to the AKA to support its lobbying efforts.

At best, the AKA’s bulletin was premature. At worst, it was misleading. Gottlieb is certainly no friend of kratom, but he’s not issued orders shutting down imports of kratom, an herbal supplement long used as a stimulant and pain reliever in southeast Asia.

The FDA declared an “import alert” for kratom in 2012 and again in 2014 – long before Gottlieb became commissioner – authorizing the seizure of dietary supplements containing kratom. Several large shipments were confiscated as a result of the alert, but clandestine imports of kratom into the U.S. continued largely unchecked.

Kratom has since become widely available online and in many smoke shops, and millions of Americans have discovered kratom can be used to self-treat their chronic pain, anxiety, depression and addiction.

AKA president Dave Herman told PNN the bulletin was based largely on anecdotal reports from a handful of vendors who had kratom shipments confiscated in recent months.  

“I’m sure some of them don’t want to talk about it, but I’ve talked to at least four or five that said their stuff has been grabbed,” Herman said. “I know of one vendor that had a hundred tons literally confiscated.

“We feel from day one that commissioner Gottlieb has been running a shadow ban. It’s clearly an attempt to ban and they’re using any and all portals to do that. But can I hand you a piece of paper (from FDA) that says, ‘We’re doing it?’ No.”

Herman said some kratom vendors are down to a few weeks supply.  

“There’s a lot of fear about what’s going on out there,” he said.

Kratom Demonized

Inflammatory rhetoric and scare tactics have become increasingly common in the escalating debate over kratom.

Gottlieb publicly calls kratom an “opioid” – even though its active ingredients are alkaloids -- while claiming there is “no evidence to indicate that kratom is safe or effective for any medical use.” Last year, the FDA claimed dozens of fatal overdoses were associated with kratom, while admitting nearly all of the deaths involved other drugs and “could not be fully assessed.”

Several kratom products were recalled earlier this year during an FDA and CDC investigation of a small salmonella outbreak associated with the herb. Although the source of the outbreak was never identified and only about 200 people were sickened, Gottlieb said “anyone consuming kratom may be placing themselves at a significant risk of being exposed to salmonella.”

More recently, Ohio health officials have claimed kratom produces a “heroin-like high” and was being used intravenously by drug addicts – a notion that most kratom users found preposterous.

“Who the hell is injecting kratom? These people are out of their minds,” one reader told us.

The FDA did not directly respond to a request for comment on the AKA’s bulletin, only saying that “certain kratom products and importers” were targeted in its 2012 import alert. But Herman says it is clear to him what’s happening in 2018. “It’s a full demonization. I don’t think there is any doubt about that,” he said.

Herman believes federal health officials may be trying to avoid scheduling kratom as a controlled substance, something the DEA tried and failed to do in 2016 after a public outcry.  Scheduling kratom would require a public comment period and likely get Congress involved, which the FDA can avoid with a “shadow ban.”

“It’s a concerted effort. There is a (kratom) shortage out there. The shortage didn’t exist previously,” Herman said. “The range I’ve heard of any (vendor) inventory is the highest is 6 months and the lowest is two weeks. There’s definitely a movement there and its harder and harder to get the product into the country.”

When asked if the AKA bulletin could incite fear and lead to hoarding and price increases, Herman was circumspect.

“Some people will stock up. Some won’t,” he said. “How people react, I can’t anticipate. I don’t know the answer to that. I do know that’s there’s a shortage of product. And I think prices have already risen, best as I can tell.”   

Do Drug Addicts Really Shoot Kratom?

By Pat Anson, PNN Editor

Our story last week about drug addicts in Ohio allegedly shooting kratom to get a “heroin-like high” angered many people who use the herbal supplement to treat chronic pain and other medical conditions.

“Who the hell is injecting kratom? These people are out of their minds,” wrote one reader.

“No one and I mean no one has ever injected kratom. Kratom is a wonderous, natural plant with many positive effects,” said Erik.

“It’s pathetic that lies like this are being spread about a natural leaf that helps with pain,” wrote Jennifer Greenwood. “Nobody buys kratom from heroin dealers.”

But that’s exactly what the Ohio Substance Abuse Monitoring Network (OSAM) reported earlier this year in its statewide assessment of drug abuse trends. OSAM called a kratom “a psychoactive plant” and claimed drug users in northeast Ohio were buying kratom from heroin dealers and then injecting it.

“Participants reported that the most common route of administration for kratom is intravenous injection (aka “shooting”). Participants in the Akron-Canton region estimated that out of 10 kratom users, seven would shoot the drug and three would orally consume the drug (including drinking it as a tea),” OSAM said.

The OSAM report was cited by the Ohio Board of Pharmacy when it voted last week to classify kratom as a Schedule I controlled substance, alongside heroin, LSD and other dangerous drugs.

The board said kratom can cause hallucinations, psychosis, seizures, weight loss and insomnia, and cited six deaths in Ohio in which kratom was “the primary cause of death.”

The FDA and DEA have made similar claims about the health risks of kratom, but OSAM appears to be the first public agency to allege that kratom is taken intravenously. Repeated calls to OSAM for further information were not returned.    

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a pain reliever and stimulant. In recent years, millions of Americans have discovered kratom and started using it as a treatment for pain, addiction, anxiety and depression.

“I don’t think most kratom users are injecting it.  Most users that I’ve ever talked to either mix it with a beverage, ‘toss and swish’, or take capsules,” says Jane Babin, PhD, a molecular biologist and consultant to the American Kratom Association, an organization of kratom vendors and consumers.

While skeptical that anyone would inject kratom, Babin says some addicts are desperate enough to try anything. She thinks the kratom sold by drug dealers in Ohio could be adulterated heroin.

“They describe kratom as a brown substance that resembles heroin.  So I can’t help wondering if what they were using was heroin or at least something other than kratom,” Babin wrote in an email to PNN.

“I can’t imagine that they would be mixing powdered leaf kratom with liquid, heating it and injecting it.  There’s too much insoluble plant matrix/cellulose.  If they did, I would expect problems unless they could filter it… which isn’t likely.  Injecting an ethanol extract directly would likely cause tissue damage, and I have to wonder how sterile any of it is.”

But there is a case in the medical literature of a 29-year old Rhode Island man doing just that. He started using kratom to treat his opioid addiction, but eventually developed a tolerance for it and needed more.

“He was initially drinking Kratom tea daily, then several times daily, until he found a way to inject it intravenously,” researchers reported last year in the Journal of Toxicology and Pharmacology.

“He began buying Kratom extract in alcohol. He let the alcohol evaporate in a spoon, and then dissolved the remaining resin in water to inject. Subsequently, he began cooking off the alcohol with heat. Finally, the patient said that he was impatient, and began injecting the extract directly. At the time of presentation, he was buying Kratom extract from multiple online vendors, and injecting 1 ml of extract six times daily.”

The man eventually checked himself into an emergency room and sought treatment for kratom addiction.

“This case is an important reminder of the chronic nature of opioid addiction, which has a high rate of relapse. As Kratom becomes more popular in patients seeking abstinence from opiates, including heroin, such intravenous use may also increase,” researchers warned.

Adulterated Kratom

One of the co-authors of that study believes there is another potential risk. Like other food and herbal supplements, kratom products are essentially unregulated and there are little or no quality controls.

“The stuff that’s sold as kratom in the United States cannot be reliably proven to be kratom,” says Edward Boyer, MD, a Professor of Emergency Medicine at Harvard Medical School.   

“There is evidence to suggest that some of the kratom sold in the United States is adulterated to make it more potent, to make it more powerful.”

Boyer says some kratom supplements have been found to have artificially elevated levels of 7-hydroxymitragynine, one of the naturally occurring alkaloids that make kratom act on opioid receptors in the brain. He suspects opioid drugs are also being used to boost kratom’s potency.

“The fact that a lot of kratom is adulterated is not surprising,” says Jane Babin.  “I suspect it is more prevalent in the stuff that’s being sold at smoke shops and gas stations.  This is a red herring when it comes to kratom, in the same way that Salmonella contamination is.  Both are ‘problems’ with simple solutions through regulation and oversight of kratom identity and purity.”

Instead of banning kratom, Babin says it should be regulated with a standards and certification program that would help keep adulterated products off the market.

Kratom is already banned in Alabama, Arkansas, Indiana, Vermont, Wisconsin and the District of Columbia. And there is speculation that the DEA may try again to classify kratom as a federal Schedule I controlled substance, which would make sales and possession of the plant illegal nationwide. The DEA withdrew a plan to ban kratom in 2016 after a public outcry.

Last week’s vote by the Ohio pharmacy board starts a months-long process of drafting new regulations for kratom, so a ban isn’t in effect yet. Public comments will be accepted until October 18. 

“If Ohio does ban kratom (and I hope they don’t), I predict that the already epic opioid overdose problem in that state will get worse,” says Babin. “It would be a shame for Ohio to indirectly prove the value of kratom in combating the opioid crisis when, after it is banned, overdose deaths and suicides increase.”

More Salmonella Cases Linked to Kratom

By Pat Anson, Editor

The Centers for Disease Control and Prevention says another 45 people have been sickened in a salmonella outbreak linked to the herbal supplement kratom.  A total of 132 people have been infected in 38 states, with 38 of them hospitalized. There have been no deaths.

Salmonella is a bacterial infection usually spread through contaminated food or water. Most people who become infected develop diarrhea, fever and stomach cramps. Salmonella causes an estimated one million food-borne illnesses a year in the United States.

This particular outbreak is small compared to previous ones, but it’s been long-lasting. While the vast majority of cases have only been reported in the last few months, CDC traced the first illnesses back to January 2017. Three different Salmonella strains have been identified – none of them resistant to antibiotics.

Millions of Americans use kratom to treat chronic pain, addiction, depression, anxiety and other medical conditions. The CDC says kratom is the “likely source” of the outbreak – although the evidence behind it is not entirely clear.

Several kratom samples have been found to be contaminated with salmonella bacteria, but less than half the people sickened in the outbreak say they consumed kratom. Their ages are also unusual, ranging from 1 to 73 years old.

salmonella bacteria

“State and local health officials continue to interview ill people to ask about the foods they ate and other exposures before they became ill. Fifty-seven (73%) of 78 people interviewed reported consuming kratom in pills, powder, or tea,” the CDC said in its latest update.

“People who reported consuming kratom purchased it from retail locations in several states and from various online retailers. Despite the information collected to date about where ill people purchased kratom, a single common brand or supplier of kratom has not been linked to the outbreak. CDC continues to recommend that people not consume kratom in any form because it could be contaminated with Salmonella and could make people sick.”

Earlier this week, the Food and Drug Administration ordered a Las Vegas company – Triangle Pharmanaturals -- to recall all of its dietary supplements containing kratom. The rare mandatory recall order was issued after the company refused to make a voluntary recall when some of its kratom capsules were found contaminated with salmonella.

There other kratom distributors – PDX Aromatics, Tamarack and NutriZone voluntarily recalled their products after samples tested positive for salmonella. A complete list of recalled kratom products can be found here.

Many kratom supporters remain suspicious of the motives behind the federal government’s salmonella investigation. The Drug Enforcement Administration tried unsuccessfully to list kratom as a controlled substance in 2016, which would have effectively banned its sale and use. In recent months, the FDA has also released several warnings that kratom should not be used to treat any medical conditions because it has opioid-like properties and could cause addiction.

The American Kratom Association (AKA) – a pro-kratom association of consumers and vendors -- is currently surveying members “to get a clearer picture” of the actions taken by the FDA and CDC in the salmonella outbreak.

“We are particularly concerned with reports that the FDA/CDC may be using the salmonella outbreak purportedly in kratom products as a pretext to allow the FDA to expand their war on kratom,” the AKA says on its website. “If your business was contacted by either the FDA or CDC regarding the salmonella outbreak that has been associated with kratom, we are asking that you take the following survey.”

Among other things, the survey asks vendors if they were given a laboratory analysis of any “alleged salmonella contamination” by the FDA or CDC, and if they were given time to conduct their own independent lab test.