Researchers Call Kratom a Public Health Threat

By Pat Anson, PNN Editor

The herb kratom poses a public health threat and should not be sold as a dietary supplement, according to a team of researchers who say kratom should be regulated like a prescription drug because it has “opioid-like” qualities.

"Although it is not as strong as some other prescription opioids, kratom does still act as an opioid in the body," said William Eggleston, PharmD, a professor of pharmacy practice at Binghamton University in New York. "In larger doses, it can cause slowed breathing and sedation, meaning that patients can develop the same toxicity they would if using another opioid product.

“Our findings suggest kratom is not reasonably expected to be safe and poses a public health threat due to its availability as an herbal supplement.”

Eggleston is lead author of a recent study published in the journal Pharmacotherapy that looked at the growing number of calls about kratom to U.S. Poison Control Centers. In recent years, millions of Americans have discovered kratom and use it to self-treat chronic pain, addiction, anxiety and depression.

Eggleston and his colleagues identified 2,312 kratom exposures in the National Poison Data System (NPDS) from 2011 to 2018, with 935 cases involving kratom as the only substance.

The chief complaint for many of the calls was that kratom caused agitation, tachycardia (rapid heartbeat), drowsiness, vomiting and confusion. Infrequent but serious side effects included seizure, withdrawal, hallucinations, respiratory depression, coma, and cardiac or respiratory arrest.

KRATOM CALLS TO U.S. POISON CONTROL CENTERS

SOURCE: AMERICAN ASSOCIATION OF POISON CONTROL CENTERS

‘Significant Toxicity’

“Despite kratom’s growing popularity as a safe and natural self-treatment option for patients with OUD, our findings suggest there are concerns for significant toxicity. Reports of kratom exposures to the NPDS are rising and have already been associated with serious opioid toxicities, including seizures, agitation, and death,” researchers reported.

“According to the United States Dietary Supplement Health and Education Act of 1994, herbal and dietary supplements must contain ingredients that are reasonably expected to be safe. Our findings repudiate the idea that kratom meets this criterion. Kratom’s opioid effects put patients at risk for withdrawal, respiratory depression, and death.”

But critics say calls to poison centers are anecdotal, misleading and a poor choice for research.

“The data drawn from the Poison Control Centers are notoriously unreliable, inasmuch as they are anecdotal reports from the public that are gathered and reported in an unscientific fashion,” said Max Karlin, a spokesman for the Kratom Information & Resource Center. “In the absence of good data, you just end up with a garbage-in, garbage-out situation.”

“All the Eggelston paper shows is that the anti-kratom bias is deeply entrenched in conventional medical, pharmacological and government sectors,” said Jane Babin, PhD, a molecular biologist, patent lawyer and consultant to the American Kratom Association (AKA). “It seems to be more of the same unscientific attack on kratom. I don’t see anything in this that warrants their conclusion.

“AKA now estimates that there are 16 million kratom users in the U.S. based on data from Indonesia on how much kratom is exported to the U.S. annually. 2,312 exposures out of 16 million users is a pretty low percentage of users who have anything to report to poison control.”

The 2,312 calls about kratom over an 8-year period pale in comparison to calls about other substances. In the first six months of this year alone, over 13,400 calls were made to U.S. poison centers about children ingesting hand sanitizers or laundry detergent packets.

Kratom Scheduling

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. As a dietary supplement, kratom is loosely regulated in the United States, although federal agencies are engaged in a protracted public campaign against its use.

The FDA says kratom is addictive, has opioid-like qualities and is not approved for any medical condition. The agency has also released studies showing salmonella bacteria and heavy metals contaminating a relatively small number of kratom products. 

The CDC recently linked kratom to dozens of fatal overdoses -- although multiple substances were involved in nearly all of those deaths.

The Department of Health and Human Services (HHS) has recommended to the DEA that kratom be classified as a Schedule I controlled substance – alongside heroin and marijuana — which would effectively ban it nationwide.

“At some level, we do need to have better control over it,” says study co-author Lewis Nelson, MD, a Professor of Emergency Medicine at Rutgers New Jersey Medical School. “We know that (kratom) has two big uses out there. One of them is for people to get high and the other one is to treat opioid withdrawal. Those are the real reasons people use it.

“Whether its an opioid or not an opioid, people use it do things that they would typically do with opioids, like pain, get high, and treat withdrawal. I think empirically we know it has enough of an opioid-like character that it’s being marketed and used that way.”

Lewis said kratom should be scheduled as a controlled substance, but not under Schedule I. He thinks it may be more appropriate to classify kratom as a Schedule II or III drug, where it could still be available by prescription.

“I would like to see that. If they could show this drug has benefits and we could understand and moderate the risk, I don’t see why it couldn’t be used like any other drug,” said Lewis, who is a longtime critic of opioid prescribing.

“Let’s create a safe product and let’s get it appropriately scheduled. Have it available by prescription. I don’t have a problem with that.”

— Dr. Lewis Nelson

“Prove it works. Let’s create a safe product and let’s get it appropriately scheduled. Have it available by prescription. I don’t have a problem with that.”

But getting kratom approved by the FDA as a prescription drug would require years of clinical studies. Pharmaceutical companies may be reluctant to fund research on a natural substance that they may not be able to patent. And kratom users, long accustomed to buying it online or in smoke shops, dislike the idea of needing a doctor’s prescription.

In a 2016 PNN survey of over 6,400 kratom users, nearly 98 percent said they wanted kratom to remain available as a dietary supplement.  Over 70 percent said pharmaceutical companies should not be allowed to produce kratom-based drugs.  And nearly three out of four dispute the notion that it’s possible to get high from kratom.  

Lewis remains skeptical that people are not using kratom recreationally and that it should remain on the market as a dietary supplement.  

“I find it a little disingenuous to say we should leave this potentially unsafe drug on the market unregulated, just because some people already use it,” he told PNN.

Over 22,000 Comments on DEA’s Kratom Ban

By Pat Anson, Editor

Over 22,000 public comments – a record number on any issue -- have been posted on a government website taking comments on a threatened federal ban on the herbal supplement kratom. The final number is likely to be even higher once all the comments are recorded.

The vast majority of commenters oppose plans by the Drug Enforcement Administration for the emergency scheduling of two ingredients in kratom as Schedule I controlled substances, a move that would make the sale and possession of the herb a felony.

Thursday, December 1 was the last day that public comments were accepted at Regulations.gov on the kratom ban. The number of kratom comments is over five times the number who commented on the controversial opioid prescribing guidelines released by the Centers for Disease Control and Prevention earlier this year.

“I think the quality of the comments and the quantity of the comments show that kratom really does have potential and that the three to five million people that are consuming kratom would suffer greatly if it becomes a Schedule I controlled substance,” Susan Ash, founder of the American Kratom Association, told Pain News Network.

Ash started using kratom several years ago to help fight opioid addiction. Many others use it to treat their chronic pain, anxiety and depression.

“If Kratom is banned by the DEA my quality of life will decrease tremendously,” wrote a 62-year old veteran who started using kratom four years ago as an alternative to anti-anxiety medication. “My life was out of control with benzodiazepines. With kratom, I can live a somewhat anxiety-free life and not have all the negative side effects that come with benzodiazepines.”

“The VA prescribes lots of pain medication that’s very addictive. I have since gone off the medication and switched to kratom,” wrote Brandon Lang, another military veteran.  “The effect as far as pain relief is comparable, but the addictive nature and the ‘high’ is nearly nonexistent. I feel much better knowing pain relief is available and affordable. I am now free and clear of narcotics.”

“Kratom is nowhere near as dangerous as alcohol, tobacco, acetaminophen, aspirin, and countless other things which are widely available. It makes absolutely no sense to ban kratom,” said John Miller.

“I am a former addict and know others who suffer from addiction including alcoholism,” wrote Chris Simmons. “In my experience kratom significantly reduces cravings while allowing people to go about their day as normally as possible. Please keep this legal.”

One of the comments opposing the ban came from a retired deputy chief of the Los Angeles Police Department.

“Kratom has been used safely by millions of people in the U.S., just like marijuana was used safely prior to its prohibition. And, just like marijuana, kratom has many medicinal benefits that scheduling would deny to those who benefit from its use. Its prohibition would only drive thousands more to opiate use,” wrote Stephen Downing, who has called for the legalization of many illicit drugs.

“There is no evidence to support prohibition of this plant. Putting it on the Controlled Substances Schedule will serve no useful purpose other than the continued survival of a massive and harmful out-of-control government bureaucracy.”

Only a small minority of commenters support a ban on kratom.

“Adding an untested and unregulated substance such as kratom to our food supply without the application of longstanding federal rules and guidelines would not only be illegal, it could likely be dangerous, leading to serious unintended consequences as our nation struggles with the crisis of opioid addiction,” wrote Daniel Fabricant, PhD, a former FDA official who is now CEO and Executive Director of the Natural Products Association (NPA), a trade association that represents the food and dietary supplement industry.

“NPA strongly urges DEA and FDA to take appropriate legal action to ensure that American consumers are protected from an unknown and unregulated botanical ingredient whose use could have widespread and unintended negative consequences for public health and safety.”

Fabricant’s comments to the DEA rely primarily on anecdotal reports that kratom might be harmful or have a narcotic effect.  Although kratom leaves have been used for centuries as a natural remedy in southeast Asia, it is relatively new in the United States, and there have been few clinical studies on its safety and efficacy.

In a new analysis of existing studies funded by the American Kratom Association, Jack Henningfield, PhD, said kratom was no more dangerous than many other herbal supplements, such as St. John’s Wort, lavender, kava and hops. 

"For both abuse potential and dependence liability, kratom's profile is comparable to or lower than that of unscheduled substances such as caffeine, nicotine-containing smoking cessation products, dextromethorphan, and many antihistamines, antidepressants, and other substances sold directly to consumers,” said Henningfield, who is a former chief of research at the National Institute on Drug Abuse and is currently an adjunct professor in the Department of Psychiatry and Behavioral Sciences at the Johns Hopkins University School of Medicine. 

What happens now with the threatened ban is not clear. The DEA has asked for a new analysis of kratom from the Food and Drug Administration, which initially recommended that the herb be made a controlled substance. The new analysis has yet to be released publicly.

It appears likely that a final decision on kratom will be left to the incoming Trump administration, and there are conflicting signs where that may lead. Trump’s nominee as Attorney General, Alabama Sen. Jeff Sessions, has been a longtime critic of marijuana legalization. If confirmed by the Senate, Sessions will oversee the DEA.

Trump’s nominee as Secretary of Health and Humans Services, Georgia Rep. Tom Price, will oversee both the CDC and FDA if he is confirmed. Price is a noted Tea Party member and longtime critic of Obamacare, who wants a more free market approach to healthcare that allows patients to make their own decisions. 

Susan Ash is hopeful that these dueling interests will decide that kratom is best left alone as a dietary supplement. 

“I’m nearly 100% confident that they are not going to emergency schedule this again,” she told PNN. “I truly believe that science is going to be on our side. How long it is going to take for that science is my concern.”

Medical Use of Kratom ‘Too Large to Be Ignored’

By Pat Anson, Editor

A threatened ban on kratom would stifle scientific understanding of the herb and its value in treating pain, addiction and other medical problems, according to a commentary published in the Journal of the American Osteopathic Association.

"There's no question kratom compounds have complex and potential useful pharmacologic activities and they produce chemically different actions from opioids," said Walter Prozialeck, PhD, chairman of the Department of Pharmacology at Midwestern University Chicago College of Osteopathic Medicine.

“In my opinion, the therapeutic potential of kratom is too large to be ignored. Well-controlled clinical trials on kratom or the many active compounds in kratom are needed to address this issue.”

In August, the U.S. Drug Enforcement Administration issued an emergency order saying it would classify two of kratom’s active ingredients -- mitragynine and 7-hydroxymitragynine -- as Schedule I controlled substances.

Such an order would have effectively banned the sale and possession of an herbal supplement that millions of people use to treat pain, anxiety, depression and addiction. It would also make it harder for researchers to conduct clinical trials of kratom.

The DEA postponed its decision only after a backlash from kratom supporters and some members of Congress. The agency said it would seek new guidance from the FDA and allow public comment on the proposed ban until December 1. Over 7,000 people have commented so far at Regulations.gov.

In its emergency order, the DEA said kratom posed an “imminent hazard to public safety” and referred to its chemical compounds as “opioid substances.” But Prozialeck says kratom behaves differently than opioids, because it doesn't produce euphoria or depress respiration.

“At the molecular level, mitragynines are struc­turally quite different from traditional opioids such as morphine. Moreover, recent studies indicate that even though the mitragynines can interact with opioid receptors, their molecular actions are different from those of opioids,” he wrote. “Based on all of the evidence, it is clear that kratom and its mitragy­nine constituents are not opioids and that they should not be classified as such.”

Prozialeck also disputes the notion that kratom is linked to several deaths, saying other drugs or health problems could have been involved. While he thinks banning the herb would be a mistake, Prozialeck believes some regulation is needed to prevent kratom products from being adulterated or contaminated with other substances.

"After evaluating the literature, I can reach no other conclusion than, in pure herbal form, when taken at moderate doses of less than 10 to 15 g (grams), pure leaf kratom appears to be relatively benign in the vast majority of users. Without reported evidence, however, it would not be appropriate for phy­sicians to recommend kratom for their patients,” he concludes.

That’s a sentiment that Dr. Anita Gupta agrees with.  She says several of her patients have successfully used kratom for pain relief, but until more research is conducted on the herb’s safety and efficacy, Gupta won’t recommend it to other patients.

“What I hear from patients is that they’re getting good benefit from it. But we have to wonder if kratom itself has pharmacological benefit or if it’s a placebo effect,” said Gupta, an osteopathic anesthesiologist and pharmacist who also serves on an FDA advisory board.

“I would encourage more oversight of kratom. There should be more regulation of kratom substances. That could come from the FDA or DEA, to make sure patients are safe and there’s no harmful interaction. To say that it’s only a dietary supplement, I don’t know if that’s the right classification, because we’re using it for clinical conditions and diseases. I think we need more oversight and more research should be conducted,” Gupta told PNN.

It’s a Catch-22 for kratom supporters. If research confirms its therapeutic value, that could result in kratom being classified as a Schedule II or III controlled substance, on the same level as other medications that have a potential for abuse. Kratom would still be legal to obtain, but only with a prescription.

In a survey of over 6,000 kratom users by Pain News Network and the American Kratom Association, over 98 percent said they wanted kratom to remain available as a dietary supplement without a prescription.  Seven out of 10 also said pharmaceutical companies should not be allowed to produce and market kratom products.

New Website Launched for Kratom Comments

By Pat Anson, Editor

In a sign of their distrust of the federal government, kratom community activists have created their own website for supporters to submit comments to the U.S. Drug Enforcement Administration on the proposed classification of kratom as a controlled substance.

On October 12, the DEA formally withdrew its controversial plan to classify two of the active ingredients in kratom as a Schedule I substances, which would have made the sale and possession of the herb a felony.  Instead, the DEA said it would ask the Food and Drug Administration for a full medical and scientific evaluation of kratom, and solicit public comments on the issue at Regulations.gov. 

But issues arose almost immediately with the Regulations.gov website, where some kratom supporters said their comments weren’t accepted or the website was having technical difficulties.

Similar problems were reported when the Centers for Disease Control and Prevention took comments at Regulations.gov on its opioid prescribing guidelines. In the end, over 4,000 comments on the guidelines were received, a record number.

This week the American Kratom Association (AKA) and the Botanical Education Alliance launched KratomComments.org to take comments from the public that will then be automatically submitted to Regulations.gov with an independent record of their submission. Software used by the website was created by The Soft Edge, Inc. (TSE) to avoid some of the pitfalls of Regulations.gov.

“KratomComments.org is the best way of protecting the kratom community,” the AKA said in a statement. “No comments can be ‘lost’ due to glitches at Regulations.gov. That site has been down already and no one knows what was lost. KratomComments.org ensures that comments made will be independently stored and recorded.

“There is no track record whatsoever of submissions made through TSE platforms to Regulations.gov being rejected. To the contrary, the platform has been used to facilitate the successful submission of several hundred thousand comments.”

But not everyone is on board with a third party submitting comments to the government.

“If you use the American Kratom Association’s ‘kratomcomments.org’ you are risking your comment not being counted,” warns kratom supporter Levi Beers on his website. Beers said he was advised by the DEA to submit comments directly to Regulations.gov and not through a third party.

“People are so confused you’ve got people submitting comments through regulations.gov and kratomcomments.org, which is going to hurt this process,” Beers said.

Hundreds of Comments Submitted

So far, over 800 comments have been submitted to Regulations.gov. The vast majority are from people who say kratom – which comes from the leaves of a tree in Southeast Asia – has helped them manage symptoms of chronic pain, anxiety, depression or addiction.

“Kratom has allowed me to live a highly productive, healthy and enjoyable life after my personal journey through addiction,” wrote Troy Foos, a 51-year old man who said he was addicted to alcohol and opioid pain medication.

“My life, my marriage and my relationship with my kids is a thousand times better because of the 'helping hand' of this plant. Similar to how two cups of coffee get me rolling in the morning, it has allowed me to successfully navigate my addictions and live a healthy, highly effective life at work and at home.”

“As a person with chronic pain caused by fibromyalgia, having kratom as a non-addictive option has been great,” wrote Wyatt Gaylor.  “I can now take it when I'm having a bad day without the side effects associated with opiates.”

“Kratom definitely needs to be banned,” wrote an anonymous poster who left one of the few negative comments about kratom. “My son is currently in rehab for addiction to kratom. This is a very serious product which has caused very serious health issues in someone who is only 20 years old.” 

There is usually a discrepancy at Regulations.gov between the number of the comments received and the number posted. That’s because comments are not posted until the next business day. Others are under review by DEA because of personal information or inappropriate language. Comments will be accepted until December 1, 2016.

DEA Withdraws Plan to Ban Kratom

By Pat Anson, Editor

Facing opposition from the public and some members of Congress, the U.S. Drug Enforcement Administration has withdrawn plans to classify two of the active ingredients in kratom as Schedule I controlled substances, a move that would have made the sale and possession of the herb a felony.

“DEA has received numerous comments from members of the public challenging the scheduling action and requesting that the agency consider those comments and accompanying information before taking further action,” the DEA said in a notice published in the Federal Register.

“DEA is therefore taking the following actions: DEA is withdrawing the August 31, 2016 notice of intent; and soliciting comments from the public regarding the scheduling of mitragynine and 7-hydroxymitragynine under the Controlled Substances Act.” 

Mitragynine and 7-hydroxymitragynine are alkaloids in kratom that appear to act on opioid receptors in the brain. They are not approved for any medical use in the United States, even though millions of kratom consumers use the the herb to manage pain, anxiety, depression, addiction and other medical conditions.

The unprecedented decision to withdraw the scheduling of a controlled substance does not end the possibility that kratom will be banned. The DEA said it would re-evaluate its decision after the public comment period ends on December 1, 2016. The agency will also ask the Food and Drug Administration to expedite a full scientific and medical evaluation of kratom.

“DEA will consider all public comments received under the above procedures, as well as FDA’s scientific and medical evaluation and scheduling recommendation for these substances.  Once DEA has received and considered all of this information, DEA will decide whether to proceed with permanent scheduling of mitragynine and 7-hydroxymitragynine , or both permanent and temporary scheduling of these substances,” the agency said in its announcement.

If the DEA decides to schedule kratom permanently, the agency said it would publish a new notice in the Federal Register and allow for a second public comment period. Under the original emergency scheduling notice published on August 30, there was no public notice or comment period.

“We moved a mountain and now we’re parting the sea!!! Keep the pressure on; wait for commenting instructions please, we still have A LOT of work ahead of us,” wrote Susan Ash, founder of the American Kratom Association (AKA) in a note to supporters on Facebook.

“I think what this clearly shows is that there is no imminent public health threat or they wouldn’t be adding on a 6 week public comment process and putting it back on the FDA,” Ash told PNN.

She said her organization would resist any effort to classify kratom in a less restrictive category than Schedule I, which is how marijuana, LSD and heroin are classified. At present. there are no federal limits on kratom as a dietary supplement, although it is banned in a handful of states.

"We still believe it should not be scheduled in any way, shape or form. It's been consumed safely here for decades and worldwide for a millennium, so there's really no impetus to make it a controlled substance, period," said Ash.

In its initial attempt to ban kratom -- which comes from the leaves of a tree in Southeast Asia -- the DEA said the herb had “psychoactive effects” and was linked to dozens of overdose deaths.

In reaching that assessment, the agency relied primarily on the research and advice of the FDA and the Centers for Disease Control and Prevention.  Critics, however, say much of that research was deeply flawed and unreliable. For example, a recent CDC report claimed kratom was “an emerging public health threat” and cited two published research reports that “associated kratom exposure with psychosis, seizures, and deaths.”

Those two reports, however, make no mention of deaths caused by kratom. The CDC also relied on a newspaper article to help document one kratom-related death, even though it was actually caused by a self-inflicted gunshot wound.

"Nowhere does DEA rely on the scientific, epidemiological, and public health sources that normally undergird the assertion that a substance poses a high potential for abuse, let alone an imminent public health threat,” lawyers for the AKA said in a letter to DEA acting administrator Chuck Rosenberg.

To overturn the ban, the AKA enlisted the help of over 60 members of Congress, who signed letters urging the DEA to delay scheduling kratom and to solicit more public input. Over 142,000 kratom supporters also signed a White House petition asking the Obama administration to postpone the scheduling.

"I think the DEA was pressured so much by Congress, the public and by the media that they realized that they didn't really have the proof and the science to emergency schedule this," Ash said. "It put the DEA in a really difficult position and now the DEA is just trying to admit the fact that they don't have what they need to call this a public health threat."

In a survey of over 6,000 kratom consumers by Pain News Network and the AKA, nine out of ten said kratom was a “very effective” treatment for pain, depression, anxiety, insomnia, opioid addiction and alcoholism. Many also predicted that banning the herb would only lead to more drug abuse, addiction and death.

"The DEA missed the mark here and it would be a gross miscarriage of due process to simply tell millions of American consumers and the legal businesses that serve them that they are now felons,” said Travis Lowin of the Botanical Education Alliance in a statement before the DEA reversed its decision. 

“The DEA has a strict set of rules it is supposed to follow for an emergency scheduling of a drug and kratom meets none of those tests.  There are reasonable limits on the power of what government can do precisely to avoid situations like this where legal consumer conduct and legitimate free enterprise would otherwise be crushed overnight by indiscriminate use of the power of government."

Kratom Vendors File Lawsuit Against Feds

By Pat Anson, Editor

Four kava bar owners in South Florida – one of them a retired police officer – have filed a federal lawsuit against the U.S. Department of Justice over its threated ban on kratom.

Named as co-defendants are Attorney General Loretta Lynch and Chuck Rosenberg, the acting administrator of the Drug Enforcement Administration.

The lawsuit, first reported by New Times Broward Palm Beach , was filed by Michael Dombrowksi, who owns the Tenaga Kava bar in Palm Beach Gardens.  Dombrowski says his business relies on kratom tea sales and he risked losing a million dollars in revenue if the DEA carried out plans to list two of the active ingredients in kratom  as Schedule I controlled substances.

“Plaintiff business relies primarily on kratom tea sales, as do 9 other kava and tea lounges where consumers purchase and rely upon kratom tea for a variety of claims from medicinal value to relaxation,” the lawsuit states. 

“Defendant will lose all of his investment in the creation of his business in 2015 including the bulk of his law enforcement retirement and the loss of his livelihood which he planned for his happy retirement.”

Listed as co-plaintiffs in the lawsuit are James Scianno of the Purple Lotus Kava Bar in Boynton Beach and Keith Engelhardt and Thomas Harrison of Kavasutra in West Palm Beach. 

The lawsuit, filed in U.S. District Court in West Palm Beach, seeks an emergency injunction to prevent the scheduling of kratom, along with punitive damages of $14 million.

The lawsuit was filed on September 30, the same day the DEA could have made the sale and possession of kratom a felony by putting it in the same class of controlled substances as heroin, LSD and marijuana.. The agency delayed the scheduling after a backlash from kratom consumers and some members of Congress, who urged the DEA to seek public comment on its ruling.

The DEA claims kratom, which comes from the leaves of a tree in Southeast Asia, has a high potential for abuse because of its “psychoactive effects” and that imported kratom products are “routinely misdeclared and falsely labelled.”

Kratom is usually sold as dried or crushed leaves, powder, capsules, and tablets. Some kava bars, like the ones in Florida, brew kratom leaves with kava root to make a strong tea. In 2013, a lawsuit was filed against the owners of the Purple Lotus bar for not disclosing that the tea contained kratom. The plaintiff in that suit – a recovering alcoholic -- claimed she became addicted to kratom tea.

Kratom supporters say the herb is no more addictive than caffeine and helps treat symptoms of chronic pain, anxiety, depression and addiction.

Lawmakers Ask DEA to Delay Kratom Ban

By Pat Anson, Editor

A bipartisan group of nearly 50 congressmen have signed a letter asking the U.S. Drug Enforcement Administration to delay a decision that would classify kratom as a Schedule I controlled substance, a move that would make the sale and possession of the herb a felony offense.

The letter, which is being sent to acting DEA administrator Charles Rosenberg, was written and circulated on Capitol Hill by Rep. Mark Pocan (D-Wisconsin) and Rep. Matt Salmon (R-Arizona). A second letter is being sent to Shaun Donovan, the director of the Office of Management and Budget (OMB), urging him to use his “statutory authority” to delay the DEA’s regulatory action.

“While Republicans and Democrats are having a difficult time seeing eye-to-eye on many critical issues, and in the midst of a very busy election cycle, it is unprecedented to see so many join forces together, agreeing that the DEA has overstepped its emergency scheduling authority,” said Susan Ash, founder of the American Kratom Association, a consumer group lobbying against the DEA scheduling.

The letters are signed by 28 Democrats and 21 Republicans in the House, including two physicians, Rep. Daniel Banishek (R-Michigan) and Rep. Brad Wenstrup (R-Ohio).

"We urge the DEA to delay finalizing the decision to define Kratom as a schedule I substance under the Controlled Substances Act and to engage consumers, researchers, and other stakeholders, in keeping with well-established protocol for such matters,” states the letter to the DEA administrator. 

"A departure from such guidelines threatens the transparency of the scheduling process and its responsiveness to the input of both citizens and the scientific community."

Under its emergency scheduling order, the DEA said it would classify kratom as a Schedule I substance – alongside heroin, LSD and marijuana – without any public notice or comment. The order could be implemented as early as September 30.  The DEA maintains that kratom – which comes from the leaves of a tree that grows in Southeast Asia -- poses “an imminent hazard to public safety” and has been linked to several deaths.

In a survey of over 6,000 kratom consumers by Pain News Network and the American Kratom Association, 98 percent said kratom was not a harmful or dangerous substance and 95% said banning the herb will have a harmful effect on society.  Many said they use the herb in teas and supplements to treat chronic pain, anxiety, depression and other medical conditions.

The congressional letter to OMB director Donovan points out that the National Institutes of Health has funded kratom research at the University of Massachusetts and the University of Mississippi. Those studies led researchers to apply for a patent identifying mitragynine – an active ingredient in kratom -- as a useful treatment for opioid addiction.

“The DEA’s decision to place Kratom as a Schedule I substance will put a halt on federally funded research and innovation surrounding the treatment of individuals suffering from opioid and other addictions—a significant public health threat,” the letter to Donovan states. “We urge your agency to immediately utilize your statutory authority and delay the process to place Kratom in schedule I until sufficient public comment is received and inconsistencies between Federal Agencies view of the product are addressed.”

It’s unclear what impact the two letters will have, but kratom supporters hope the involvement of a bipartisan group of congressmen will put more political pressure on the Obama administration. A citizens petition to the White House urging the administration to delay the DEA decision has been signed by over 135,000 people.  

“This will send a very clear message that Congress will not sit idly by and allow grandparents, parents, disabled people, and professionals in everything from law enforcement to the medical field, to be turned into felons for responsibly using the one thing that provides them with relief,” said Susan Ash.

“Kratom can help ease suffering. While our nation is in the midst of the worst opiate and heroin epidemic crisis we've ever seen, this little plant holds the key to many Americans' health and well-being and is helping to reduce the staggering, terrifying rise in opiate overdose deaths.”

DEA Head Calls Kratom an "Opioid"

None of this has apparently swayed the acting administrator of the DEA, who called kratom an "opioid" at a recent public forum on opioid addiction at Georgetown University.

"Kratom, as you know, is an opioid in its classification, so this is a good place to talk about it,"  Charles Rosenberg said in response to a student's question.

Kratom is not a member of the opium poppy family, where traditional opioids come from. But kratom leaves do contain mitragynine and 7-hydroxymitragynine, alkaloids that act on the same receptors in the brain as opioids. For that reason, the DEA is calling kratom an opioid.

"The FDA has decided, ruled, after its considered judgement that there is no medical value. We are bound by its scientific determinations in that arena. It's in Schedule I therefore because it has no medical value, there is a high potential for abuse, and most importantly we're now getting data from folks around the country that people are dying from kratom overdoses," Rosenberg explained. "So if we made an error and perhaps some people think we did, I frankly do not, then we aired on the side of protecting the public and I'm okay with that."

Below is a list of congressmen who have signed the letters to Rosenberg and Donovan:

• Mark Pocan - D - WI
• Matt Salmon - R - AZ
• John Conyers - D - MI
• Hank Johnson - D - GA
• Tim Ryan - D - OH
• Jared Polis - D - CO
• Adam Smith - D - WA
• Dana Rohrabacher - R - CA
• Daniel Benishek, MD - R - MI
• Steve Cohen - D - TN
• Joe Heck, D.O. - R - NV
• John Yarmuth - D - KY
• Mark Sandord - R - SC
• Mick Mulvaney - R - SC
• Steve Israel - D - NY
• Gerald E. Connolly - D - VA
• Betty McCollum - D - MN
• Earl Blumenauer - D - OR
• Tulsi Gabbard - D - HI
• Michael Honda - D - CA
• Gwen Moore - D - WI
• Brad Wenstrup, MD - R - OH
• Tom Graves - R - GA
• Justin Amash - R - MI
• Barbara Lee - D - CA
• Raul Labrador - R - ID
• Peter DeFazio - D - OR
• Scott Tipton - D - CO
• Julia Brownley - D - CA
• H. Morgan Griffith - R - VA
• Jim Costa - D - CA
• Suzan DelBene - D - WA
• Denny Heck - D - WA
• Zoe Lofgren - D - CA
• Scott Peters - D - CA
• Suzanne Bonamici - D - OR
• Ted Poe - R - TX
• Dave Brat - R - VA
• Tom Emmer - R - MN
• Paul Gosar - R - AZ
• MIchael Capuano - D - MA
• Bobby Scott - D - VA
• Steve King - R - IA
• Lois Frankel - D - FL
• Leonard Lance - R - NJ
• Frank LoBiondo - R - NJ
• Steve King - R - IA
• Barry Loudermilk - R - GA
• Richard Hudson - R- NC

Survey: Kratom ‘Very Effective’ for Chronic Pain

By Pat Anson, Editor

Chronic pain sufferers often struggle to find a treatment that works. Opioids dull the pain, but come with the risk of addiction; drugs like Lyrica and Cymbalta can have unwelcome side effects; over-the-counter pain relievers often don’t work for severe pain; and alternative treatments like massage and acupuncture are not always covered by insurance.

So people experiment and try different things – often settling for something that just takes the edge off their pain.

That brings us to kratom, an herbal supplement largely unknown to most pain patients and their doctors. At a recent pain management conference attended by thousands of practitioners, I could find only a handful of doctors who’d even heard of kratom. I’ll confess I didn’t know much about it myself until a few months ago.

Maybe we should all start paying more attention.

In an online survey of 6,150 kratom consumers by Pain News Network and the American Kratom Association, nine out of ten said the herb was a “very effective” treatment for pain, depression, anxiety, insomnia, opioid addiction and alcoholism.

Less than one percent said it did not help.

This was not a scientific study by any means on the safety and efficacy of kratom. It was an online survey of self-selected kratom consumers, many of them quite upset that the U.S. Drug Enforcement Administration is planning to make the sale and possession of kratom illegal, perhaps as soon as the end of the month.

In a 21-page notice published in the Federal Register, the DEA said kratom does not have "an approved medical use” and “is misused to self-treat chronic pain.”

WAS KRATOM EFFECTIVE IN TREATING YOUR PAIN OR MEDICAL CONDITION?

The agency cited no studies to support its claim that kratom was being “misused” to treat pain, so we decided to ask the people who actually use it:

"Honestly, I was blown away at how good it was for my pain and also had the benefit that it lifted my mood, which was important because of the depression I had been experiencing from the chronic pain."

"This natural approach to pain management has allowed me to work full time as a school teacher and be an actively involved mom. These are things I never thought I would be able to have in my life as a result of debilitating pain from a neurological condition for which there is no medical cure."

"I have acute chronic migraines that, unmedicated, result in pain that is completely debilitating, and at times have landed me in the emergency room with stroke symptoms. Multiple doctors have okayed my use of kratom for pain management, as over-the-counter medicine simply does not work and I cannot take opiates."

"My wife has fibromyalgia and has taken kratom for more than 12 years with no adverse effects. Prior to finding kratom, she had tried all of the medication that was prescribed to her. The prescription medication either didn't work, or the side effects outweighed the benefits. Kratom has been a godsend for my wife and has allowed her to function as a mother of 4 children for more than a decade."

"I have been living with chronic pain from multiple reconstructive foot surgeries for 20+ years. Kratom not only effectively treats my pain, but it enabled me to tell my doctor that I no longer wanted my monthly tramadol prescription."

What pain conditions does kratom work best on? Again, this is not a scientific study, and we don’t have a lot of data for certain conditions. For example, 100% of the people who used kratom for cancer pain said it was “very effective” for them, but we only had 27 respondents who identified cancer as the primary reason they used kratom.

On the flip side, over 1,700 respondents said they used kratom for back pain, so the data is probably more reliable for them. And 92% said kratom was very effective for back pain.  

Percentage Who Rated Kratom “Very Effective” for their Pain Condition

powdered kratom

• 100% Cancer
•   97% Multiple Sclerosis
•   94% Irritable Bowel Syndrome
•   93% Migraine
•   93% Fibromyalgia
•   92% Rheumatoid Arthritis
•   92% Back pain
•   92% Acute Pain
•   91% Lupus and other autoimmune diseases
•   90% Osteoarthritis
•   90% Neuropathy
•   88% Trigeminal Neuralgia
•   79% RSD or CRPS
•   76% Ehlers Danlos syndrome   

Quite a few people said they use kratom for pain conditions we didn’t ask about or discovered that it helped them feel better in unexpected ways:

"I tried kratom for many things and it has worked for all. Toothaches, back and knee pain, sore joints and ligaments, flu symptoms, and insomnia."

"I have had very little back pain since I starting taking kratom to treat it. Three side effects I didn't expect is that it eliminated my restless leg syndrome, reduced my blood pressure to a normal level and significantly reduced my overall cholesterol levels."

"I have found so much relief for my ulcerative colitis and carpal tunnel syndrome from this plant that I fear how my body will respond when I no longer have it."

"I use kratom for severe TMJ disorder and sacroiliac joint dysfunction. I am also a recovering addict, and kratom has helped me stay clean and be the best 4th grade teacher I can be. If I hadn't had kratom to help ease chronic pain and the urge to use, I wouldn't be doing my dream job. I'd probably be in jail without a job, divorced, and possibly even dead."

"Kratom without a doubt helps any part of my body to not be in pain. Not only does it help with pain, it helps with my depression and it helps me get to sleep very easily."

Many also have strong feelings about allowing drug companies to use kratom in pharmaceutical products, which would require approval from the Food and Drug Administration. 

Seven out of ten kratom consumers are opposed to that idea, believing drug makers have conspired with the DEA to make kratom illegal.

"This is big pharma using the DEA to eliminate an all-natural herb that is taking a bite out of their drug selling profits."

"Everyone knows all this has to do with the DEA and big pharma being in each other’s back pockets. Money is the root of all evil and here it shows again."

"I feel that the pharmaceutical companies are behind this. People are weaning themselves from their addictions and those that don't end up overdosing requiring Narcan. That is a lot of money they stand to lose."

"If pharmaceutical companies produce kratom, the cost will probably triple. There will be tremendous red tape in even getting the drug from a doctor."

SHOULD DRUG MAKERS BE ALLOWED TO PRODUCE AND MARKET KRATOM?

To see the complete survey results, click here.

Meanwhile, lobbying efforts continue by the American Kratom Association to get the DEA to postpone its decision to classify the two active ingredients in kratom as controlled substances. Two congressmen, Rep. Mark Pocan (D-Wisconsin) and Rep. Matt Salmon (R-Arizona) are circulating a letter on Capitol Hill urging the DEA to delay enacting its order.

“We hope to see a lot of congressmen and women sign onto this,” says Susan Ash, founder of the American Kratom Association. “The letter asks that the director of the Office of Management and Budget and the acting director of the DEA delay a final decision on the placement of kratom as a Schedule I substance, provide ample time for public comment on this significant decision, and resolve any other inconsistencies with other federal agencies.”

A similar letter is being prepared by a law firm hired by the American Kratom Association. Ash told PNN it’s possible the DEA will not formally act on the scheduling of kratom until well after September 30.   

“When we’ve looked back at some of the other emergency scheduling processes that have happened, we have found that they will say it’s going to happen in 30 days, but it’s usually a few weeks after that. That’s just what’s happened historically. We don’t think September 30 is essentially a firm date, just based on history, but we are prepared in case it is.”

Ash said her organization would seek a restraining order from a judge if the emergency scheduling is implemented by DEA.