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.

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“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.”

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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.   

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“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.”

Ohio Banning Sales of Kratom and CBD  

By Pat Anson, PNN Editor

At a time when many pain sufferers are turning to natural supplements to relieve their pain, the state of Ohio is moving to ban two of the most popular ones.

The Ohio Board of Pharmacy voted Monday to classify kratom as a Schedule I controlled substance alongside heroin, LSD and other dangerous drugs. The move came two months after the board issued an advisory warning that sales of CBD-infused products are illegal under Ohio’s new medical marijuana program.

The pharmacy board considers kratom – which come from the leaves of a tree that grows in southeast Asia – a “psychoactive plant” that can cause hallucinations, psychosis, seizures and death. State health officials have identified six recent deaths in Ohio in which kratom “was indicated as the primary cause of death.”

A recent report from the Ohio Substance Abuse Monitoring Network (OSAM) raised the demonization of kratom to a new level by comparing it to heroin — and falsely claiming it was common for people to inject kratom.

“Participants reported that the drug looks similar to brown powdered heroin, produces similar effects as heroin, and is primarily used by individuals subject to drug screening and by people addicted to heroin who use the drug to alleviate opiate withdrawal symptoms,” the OSAM report warns.

“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).”

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Monday’s vote by the pharmacy board starts a months-long process of drafting new regulations for kratom. Public comments will be accepted until October 18.  Over 1,500 comments have already been received, most of them from kratom users asking the board to keep the supplement legal.

"The findings of the Ohio Board of Pharmacy… parrot the false propaganda of the U.S. Food and Drug Administration in their crusade to ban kratom," said Dave Herman, chair of the American Kratom Association, which represents kratom vendors and consumers. "The FDA has flooded state regulators, including the Ohio Board of Pharmacy with false claims and disinformation about the addiction profile and safety of this safe botanical plant.

“The nearly 5 million kratom consumers, and the tens of thousands of Ohio citizens, who safely consume kratom as a part of their health and well-being regimen should not have that freedom infringed upon by any regulation that is premised on bad science, inaccurate data provided by the FDA, and a deliberate attempt to manipulate the scheduling process by a federal agency.”

Kratom has been used for centuries as a pain reliever and stimulant, particularly in rural areas of Indonesia and Thailand.  In recent years, millions of Americans have discovered kratom and started buying it online or in “head shops” as a treatment for pain, addiction, anxiety and depression.

The Food and Drug Administration maintains that kratom is not approved for any medical use and insists on calling the plant an “opioid,” although its active ingredients are mitragynine and 7-hydroxymitragynine, two alkaloids that act on opioid receptors in the brain.

Kratom is already banned in Alabama, Arkansas, Indiana, Vermont, Wisconsin and the District of Columbia. There is speculation that the FDA and DEA may also seek to classify kratom as a 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.

CBD Sales Banned

Ohio’s crackdown on CBD sales is not as restrictive as the ban on kratom. CBD infused products such as edibles, tinctures and oils usually contain little or no THC – the psychoactive ingredient in marijuana that makes people high. Many people use CBD to relieve pain and help them sleep.

Under state law, marijuana is defined as “all parts of a plant of the genus cannabis” and only state-licensed dispensaries can sell products made with CBD (cannabidiol). There will eventually be 56 dispensaries across the state, although none are expected to open until later this year.

Some retailers pulled CBD products from their shelves after the warning from the pharmacy board, but many have chosen to sell off their supplies first. One retailer in Dayton predicts the price of CBD products will soar once they are no longer widely available.

“The prices, if they’re going to skyrocket, are going to hurt customers’ pockets,” Rabi Ahmad told WHIO.com. “Senior citizens mostly buy the CBD. The young kids, they don’t buy CBD at all.”  

A spokesman for the pharmacy board said there are no state plans to enforce the ban on CBD sales, although local law enforcement agencies could. Also unclear is how the ban will affect online sales and shipments from out-of-state vendors.

“The public should have uninhibited access to hemp-derived products no matter what state you live in. We will continue to produce these products and support our retailers and customers through this moment of confusion,” Nic Balzer, CEO of QC Infusion, a Cincinnati-based manufacturer of CBD products, told Cincinnati.com.

PNN’s coverage of medical marijuana is sponsored by Every Day Optimal CBD.  

Everything I Learned About Using Kratom for Pain

By Crystal Lindell, PNN Columnist

Here’s the thing about kratom. It works. It seriously works. If you are having a horrific pain flare and you put some under your tongue, your pain will be gone in less than three minutes. True story.

It also made me gain 27 pounds because it acts like an antidepressant in a lot of ways, and my body always gains weight when I’m on drugs like that.

And it’s pretty expensive — about $20 for 30 grams if you don’t get it in bulk, which is about six servings. For me each dose only lasts between two to five hours depending on how bad my pain is. You can get it in bulk, which I recommend, and then it’s $150 for 1 Kilo — so much cheaper per serving.

But even if you get it cheap, it’s really disgusting. I take it by shoving a spoonful under my tongue, saying a prayer, holding back the urge to vomit, and chugging Gatorade to get it down. It’s not the only way to take it, but it’s the only way that hits you in less than three minutes.

I’ve heard others put it in tea or smoothies, and of course there are capsules, but those take longer to kick in and don’t seem to work as well.

There’s also a lot of brands and strains and it can be hard to find the ones that works best for you.

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Trainwreck Kratom by Earth Kratom is by far the best version I have found, and it literally relieves my pain as much as hydrocodone would on most days. It’s a mix of 11 different kratom strains and they seem to work better together.

But even with all the drawbacks, kratom has some serious advantages.

First and foremost, I have access to it. There’s no need for a prescription or a trip to the doctor — just a quick stop by the local smoke shop and I’m all stocked up. And it’s completely legal in most states, so there’s no need to worry about some of the issues that come with marijuana usage.

In addition to helping with pain, it also helps with depression and anxiety, which is great seeing as how most people in chronic pain have one or both.

It’s also the perfect way to get through a physical opioid withdrawal, as it will eliminate your symptoms in most cases. Yes, then you’ll have to go off kratom after that, but it’s much easier than the withdrawal that hydrocodone tends to bring with it.

One drawback is that most doctors don’t know much about it, so it can be hard to explain to them that you’re using it and they likely won’t be able to tell you how it will interact with other medications. There’s also been some bad press around it, including reports of deaths, so doctors may be wary about you using it at all. The FDA considers kratom to be an opioid and says it should not be used to treat any medical condition.

But if you’re dealing with serious chronic pain, and you’re sick of jumping through hoops to get an opioid prescription or your medication just isn’t cutting it, I would highly recommend you give kratom a try.

Just don’t try to take it with a carbonated beverage. The bubbles will lift it into your sinuses, and it feels like you’re being waterboarded with dirt. But other than that — it’s awesome!

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Crystal Lindell is a journalist who lives in Illinois. She eats too much Taco Bell, drinks too much espresso, and spends too much time looking for the perfect pink lipstick. Crystal has hypermobile Ehlers-Danlos syndrome. 

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Ends Probe into Kratom Salmonella Link

By Pat Anson, Editor

The Food and Drug Administration has ended its investigation of a small salmonella outbreak linked to kratom – but not without taking some parting shots at the herbal supplement used by millions of Americans to treat chronic pain, addiction, depression and other conditions.

“It appears the salmonella problem with kratom uncovered earlier this year has probably been occurring for some time and is ongoing. We have closed our outbreak investigation, concluding that anyone consuming kratom may be placing themselves at a significant risk of being exposed to salmonella,” said FDA commissioner Scott Gottlieb, MD, and Stephen Ostroff, MD, FDA Deputy Commissioner for Foods and Veterinary Medicine, in a lengthy joint statement.

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The FDA ended its investigation five weeks after the Centers for Disease Control and Prevention wrapped up its own probe of the salmonella outbreak that sickened 199 people in 41 states. The CDC investigation began in February of this year, but salmonella illnesses linked to kratom were traced back as far as January 2017.

No single source of the outbreak was ever identified, but kratom was considered the “likely source.” A little over half of the 81 kratom samples that were analyzed tested positive for strains of salmonella bacteria.

“This means that users of these products had essentially a one in two chance of being exposed to this pathogen,” Gottlieb and Ostroff said. “The more than 50 percent contamination rate is stunningly high. It represents a level rarely seen in outbreak investigations of this nature. It shows that a high proportion of kratom being shipped into the United States may be contaminated with salmonella.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a natural pain reliever and stimulant, particularly in rural areas of Indonesia and Thailand.  

“In these locations, the plant is being grown, harvested and processed in problematic conditions that readily create the circumstance for widespread contamination with foodborne pathogens. Although some of the kratom is further processed once in the United States into capsules, powders or herbal remedies, based on our findings, these procedures do not appear to be eliminating microbial contamination,” wrote Gottlieb and Ostroff.

In recent years, millions of Americans have discovered kratom and started buying it online or in convenience stores and “head shops.” But not until this year did federal health officials show any concern that kratom products were contaminated with salmonella bacteria. Their primary focus was that kratom was being marketed as an unapproved medical treatment, particularly for pain and addiction.

The FDA has even started calling kratom an addictive “opioid,” when in reality its active ingredients are mitragynine and 7-hydroxymitragynine, two alkaloids that are believed to act on opioid receptors in the brain. Earlier this year, the FDA released a computer analysis that found kratom contains over two dozen opioid-like substances – a report that critics say was biased and amounted to “junk science.”

Over a dozen kratom products were recalled during the FDA and CDC salmonella investigations. Salmonella is a bacterial infection usually spread through contaminated food or water. Most people who become infected develop diarrhea, fever and stomach cramps. Severe cases can result in death.

There have been several other salmonella outbreaks this year, including infections linked to melons, raw sprouts, dried and shredded coconut, live poultry, chicken salad, pet guinea pigs, and Kellogg’s Honey Smacks cereal.

CDC Ends Salmonella Investigation of Kratom

By Pat Anson, Editor

The Centers for Disease Control and Prevention has officially ended its investigation of a nationwide salmonella outbreak linked to the herbal supplement kratom.  A total of 199 people were infected and 50 of them hospitalized. There have been no deaths.

Although this particular outbreak was small – there are over one million Salmonella illnesses every year in the U.S. – it covered a lot of territory. Illnesses were reported in 41 states.

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SALMONELLA BACTERA

Salmonella is a bacterial infection usually spread through contaminated food or water. Most people who become infected develop diarrhea, fever and stomach cramps. Severe cases can result in death.

Although the CDC investigation did not identify a single, common source of contaminated kratom, it found enough evidence to declare that kratom was the “likely source.”

State and local health officials interviewed 103 people who were sickened in the outbreak and found that 74 percent reported consuming kratom in pills, powder or tea. The kratom was purchased online and from retail locations in several states. Over a dozen brands of kratom were recalled as a result.

“This outbreak investigation is over. However, some kratom products that were contaminated with Salmonella have not yet been recalled and may still be available for purchase or in people’s homes,” the CDC said in a statement.  “Salmonella was identified in nearly half of the kratom products tested during this investigation. Eighty-five different DNA fingerprints of Salmonella were identified in samples of kratom products. This information indicates widespread Salmonella contamination in kratom from multiple retailers."

The CDC has modified a previous recommendation that no one consume kratom “in any form.” The agency now recommends that only people at risk of a Salmonella infection – such as pregnant women, children, older adults, and people with compromised immune systems -- avoid consuming kratom products.

“If you are considering using kratom, talk to your health care provider first, especially if you are in a group more likely to get a severe Salmonella infection,” the CDC said.

Millions of Americans use kratom to treat chronic pain, addiction, depression, anxiety and other medical conditions. Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a natural pain reliever and stimulant.

To see an FDA list of recalled kratom products, click here.

FDA Continues Crackdown on Kratom Vendors

By Pat Anson, Editor

The U.S. Food and Drug Administration has stepped up its campaign against the herbal supplement kratom by sending warning letters to three distributors of kratom products – the latest effort in what appears to be a concerted government effort to stop all sales of the herb.

Front Range Kratom, Kratom Spot and Revibe are accused of illegally selling unapproved “drug products” and making unproven claims about kratom’s ability to treatment opioid addiction, chronic pain and other medical conditions.

The FDA and the Centers for Disease Control and Prevention have previously warned consumers not to consume any kratom products. The CDC said kratom was the “likely source” of a small salmonella outbreak, while the FDA alleged that kratom has opioid-like qualities and could lead to addiction and overdose.

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“Despite our warnings that no kratom product is safe, we continue to find companies selling kratom and doing so with deceptive medical claims for which there’s no reliable scientific proof to support their use,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

“We cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction. Far from treating addiction, we’ve determined that kratom is an opioid analogue that may actually contribute to the opioid epidemic and puts patients at risk of serious side effects.”

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, millions of Americans have discovered kratom and started using the herb as an alternative to prescription drugs for treating chronic pain, anxiety, depression, and addiction.

Like most herbal and dietary supplements, there is little scientific research to support the use of kratom and it is not approved for any medical condition by the FDA. As a result, many kratom distributors are careful to avoid making unsubstantiated medical claims. Front Range Kratom, for example, currently has a clear disclaimer on its website stating that:

Information on this website is not for health-related guidance. The products mentioned on this website are not intended to diagnose, prevent, treat or cure any diseases or health conditions. You need to consult with a medical practitioner for all issues with regards to your overall health.”

But even sharing customer testimonials about kratom is considered illegal marketing by the FDA. The agency alleges in its warning letter to Front Range Kratom that the website contained comments from new customers such as “Certainly kratom is useful for pain — myself and everyone else on the internet can attest to that.” Another customer wrote that “the two things I think kratom works the best for are pain and to help people get through some of the post acute withdrawl (sic) symptoms they get when they come off of their pain medications.”

Those testimonials from kratom users can’t be found on the website today.

“If people believe that the active ingredients in kratom have drug-like effects that can treat pain or addiction, then the FDA is open to reviewing that data under our new drug approval process,” said Gottlieb. “In the meantime, I promised earlier this year that the FDA would step up our actions against unapproved and unsafe products that are being deceptively marketed for the treatment of opioid addiction and withdrawal symptoms.”

FDA investigators are also monitoring the social media sites of kratom vendors. Last October, Kratom Spot shared on its Facebook page a CNN story about kratom as a possible treatment for pain and opioid addiction. The company only said the story was “positive news for kratom as... an all natural alternative.” But the FDA said that amounted to the illegal marketing of an unapproved drug.

“The claims on your website and social media sites establish that your kratom products are drugs…  because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease—in particular, for opiate withdrawal and addiction,” the warning letter states.

It probably didn’t help that Kratom Spot shared a picture on its Facebook page of hundreds of kratom orders being readied for shipment by another federal agency -- the U.S. Postal Service.

Kratom Spot, Front Range Kratom and Revibe were all given 15 days to respond to the warning letters, which state that “failure to correct violations may result in law enforcement action such as seizure or injunction.”

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KRATOM SPOT/FACEBOOK

The threat of legal action can be all that it takes to drive a kratom vendor out of business. In February, the FDA forced  Divinity Products Distribution to recall and stop selling kratom products. The FDA said the company agreed to the “voluntary destruction” of its kratom products, even though there were no reports of illnesses associated with them.

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.

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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.    

FDA Orders Recall of Kratom Linked to Salmonella Scare

By Pat Anson, Editor

The U.S. Food and Drug Administration has issued a mandatory recall for kratom capsules made by a Las Vegas company after several of its products were found to be contaminated with salmonella bacteria.

The FDA said it ordered the recall after Triangle Pharmanaturals failed to cooperate with the agency’s request to conduct a voluntary recall.

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The FDA is advising consumers to discard kratom products made by Triangle, which include Raw Form Organics Maeng Da Kratom Emerald Green, Raw Form Organics Maeng Da Kratom Ivory White, and Raw Form Organics Maeng Da Kratom Ruby Red. The products are sold in 300 capsule plastic bottles.

It’s possible other brands may be included in the recall because Triangle manufactures and packages kratom products for other companies.

“This action is based on the imminent health risk posed by the contamination of this product with salmonella, and the refusal of this company to voluntarily act to protect its customers and issue a recall, despite our repeated requests and actions,” said FDA Commissioner Scott Gottlieb, MD, in a statement.

“We continue to have serious concerns about the safety of any kratom-containing product and we are pursuing these concerns separately. But the action today is based on the risks posed by the contamination of this particular product with a potentially dangerous pathogen. Our first approach is to encourage voluntary compliance, but when we have a company like this one, which refuses to cooperate, is violating the law and is endangering consumers, we will pursue all avenues of enforcement under our authority.”

The FDA said Triangle did not cooperate with its investigation or order a voluntary recall after six samples of its kratom products tested positive for salmonella. “FDA investigators were denied access to the company’s records relating to potentially affected products and Triangle employees refused attempts to discuss the agency’s findings,” the FDA said.

The company did not immediately respond to a request for comment.

At least 87 people have been sickened in 35 states by a salmonella outbreak linked to kratom – an herbal supplement used by millions of Americans to treat chronic pain, depression, anxiety and addiction. At least one other kratom distributor – PDX Aromatics of Portland, Oregon – agreed to voluntarily recall its products after several were found contaminated with salmonella.

Salmonella is a bacterial infection usually spread through contaminated food or water. Most people who become infected develop diarrhea, fever and stomach cramps. Severe cases can result in hospitalization or even death.

Kratom is usually sold in powder, capsules or leaves.  The Centers for Disease Control and Prevention has not been able to trace the salmonella outbreak to a single brand or source, so it is recommending that people not consume “any brand of kratom in any form.”

The FDA has also warned against consuming kratom, claiming it has opioid-like qualities and could lead to addiction. In recent months, the FDA has released a public health advisory warning that kratom should not be marketed as a treatment for any medical condition. The agency also released a computer analysis that found kratom contains over two dozen opioid-like substances.

Under the Food Safety Modernization Act, the FDA has broad authority to order the recall of food products when the agency determines that there is a reasonable probability the food is adulterated or could have serious health consequences.

Salmonella Outbreak Linked to Kratom Spreading

By Pat Anson, Editor

The number of people infected by a Salmonella outbreak linked to the herbal supplement kratom has more than doubled – with 87 illnesses now reported. Twenty-seven people have been hospitalized, according to a new CDC report.

Although this particular outbreak is small – there are about one million Salmonella cases every year in the U.S. – it covers a lot of territory. Illnesses have been reported in 35 states from New York to California. No deaths have been reported.

Evidence is also increasing that the outbreak involves kratom, an herbal supplement that millions of Americans use to treat chronic pain, depression, anxiety and addiction.

In a survey of 55 patients sickened in the outbreak, 40 said they had consumed kratom in pills, powder, or tea. Most reported consuming kratom in powder form.

"People who reported consuming kratom purchased it from retail locations in several states and from various online retailers," the CDC said in a statement.  “At this time, CDC recommends that people not consume any brand of kratom in any form because it could be contaminated with Salmonella and could make people sick.”

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The origin of the contaminated kratom has not been identified, but three brands of kratom sold by PDX Aromatics of Portland, Oregon have been recalled. Health officials in California collected leftover kratom powder from one of PDX's brands (Phytoextractum) from an ill person in California, and the outbreak strain of Salmonella was identified in the sample. PDX blames the contamination on an unidentified "supplier" that it is no longer taking shipments from.

(Update: On March 16, after "additional positive findings of Salmonella" in its kratom products, PDX expanded the recall.)

Investigators in Oregon and Utah have also collected kratom powder from retail locations and online retailers where ill people reported purchasing kratom. Outbreak strains of Salmonella Okatie and Salmonella Thompson were identified in those samples. No brand information was available for the kratom collected in Oregon. The ill person in Utah purchased kratom powder from the website kratoma.com.

In a statement on its website, Kratoma said it "would not restock any kratom in future" and would close its online store by March 31, 2018.

The CDC now traces the start of the outbreak back to January 2017. The CDC says there could be more than the current count of 87 cases, because it takes an average of two to four weeks for a Salmonella illness to be reported.

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, with 19,000 hospitalizations and 380 deaths.

Last month the Food and Drug Administration recalled three brands of kratom made by Missouri-based Divinity Products. The company agreed to the “voluntary destruction” of its kratom products, even though there have been no reports of illnesses associated with them.

Kratom Linked to Salmonella Outbreak Recalled

By Pat Anson, Editor

A kratom wholesaler and retailer based in Oregon is recalling three brands of the herbal supplement that may be contaminated with Salmonella bacteria.

PDX Aromatics of Portland, Oregon said the recall involves 10,000 packages of kratom powder that were sold to customers between January 18, 2018 and February 18, 2018 through company websites, under the brand names Kraken Kratom, Phytoextractum and Soul Speciosa.

“PDX Aromatics has identified a supplier in our supply chain as the source of Salmonella. The company has removed that supplier from our supply chain and all associated products from our facility. We have ceased distribution of products in order to perform a facility audit and have initiated a voluntary recall," the company said in a statement on its website.

(Update: On March 16, after "additional positive findings of Salmonella" in its kratom products, PDX expanded the recall.)

The company said it was notified by health officials in California that “certain lots of the product” tested positive for Salmonella bacteria and that there was one confirmed illness associated with its kratom powder.

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Salmonella is a bacterial infection usually spread through contaminated food or water. Most people who become infected develop diarrhea, fever and stomach cramps. Severe cases can result in hospitalization or even death.

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The Centers for Disease Control and Prevention announced last month that it was investigating a Salmonella outbreak linked to kratom – an herbal supplement imported from southeast Asia that millions of Americans use to treat chronic pain, addiction, depression and anxiety.

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At least 40 people have been sickened by the outbreak in 27 states. Seventeen of them said they had consumed kratom in pills, powder or tea. Most said they had bought kratom online, but some purchased it at retail locations.

The first illnesses were reported in October 2017 – three months before the timeline of kratom products involved in the PDX Aromatics recall.  Until a common source of Salmonella bacteria is identified, the CDC has recommended that people stop consuming all kratom products.

PDX Aromatics said customers would receive a full refund once the recalled kratom products are returned. A complete list of the brands and lot numbers involved in the recall can be found here.

Last month the Food and Drug Administration recalled three brands of kratom dietary supplements made by Missouri-based Divinity Products. The company agreed to the “voluntary destruction” of its kratom products, even though there have been no reports of harm or illnesses associated with them.

Salmonella Outbreak Linked to Kratom Spreads

By Pat Anson, Editor

The Centers for Disease Control and Prevention says a dozen more people have been sickened by a Salmonella outbreak linked to the herbal supplement kratom – raising to 40 the number of suspected cases. The number of states where the illnesses have been reported rose from 20 to 27.

For the first time, investigators have also found Salmonella bacteria linked to the outbreak in kratom powder samples in North Dakota and Utah.

“The outbreak strain of Salmonella was identified in both samples. The ill person in North Dakota purchased S.K. Herbalist brand kratom powder from the website soapkorner.com. The ill person in Utah purchased kratom powder from the website kratoma.com,” the CDC said in a statement.

“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. At this time, CDC recommends that people not consume kratom in any form because it could be contaminated with Salmonella and could make people sick.”

 STATES reporting SALMONELLA ILLNESSES

STATES reporting SALMONELLA ILLNESSES

State and local health officials have interviewed 24 people sickened by Salmonella, asking them about food and other substances they were exposed to before they became ill.

Seventeen of the 24 reported consuming kratom in pills, powder, or tea. Three said they purchased kratom from retail locations and 10 said they bought kratom online.

Illnesses from the Salmonella outbreak began last October, with the most recent case reported on February 13. Fourteen people have been hospitalized. No deaths have been reported.

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, with 19,000 hospitalizations and 380 deaths.

It generally takes about two to four weeks before a person infected with Salmonella is reported, so its possible there could be more than 40 cases in the current outbreak. 

Kratom comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries for its medicinal properties. In recent years, millions of Americans have started using kratom to treat chronic pain, depression, anxiety and addiction, conceivably costing the pharmaceutical industry billions of dollars in lost revenue.

FDA Warns Utah Company

In a move apparently unrelated to the Salmonella outbreak, the Food and Drug Administration warned a Utah company this week not to launch a new dietary supplement that is based on mitragynine -- one of the alkaloids found in kratom.

The FDA said Industrial Chemicals was using “inaccurate and misleading statements” on its website to promote Mitrasafe. Among other things, the company said that Mitrasafe was “fully compliant with all FDA laws and rules.”  

“Today, we notified a company making claims for a compound in kratom that its product is an unapproved new drug and an adulterated dietary supplement,” FDA commissioner Scott Gottlieb, MD, said in a statement.

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“The company is claiming that its product is a ‘natural substitute for opium,’ that it has ‘morphine-like effects,’ and that it can help relieve pain along with a litany of other ailments. Just as troubling, this company promotes kratom as effective in ‘curing addiction’ and treating ‘withdrawal symptoms.’ These unlawful practices not only mislead consumers, but can also prevent people suffering from addiction from seeking effective treatments.”

Industrial Chemicals planned to start selling Mitrasafe on February 28. A spokesman for the company said the launch date has been postponed while it appeals the FDA decision.

“We did not make any drug claims. On the contrary. We did not claim that Mitrasafe itself could do these things or have opium like qualities at all. We never even came close,” said attorney John VanOphem. “The FDA wants to be taken seriously on this stuff? I’m sorry, they haven’t followed their own guidance. This is alarming to me. To have us become the whipping boy poster child on this is just outrageous."

VanOphem told PNN the company has spent years trying to work with the FDA to get Mitrasafe approved.

“The FDA has done nothing to prove that they’re actually interested in addressing the substance of this. They’re just not credible and it’s a shame,” said VanOphem. “All they intend to do is ban kratom, period. There’s no other option for them. They’ve never acknowledged any other option.”  

Unlike pharmaceutical drugs, dietary supplements like kratom are -- for the most part -- loosely regulated by the FDA. But in recent months the agency has launched an unprecedented public campaign to discourage people from using kratom.

In November, the FDA released a public health advisory warning about kratom's potential health risks, especially when used to treat opioid addiction. Last month the agency released a computer analysis that alleged kratom contains over two dozen opioid-like substances that share structural similarities to painkillers such as morphine.

“Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use. And claiming that kratom is benign because it’s ‘just a plant’ is shortsighted and dangerous,”  Gottlieb said in a statement.

In 2016, the Drug Enforcement Administration attempted to ban kratom by scheduling it as an illegal controlled substance, but a public outcry and lobbying campaign forced the DEA to suspend its scheduling decision. Many kratom supporters fear that another attempt to ban kratom is imminent.

“We’re in for a fight,” said David Herman, president of the American Kratom Association, a pro-kratom consumer group. “There’s no question they want to ban it.”

FDA Recalls Three Kratom Brands

By Pat Anson, Editor

The U.S. Food and Drug Administration Wednesday announced the recall of three brands of dietary supplements containing kratom, the latest move in what appears to be a concerted government campaign to stop all sales of the herb.

The recall involves a large volume of kratom supplements sold under the brand names Botany Bay, Enhance Your Life and Divinity, which are manufactured and sold nationwide by Divinity Products Distribution of Missouri. The FDA said the company had agreed to the “voluntary destruction” of its kratom products, even though there have been no reports of illnesses associated with them.

“The company has also agreed to stop selling all products containing kratom. Based on the scientific evidence of the serious risks associated with the use of kratom, in the interest of public health, the FDA encourages all companies currently involved in the sale of products containing kratom intended for human consumption to take similar steps to take their products off the market,” the FDA said in a statement.

The move appears unrelated to Tuesday’s warning from the CDC linking kratom to a Salmonella bacteria outbreak in 20 states. The CDC said 8 of the 28 people who were sickened by Salmonella had recently used kratom, making it the "likely source." No actual bacteria was found in a kratom product.

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In recent months, the FDA has released a public health advisory warning that kratom should not be marketed as a treatment for opioid addiction, chronic pain, depression or any other medical condition. The agency also released a computer analysis that found kratom contains over two dozen opioid-like substances.

“The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death. At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

“To protect the public health, we’ll continue to affirm the risks associated with kratom, warn consumers against its use and take aggressive enforcement action against kratom-containing products. We appreciate the cooperation of companies currently marketing any kratom product for human consumption to take swift action to remove these products from circulation to protect the public.” 

'No Question They Want to Ban It’

“We’re in for a fight,” said David Herman, president of the American Kratom Association, a pro-kratom consumer group. “This is clearly a disinformation campaign. They are creating through a grassroots effort what they can’t seem to be able to (prove) with science.

“This is a bazooka against a fly. What are they doing? We’ve got misinformation everywhere.”

Herman says there is little doubt the FDA is moving to have all kratom products taken off the market.

“This is a concerted movement and it’s had a lot of disinformation with it,” he told PNN. “This is clearly what FDA wants to do. We hope the DEA has some thoughts against it, but no, there’s no question they want to ban it.”  

In 2016, the Drug Enforcement Administration attempted to ban kratom by scheduling it as an illegal controlled substance, but a public outcry and lobbying campaign forced the DEA to suspend its scheduling decision.

Herman said any renewed attempt to schedule kratom as a controlled substance would have to go through a public comment and hearing process, which could take a year or longer. He sees it as part of a larger effort by the FDA to have greater control over the loosely regulated dietary supplement industry.

“The only logical conclusion is that this is the first salvo in controlling the supplement business. We are on the frontline of a fight that will encompass a whole lot more than kratom,” Herman said.

Kratom Linked to Salmonella Outbreak

By Pat Anson, Editor

Kratom just can’t get a break. In recent weeks, the herbal supplement used by millions of Americans to treat chronic pain, depression and addiction has been blamed by federal agencies for dozens of fatal overdoses and even been called an opioid.

Now the Centers for Disease Control and Prevention has linked kratom to a salmonella outbreak and is recommending that people "not consume kratom in any form."

The bacterial infection has sickened 28 people, eleven serious enough to be hospitalized, but there have been no deaths. The outbreak began in October 2017 and has reached 20 states scattered around the country, which are highlighted in the map below.

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“Epidemiologic evidence indicates that kratom is a likely source of this multistate outbreak,” the CDC said in a statement.

“In interviews, ill people answered questions about the foods they ate and other exposures in the months before they became ill. Eight (73%) of 11 people interviewed reported consuming kratom in pills, powder, or tea. No common brands or suppliers of kratom have been identified at this time."

The CDC statement did not say that Salmonella bacteria had actually been found in any samples of kratom. Nor did it explain how kratom use in 8 out of 28 cases establishes a link or proves that it was "a likely source."

The only "epidemiologic evidence" that investigators have established is that when they compared bacteria samples from people who were infected, they found the bacteria were closely related genetically.

"This means that people in this outbreak are more likely to share a common source of infection," the CDC said. "At this time, CDC recommends that people not consume kratom in any form. The investigation indicates that kratom products could be contaminated with Salmonella and could make people sick."

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, with 19,000 hospitalizations and 380 deaths.

In the current outbreak, the CDC says there could be more cases than the 28 reported, because salmonella infections typically take 2 to 4 weeks before the illnesses are confirmed.

 salmonella bacteria

salmonella bacteria

It was a July 2016 report from the CDC that claimed kratom was linked to several overdose deaths and was “an emerging public health threat” that led the Drug Enforcement Administration to attempt to schedule kratom as an illegal controlled substance. Kratom supporters said the CDC research was amateurish and flawed, and a public outcry and lobbying campaign eventually forced the DEA to suspend its scheduling decision.

Earlier this month, the Food and Drug Administration released a computer analysis that found kratom contains over two dozen opioid-like substances – a report that critics say was biased and amounted to “junk science.” The computer analysis and a recent FDA public health advisory may indicate the federal government is planning another attempt at scheduling.

Kratom comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries for its medicinal properties.

Kratom Supporters Say Ban Would Worsen Opioid Crisis

By Pat Anson, Editor

Nine scientists are warning that a renewed effort to make the herbal supplement kratom an illegal Schedule I controlled substance would worsen the opioid crisis and lead to more overdoses.

“It is our collective judgment that placing kratom into Schedule I will potentially increase the number of deaths of Americans caused by opioids because many people who have found kratom to be their lifeline away from strong opioids will be vulnerable to resumption of that opioid use,” wrote lead author Jack Henningfield, PhD, in a letter to Acting DEA administrator Robert Patterson and White House advisor Kellyanne Conway.

“A ban on kratom that would be imposed by CSA Scheduling would put them at risk of relapse to opioid use with the potential consequence of overdose death. Similar unintended consequences are to be expected in some who would be forced to use opioids to manage acute or chronic pain.”

The letter was released by the American Kratom Association (AKA), a pro-kratom consumer group, in response to an FDA analysis this week stating that kratom contains risky chemical compounds that act as opioids.   

“Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use,” said FDA Commissioner Scott Gottlieb, MD, in a lengthy statement.

“As the scientific data and adverse event reports have clearly revealed, compounds in kratom make it so it isn’t just a plant – it’s an opioid. And it’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated, sold and used recreationally and by those who are seeking to self-medicate for pain or who use kratom to treat opioid withdrawal symptoms."

Kratom comes from a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties. Kratom leaves are typically ground up into powder to make tea or used in capsules. Millions of Americans have discovered kratom in recent years, using it to treat chronic pain, anxiety, depression, and addiction.

In 2016, the Drug Enforcement Administration tried to list two of kratom’s active ingredients as Schedule I substances, which would have made it a felony to sell or possess kratom. The DEA suspended its plan after a public outcry and asked for a full medical evaluation of kratom from the FDA.

 KRATOM POWDER

KRATOM POWDER

The new report from the FDA -- which links kratom to dozens of overdose deaths – seems likely to trigger a new effort by the DEA to make the herb an illegal controlled substance. That would be a serious mistake, according to the scientists engaged by the AKA, because it would stifle kratom research.

“Placing kratom into Schedule I of the CSA (Controlled Substances Act) will also have a profound and pervasive chilling effect on this needed additional research,” they wrote. “The federal government should be encouraging additional research into the potential benefits of kratom, as well as the possibility that extracts of kratom and/or new medicines that are similar to kratom’s active ingredients might serve as breakthroughs in pain relieving medicines that are so desperately needed.”

The letter was signed by scientists and researchers affiliated with the Johns Hopkins University School of Medicine, Columbia University, Temple University School of Medicine, University of Rochester Medical Center, University of British Columbia, and other academic and medical institutions.

FDA Report Calls Kratom an Opioid

By Pat Anson, Editor

The herbal supplement kratom contains opioids and should not be used to treat any medical condition, according to a new analysis by the U.S. Food and Drug Administration. The report seems likely to trigger a renewed effort to classify kratom as an illegal Schedule I substance under the Controlled Substances Act.

“Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use. And claiming that kratom is benign because it’s ‘just a plant’ is shortsighted and dangerous,” said FDA Commissioner Scott Gottlieb, MD, in a lengthy statement.

“It’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated, sold and used recreationally and by those who are seeking to self-medicate for pain or who use kratom to treat opioid withdrawal symptoms.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties.  Millions of Americans have discovered kratom in recent years, using it to treat chronic pain, anxiety, depression, and addiction.

In 2016, the Drug Enforcement Administration attempted to list two of kratom’s active ingredients as Schedule I substances. The DEA suspended its plan after a public outcry, and said it would wait for a scheduling recommendation and medical evaluation of kratom from the FDA.

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The new report may prompt the DEA to try again.  In a computer analysis using what the FDA calls Public Health Assessment via Structural Evaluation (PHASE) methodology, FDA researchers identified 25 chemical compounds in kratom that share structural similarities with opioid analgesics such as morphine. Like painkillers, the substances bind to mu-opioid receptors in the brain and – according to the computer models -- act the same way as opioids.

“The data from the PHASE model shows us that kratom compounds are predicted to affect the body just like opioids. Based on the scientific information in the literature and further supported by our computational modeling and the reports of its adverse effects in humans, we feel confident in calling compounds found in kratom, opioids,” Gottlieb said.

FDA Analysis Called ‘Junk Science'

Critics of the FDA analysis say it contains numerous errors and signs of confirmation bias.

"The failure of the FDA to justify its attempt to schedule kratom using traditional and well-accepted scientific methods has apparently driven the FDA to move into the world of junk science.  Using computer modeling is very susceptible to bias in the assumptions the are built into the computer algorithms.  In short, the old adage of 'garbage in – garbage out' applies to such dramatic testing standards," said Dave Herman, chairman of the American Kratom Association (AKA), a pro-kratom consumer group.

In addition to its analysis, the FDA released a detailed report on 36 deaths associated with kratom over the past several years. The agency admits all but one of the overdose deaths involved other drugs and “could not be fully assessed.” There was only one death involving a person who had no prior opioid use.  

“We’re continuing to investigate this report, but the information we have so far reinforces our concerns about the use of kratom. In addition, a few assessable cases with fatal outcomes raise concern that kratom is being used in combination with other drugs that affect the brain, including illicit drugs, prescription opioids, benzodiazepines and over-the-counter medications, like the anti-diarrheal medicine, loperamide,” Gottlieb said.

"It is more of the same useless rhetoric from FDA," says Jane Babin, a molecular biologist who authored a report last year for the AKA that discredited many of the reports linking overdoses to kratom.

"Bottom line:  36 deaths over 3, 5, 7 or more years that they can't prove were caused by kratom, versus 16,000 deaths from killer street opioids," Babin wrote in an email. 

In a survey of 6,150 kratom users by Pain News Network and the AKA, most reported they used kratom as a treatment for chronic pain, depression, anxiety or addiction. Many say the herb is safe, effective and has literally saved their lives

“Kratom is the one thing that has kept me from using opiates and other illegal substances. I've been able to stay clean for 3 years now. It's given me my life back,” one survey respondent wrote.

“Kratom is the only reason I was finally able to end my addiction to hydrocodone. It is nowhere near as potent as hydrocodone, and you can't overdose” said another.

“I've had several friends who have died from heroin overdose. If they knew about kratom they may still be alive today,” wrote another kratom user.

One of the dilemmas faced by the FDA and DEA is that kratom products are currently classified as dietary supplements, and there are few regulatory standards applied to their importation or ingredients. The only requirement for kratom vendors is that they don't make unsubstantiated health claims. Classifying kratom as a Schedule I controlled substance would radically change that, making it a felony to possess or sell kratom, and likely creating an underground black market for the herb.

FDA Warns Promoters of Herbal Addiction Treatments

By Pat Anson, Editor

The U.S. Food and Drug Administration is following through on its threat to crackdown on companies selling kratom and other herbal supplements as treatments for opioid addiction and withdrawal.

The FDA and the Federal Trade Commission (FTC) have sent joint warning letters to the distributors of 15 herbal supplements for illegally marketing unapproved products.

“The FDA is increasingly concerned with the proliferation of products claiming to treat or cure serious diseases like opioid addiction and withdrawal,” said FDA Commissioner Scott Gottlieb, MD. “People who are addicted to opioids should have access to safe and effective treatments and not be victimized by unscrupulous vendors who are trying to capitalize on the opioid epidemic by taking advantage of consumers and selling products with baseless claims.”

The companies used websites or social media to make claims about their products' ability to cure, treat or prevent opioid withdrawal and addiction.

TaperAid, for example, claims its “17 all-natural organic herbs” can relieve symptoms of withdrawal and even reduce tolerance to opioid painkillers.

“Use of TaperAid may increase sensitivity to opioids. You may need to lower your usual intake of opioids to account for reduced tolerance,” the company claimed. “People using short acting opioids (which includes many pain management medications and heroin) will notice a significant lowering of tolerance to their opiate of choice.”

TaperAid’s website and Facebook account have been taken down, although a TaperAid review can still be found on YouTube.

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“Opioid addiction is a serious health epidemic that affects millions of Americans,” said acting FTC Chairman Maureen Ohlhausen. “Individuals and their loved ones who struggle with this disease need real help, not unproven treatments.”

In addition to the warning letters, the FTC released a “fact sheet” warning consumers about companies that promise miracle cures or fast results.

“Dietary supplements – such as herbal blends, vitamins, and minerals – have not been scientifically proven to ease withdrawal or to treat opioid dependence,” the FTC warned. “Products like Kratom, which some claim can help, are actually not proven treatments, and can be addictive and dangerous to your health.”

The FDA issued a public health advisory about kratom last November, saying there was “no reliable evidence to support the use of kratom as a treatment for opioid use disorder.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties.  Millions of Americans have discovered kratom in recent years, and use it to treat addiction, chronic pain, anxiety and depression. The herb is not approved by the FDA for any medical condition. 

In 2016, the Drug Enforcement Administration attempted to list kratom’s two active ingredients as Schedule I controlled substances, which would have made it a felony to possess or sell kratom. The DEA suspended its plan after a public outcry, saying it would wait for a scheduling recommendation and medical evaluation of kratom from the FDA. Over a year later, that report has still not been released.

Lawmakers Ask FDA to Lift Kratom Warning

By Pat Anson, Editor

A bipartisan group of 17 congressmen is asking the Food and Drug Administration to lift a public health warning about kratom, an herbal supplement used by millions of Americans to treat chronic pain, addiction, depression and anxiety.

In a joint letter to FDA commissioner Scott Gottlieb, MD, the lawmakers said kratom was “a natural alternative to opioids” and was “found to be as safe as coffee.”  The letter was drafted by Rep. Jared Polis (D-CO) and Rep. Dave Brat (R-VA).

“We have heard from many constituents who have used kratom to successfully end their dependence on dangerous opioids, and maintaining legal access to kratom is important to many Americans to maintain sobriety,” the letter states. “We believe that if legal access to professionally-manufactured kratom were made difficult or illegal, instances of kratom laced with opioids or other dangerous compounds would likely become more common.”

The FDA issued a public health advisory in November, warning that there were “increasing harms associated with kratom” and that the herb was involved in 36 deaths. The agency did not say when or where the deaths occurred.

“There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder. Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product’s dangers, potential side effects or interactions with other drugs,” Gottlieb said in a statement.

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties. The leaves are usually ground up to make tea or turned into powder and used in capsules. Most kratom users say the herb has a mild analgesic and stimulative effect.

Last year, the Drug Enforcement Administration attempted to list kratom as a Schedule I controlled substance, which would have made it a felony to possess or sell. The DEA suspended its plan after an outcry by kratom supporters and a lobbying campaign that enlisted the help of dozens of senators and congressmen.

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“We need to improve access to alternative pain relief options beyond addictive opioids.  For some, kratom, a cousin of the coffee plant, can be that alternative.  Like cannabis, it should be legal and available,” Rep. Polis said in a statement. “The FDA must end its bogus ‘public health warning’ that has already led to several cities banning kratom.  Patients need and deserve options.”

Kratom Pioneer Calls for Government Regulation

One of the dilemmas faced by the FDA is that kratom products are considered dietary supplements, and there are few regulatory standards applied to their importation or ingredients. The only requirement for kratom vendors is that they don't make unsubstantiated health claims.

“I know that regulation is needed and I think that is something we conscientiously have to work towards,” says Duncan Macrae, the founder of Kratom.com and one of the first commercial suppliers to bring kratom products into the United States, Canada and Europe.

“I think that direct government regulation will eventually come about. But while everybody’s waiting for that to happen, I think that vendors in the industry that are making money from this should get together and start their own internal regulation to try to be more transparent,” Macrae told PNN.

“I can tell you for sure that there are a lot of adulterated products on the market, and vendors going in and out of business the whole time, changing names and companies. There’s no central body checking or controlling anything.”

Macrae says kratom vendors should certify their products and list their ingredients – or risk the government stepping in and banning kratom altogether.

“Right now the problem is that every vendor is labeling their product ‘not for consumption.’ And there’s no information about the product or what’s inside it,” he said. “This is the regulation we need to do from inside and hopefully the government won’t (ban kratom) because it is an extremely valuable medicinal herb and they will embrace some kind of regulation that makes sense, so that kratom can be administered safely and distributed safely and people will know exactly what they’re getting.”

Macrae is working to ensure the quality of his own products by growing kratom on farms in Indonesia, as opposed to just harvesting the leaves from trees growing wild in remote jungles. He’s planted hundreds of thousands of kratom trees, with hopes of somebody mass producing kratom tea, pills and extracts.

“I think this is the future for the industry and that is the product that we need to develop, and that’s what I’ve been working on,” he said.

FDA Head Tweets New Warning About Kratom

By Pat Anson, Editor

The head of the Food and Drug Administration is warning again about the marketing of kratom and other dietary supplements to treat opioid addiction – calling them “health fraud scams.”

“FDA believes strongly people addicted to opioids should have access to safe and effective, approved treatments for addiction. Unfortunately, unscrupulous vendors are trying to capitalize on opioid epidemic by illegally marketing products for these purposes,” FDA commissioner Scott Gottlieb, MD, warned on Twitter Friday.

Gottlieb was reacting to a story in The New York Times about the marketing of dietary supplements like “Opiate Detox Pro,” a blend of vitamins and amino acids said to have “amazing benefits” in reducing opioid withdrawal symptoms. 

Similar claims are made about kratom by websites such as HowtoQuitHeroin.com, which was founded by Jorge Fernandez, a recovering heroin addict.

“Kratom works. Kratom helps. It can help you to quit heroin. It can help you to quit Suboxone. It can help you to quit Oxycontin. And believe it or not, it can even help you to quit Methadone as well,” Fernandez claims.

Kratom is not approved by the FDA as a treatment for opioid addiction or any other health condition. But because kratom is classified as a dietary supplement, it’s not held up to the same regulatory standards as pharmaceutical drugs -- as long as vendors don’t make any misleading claims about its health benefits. That’s when the FDA can intervene by seizing kratom products or prohibiting their sale.

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“They’re marketing products as dietary supplements with unproven claims about ability to treat addiction; or as all-natural alternatives to opioids. Health fraud scams like these can pose serious health risks,” Gottlieb tweeted. “FDA will continue to act when it learns of the deceptive sale or advertising of products that claim to effectively treat opioid use disorder, but which have not been proven safe and effective for these purposes.”

 SCOTT GOTTLIEB, MD

SCOTT GOTTLIEB, MD

Although Gottlieb didn’t specifically name kratom as one of those “health fraud scams,” there’s little doubt that’s one of the supplements he was referring to. Last month the FDA issued a public health advisory about kratom, warning that it was addictive and linked to dozens of overdose deaths.

“The FDA knows people are using kratom to treat conditions like pain, anxiety and depression, which are serious medical conditions that require proper diagnosis and oversight from a licensed health care provider,” Gootlieb said at the time.

“I understand that there’s a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties. The leaves are usually ground up to make tea or turned into powder and used in capsules. Most kratom users say the herb has a mild analgesic and stimulative effect, similar to coffee.

In a survey of 6,150 kratom users last year by Pain News Network and the American Kratom Association, most said they used kratom as a treatment for chronic pain, depression or anxiety. But a fair number -- nearly 10 percent -- said the primary reason they used kratom was to treat opioid addiction.

“Kratom is the one thing that has kept me from using opiates and other illegal substances. I've been able to stay clean for 3 years now. It's given me my life back,” one survey respondent wrote.

“Kratom is the only reason I was finally able to end my addiction to hydrocodone. It is nowhere near as potent as hydrocodone, and you can't overdose” said another.

“It has saved my life. I am a mother of four and have anxiety, depression, acute back pain, and I am an opioid addict. It has kept all these at bay for me,” one woman wrote. “I want to be there for my children, but the sad truth is I know I can't live with these conditions and not find something. It's a sad day when I have to turn to the streets again to have any kind of life.”

“I've had several friends who have died from heroin overdose if they knew about kratom they may still be alive today,” wrote another kratom user.

Last year, the Drug Enforcement Administration attempted to list kratom’s two active ingredients as Schedule I controlled substances, which would have made it a felony to possess or sell kratom. The DEA suspended its plan after a public outcry and lobbying campaign by kratom supporters, saying it would wait for a medical evaluation and scheduling recommendation for kratom from the FDA. Although the FDA has warned the public about using kratom, its full report and recommendations have yet to be released.

Can Kratom Be Patented?

By Jane Babin, Guest Columnist

Discussions surrounding kratom are heating up following the Food and Drug Administration’s public health advisory, and questions have appeared about whether kratom and its constituents are patented or could be. 

The short answer is no.

Patents are important tools for protecting investment in innovation.  Without patent protection, far fewer new drugs would be developed.  An alternative is to keep details of an invention secret to ensure that no one will be able to copy it.  However, this approach isn’t possible in the pharmaceutical industry, where regulations require extensive public disclosure. 

To encourage inventors to share details about their inventions, the U.S. grants a patent right to prevent other people from making the same invention for a limited time, in exchange for publicly disclosing the details about the invention.  The public can read patents and apply their disclosures to other situations, which immediately advances science and technology.  After a patent expires, the invention itself can be made by anyone.

Patents Granted for a Limited Time

U.S. Patents 3,256,149 (“Compositions Compromising an Alkaloid of Mitragyna Speciosa and Methods of Using Same”) and 3,324,111 (“Speciofoline, an Alkaloid from Mitragyna Speciosa”), were both granted to Smith Kline & French Laboratories.

FDA Commissioner Scott Gottlieb has ties to GlaxoSmithKline (the successor to Smith Kline & French) and some have suggested a conflict of interest motivated his warning about kratom.

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If there is a conflict, it isn't over these patents, which were issued in the 1960's and have long since expired.  Patents are granted for a limited time.  Currently, patents expire 20 years after filing.  Prior to 1995, a patent term was 17 years from the date of issuance.

Products of Nature are Not Patentable

Prior to their expiration, the two patents gave Smith Kline & French the right to prevent others from making, using, selling, and importing certain alkaloids isolated from kratom, but not the whole plant or leaf. 

Plants themselves and other substances found in nature have never been patentable, unless they are changed substantially by an inventor.  In the 1960s, isolating a substance from a plant was considered a substantial change to the substance. Today it isn’t. 

Courts have held that substances found in nature, even in impure form, cannot be patented whether they are isolated from a natural source or synthesized in a lab.  If a chemical has the same structure as a natural substance, it is not patentable.

Derivatives are Patentable

Derivatives of natural chemicals can be patented, however.  As good as a natural chemical may be, changing it slightly may make it even better -- or worse.  Scientists tweak a compound's structure to alter its properties, repurpose it, investigate interactions with other molecules, and design around compounds that are unpatentable. 

Patents have been granted for derivatives of kratom alkaloids, particularly derivatives of mitragynine and 7-hydroxymitragynine (e.g. U.S. Patent Nos. 8,247,428 & 8,648,090), which potentially may become new drugs that are improved over natural alkaloids. 

Even if they are never commercialized, studying how structural changes affect biological activity can lead scientists to modify other compounds to impart similar properties.  For example, making non-addictive kratom derivatives may show scientists ways opioids could be made non-addictive. 

U.S. patent law recognizes the importance of such inquiry and includes an exception under 35 USC §371(e), allowing scientists to use patented inventions in certain types of research.  Unlike scheduling under the Controlled Substances Act, no permission or pre-approval is needed to take advantage of this exception.

Distinguishing a Patent from a Published Application

Another misconception about patents is that every document that looks like a patent is one.  To obtain a patent, an inventor must first file an application, which doesn't become a patent until the Patent Office is satisfied that it meets all legal requirements. Whether granted or not, the application is usually published, and it looks very much like a granted patent. 

There are two ways to distinguish a U.S. patent from an application:

  1. U.S. Patents have the words "US Patent" at the top of the first page, while applications have "US Patent Application Publication."
  2. Current patents are identified by a 7 digit number.  Published applications numbers have eleven digits beginning with a 4 digit year. For example, 9,458,426 is a US patent, while 2014/0186948 is a published application.

Foreign countries also issue patents and an inventor must obtain a patent in each country where he or she wants to enforce patent rights.  Thus, there may be multiple patents covering the same invention in different countries.  Each country has its own numbering system and may or may not publish applications prior to granting them.  Instead of immediately filing multiple applications in foreign countries, inventors can initially file a single international application with the World International Patent Organization (WIPO) under the Patent Cooperation Treaty (PCT), which can be used as the first step toward patents in many countries.  

Requirements for a Patent and Examination

Applications don't automatically become patents.  They are first examined to see if a patentable invention that meets certain legal criteria is described and claimed.  In addition to claiming patentable subject matter, an invention must be novel, non-obvious, and the application must disclose sufficient description that someone in the field would be able to make and use the invention. 

Examination involves a dialogue between applicant and a patent examiner, often resulting in changes to the claims (the legally enforceable part of a patent).  Some applications are never granted.

US 2010/0209542 is a kratom-related application that is frequently discussed.  It claims a method for treating withdrawal from an addictive substance using a kratom extract.  When this application was first examined, it was rejected because existing literature described kratom itself as being addictive.  The applicant might have overcome this rejection by arguing that kratom is non-addictive or that other addictive substances are used to treat withdrawal.  However, the inventors faced bigger challenges because they didn't actually treat anyone for withdrawal with a kratom extract and described no studies of their own showing the method actually worked. 

Self-treatment using kratom had been reported, but that didn’t help the application because it meant that the applicant was not the first to "invent" the method and the invention was not novel.  Facing an uphill battle, the application was abandoned and never matured into an enforceable patent.

There may be many obstacles on the path to general acceptance of kratom as a beneficial herbal supplement.  Fortunately, patents are not one of them.

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Jane Babin, PhD, is a molecular biologist and a biotechnology patent attorney in southern California. Jane has worked as a consultant for the American Kratom Association, a pro-kratom consumer group.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Issues New Kratom Warning

By Pat Anson, Editor

The Food and Drug Administration has issued a public health advisory about kratom, an herbal supplement used by millions of Americans to self-treat pain, anxiety, depression and addiction.

In a lengthy statement, FDA Commissioner Scott Gottlieb, MD, said the agency has “significant concerns” about the increasing use of kratom and its potential health risks – especially when it is used to treat opioid addiction.

“At a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning. It’s very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms,” Gottlieb wrote.

“There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder. Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product’s dangers, potential side effects or interactions with other drugs.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties. The leaves are usually ground up to make tea or turned into powder and used in capsules.

Most kratom users say the herb has a mild analgesic and stimulative effect, similar to coffee.

In his statement, Gottlieb claimed that kratom was addictive and was being used recreationally for its euphoric effects. But he also acknowledged that the herb could have legitimate medical uses.   

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“The FDA knows people are using kratom to treat conditions like pain, anxiety and depression, which are serious medical conditions that require proper diagnosis and oversight from a licensed health care provider,” he wrote. “I understand that there’s a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence.”

The evidence is lacking, in large part, because kratom and its active ingredients are natural substances that cannot be patented and have less potential for profit. That discourages pharmaceutical companies from investing in research and clinical studies to prove kratom's safety and efficacy.

"To date, no marketer has sought to properly develop a drug that includes kratom," said Gottlieb. "We believe using the FDA’s proven drug review process would provide for a much-needed discussion among all stakeholders. Until then, I want to be clear on one fact: there are currently no FDA-approved therapeutic uses of kratom."

Last year, the Drug Enforcement Administration attempted to list kratom as a Schedule I controlled substance, which would have made it a felony to possess or sell. The DEA suspended its plan after an outcry and lobbying campaign by kratom supporters.

The DEA said at the time that kratom was linked to several deaths, as well as psychosis, seizures and an increased number of calls to poison control centers. Gottlieb renewed those claims today and said the FDA was “aware of reports” of 36 deaths associated with kratom. But he did not go into detail about where or when those deaths occurred.

The American Kratom Association (AKA) – a pro-kratom consumer group – has strongly disputed recent autopsy reports linking kratom to sudden deaths in Florida, Georgia and New York, calling them a "rush to judgement."

The AKA filed a dispute resolution petition challenging the "weak scientific basis" of the FDA advisory and asked that it be withdrawn.

“For years, the FDA has published scientifically inaccurate information on the health effects of consuming kratom, directly influencing regulatory actions by the DEA, states, and various local government entities.  AKA believes the FDA health advisory on kratom will lead to more state and local bans, all based on discredited, incomplete, and mischaracterized scientific claims," the AKA said in a statement.

In a survey of 6,150 kratom consumers by Pain News Network and the AKA, over 90% said the herb was “very effective” in treating their medical condition, whether it was pain, anxiety, depression or addiction. Many predicted that if kratom were classified as a controlled substance and made illegal, it would only increase the use of alcohol, marijuana, prescription opioids and illegal substances like heroin.