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.

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.

SALMONELLA BACTERA

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.”

KRATOM SPOT/FACEBOOK

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.”