FDA Finds Unsafe Levels of Heavy Metals in Kratom

By Pat Anson, PNN Editor

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

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

“The analysis found significant levels of lead and nickel at concentrations that exceed safe exposure for oral daily drug intake,” the FDA said in a statement. “Based on these test results, the typical long-term kratom user could potentially develop heavy metal poisoning, which could include nervous system or kidney damage, anemia, high blood pressure, and/or increased risk of certain cancers.”

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 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.

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.

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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.