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."

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.