Food Source Information Kratom

Kratom, also referred to as thang, kakuam, thom, ketom, biak, kratho, or ketum is a group of tree-like plants in the Mitragyna genus of the Rubiacea family. The species, Mitragyna speciose, has two active chemical compounds: miragyna and 7-hydroxymitragynine. The physiological effects of these compounds are similar to sedatives (e.g., opioids) when consumed in high doses and to stimulants (e.g., cocaine) when consumed in low doses. Kratom plants are indigenous to Southeast Asia, specifically Thailand, Indonesia, Myanmar, and Papua New Guinea, where they have historically been used in socio-religious ceremonies, in traditional medicines, during social gatherings, and as a stimulant to improve work productivity. Thailand first regulated kratom under the Kratom Act of 1943 and, currently, planting, possession, import, and export of the plant are all considered illegal.

It is also banned in Australia, Bhutan, Malaysia, and Myanmar. However, kratom plant extracts have recently emerged in other regions, including the U.S. The Federal Drug Administration (FDA) has declared kratom to be an opioid substance, but the scheduling of the drug remains to be determined. Because the drug has not been labeled as a scheduled drug by the FDA, state and local governments can create their own laws on the banning of kratom. Currently, it is illegal to buy, possess, or use kratom in Alabama, Arkansas, Indiana, Tennessee, Vermont, and Wisconsin. There are some cities and counties throughout the US that have banned kratom including Denver, Colorado, Jerseyville, Indiana, and Sarasota County, Florida.

Between 2000 and 2020, at least one kratom-associated outbreak was reported to CDC’s National Outbreak Reporting System (NORS), causing 199 illnesses, 54 hospitalizations, and no deaths. The implicated pathogen was Salmonella enterica of multiple serotypes, including Heidelberg, I 4,[5],12:b:-, Javiana, Okatie, Thompson, and Weltevreden.

Below are examples of outbreaks and recalls associated with kratom reflecting the diversity of vehicles, pathogens, and other circumstances:

From January of 2017-May of 2018, there was a multistate outbreak of Salmonella enterica, including the serotypes I 4,[5],12:b:-, Heidelberg, Javiana, Okatie, Weltevreden, and Thompson, epidemiologically linked to kratom, with 199 ill persons and 54 hospitalizations across 41 states. There were no reported deaths. Ill persons reported consuming kratom in various forms, including pills, powders, and teas. Early in the investigation, North Dakota and Utah public health officials tested leftover kratom powder obtained from ill persons, and the powder was positive with one of the outbreak strains, Salmonella serotype I 4,[5],12:b:-. The ill persons reported purchasing the powder from online kratom retailers. Throughout the investigation, testing of multiple kratom products by the FDA and their state partners also yielded the outbreak strains as well as other Salmonella isolates. Investigators were unable to identify a common source of contaminated kratom products and both the CDC and FDA recommend not consuming any form of kratom or its psychoactive compounds from any manufacturer.

In March of 2018, PDX Aromatics, of Portland, Oregon, issued multiple voluntary recalls of kratom products sold under the brand names Kraken Kratom, Phytoextractum, and Soul Speciosa. Approximately 10,000 units of powdered products were subjected to the recall after the company identified a supplier in its supply chain as the source of Salmonella. The company was alerted by the California Department of Health after certain lots of product tested positive for Salmonella and were associated with a confirmed case of Salmonella.

On March 30, 2018, the FDA issued Triangle Pharmanaturals of Las Vegas, Nevada a “Notification of Opportunity to Initiate a Voluntary Recall.” The FDA allowed the company 24 hours to respond to the notice; however, Triangle chose not to voluntarily recall their kratom products within the allotted time frame. This inaction led the FDA to issue its first ever agency mandated recall since gaining that power under the Food Safety and Modernization Act of 2011. On April 2, 2018, the FDA issued a mandatory recall order for all food products containing powdered kratom that were manufactured, processed, packed, or held by Triangle. The recall was prompted when products from the company tested positive for Salmonella. In response, Triangle initiated a recall for products containing powdered kratom on April 6, 2018.

In April of 2018, testing by FDA yielded Salmonella from kratom products distributed by Revibe, LLC of Kansas City, Missouri and the agency oversaw destruction of these products at Revibe’s facility. However, Revibe did not provide the FDA with information to confirm the recall of potentially contaminated products on the market.

Other companies, including Tamarack Inc. of Cheyenne, Wyoming, NutriZone LLC of Houston, Texas, Club 13 Enterprises Warehouse of Saint Augustine, Florida, NextGen Botanicals Corporation of West Jordan, Utah, Viable Solutions of Nampa, Idaho, Pious Lion of Asheville, North Carolina, and Gaia Ethnobotanical of Jacksonville, Florida also issued voluntary recalls as a precaution or in response to products testing positive for Salmonella. FDA testing of products from Avalon Packaging of Orem, Utah also yielded Salmonella. The firm destroyed all kratom powder and agreed not to manufacture any kratom products going forward.

Kratom plants are best grown in hot, extremely humid environments. Therefore, many of these plants are currently grown in the jungles of Thailand, Indonesia, and Malaysia where they can grow up to 115 feet in a cluster arrangement.

In southeast Asia, harvest season for the plants is considered to be late summer through early autumn for maximum yield and potency. For smaller production, plants, and seeds can be purchased through internet vendors and grown at home. These plants can be difficult to grow in open air due to their need for a tropical climate, excessive water, and fertile, rich soil. If the seeds germinate, the leaves will not be ready for harvest for up to a year. Once the harvest occurs, either by the leaves falling off or by picking the leaves off the plant, the leaves can be crushed and refined for personal consumption. On a larger scale, growers harvest and send crushed leaves to distributors, who then use an industrial grinder to refine the leaves into a powder. The powder is then sifted to remove stems and vein material and is sold in its existing form or is used to make other products, such as capsules and tablets.

Traceback of kratom during investigations is challenging, as kratom enters the market by means unusual for food products, such as personal importation or false declaration of product at the port of entry. The FDA is also unable to confirm that growers and processors of kratom are observing Good Manufacturing Processes (GMPs), or otherwise taking steps to prevent Salmonella contamination. Due to the lack of industry standards and the high rate of contamination found during the 2018 outbreak, the FDA cannot ensure that any kratom products are not contaminated with Salmonella.

Kratom products are frequently marketed for the treatment of opioid addiction and withdrawal, pain, and other medical conditions. However, the sale of unapproved products with unsubstantiated claims violates the Federal Food, Drug, and Cosmetic Act. As kratom affects the same opioid brain receptors as morphine, the FDA is concerned that kratom and its psychoactive compounds, mitragynine and 7-hydroxymitragynine, are opioid analogues and may expose consumers to the risks of addiction, abuse, and dependence. Currently, there are no FDA-approved therapeutic uses for kratom. Due to marketing, ease of access, and lower cost compared to other drugs, kratom is rising in popularity in the U.S. and elsewhere, with consumers using kratom products both for the self-treatment of medical conditions and recreationally.

Kratom is included on the Drug Enforcement Administration’s (DEA) Drugs of Concern list and has been identified as an emerging drug of abuse by the National Institute of Drug Abuse. Published case reports have associated kratom exposure with psychosis, seizures, and deaths. Due to these severe outcomes, some jurisdictions within the U.S. have passed or are considering legislation to make kratom use a felony.

Both fresh and dried kratom leaves are consumed in Southeast Asia, either by brewing tea or by chewing or smoking leaves. In the U.S., individuals purchase kratom powders, capsules, raw leaves, tablets, and concentrated extracts from Internet sellers or local shops. In that last 5-10 years, kratom has become easier to purchase and is no longer an underground, or black market, substance. Individuals can purchase the product at local tobacco/smoke shops in states and cities where it is legal. The product is also sold online through legal, domestic vendors, but distributors buy the seeds, plants, and leaves on the dark web. The origin and contents of kratom products are not easily identifiable or verified. Information on suppliers and distributors outside the U.S. is limited, given many of the plants are grown in hiding among other crops, in ditches, or near fishing ponds. In some countries, individuals have personal connections with suppliers and will purchase kratom from salesmen or will patron local coffee shops where products are sold ready for consumption. Contamination of the product can occur during growing, production, and distribution.

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6. Reference Required.
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