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The U.S. Food and Drug Administration along with the Centers for Disease Control and Prevention (CDC) and state and local officials are investigating a multistate outbreak of Salmonella infections linked to products reportedly containing kratom.. June 29, 2018 Update The FDA’s outbreak investigational activities have concluded, but the FDA continues to address the issue of Salmonella in kratom. The FDA reminds consumers that raw products contaminated with Salmonella can make people sick if they consume them, and can also cross-contaminate surrounding surfaces and possibly expose others to Salmonella.

Fast Facts

The FDA is advising consumers to avoid kratom and kratom-containing products. These products have been linked to a multistate outbreak of salmonellosis from multiple strains of Salmonella. Mitragyna speciosa, commonly known as kratom, is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea.

On April 6, 2018, in response to a mandatory recall order from the FDA after several of its kratom products were found to contain Salmonella, Triangle Pharmanaturals, LLC of Las Vegas, NV, initiated a recall of such products. As of April 17, 2018, the firm is recalling all kratom powder products it manufactured, processed, packed and/or held from April 4, 2017 to present. This recall includes at least 26 different products.

There have been several voluntary recalls in association with this outbreak [see Timeline below], including products not currently included in the outbreak. These actions are unrelated to the agency’s action on Triangle Pharmanaturals’ products. The FDA will continue to work with companies conducting recalls after notification of Salmonella contamination in their products to protect public health.

During interviews conducted by state and local health officials, ill people were asked about the foods they ate and other exposures before they became ill. As of May 24, 2018, 76 (74%) of 103 people specifically asked about kratom reported consuming kratom before getting sick.

As of May 24, 2018, a total of 199 people infected with the outbreak strains of Salmonella were reported from 41 states. Thirty-eight percent of ill people were hospitalized, and no deaths were reported. This outbreak included infections from several types of Salmonella: Salmonella I 4,[5],12:b:-, Salmonella Heidelberg, Salmonella Javiana, Salmonella Okatie, Salmonella Weltevreden, and Salmonella Thompson.

As of April 5, 2018, thirty-seven different kratom-containing products have been tested and reported positive for Salmonella (this includes both FDA and state samples). FDA, CDC, and state laboratories continue genetic analysis on isolates recovered from these samples and isolates from ill people to determine relatedness.

FDA testing confirmed Salmonella contamination in kratom products distributed by Revibe, LLC of Kansas City, MO. On April 3, 2018, the agency oversaw the destruction of these products at Revibe’s facility. On March 26, 2018, the FDA contacted Revibe regarding a recall of these products currently on the market that may be contaminated. As of April 17, 2018, the company has not provided the FDA information to confirm that they have recalled the products. The FDA reminds consumers not to use these and other kratom products.

The FDA is concerned about the high frequency of several Salmonella serotypes found in the products it has tested during the course of this investigation. As of April 19, 2018, out of 66 FDA samples analyzed from distributors and retail locations of interest, 33 have been found positive for one or more strains of Salmonella. The FDA reminds consumers that raw products contaminated with Salmonella can make people sick if they consume them, and can also cross-contaminate surrounding surfaces and possibly expose others to Salmonella.

In addition to the public health concerns raised by this outbreak, the FDA continues to warn consumers not to consume any kratom product. There is no FDA-approved use for kratom and the agency has received concerning reports about the safety of kratom, including deaths associated with its use.

What was the Problem and What was being Done About It?

The FDA, CDC, states and local health officials investigated a multistate outbreak of salmonellosis from multiple serotypes of Salmonella: I 4,[5],12:b:-, Thompson, Okatie, Heidelberg, Weltevreden, and Javiana. CDC reports that epidemiologic evidence collected to date indicates that kratom or kratom containing products are a likely source of this outbreak. These products are marketed in many forms, including leaves, pills, capsules, powder and tea, and may not mention kratom on the labeling. Other names for kratom that have been identified by the U.S. Drug Enforcement Administration (DEA) are: Mitragyna speciosa, mitragynine extract, biak-biak, cratom, gratom, ithang, kakuam, katawn, kedemba, ketum, krathom, krton, mambog, madat, Maeng da leaf, nauclea, Nauclea speciosa, or thang.

As of May 24, 2018, CDC reports that a total of 199 people infected with the outbreak strains of Salmonella were reported from 41 states. Thirty-eight percent of ill people were hospitalized, and no deaths were reported. The states include: AK (1), AR (1), AL (1), AZ (7), CA (13), CO (4), CT (2), DE (1), FL (8), GA (3),IA (2), ID (10) IL(5), IN(2), KS (2), KY (6), LA (3), MA (4), MD(3), MI (4), MN (11), MO (7), MS(2),NE (1), NC (7), ND (1), NV(2), NY (11), OH (7), OK (7), OR (13) PA (3), SC (4), TN (1), TX(4), UT (3), VA (7), WA (16), WI (6) and WV(1). Fifty of these people have been hospitalized and no deaths have been reported. Ill people range in age from less than 1 to 75 years. Illnesses started on dates ranging from January 11, 2017 to May 18, 2018.

During interviews conducted by health officials, ill people were asked about the foods they ate and other exposures before they became ill. As of May 24, 2018, 76 (74%) of103 people specifically asked about kratom reported consuming kratom before getting sick. On April 2, the FDA issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals, LLC of Las Vegas, NV, after several of these products were found to contain Salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall.

On April 6, 2018, in response to FDA’s mandatory recall order, Triangle Pharmanaturals, LLC of Las Vegas, NV initiated a recall of its kratom powder products. As of April 17, 2018, the firm is recalling all kratom powder products it manufactured, processed, packed and/or held from April 4, 2017 to present. This recall now includes at least 26 different products.

There have been several voluntary recalls of kratom-containing products as a result of testing performed as part of the investigation. On March 9, 2018, PDX Aromatics of Portland, OR, doing business under the names Kraken Kratom, Phytoextractum, and Soul Speciosa, in full cooperation with the FDA, recalled certain kratom-containing powder products after testing by the California Department of Public Health identified Salmonella in samples of kratom products collected from the business. Additional testing by the FDA has identified Salmonella in products with the Kraken Kratom brand name. PDX expanded its recall on March 16 and March 22 in response to additional findings of Salmonella associated with their products. On March 23, Tamarack Inc recalled Eclipse kratom-containing products after the FDA notified the company of Salmonella-positive product testing. On March 29, NutriZone,LLC of Houston, TX, issued a recall of certain lots of Pain Out and Nirvanio products in response to positive product samples of Salmonella. On March 31, 2018, Club 13 Enterprises Warehouse of Saint Augustine, FL, initiated a recall in response to positive product samples of Salmonella associated with Club 13 kratom products.

The FDA also collected samples from Avalon Packaging in Orem, UT, that were found to be positive for Salmonella. This firm destroyed positive kratom powder that had not been distributed and agreed not to manufacture any further kratom products.

The FDA is concerned about the high frequency of several Salmonella serotypes found in the products it has tested during the course of this investigation. The FDA reminds consumers that raw products contaminated with Salmonella can make people sick if they consume them, and can also cross-contaminate surrounding surfaces and possibly expose others to Salmonella.

FDA’s outbreak investigation has closed. The FDA is continuing efforts to protect the public from Salmonella in kratom. Traceback was particularly challenging in this outbreak because kratom enters the market through channels that are atypical for foods, such as through personal importation or false declaration of product at the port of entry into the U.S. The FDA has not been able to confirm that growers or processors of kratom are using Good Manufacturing Practices or otherwise taking steps to ensure that their products are not contaminated with Salmonella. In the absence of established industry standards, coupled with the high rate of Salmonella positives found in FDA’s testing, the agency cannot provide any assurance that any kratom products are not adulterated with Salmonella.

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Timeline

On February 12, 2018, the FDA learned of a multistate outbreak of salmonellosis from a rare strain of Salmonella I 4,[5],12:b:

On February 20, 2018, CDC announced that, as of February 16, 28 people in 20 states had been infected, and that 11 people had been hospitalized. Eight of 11 people interviewed reported consuming kratom as pills, powder, or tea.

On February 28, 2018, CDC reported 40 people in 27 states infected with Salmonella I 4,[5],12:b:-. Fourteen people had been hospitalized. Seventeen of 24 of ill people interviewed reported consuming kratom before getting sick.

On February 28, 2018, the North Dakota and Utah Departments of Health collected leftover kratom powder from ill people in their states. The outbreak strain of Salmonella I 4,[5],12:b:- was identified in both samples. The ill person in North Dakota reported purchasing S.K. Herbalist brand kratom powder from the website soapkorner.com. The ill person in Utah reported purchasing kratom powder from the website kratoma.com.

On March 8, 2018, Oregon Health Agency issued a press release warning that kratom products could be contaminated with the Salmonella bacteria after two people in Oregon who consumed the herbal supplement fell ill.

On March 9, 2018, PDX Aromatics voluntarily recalled the Red Dragon Kratom Powder, Red Vein Borneo Kratom Powder, Red Vein Sumatra Kratom Powder, Red Vein Thai Kratom Powder and Super Indo Kratom Powder sold through Kraken Kratom, Phytoextractum, and Soul Speciosa.

As of March 14, 2018, the FDA and state partners had tested multiple kratom products and 25 of these products were positive for Salmonella. Three matched this outbreak strain, while 22 have tested positive for a different Salmonella or tested positive for Salmonella and further testing is pending.

As of March 14, 2018, the CDC reported that 87 people in 35 states have been reported infected with outbreak strains from four serotypes of Salmonella I 4,[5],12:b:-, Salmonella Javiana, Salmonella Okatie, and Salmonella Thompson. Twenty-seven people had been hospitalized.

On March 16, 2018, PDX Aromatics of Portland, OR, expanded its recall in response to additional positive product samples of Salmonella associated with Aromatics’ products. On March 21, 2018, FDA listed four additional products in the table below tested by Oregon Health Authority identified as positive for Salmonella collected from the retailer Torched Illusions. The two labeled distributors of these products collected at Torched Illusions are Triangle Pharmanaturals and Pure Distribution LLC, both of Las Vegas, NV.

On March 22, 2018, PDX Aromatics of Portland, OR, again expanded its recall in response to additional positive product samples of Salmonella associated with PDX Aromatics’ products.

On March 19, 2018 Tamarack Inc. voluntarily recalled Eclipse kratom-containing powder products.

On March 29, 2018, NutriZone LLC of Houston, TX, issued a recall in response to positive product samples of Salmonella associated with NutriZone, LLC’s products.

On March 31, 2018, Club 13 Enterprises Warehouse of Saint Augustine, FL, issued a recall in response to positive product samples of Salmonella associated with Club 13 kratom products.

On April 2, 2018, the FDA issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals, LLC of Las Vegas, NV, after several of these products were found to contain Salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall.

As of April 5, 2018, the FDA and state partners have tested multiple kratom products, and 37 different products were positive for Salmonella (this includes both FDA and state samples)

As of April 5, 2018, CDC announced that a total of 132 people infected with outbreak strains of Salmonella I 4,[5],12:b:- (61), Salmonella Javiana (15), Salmonella Okatie (21), or Salmonella Thompson (35) have been reported from 38 states. Thirty-eight people (40%) have been hospitalized.

FDA testing confirmed Salmonella contamination in kratom products distributed by Revibe, LLC of Kansas City, MO. On April 3, 2018, the agency oversaw the destruction of these products at Revibe’s facility. On March 26, 2018, the FDA contacted Revibe regarding a recall of these products currently on the market that may be contaminated. As of April 12, 2018, the company has not provided the FDA information to confirm that they have recalled the products. The FDA reminds consumers not to use these and other kratom products.

On April 6, 2018, in response to FDA’s mandatory recall order of April 2, 2018, Triangle Pharmanaturals, LLC of Las Vegas, Nevada initiated a recall for its products containing powdered kratom.

On April 10, 2018, NextGen Botanicals Corporation issued a recall in response to positive product samples of Salmonella associated with NextGen Botanicals’ products.

On April 17, 2018, Viable Solutions of Nampa, ID issued a recall in response to positive product samples of Salmonella associated with Viable Solutions’ products.

As of April 17, 2018, Triangle Pharmanaturals, LLC of Las Vegas, NV, is recalling all kratom powder products it manufactured, processed, packed and/or held from April 4, 2017 to present. This recall now includes at least 26 different products.

On April 18, 2018, NutriZone, LLC of Houston, Texas has expanded its recall of various kratom products to additional lot numbers, which contain the same source material as the original recalled lots.

As of May 24, 2018, CDC reports that a total of 199 people infected with the outbreak strains of Salmonella were reported from 41 states. Thirty-eight percent of ill people were hospitalized, and no deaths were reported.

On May 24, 2018, Pious Lion of North Carolina issued a press release recalling various kratom products. On June 1, 2018, the firm began mailing recall letters to their customers.

On June 21, 2018, Gaia Ethnobotanical of Jacksonville, Florida, issued a recall of all kratom powder products, with Lot No.: 0102031800 that was manufactured, processed, packed, and/or held, between March 18 to March 30, 2018.

As of June 27, 2018, the FDA’s outbreak investigational activities have closed, however the FDA continues to address the issue of Salmonella in kratom. The FDA reminds consumers that raw products contaminated with Salmonella can make people sick if they consume them, and can also cross-contaminate surrounding surfaces and possibly expose others to Salmonella.

Products that tested positive for Salmonella and associated companies:

Product Retailer Known or Labeled Distributor Red MD Gaia Ethnobotanical, Jacksonville, FL Red Borneo Gaia Ethnobotanical, Jacksonville, FL Green MD Gaia Ethnobotanical, Jacksonville, FL White MD Gaia Ethnobotanical, Jacksonville, FL White Borneo Gaia Ethnobotanical, Jacksonville, FL Plantation RMD Gaia Ethnobotanical, Jacksonville, FL Maeng Da Kratom www.kravekratom.com Ashlynn Marketing Group, Santee, CA Gold Kratom www.kravekratom.com Ashlynn Marketing Group, Santee, CA Red Horn Spa & Organic Essentials of PA, LLC, Williamsport, PA Red Borneo Spa & Organic Essentials of PA, LLC, Williamsport, PA Red Maeng Da Spa & Organic Essentials of PA, LLC, Williamsport, PA Red Malay Spa & Organic Essentials of PA, LLC, Williamsport, PA Red Suma Badger Botanicals LLC, Springville, UT Red Hula Badger Botanicals LLC, Springville, UT Green Hula Badger Botanicals LLC, Springville, UT Green Suma Acadica.co Badger Botanicals LLC, Springville, UT Raw Source Health Lucky 7 Cloud 9 Smoke Shop, Dallas, GA Pious Lion Pure Premium Potent White Maeng Da BJ’s Food Mart, Chandler NC Pious Lion, Asheville, NC Pious Lion Pure Premium Potent Limited Release Pink Bali BJ’s Food Mart, Chandler NC Pious Lion, Asheville, NC Earth Kratom Bali Fire Wholesale Blissful Remedies, Red Maeng Da World Organix LLC, Las Vegas NV Blissful Remedies, Gold Series, Ultra Enhanced Indo World Organix LLC, Las Vegas NV Blissful Remedies, Kratom + CBD, CBD Infused Maeng Da World Organix LLC, Las Vegas NV Unspecified Kratom CV Indo Perkasa, Indonesia Club 13 Maeng Da Red Staxx Smoke Shop, OK Club 13, St Augustine, FL Pain Out Malay Kratom NutriZone, LLC, Houston, TX Nirvanio Green Malay NutriZone, LLC, Houston, TX Pain Out Maeng Da Kratom NutriZone, LLC, Houston, TX Pain Out Thai Kratom NutriZone, LLC, Houston, TX Nirvanio Special Reserve NutriZone, LLC, Houston, TX Nirvanio Premium Quality Maeng Da NutriZone, LLC, Houston, TX Nirvanio Green Malay NutriZone, LLC, Houston, TX Green Vein Maeng Da Herbal-Salvation, Nampa, ID Thai Maeng Da Herbal-Salvation/Viable Solutions, LLC, Nampa, ID Red Vein Bali Herbal-Salvation/Viable Solutions, LLC, Nampa, ID Red Vein Sumatra Herbal-Salvation/Viable Solutions, LLC, Nampa, ID Non-branded kratom powder Revibe LLC, Kansas City, MO White Maeng Da BuyKratomBulk USA, Kansas City, MO Revibe LLC, Kansas City, MO Red Borneo BuyKratomBulk USA, Kansas City, MO Revibe LLC, Kansas City, MO Molecule Super Green Malay Pure Distribution LLC, Las Vegas, NV Red Maeng-Da Avalon Packing White Maeng-Da Avalon Packing Green Maeng-Da Avalon Packing Molecule White Vein Torched Illusions, Beaverton, OR Pure Distribution LLC, Las Vegas, NV Molecule Green Maeng Da Torched Illusions, Tigard, OR Pure Distribution LLC, Las Vegas, NV Non-branded kratom powder Triangle Pharmanaturals, Las Vegas, NV Raw Form Organics Maeng Da Kratom Emerald Green Torched Illusions, Tigard, OR Triangle Pharmanaturals, Las Vegas, NV Raw Form Organics Maeng Da Kratom Ivory White Torched Illusions, Tigard, OR Triangle Pharmanaturals, Las Vegas, NV Raw Form Organics Maeng Da Kratom Ruby Red Triangle Pharmanaturals, Las Vegas, NV Red Maeng Da (RMD 1-kg) Kratoma (buy-kratom.us) Kratoma S.K. Herbalist Red Tea MD Soap Korner (soapkorner.com) Soap Korner, Colorado Springs, CO Red Vein Borneo Phytoextractum (phytoextractum.com) PDX Aromatics, Portland, OR Red Borneo Kraken Kratom (krakenkratom.com) PDX Aromatics, Portland, OR Red Dragon (Red Vein) Kraken Kratom (krakenkratom.com) PDX Aromatics, Portland, OR White Maeng Da Kraken Kratom (krakenkratom.com) PDX Aromatics, Portland, OR Bali PDX Aromatics, Portland, OR Jamal White PDX Aromatics, Portland, OR Jamal Red PDX Aromatics, Portland, OR NXT GEN Botanicals Maeng Da Smoke Station, Salt Lake City, UT NGB Corp, West Jordan, UT Eclipse Premium Maeng Da Smoke Station, Salt Lake City, UT Tamarack, Cheyenne, WY Dragon Bali Fastrac, Salt Lake City, UT Not stated Green Bali bulk powder Torched Illusions, Tigard, OR Unlabeled Green Sumatra bulk powder Torched Illusions, Tigard, OR Unlabeled Green Malaysian bulk powder Torched Illusions, Tigard, OR Unlabeled White Maeng Da bulk powder Torched Illusions, Tigard, OR Unlabeled White Borneo bulk powder Torched Illusions, Tigard, OR Unlabeled White Sumatra bulk powder Torched Illusions, Tigard, OR Unlabeled

Note: Some of these products were collected at the distributor rather than at retail.

What are the Symptoms of Salmonella Infection?

Salmonella bacteria cause the foodborne illness salmonellosis. Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps. The illness usually lasts 4 to 7 days, and most people recover without treatment. However, in the current outbreak, an unusually high rate of cases has been hospitalized for their illness.

Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after infection.

In some people, the diarrhea may be so severe that they need to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream and then to other body sites and can cause death unless the person is treated promptly with antibiotics.

Who is at Risk?

Children are the most likely to get salmonellosis, although other groups are also at risk. Children younger than five, the elderly, and those people with weakened immune systems are more likely to have severe infections. It is estimated that approximately 400 persons in the United States with acute salmonellosis die each year.

What Do Consumers Need To Do?

Consumers who have symptoms of salmonellosis should contact their health care provider. If you are diagnosed with salmonellosis, be sure to tell your health care provider about all products you may be using, including products reported to contain kratom. Consumers should be aware that some products may not list kratom on the labeling.

If consumers have one or more of these products in their homes, they should throw them away. As a precaution, kratom no longer stored in its original packaging should be discarded, and the containers used to store it should be thoroughly washed and sanitized. In order to prevent cross-contamination, wash hands, work surfaces, and utensils thoroughly after contact with these products, and do not prepare food in the area at the same time.

The FDA is concerned about the high rate of several Salmonella serotypes found in the products it has tested during the course of this investigation. As of April 18, 2018, out of 66 FDA samples analyzed from distributors and retail locations of interest, 33 have been found positive for one or more strains of Salmonella. Analysis of additional samples is still ongoing. The FDA reminds consumers that raw products contaminated with Salmonella can make people sick if they eat them, and can also cross-contaminate surrounding surfaces and possibly expose others to Salmonella.

The FDA advises consumers to avoid kratom in any form. In addition to the public health concerns raised by this outbreak, there is strong evidence that kratom affects the same opioid brain receptors as morphine and appears to have properties that expose people who consume kratom to the risks of addiction, abuse, and dependence.

There are no FDA-approved uses for kratom, and the agency has received concerning reports about the safety of kratom, including deaths associated with its use. The FDA is actively evaluating available scientific information on this issue and continues to warn consumers not to consume any products containing the botanical substance kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine. The FDA encourages more research to better understand kratom’s safety profile, including the use of kratom combined with other substances.