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                Outbreaks of Foodborne Illness

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          FDA Investigated Multistate Outbreak of Salmonella Infections Linked to Products Reported to Contain KratomOutbreaks of Foodborne Illness FDA Investigated Multistate Outbreak of Salmonella Infections Linked to Products Reported to Contain Kratom
  
  	
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Update
	Fast Facts
	What was the Problem and What was Being Done About It?
	Timeline
	What are the Symptoms of ****Salmonella**** Infection?
	Who is at Risk?
	What Do Consumers Need To Do?
	Who Should be Contacted?*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**.*

**Learn more:**

FDA and Kratom
	CDC: Multistate Outbreak of *Salmonella*Infections Linked to KratomTimeline

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 DistributorRed MD
			
			Gaia Ethnobotanical, Jacksonville, FLRed Borneo
			
			Gaia Ethnobotanical, Jacksonville, FLGreen MD
			
			Gaia Ethnobotanical, Jacksonville, FLWhite MD
			
			Gaia Ethnobotanical, Jacksonville, FLWhite Borneo
			
			Gaia Ethnobotanical, Jacksonville, FLPlantation RMD
			
			Gaia Ethnobotanical, Jacksonville, FLMaeng Da Kratom
			www.kravekratom.com
			Ashlynn Marketing Group, Santee, CAGold Kratom
			www.kravekratom.com
			Ashlynn Marketing Group, Santee, CARed Horn
			
			Spa & Organic Essentials of PA, LLC, Williamsport, PARed Borneo
			
			Spa & Organic Essentials of PA, LLC, Williamsport, PARed Maeng Da
			
			Spa & Organic Essentials of PA, LLC, Williamsport, PARed Malay
			
			Spa & Organic Essentials of PA, LLC, Williamsport, PARed Suma
			
			Badger Botanicals LLC, Springville, UTRed Hula
			
			Badger Botanicals LLC, Springville, UTGreen Hula
			
			Badger Botanicals LLC, Springville, UTGreen Suma
			Acadica.co
			Badger Botanicals LLC, Springville, UTRaw Source Health Lucky 7
			Cloud 9 Smoke Shop, Dallas, GAPious Lion Pure Premium Potent White Maeng Da
			BJ’s Food Mart, Chandler NC
			Pious Lion, Asheville, NCPious Lion Pure Premium Potent Limited Release Pink Bali
			BJ’s Food Mart, Chandler NC
			Pious Lion, Asheville, NCEarth Kratom Bali
			
			Fire WholesaleBlissful Remedies, Red Maeng Da
			
			World Organix LLC, Las Vegas NVBlissful Remedies, Gold Series, Ultra Enhanced Indo
			
			World Organix LLC, Las Vegas NVBlissful Remedies, Kratom + CBD, CBD Infused Maeng Da
			
			World Organix LLC, Las Vegas NVUnspecified Kratom
			
			CV Indo Perkasa, IndonesiaClub 13 Maeng Da Red
			Staxx Smoke Shop, OK
			Club 13, St Augustine, FLPain Out Malay Kratom
			
			NutriZone, LLC, Houston, TXNirvanio Green Malay
			
			NutriZone, LLC, Houston, TXPain Out Maeng Da Kratom
			
			NutriZone, LLC, Houston, TXPain Out Thai Kratom
			
			NutriZone, LLC, Houston, TXNirvanio Special Reserve
			
			NutriZone, LLC, Houston, TXNirvanio Premium Quality Maeng Da
			
			NutriZone, LLC, Houston, TXNirvanio Green Malay
			
			NutriZone, LLC, Houston, TXGreen Vein Maeng Da
			
			Herbal-Salvation, Nampa, IDThai Maeng Da
			
			Herbal-Salvation/Viable Solutions, LLC, Nampa, IDRed Vein Bali
			
			Herbal-Salvation/Viable Solutions, LLC, Nampa, IDRed Vein Sumatra
			
			Herbal-Salvation/Viable Solutions, LLC, Nampa, IDNon-branded kratom powder
			
			Revibe LLC, Kansas City, MOWhite Maeng Da
			BuyKratomBulk USA, Kansas City, MO
			Revibe LLC, Kansas City, MORed Borneo
			BuyKratomBulk USA, Kansas City, MO
			Revibe LLC, Kansas City, MOMolecule Super Green Malay
			
			Pure Distribution LLC, Las Vegas, NVRed Maeng-Da
			
			Avalon PackingWhite Maeng-Da
			
			Avalon PackingGreen Maeng-Da
			
			Avalon PackingMolecule White Vein
			Torched Illusions, Beaverton, OR
			Pure Distribution LLC, Las Vegas, NVMolecule Green Maeng Da
			Torched Illusions, Tigard, OR
			Pure Distribution LLC, Las Vegas, NVNon-branded kratom powder
			
			Triangle Pharmanaturals, Las Vegas, NVRaw Form Organics Maeng Da Kratom Emerald Green
			Torched Illusions, Tigard, OR
			Triangle Pharmanaturals, Las Vegas, NVRaw Form Organics Maeng Da Kratom Ivory White
			Torched Illusions, Tigard, OR
			Triangle Pharmanaturals, Las Vegas, NVRaw Form Organics Maeng Da Kratom Ruby Red
			
			Triangle Pharmanaturals, Las Vegas, NVRed Maeng Da (RMD 1-kg)
			Kratoma (buy-kratom.us)
			KratomaS.K. Herbalist Red Tea MD
			Soap Korner (soapkorner.com)
			Soap Korner, Colorado Springs, CORed Vein Borneo
			Phytoextractum (phytoextractum.com)
			PDX Aromatics, Portland, ORRed Borneo
			Kraken Kratom (krakenkratom.com)
			PDX Aromatics, Portland, ORRed Dragon (Red Vein)
			Kraken Kratom (krakenkratom.com)
			PDX Aromatics, Portland, ORWhite Maeng Da
			Kraken Kratom (krakenkratom.com)
			PDX Aromatics, Portland, ORBali
			
			PDX Aromatics, Portland, ORJamal White
			
			PDX Aromatics, Portland, ORJamal Red
			
			PDX Aromatics, Portland, ORNXT GEN Botanicals Maeng Da
			Smoke Station, Salt Lake City, UT
			NGB Corp, West Jordan, UTEclipse Premium Maeng Da
			Smoke Station, Salt Lake City, UT
			Tamarack, Cheyenne, WYDragon Bali
			Fastrac, Salt Lake City, UT
			Not statedGreen Bali bulk powder
			Torched Illusions, Tigard, OR
			UnlabeledGreen Sumatra bulk powder
			Torched Illusions, Tigard, OR
			UnlabeledGreen Malaysian bulk powder
			Torched Illusions, Tigard, OR
			UnlabeledWhite Maeng Da bulk powder
			Torched Illusions, Tigard, OR
			UnlabeledWhite Borneo bulk powder
			Torched Illusions, Tigard, OR
			UnlabeledWhite 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.

Who to Contact

**Consumers who have symptoms**should contact their health care provider to report their symptoms and receive care.

To report a **complaint**or **adverse event**(illness or serious allergic reaction), you can

Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
	Complete an electronic Voluntary MedWatch form online.
	Complete a paper Voluntary MedWatch form that can be mailed to FDA.Submit Questions/Get Assistance

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                                                                                  Content current as of:
      06/29/2018
              
              
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