GESTIÓN EN SALUD PÚBLICA: Outbreak Update from FDA

FDA Investigates Multistate Outbreak of Salmonella Infections Linked to Products Reported to Contain Kratom

April 3, 2018

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.

Update

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, Nevada, 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. The products that are part of the mandatory recall include, but are not limited to: 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. Although the strains of Salmonella found in Triangle Pharmanaturals’ products are not currently linked to the outbreak, all Salmonella bacteria can cause the foodborne illness salmonellosis.
The FDA will continue to work with companies notified of Salmonella contamination who want to voluntarily recall their products in a cooperative manner. The following voluntary actions are unrelated to the agency’s action on Triangle Pharmanaturals’ products.
On March 22, 2018, PDX Aromatics of Portland, Oregon, issued their second expanded recall in response to additional positive product samples of Salmonella associated with PDX Aromatics’ products.
On March 23, 2018 Tamarack Inc. voluntarily recalled Eclipse kratom-containing powder products.
On March 29, 2018, NutriZone, LLC of Houston, Texas issued a recall in response to positive product samples of Salmonella associated with NutriZone, LLC’s products.

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 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, Nevada, 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. The products that are part of the mandatory recall include, but are not limited to: 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 strains of Salmonella found in Triangle Pharmanaturals’ products are not currently linked to the outbreak.
There have been several voluntary recalls in association with this outbreak [see Timeline below]. These actions are unrelated to the agency’s action on Triangle Pharmanaturals’ products. The FDA will continue to work with companies notified of Salmonella contamination who want to voluntarily recall their products in a cooperative manner.
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 March 14, 2018, 40 of 55 (73%) ill people specifically asked about kratom reported consuming kratom before getting sick.
As of March 14, 2018, CDC reports that 87 people infected with outbreak strains of Salmonella I 4,[5],12:b:- (50), Salmonella Javiana (5), Salmonella Okatie (16), or Salmonella Thompson (16) have been reported from 35 states. Twenty-seven people have been hospitalized.
As of April 2, 2018, twenty-six different kratom-containing products have been tested and reported positive for Salmonella. The FDA, CDC, and state laboratories continue genetic analysis on isolates recovered from these samples and isolates from ill people to determine relatedness.
Testing by the FDA and states has revealed Salmonella in several brands of kratom, meaning it is likely that multiple kratom and kratom-containing brands and retailers are supplying contaminated product to the public. The FDA is continuing to work with state and local health officials and CDC to identify specific brand names and suppliers of products to learn more about the possible source and route of Salmonella contamination and will share more information as it becomes available.
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 is the Problem and What is being Done About It?

The FDA, CDC, states and local health officials are investigating a multistate outbreak of salmonellosis from multiple serotypes of Salmonella: I 4,[5],12:b:-, Thompson, Okatie, 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 March 14, 2018, the CDC reports that 87 people in 35 states are infected with outbreak strains of Salmonella I 4,[5],12:b:-, Salmonella Javiana, Salmonella Okatie, or Salmonella Thompson. The states include: AK (1), AL (1), AZ (4), CA (4), CO (2), DE (1), FL (3), GA (2), IL(1), IN(1), KS (1), KY (3), LA (1), MA (2), MD(1), MI (3), MN (2), MO (2), MS(1), NC (4), ND (1), NV(1), NY (2), OH (4), OK (3), OR (4) PA (2), SC (1), TN (1), TX(1), UT (3), VA (4), WA (10), WI (6) and WV(1). Twenty-seven of these people have been hospitalized and no deaths have been reported. Ill people range in age from 6 to 67 years. Illnesses started on dates ranging from January 21, 2017 to February 24, 2018.
All of the cases have been confirmed to have an outbreak strain of Salmonella I 4,[5],12:b:- (50), Salmonella Javiana (5), Salmonella Okatie (16), or Salmonella Thompson (16).
During interviews conducted by health officials, ill people were asked about the foods they ate and other exposures before they became ill. As of March 12, 40 of 55 ill people specifically asked about kratom reported consuming kratom before getting sick. Most people report having used Maeng da red vein kratom.
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, Nevada, 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. The products that are part of the mandatory recall include, but are not limited to: 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 strains of Salmonella found in Triangle Pharmanaturals’ products are not currently linked to the outbreak.
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, Oregon, 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, Texas issued a recall of certain lots of Pain Out and Nirvanio products in response to positive product samples of Salmonella.
The FDA is conducting additional testing of all Salmonella strains isolated from kratom products to see if they match strains of Salmonella that have caused human illness. Any positive result for Salmonella poses a threat to consumers and can result in severe illness. 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.
The FDA is continuing to work with state and local health officials and CDC to identify specific brand names or suppliers of products to learn more about the possible source and route of Salmonella contamination and will share more information as it becomes available.
This investigation is ongoing. The FDA is continuing traceback efforts in order to determine the source(s) of the outbreak. Based on the information presented above, it is likely that multiple brands and retailers are supplying contaminated product to the public. The positive results also indicate possible concerns with the manufacturing practices used in production and/or handling of these products.
back to top

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 were 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 are infected with Salmonella I 4,[5],12:b:-. Fourteen people have 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 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, CDC reports 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 have been hospitalized.
On March 16, 2018, PDX Aromatics of Portland, Oregon, expanded its recall in response to additional positive product samples of Salmonella associated with Aromatics’ products.
On March 21, 2018, the 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, Oregon, again expanded its recall in response to additional positive product samples of Salmonella associated with PDX Aromatics’ products.
On March 29, 2018 NutriZone, LLC of Houston, Texas issued a recall in response to positive product samples of Salmonella associated with NutriZone, LLC’s 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, Nevada, 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. The products that are part of the mandatory recall include, but are not limited to: 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 strains of Salmonella found in Triangle Pharmanaturals’ products are not currently linked to the outbreak.
As of April 2, 2018, the FDA and state partners have tested multiple kratom products, and 26 different products were positive for Salmonella.
Products that tested positive for Salmonella and associated companies:

Product	Retailer	Known or Labeled Distributor
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
Non-branded kratom powder		Triangle Pharmanaturals, Las Vegas, NV
Molecule Precision Labs Kratom Super Green Malay		Pure Distribution LLC, Las Vegas, NV
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
Raw Form Organics Maeng Da Emerald Green	Torched Illusions, Tigard, OR	Triangle Pharmanaturals, Las Vegas, NV
Raw Form Organics Maeng Da Ivory White	Torched Illusions, Tigard, OR	Triangle Pharmanaturals, Las Vegas, NV
Raw Form Organics Maeng Da 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 (phytoextraxtum.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
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.
back to top

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.

How Soon After Exposure do Symptoms Appear?

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

What are the Complications of Salmonella Infections?

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.
back to top

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 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.
back to top