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CFSAN Constituent Update

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

February 20, 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.

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 a rare strain of Salmonella. Mitragyna speciosa, commonly known as kratom, is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea.
The CDC reports that 28 people in 20 states are infected with Salmonella I 4,[5],12:b:-. Eleven people have been hospitalized.
During interviews conducted by health officials, ill people were asked about the foods they ate and other exposures before they became ill. Eight (73%) of 11 people interviewed reported consuming kratom in pills, capsules, powder, or tea.
Kratom is marketed in many forms, including as leaves, pills, capsules, powder, and tea. No common brands or suppliers of products reportedly containing kratom associated with this outbreak have been identified at this time. The FDA is working 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.

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

The FDA, CDC, and state and local officials are investigating a multistate outbreak of salmonellosis from a rare strain of Salmonella I 4,[5],12:b:-. CDC reports that epidemiologic evidence collected to date indicates that products reported to be kratom or contain kratom are a likely source of this outbreak. These products are marketed in many forms, including as 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.

During interviews conducted by health officials, ill people were asked about the foods they ate and other exposures before they became ill. Eight (73%) of 11 people interviewed reported consuming kratom in pills, powder, or tea. No common brands or suppliers of kratom associated with the outbreak have been identified at this time. The FDA is currently working with state and local health officials to identify specific brand names or suppliers of products reportedly containing kratom used by ill people to learn more about the source and route of Salmonella contamination.

As of February 16, the outbreak includes 28 people in 20 states [AL(1), AZ (1), CA (3), CO (1), FL (1), KS (1), KY (1), LA (1), MA(1), MI (1), NC (2), ND(1), NY(1), OH (2), OK (2), OR (2), PA (2), SC(1), TN(1), UT (2)]. Eleven of these people have been hospitalized and no deaths have been reported. Ill people range in age from 6 to 67 years.

All of the cases have been confirmed to have a rare strain of Salmonella I 4,[5],12:b:-. Whole genome sequencingperformed to date on isolates from ill people are closely relatedly genetically. This means that people in this outbreak are more likely to share a common source of infection.

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 have 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.

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.

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.

The FDA advises consumers to avoid kratom in any form. In addition to the public health concerns raised by this outbreak, 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. FDA is actively evaluating all available scientific information on this issue and continues to warn consumers not to use any products labeled as containing the botanical substance kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine. FDA encourages more research to better understand kratom’s safety profile, including the use of kratom combined with other drugs.