FDA Orders Mandatory Recall for Kratom Products Due to Risk of Salmonella

PUBLISHED: Apr 3, 2018
Relevant to: All Healthcare Organizations

The US Food and Drug Administration (FDA) has announced a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several 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. This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products.

The FDA is advising consumers to discard the products that are part of the mandatory recall, which 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 FDA understands that Triangle Pharmanaturals may manufacture, process, pack and/or hold additional brands of food products containing powdered kratom, including powder and encapsulated powder forms.

Mitragyna speciosa, commonly known as kratom, is a plant that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. Importantly, the FDA advises consumers to avoid kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine, in any form and from any manufacturer. The agency also has received concerning reports about the safety of kratom, including deaths associated with its use. 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. The agency also remains concerned about the use of kratom as an alternative to FDA-approved pain medications or to treat opioid withdrawal symptoms, as neither kratom nor its compounds have been proven safe and effective for any use and should not be used to treat any medical conditions.

In this instance, two samples of kratom products manufactured by Triangle Pharmanaturals of Las Vegas, Nevada, sold through the retail location Torched Illusions in Tigard, Oregon and collected by the Oregon Public Health Division, tested positive for salmonella, as did four additional samples of various types of kratom product associated with the firm collected by the FDA. Adding to the concerns, in the course of investigating a multi-state outbreak of salmonellainfections linked to kratom products in conjunction with local officials, FDA investigators were denied access to the company’s records relating to potentially affected products and Triangle employees refused attempts to discuss the agency’s findings.

Numerous brands of kratom-containing products have been linked to a multi-state outbreak of salmonellosis from multiple strains of salmonella. The FDA continues to advise consumers to avoid kratom and kratom-containing products and discard any in their possession. All salmonella bacteria can cause the foodborne illness salmonellosis, although the strains found in Triangle Pharmanaturals’ products are not currently linked to the outbreak. The FDA is working with the U.S. Centers for Disease Control and Prevention to continue to investigate the ongoing outbreak. Most people infected with salmonella develop diarrhea, fever and abdominal cramps 12 to 72 hours after infection. The illness usually lasts 4 to 7 days, and most people recover without treatment. However, in the current salmonellosis outbreak associated with kratom products, unusually high rates of individuals have been hospitalized for their illness.

Please follow the link below for additional information.

Want to read the full alert and receive alert emails?

Browse Additional Alerts