Tox Tuesday: FDA issues first-ever mandatory food recall amid kratom Salmonella outbreak

April 17, 2018

After repeated attempts to encourage a voluntary recall, the U.S. Food and Drug Administration (FDA) has imposed a mandatory recall of all kratom-related goods produced by Triangle Pharmanaturals, LLC, after several of the company’s products tested positive for Salmonella.

The mandatory recall is a first for the agency since the Food Safety Modernization Act gave it the authority to issue recalls for food-based products in 2011. Kratom is a loosely regulated plant-based drug sold as a treatment for pain and withdrawal symptoms.

The FDA first sounded the alarm regarding kratom in March, when a multistate Salmonella outbreak was first linked to products that may have contained kratom. (Around the same time, the agency also issued a warning about similarities between the way kratom and opioids affect the brain.)

Using whole genome sequencing, investigators examined the genome of Salmonella bacteria samples taken from the outbreak and found that reported salmonellosis cases likely came from a single infection source, because the bacteria belonged to the same strain.

In recent weeks, the outbreak has increased by 50%, according to the Centers for Disease Control and Prevention (CDC). Now, 132 people in 38 states have been confirmed sick from the implicated strain, 40% of whom required hospitalization. In interviews, 73% of patients said they had recently consumed kratom products.

Despite the mandatory recall, no supplier has been confirmed as the single source of the outbreak by the FDA or CDC. Several companies have voluntarily recalled kratom products that have tested positive for Salmonella.

Because of kratom’s long shelf life, and because some illnesses might not be reported yet, outbreak numbers are expected to increase in the coming days and weeks.

About kratom

Kratom comes from a leafy tree that grows in parts of Southeast Asia. For centuries its leaves have been brewed into tea for pain relief, but today it’s often sold to consumers in the form of leaves, pills, capsules and powders. The drug isn’t outright illegal in most of the world, but it’s considered a “drug of concern” to the U.S. Drug Enforcement Administration and isn’t approved for any medical use by the FDA.

In the wake of the outbreak, the FDA advised consumers to not purchase any kratom-related products — but for non-Salmonella reasons, as well.

“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 said in a statement. “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.”


Category: Food Safety, Toxicology, Food & Beverage, Pharmaceutical & Biotech, Toxicology, Toxicology, Environmental Monitoring