The FDA ordered a mandatory recall today of all food products containing powdered kratom that were manufactured, processed or packed by Triangle Pharmanaturals LLC after several were found to be contaminated with Salmonella.
This is the first time that the FDA has issued a mandatory recall because a company failed to comply with the agency’s request to conduct a voluntary recall, according to a news release.
“This action is based on the imminent health risk posed by the contamination of this product with Salmonella, and the refusal of this company to voluntarily act to protect its customers and issue a recall, despite our repeated requests and actions,” FDA Commissioner Scott Gottlieb, MD, said in the release. “We continue to have serious concerns about the safety of any kratom-containing product and we are pursuing these concerns separately. But the action today is based on the risks posed by the contamination of this particular product with a potentially dangerous pathogen.”
The FDA issued a mandatory recall of kratom-containing products manufactured by Triangle Pharmanaturals after the agency identified several products contaminated with Salmonella.
Mitragyna speciosa, known as kratom, is a plant that grows in Thailand, Malaysia, Indonesia and Papua New Guinea. According to the CDC, kratom is typically brewed in tea, chewed, smoked or ingested in capsules. It is consumed for its stimulant effects and as an opioid substitute. However, the FDA advises against its use. In November, the agency issued a warning about the potentially fatal risks linked to kratom.
“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 FDA release said. “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 February, the CDC linked a multistate outbreak of Salmonella infections to kratom-containing products. As of March 14, a total of 87 cases have been reported in 35 states, resulting in 27 hospitalizations. Seventy-three percent of ill patients who were interviewed reported consuming kratom before symptom onset.
Numerous brands of kratom-containing products have been linked to the outbreak, according to the FDA. To date, PDX Aromatics, NutriZone and Tamarack Inc. have all issued voluntary recalls after their products tested positive for Salmonella. Although products produced by Triangle Pharmanaturals are not currently linked to the outbreak, at least four tested positive for Salmonella. Some of the products included in the mandatory recall include 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.
Triangle Pharmanaturals did not immediately respond to Infectious Disease News’ request for comment.
Disclosure: Gottlieb is FDA commissioner.