Kratom products placed under mandatory recall due to risk of salmonella
05 April, 2018, 01:16 | Author: Hope Soto
On April 2, 2018, FDA issued a mandatory recall order for all products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several tested positive for salmonella.
In a statement today, the FDA said it took the action after the Las Vegas-based company failed to cooperate with its request to voluntarily recall the product, after samples of the products tested positive for Salmonella at the Oregon Public Health Division and in tests done by the FDA.
This week's action marks the first time the FDA has ever formally ordered a food recall.
The FDA said two samples of kratom products made by Triangle, sold through a retail store in Orgeon and collected by state health officials, tested positive for Salmonella in OR, as did four samples collected by the FDA for its testing. The plant grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea.
The FDA said it's the third time it has ever initiated the process of using its mandatory recall authority, but the first time the agency has gotten to the step of mandating a recall because a company opted not to conduct a voluntary recall following an FDA recommendation to do so.
Products containing kratom have recently been linked to a multi-state outbreak of salmonellosis from several strains of salmonella, prompting voluntary recalls by various companies. Three other companies have already issued voluntarily recalls, and the FDA has warned consumers not to consume any kratom-containing products.
The FDA said the Salmonella strains found in Triangle's kratom products don't match the outbreak trains, but it added that all Salmonella can cause foodborne illness.
Two samples containing kratom - mitragyna speciosa - sold to a retail location in OR tested positive for salmonella.
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"We continue to have serious concerns about the safety of any kratom-containing product and we are pursuing these concerns separately", Gottlieb said.
The most recent FDA announcement follows on the heels of a major kratom recall last month that affected numerous products. Since then the federal agency has flexed its recall muscles with two other companies - Kasel Associates for pet treats and OxyElite Pro for dietary supplements.
The state Health Department and the Tulsa Health Department are investigating the local cases.
"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", according to the FDA".
It is often advertised as a legal substitute with similar effects to opioids, but in February, the FDA published a notice that their extensive studies had found that it has no medical benefits - a use that the substance is not approved for - and suggested that it should be considered an opioid itself.
Symptoms of a Salmonella infection, called salmonellosis, typically start 6 to 72 hours after exposure to Salmonella bacteria.
People under the age of 5 or over 65, and those with weakened immune systems, are most at risk for developing serious illness, according to the CDC. In order to prevent cross-contamination, consumers should wash their hands, work surfaces and utensils thoroughly after contact with these products, and not prepare any food in the area at the same time. Food should not be prepared in the potentially contaminated area until it has been sanitized.
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