Salmonella in Kratom causes FDA to Orders Mandatory Recall

Triangle Pharmanaturals mandatory Recall

The U.S. Food and Drug Administration(FDA) announced a mandatory recall for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, (Las Vegas-based company) after several products were found to contain salmonella.

The products involved in the 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 manufacture, process, pack and/or hold additional brands of food products containing powdered kratom, including powder and encapsulated powder forms.   The forced recall follows Triangle Pharmanaturals, refusal to cooperate and voluntarily pull its products after they tested positive for Salmonella, the FDA said.

The agency statement said “This is the third time the FDA has started the process of using its mandatory recall authority, but the first time” it’s issued such an order due to a company rejected the voluntary recall request.

“Our first approach is to encourage voluntary compliance, but when we have a company like this one, which refuses to cooperate, is violating the law and is endangering consumers, we will pursue all avenues of enforcement under our authority,” FDA Commissioner Scott Gottlieb said.

“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,” said Dr. Gottlieb, M.D. “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 mandatory recall is the FDA’s first since it was given the authority to issue such an order for food products in 2011. Under the FDA Food Safety Modernization Act, the FDA has the authority to order the recall of food products when it determines that there is a reasonable probability that the article is adulterated and that its use could cause serious adverse health consequences or death to humans or animals.  Under the federal law, Dietary supplements are considered foods, not drugs. Two samples of kratom products manufactured by Triangle Pharmanaturals, 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.

What is Kratom?

Mitragyna speciosa, commonly known as kratom, is a plant that grows in Thailand, Malaysia, Indonesia and Papua New Guinea. The leaves of Kratom are used as an herbal drug by people of Southeast Asia.  Kratom leaves in low doses are used as a stimulant and at high doses as a sedative, recreational drug, pain killer, medicine for diarrhea, and treatment for opiate addiction.

The leaves can be chewed, dried and smoked, or powdered and consumed as a tea or in supplements. The product is promoted in the US as a way to treat muscle pain, diarrhea, and opiate withdrawal. Although it’s legal in the US, it’s illegal in some Southeast Asian countries.

The FDA would like people to avoid kratom or its psychoactive compounds, mitragynine, and 7-hydroxymitragynine, because there is substantial evidence that kratom affects the same opioid brain receptors as morphine and appears to have properties that expose people who consume it.

NutriZone recall Kratom

The FDA announced that NutriZone, LLC of Houston, Texas is recalling four different dietary supplements containing kratom due to contamination with Salmonella. The products were sold in Pennsylvania, Oklahoma, Washington, Missouri, Florida, Mississippi, California, and Texas.

The potential for contamination was noted after routine sampling and testing by the FDA revealed the presence of Salmonella. No illnesses have been reported to date in connection with this problem.

A multi-state outbreak of Salmonellosis linked to kratom

FDA Investigates Multistate Outbreak of Salmonella Infections Linked to Products Reported to Contain Kratom. On March 22, 2018, PDX Aromatics of Portland, Oregon, issued their second expanded recall in due to additional positive Salmonella samples associated with PDX Aromatics’ products. On March 23, 2018, Tamarack Inc.voluntarily recalled Eclipse kratom-containing powder products. These recalls are in addition to NutriZone, LLC of Houston and Triangle Pharmanaturals.

According to the Centers for Disease Control and Prevention (CDC), since late last month, 87 cases, in 35 states linked to kratom products have resulted in 27 hospitalizations. Epidemiological and laboratory data indicates the Kratom is the likely source of this outbreak. CDC reported a total of 87 people infected with outbreak strains of Salmonella I 4,[5],12:b:- (50), Salmonella Javiana (5), Salmonella Okatie (16), or Salmonella Thompson (16). Of 69 people with available information, 27 (39%) have been hospitalized. No deaths have been reported. Recent data showed additional strains including Salmonella Okatie, Salmonella Javiana, and SalmonellaThompson.

Of the 55 people interviewed, forty (73%) reported consuming kratom in pills, powder, or tea. Most people remembered consuming the powder form of kratom. The information collected about the purchasing location of kratom by the ill people, a single common brand or supplier of kratom has not been linked to the outbreak.

Most people infected recover without treatment, though the FDA said an unusually high number of people linked to the outbreak involving kratom were hospitalized.

Tests showed 26 different kratom products, from multiple manufacturers, were contaminated.