The US Food and Drug Administration (FDA) today issued a mandatory recall for all powdered kratom products from Triangle Pharmanaturals, the first time the agency has ever taken such a step to protect the public from contaminated food products.
The action comes amid federal and state investigations into a multistate Salmonella outbreak linked to kratom power—used as a stimulant and an herbal alternative to opioids—that has so far sickened at least 87 people in 35 states. Three other companies have already issued voluntarily recalls, and the FDA has warned consumers not to consume any kratom-containing products.
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.
In 2010, Congress gave the FDA the power to order mandatory recalls as part of the Food Safety Modernization Act.
'Imminent health risk'
In the statement, FDA Commissioner Scott Gottlieb, MD, 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."
He added that the FDA's first approach is to encourage voluntary compliance, but when a company refuses to cooperate and violates the law, the agency will pursue all enforcement avenues under its authority.
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 Oregon, as did four samples collected by the FDA for its testing. The agency added that the company denied the FDA access to its records related to potentially affected products and that Triangle employees refused the FDA's attempts to discuss the test findings.
On Mar 30, the FDA gave Triangle a notification to initiate a voluntary recall, warning that the FDA could order a cease and desist within 24 hours if the company didn't comply. Triangle didn't respond within the specified time frame, waiving its opportunity for an informal hearing and triggering the mandatory recall.
The mandatory recall includes but is 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. FDA is urging consumers who have the recalled products to discard them. Products may be in powder or encapsulated powder form.
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.
Multiple contaminated 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. As of the middle of March, four subtypes had been linked to the outbreak: Salmonella I 4,[5],12:b:, Salmonella Javiana, Salmonella Okatie, and Salmonella Thompson.
So far, 26 different kratom products have tested positive for Salmonella, with investigations still under way to assess the relationship to sick patients and underscoring the FDA's assessment that multiple kratom and kratom-containing brands and retails are supplying contaminated products to the public.
See also:
Apr 3 FDA mandatory recall notice
Apr 3 FDA outbreak investigation update
