Triangle Pharmanaturals staff refused to discuss lab tests with FDA, also would not reveal records.For the first time ever the FDA has ordered a company to recall products, with the dubious honor going to Triangle Pharmanaturals LLC. The Las Vegas company refused to pull its kratom products after state and federal tests showed Salmonella contamination.
The recall order from the Food and Drug Administration comes amidst an ongoing outbreak of Salmonella infections that has sickened at least 87 people in 35 states. At least four different serotypes of Salmonella have been confirmed.
Of the people for whom complete information is available, 73 percent report consuming kratom products of various brands before they became sick. Several unidentified brands are implicated, according to the FDA and Centers for Disease Control and Prevention.
“The FDA is advising consumers to discard the products that are part of the mandatory recall, which include, but are 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,” according to an agency statement issued Tuesday.
Employees at Triangle Pharmanaturals would not discuss the FDA’s findings with the agency and did not respond to multiple news media seeking comment. The company also denied FDA access to its records, according to a statement from the agency. As of Tuesday night, the Triangle Pharmanaturals page on Facebook appeared to have been disabled.
The Salmonella found in the CDC, dietary supplements, FDA, herbal supplements, kratom, kratom outtbreak, products did not match any of the confirmed outbreak strains. However, FDA and CDC officials say additional victims are likely to be identified and their infections could be a match.
Outbreak cases that occurred after Feb. 20 might not yet be reported to the CDC because of the time it takes between when a person becomes ill with Salmonella and when the illness is reported. At any rate, many strains of Salmonella, including the one found in the Triangle products, can cause serious food poisoning infections.
Federal officials are concerned that Triangle Pharmanaturals may manufacture, process, pack and/or hold additional brands of products containing kratom, including powder and encapsulated powder forms. All Triangle kratom products are under recall regardless of the brand or form, even if they are not specifically identified in the FDA’s list.
Several other companies have already recalled numerous kratom products after tests showed Salmonella contamination, some of them with the outbreak strains. The companies initiated those recalls in cooperation with FDA.
‘Imminent health risk’ prompted FDA action
The FDA has only had the power to mandate a recall since January 2011 when President Obama signed the Food Safety Modernization Act into law. 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.
Those two companies’ owners agreed to voluntarily recall their products after FDA notified them that it intended to begin mandatory recall proceedings, officially known as a Notice of Opportunity to Initiate a Voluntary Recall.
“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 FDA Commissioner Scott Gottlieb in the statement Tuesday.
“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. 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.”
Before imposing the mandatory recall order, FDA officials collected and tested samples of Triangle Pharmanaturals’ kratom products, according to agency documents. Four of the samples tested positive for Salmonella bacteria.
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