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It's not clear if all of those cases are due to kratom, which is sold in supplements or as a powder. But investigators asked 55 of the sickened people about it, and 73% said they'd consumed kratom before falling ill. Tests showed 26 different kratom products, from multiple manufacturers, were contaminated.
Kratom is from a tree called Mitragyna speciosa, which grows in Indonesia, Malaysia, Thailand, and other countries. The leaves can be chewed, dried and smoked, or powdered and consumed as a tea or in supplements. It has traditionally been used in those countries to combat fatigue and boost energy, but 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.
Kratom is also called Biak, Kakuam, Ketom, Thang, and Thom.
The FDA wasn't happy about kratom even before some of the products were found to be contaminated with salmonella, a type of bacteria that can make people seriously ill. They say there's "strong evidence" that kratom affects the same opioid receptors as morphine, and using it could lead to addiction, abuse, and dependence.
"The FDA continues to warn consumers not to consume any kratom product," the agency said on its site. "There is no FDA-approved use for kratom and the agency has received concerning reports about the safety of kratom, including deaths associated with its use."
Kratom capsules. The Food and Drug Administration announced April 3 that it had ordered a mandatory recall of one company's powdered kratom products that it says contain salmonella. (Mary Esch/AP)
The Food and Drug Administration on Tuesday ordered a mandatory recall of a Las Vegas company's powdered kratom products because salmonella was found in the herbal supplement.
The recall involves powdered kratom products that were manufactured, packed and processed by Triangle Pharmanaturals. The FDA said the company did not cooperate with the agency's request for a voluntary recall.
The mandatory recall was the agency’s first-ever recall of a contaminated food item. In general, dietary supplements are considered foods under federal law. In the case of kratom, a botanical from Southeast Asia, FDA officials determine whether the products are a food or an unapproved drug depending on the way they are labeled.
The FDA doesn't have the authority to order mandatory recalls for drugs and seeks voluntary recalls if it sees a safety problem. But it got mandatory-recall authority for tainted food under the Food Safety and Modernization Act that went into effect in 2011.
“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 said in a statement.
The recall is the latest development in a high-decibel controversy surrounding kratom. The herb, which is rapidly rising in popularity, is hailed by advocates as a readily available pain remedy that is safer than traditional opioids, an effective addiction withdrawal aid and a pleasurable recreational tonic. But it has been assailed by the FDA as a dangerous and unregulated drug that can result in opioid-like abuse and death. The Drug Enforcement Administration is weighing whether to place kratom, which comes from a leafy tree, in the same category of illegal drugs as heroin.
In his statement Tuesday, Gottlieb said that while the agency has serious concerns about any kratom-containing product, the mandatory recall of the Triangle products is based on salmonella contamination. The bacteria can cause fever, diarrhea and severe abdominal cramps.
The agency said that two samples of kratom products manufactured by Triangle and sold through the retailer Torched Illusions in Tigard, Ore., were collected by state authorities and tested positive for salmonella. So did four additional samples of various types of kratom products collected by the FDA, the agency said.
The FDA also said that its investigators were denied access to the company's records that it sought as part of a probe into a multistate salmonella outbreak linked to kratom. The FDA said the strains found in Triangle's products are not linked to the outbreak.
The agency asked Triangle on Friday to voluntarily recall the kratom items. When the company did not comply with the request, the FDA the next day ordered the firm to cease distribution. The company could have requested a hearing, the agency said, but it did not respond within the required time frame. The agency then issued the mandatory recall order.
The recalled products 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.
The company couldn't be reached for comment. Its website describes the firm as a consulting company for the supplement industry.
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Story highlights Triangle Pharmanaturals LLC products are being recalled, FDA announces
Kratom is often used for pain relief or opioid withdrawal
(CNN) The Food and Drug Administration issued a rare mandatory recall Tuesday for all kratom products manufactured, processed, packed or held by Triangle Pharmanaturals LLC after several of its products tested positive for salmonella.
The FDA advises consumers to throw away any products associated with the recall, including but not limited to Raw Form Organics Maeng Da Kratom Emerald Green, Ivory White and Ruby Red.
The FDA issued the recall after the company failed to comply with the agency request for 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," FDA Commissioner Dr. Scott Gottlieb said in a statement . It is the first time the agency has issued a mandatory recall because a company has not cooperated.
Kratom is a plant native to Malaysia. The leaves are traditionally crushed and made into tea to treat pain or reduce opioid withdrawal cravings. In the US, kratom is sold as a dietary supplement in the form of pills, powders, capsules and tea.
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In this Sept. 27, 2017, file photo, kratom capsules are displayed in Albany, N.Y. U.S. health authorities are ordering a Las Vegas company to pull its herbal supplements off the market because some of its products tested positive for salmonella. (Photo: Mary Esch, AP)
Federal drug regulators issued their first-ever mandatory recall Tuesday to a company selling several products containing the herbal supplement kratom and contaminated with Salmonella.
The Food and Drug Administration (FDA) said it issued the order because Triangle Pharmanaturals of Las Vegas refused to cooperate.
The Centers for Disease Control and Prevention said last month that the kratom Salmonella outbreak was linked to 11 hospitalizations among 28 people who caught the strain.
The FDA is advising consumers to discard the products that are part of the mandatory recall, which it says include, but isn't 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. The company, which promotes itself as a consulting firm, may "manufacture, process, pack and/or hold additional brands of food products containing powdered kratom, FDA says.
FDA commissioner Scott Gottlieb speaks to members of the USA TODAY Editorial Board in August 2017. (Photo: Jasper Colt, USA TODAY Network)
FDA Commissioner Scott Gottlieb said the move was "based on the imminent health risk" of the product's contamination.
“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," said Gottlieb, a physician.
More:
Kratom — the opioid withdrawal plant — linked to salmonella in 20 states
FDA chief warns about kratom to treat opioid addiction; will seek more regulatory power
Kratom, which grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea, is often used to ease opioid withdrawal and was already under fire at the FDA. The agency has warned consumers to avoid the supplement in any form as it is linked to dozens of deaths.
Kratom is "totally unregulated" and there is a "lack of quality control," says Walter Prozialeck, a professor and chairman of the pharmacology department at Midwestern University's college of osteopathic medicine.
"If the purveyors and vendors don’t police themselves, the FDA is going to step in like they did with this vendor," says
Walter Prozialeck is a professor and chairman of the pharmacology department at Midwestern University's college of osteopathic medicine. (Photo: Susan K. Hershberg)
FDA says there is strong evidence kratom affects the same opioid brain receptors as morphine and appears to have properties that expose people to the risks of addiction and abuse. Neither kratom or its components have been proven safe or effective at treating any medical conditions, FDA says.
Prozialeck says more research is needed to show kratom's "potentially useful pharmacological effects," including easing withdrawal from opioids, which he says are far more addictive and dangerous.
Kratom has a vocal advocacy community among users, smoke shop owners and natural food trade groups. Many were critical of FDA and CDC's earlier statements linking kratom to Salmonella, which some called tenuous. Vegetables are regularly linked to Salmonella outbreaks.
The FDA says two samples of kratom products manufactured by Triangle and sold through the retailer Torched Illusions in Tigard, Oregon, tested positive for Salmonella, Four other samples of products containing kratom and associated with the Triangle also tested positive. Triangle also refused to give the FDA access to the company’s records on potentially affected products and employees refused to discuss the agency’s findings, the FDA said.
"It’s shocking the company didn’t cooperate with the FDA’s recall request – if the FDA requests a recall, the company should do it," says Katie Wowak, assistant professor of management in the University of Notre Dame's Mendoza College of Business. "The tangible and intangible repercussions of being forced to issue a mandatory recall could have a devastating long-term impact on the company that may be difficult (if not impossible) to recover from."
Triangle officials could not be reached for comment.
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