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The Food and Drug Administration (FDA) issued a mandatory recall Tuesday for all kratom products manufactured, processed, packed or held by Triangle Pharmanaturals LLC.
According to the FDA statement, “This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products.”
The FDA issued the mandatory recall when Las Vegas-based Triangle Pharmanaturals failed to comply with a request for a voluntary recall after several of its products tested positive for Salmonella.
“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, M.D., said in the statement.
“We continue to have serious concerns about the safety of any kratom-containing product, and we are pursuing these concerns separately,” Gottlieb said. “But the action today is based on the risks posed by the contamination of this particular product with a potentially dangerous pathogen.”
The FDA is advising 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.
Mandatory recall ordered:
The Centers for Disease Control and Prevention (CDC) reports that 27 victims have been hospitalized in the outbreak, which began last October. The last reported illness was Feb. 24. No deaths have been reported.
People who have become sick are between 6 and 67 years old; the median age is 39. Forty-eight of the victims are male.
Four strains of Salmonella have been identified:
- Salmonella I 4,,12:b:- (50 cases)
- Salmonella Javiana (5)
- Salmonella Okatie (16)
- Salmonella Thompson (16).
Consumers have reported purchasing kratom from retail locations and online. The CDC recommends that kratom not be consumed in any form.
Kratom trees, which are grown in Southeast Asia, produce leaves that have been used to relieve pain for centuries.
The leaves can be eaten raw, but they are more likely to be crushed and brewed as tea. The leaves also can be turned into capsules, tablets, and liquids.
Kratom is a stimulant when consumed in small doses, but when consumed in larger amounts, it acts as a sedative. The Drug Enforcement Agency (DEA) said overdosing can lead to psychotic symptoms and psychological addiction.
The CDC reports that about 42 percent of kratom usage between 2010 and 2015 required treatment, although those cases did not involve life-threatening symptoms.
About 7 percent of exposures, however, were classified as “life-threatening.” The DEA reported 15 kratom-related deaths between 2014 and 2016.
Some scientists have said kratom could be important to treating chronic pain and opioid addiction. The DEA, however, moved to ban the sale of kratom last fall, citing an “imminent hazard to public safety.”
The DEA was planning to make kratom a “Schedule 1” drug, which would place it in a category with heroin, LSD, ecstasy, even marijuana. That decision was delayed, however, after members of Congress urged the DEA to give the public time to comment.
According to the FDA, kratom goes by numerous names: Mitragyna speciosa, mitragynine extract, biak-biak, cratom, gratom, ithang, kakuam, katawn, kedemba, ketum, krathom, krton, mambog, madat, Maeng da leaf, nauclea, Nauclea speciosa, or thang.
Mandatory recall ordered:
Salmonella facts and figures
Salmonella can infect anyone, but it is most common among children. People with compromised immune systems – such as older adults, babies, and people with AIDS – are more likely to experience severe symptoms or complications.
Those symptoms usually include:
- abdominal pain
- fever and chills.
Most people recover on their own in less than a week. Severe infections, however, often require medical care, which can include intravenous fluids and antibiotics.