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article imageMandatory recall issued for kratom due to Salmonella outbreak

By Karen Graham     Apr 4, 2018 in Health
The FDA has issued a mandatory recall order for all products containing powdered kratom manufactured by Triangle Pharmanaturals LLC of Las Vegas, Nevada. Some of the products tested positive for Salmonella and are associated with a multistate outbreak.
About 87 people in 35 states have gotten sick from Salmonella bacteria, with 27 of the victims being hospitalized. Tests showed 26 different kratom products, from multiple manufacturers, were contaminated with the bacteria.
Tuesday's action marks the first time the Food and Drug Administration has ever formally ordered a food recall. Congress gave the FDA that authority in 2011 after a series of high-profile food outbreaks involving peanut butter, spinach, and other grocery staples, according to the Associated Press.
Mitragyna speciosa, commonly known as kratom, is a plant that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. Kratom is not an opioid, but it can have opioid-like effects. The herb does appear to help in managing chronic pain and overdoses reported in the U.S. have shown minimal signs or symptoms, which resolved rapidly with no residual disability.
A young Kratom plant.
A young Kratom plant.
Wikimedia Commons/Manuel Jebauer
In November 2017, the FDA issued a public health advisory, warning that kratom, "a Southeast Asian plant known for its opiate-like effects, may put users at risk of addiction and even death." The agency found that patients believe they can use kratom to treat opioid withdrawal symptoms and this was cause for concern because of the drug's side effects and risk of death.
Refusal of the company to work with FDA prompted order
While companies typically comply with government requests and voluntarily recall tainted products, Triangle Pharmanaturals refused to cooperate with the FDA. While the agency was investigating the Salmonella outbreak, agency investigators were denied access to the company’s records relating to potentially affected products and Triangle employees refused attempts to discuss the agency’s findings.
The FDA is now advising that consumers discard products that are part of the 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.
FDA Commissioner Scott Gottlieb, M.D. said: “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."
More about Fda, Kraton, salmonella outbreak, Mitragyna speciosa, Triangle Pharmanaturals
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