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Sober Nation

Putting Recovery On The Map

04-03-18 | By

FDA Recalls Kratom Linked To Salmonella

On Tuesday afternoon, the Food and Drug Administration (FDA) ordered a mandatory recall for all Kratom products manufactured processed, packed or held by Triangle Pharmanaturals LLC after several of its products tested positive for salmonella.

The FDA decided to recall the substance 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.
Studies from a joint investigation between the FDA and the US Centers for Disease Control and Prevention, the supplement is linked to an outbreak of at least 87 cases of salmonella across 35 states. Reports of illnesses began in October. Most recent reported cases of salmonella began on February 24th. Twenty-seven of the reporting illnesses have been hospitalized. Demographics of the ill range from 6 to 67 years old. Out of the 55 reports of salmonella, 40 of these patients have reported the consumption of kratom pills, tea, or powder.

 “No Evidence to Indicate Kratom Is Safe”

In the U.S., kratom is banned within six states. Kratom is not regulated and has been known to be mixed with other drugs. The DEA considers the substance a drug of concern. With no financial incentive for companies to research the plan, minimal effort and investigation have been undertaken. Since the Malaysian herb consists of crushed leaves, no company is able to patent the product. In the United States, kratom is traditionally sold as a dietary supplement in the form of pills, powders, capsules, and tea.

Some studies have found that there is potential in kratom to treat pain, however additional research is needed. In February, the FDA issued a statement over concerns about compounds in kratom that acted like opioids. In the recent statement, they noted, “There is no evidence to indicate that kratom is safe or effective for any medical use.”

An affected person with salmonella can begin to feel symptoms 12 to 72 hours after the person is infected. Symptoms can include:

  • Diarrhea
  • Fever
  • Abdominal cramping

These symptoms can persist for up to seven days, however most individuals recover without treatment. Those who may need to be hospitalized include those who are very young, or who are old and have compromised immune systems.

The CDC continues to recommend against consuming any brand of kratom while health officials investigate, including identifying where patients purchased kratom and testing samples of the substance.

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