Published: Thu, April 05, 2018
Health Care | By Oscar Goodwin

Mandatory recall issued for kratom due to Salmonella outbreak

Mandatory recall issued for kratom due to Salmonella outbreak

Kratom products sold by Las Vegas-based Triangle Pharmanaturals must be pulled from the market, the FDA ordered on Monday, after the company allegedly refused multiple requests to conduct a voluntary recall. The DEA proposed a ban on kratom in 2016 but backtracked under pressure from some members of Congress and outcry from kratom advocates who said it could help treat opioid addiction.

The recall came on the heels of the Centers for Disease Control and Prevention issuing their third warning in a month that the drug, often called an "herbal supplement," had been linked to salmonella, bringing the number of people sickened from contaminated kratom products to 87.

Kratom is a psychoactive drug derived from the leaves of Mitragyna speciosa, a plant in the coffee family that is native to Southeast Asia. That means it is nearly impossible to verify what is actually inside any kratom pills, powders, or teas. 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.

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In a separate investigation following several deaths linked to the substance, the FDA also warned that kratom is chemically similar to an opioid, and is now urging customers to avoid kratom on both grounds. A separate kratom salmonella contamination case is now being investigated by the agency after 87 people got sick from an infection last month, forcing the recall of dozens of products.

"The action today is based on the risks posed by the contamination of this particular product with a potentially risky pathogen", Gottlieb said in his statement.

The FDA is advising consumers to throw away Kratom products made by Triangle. To date, PDX Aromatics, NutriZone and Tamarack Inc. have all issued voluntary recalls after their products tested positive for Salmonella.

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Other companies have voluntarily recalled their kratom products.

Those two companies' owners agreed to voluntarily recall their products after FDA notified them that it meant to begin mandatory recall proceedings, officially known as a Notice of Opportunity to Initiate a Voluntary Recall. As an additional precaution, the FDA recommends kratom no longer stored in its original packaging should be discarded and the containers used to store it be thoroughly sanitized. However, Triangle Pharmanaturals did not comply with the request.

As of April 2, 2018, twenty-six different kratom-containing products have been tested and reported positive for Salmonella contamination. All salmonella bacteria can cause the foodborne illness salmonellosis, although the strains found in Triangle Pharmanaturals' products are not now linked to the outbreak.

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According to the Washington Post, the FDA first asked Triangle to recall their kratom products voluntarily, but the company refused. Salmonella is a bacterial infection caused by exposure to contaminated food or water that typically causes diarrhea and abdominal pain lasting up to a week. However, in some people it takes two weeks for symptoms to develop. Anyone can become sick with a Salmonella infection, but infants, children, seniors and those with weakened immune systems are at higher risk of serious illness. The FDA advised consumers to dispose of these products. After handling these products, people should wash their hands thoroughly, as well as work surfaces and utensils after contact.

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